Neo-Terramycin 50/50

Dosage Form: FOR ANIMAL USE ONLY
Neo-Terramycin® 50/50

(neomycin-oxytetracycline)

TYPE A MEDICATED ARTICLE

(Antibiotic)

Active Drug Ingredients:

Oxytetracycline (from oxytetracycline dihydrate)

equivalent to oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 g/lb

Neomycin Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 g/lb

CAUTION:

 For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

STORE IN A DRY, COOL PLACE

FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

MIXING AND USE DIRECTIONS

Thoroughly mix the amount of this Type A Medicated Article according to the directions below with at least an equal amount by weight of feed ingredients prior to blending into a complete feed.

Indications for Use	Oxytetracycline and Neomycin Amount	lb. of Neo Terramycin 50/50 per ton
CHICKENS
Increased rate of weight gain and improved feed efficiency	10-50 g/ton Feed continuously	0.2-1.0
Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline	100-200 g/ton Feed continuously for 7-14 days	2-4
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and E. colisusceptible to oxytetracycline	400 g/ton Feed continuously for 7-14 days	8
Reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline	500 g/ton Feed continuously for 5 days	10
WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Low calcium feeds at 500 g/ton, withdraw 3 days before slaughter. Zero-day withdrawal period for lower use levels. In low calcium feeds withdraw 3 days before slaughter. Do not administer to chickens producing eggs for human consumption.
TURKEYS
For growing turkeys for increased rate of weight gain and improved feed efficiency	10-50 g/ton Feed continuously	0.2-1.0
Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline	100 g/ton Feed continuously for 7-14 days	2
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline	200 g/ton Feed continuously for 7-14 days	4
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline	25 mg/lb of body weight daily Feed continuously for 7-14 days	16.7¹
WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption.
SWINE
Increased rate of weight gain and improved feed efficiency	10-50 g/ton Feed continuously	0.2-1.0
Treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days	102
For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline	10 mg/lb of body weight daily Feed continuously for not more than 14 days	10²
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage.
CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE
For calves (up to 250 lb) for increased rate of weight gain and improved feed efficiency	0.05-0.1 mg/lb of body weight daily Feed continuously	0.1-0.2³
For calves (250-400 lb) for increased rate of weight gain and improved feed efficiency	25 mg/head/day Feed continuously	0.54
For growing cattle (over 400 lb) for increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses	75 mg/head/day Feed continuously	1.54
Prevention and treatment of the early stages of shipping fever complex	0.5-2.0 g/head/day Feed 3-5 days before and after arrival in feedlots	10-404
Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.	1005
For calves (up to 250 lb) for treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.	206
WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. At the 0.5-2.0 g/head/day and 10 mg/lb levels: A milk discard time has not been established for use in lactating dairy cattle; do not use in female dairy cattle 20 months of age or older. At the 10 mg/lb level, withdraw 5 days before slaughter. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.
SHEEP
Increased rate of weight gain and improved feed efficiency	10-20 g/ton Feed continuously	0.2-0.4
Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin	10 mg/lb of body weight daily Feed continuously for 7-14 days If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms.	247
WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage.
1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day 2If pig weighs 100 lb, consuming 4 lb of complete feed per day 3If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 4Include in feed supplement based on consumption of 2 lb of supplement per head per day 5If animal weighs 500 lb, consuming 2 lb of supplement per head per day 6If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 7If lamb weighs 60 lb, consuming 1 lb of supplement per head per day

FOR USE IN ANIMAL FEEDS ONLY

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

Neo-Terramycin is a registered trademark of Pfizer, Inc., licensed to

Phibro Animal Health, for Neomycin-Oxytetracycline combination products.

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS

USE DIRECTIONS AND WARNINGS

Net Weight 50 lb (22.7 kg)

NADA #94-975, Approved by FDA

8858000

101-9012-08

Neo-Terramycin 50/50  neomycin-oxytetracycline  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 66104-0003 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE) OXYTETRACYCLINE HYDROCHLORIDE 50 g  in 0.45 kg NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 50 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength MINERAL OIL   SODIUM ALUMINIUM SILICATE   RICE BRAN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66104-0003-1 22.7 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA94975	01/11/1999

Labeler - Phibro Animal Health (006989008)

Revised: 01/2011Phibro Animal Health

Phenytoin 250mg / 5ml Solution for Injection (Beacon Pharmaceuticals)

Phenytoin 250mg/5ml Solution For Injection

(Referred to in this leaflet as Phenytoin Injection)

Please read this leaflet carefully before receiving Phenytoin Injection.

• If you have already received Phenytoin Injection because of the urgency of your condition, you should still read this leaflet. This is particularly important if you are to continue to be given phenytoin


• Keep the leaflet in case you want to refer to it again


• If you want to know more about Phenytoin Injection or have any questions, you should ask your doctor.

In this leaflet:

• 1. What Phenytoin Injection is used for


• 2. Before you are given Phenytoin Injection


• 3. How Phenytoin Injection should be given


• 4. Possible side effects


• 5. Storing Phenytoin Injection


• 6. Further information

What Phenytoin Injection Is Used For

Phenytoin belongs to a group of medicines called anti-epileptic drugs.

Phenytoin injection is used to treat:

• severe epileptic seizures or fits (status epilepticus)


• and prevent seizures for short periods of time when anti-epileptics drugs cannot be taken by mouth


• or prevent seizures during or after brain surgery and/or severe head injury


• specific changes in the rhythm of the heart (cardiac arrhythmias), particularly when these are caused by the drug digoxin.

Before You Are Given Phenytoin Injection

You must NOT be given Phenytoin Injection and you should talk to your doctor immediately if you have:

• shown signs of hypersensitivity (severe allergy) to phenytoin, phenytoin sodium, other similar drugs (hydantoins) or any of the other ingredients in this medicine


• a heart condition called heart block

Before you are given Phenytoin Injection, tell your doctor if you:

• have low blood pressure or heart failure


• have liver disease


• have diabetes


• have porphyria (an inherited blood disease)


• are due to have a surgical procedure, or if you are to be given the anaesthetic agent halothane as this may increase phenytoin levels


• are (or think you might be) pregnant or are breast-feeding


• drink large amounts of alcohol. You should limit the amount of alcohol you drink whilst being treated with phenytoin as the concentration in your blood can be altered with excess alcohol.

A small number of people being treated with anti-epileptics such as phenytoin have had thoughts of harming themselves. If at any time you have these thoughts, immediately contact your doctor. Taking/using other medicines

Before you are given Phenytoin Injection, tell your doctor if you taking medicines used to treat:

• epilepsy (carbamazepine, lamotrigine, phenobarbital, sodium valproate, succinimides e.g. ethosuximide, and vigabatrin)


• fungal infections (amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole)


• tuberculosis or other infections (chloramphenicol, isoniazid, rifampicin, sulphonamides, doxycycline and ciprofloxacin)


• pain and inflammation (phenylbutazone, steroids and salicylates e.g.aspirin)


• stomach ulcers (omeprazole, sucralfate, medicines known as H₂ antagonists e.g. cimetidine, and some antacids)


• sleeplessness, depression or psychiatric disorders (chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines, trazodone, tricyclic antidepressants and viloxazine)


• heart and circulatory problems (dicoumarol, amiodarone, reserpine, digitoxin, furosemide, quinidine, warfarin and calcium channel blockers e.g. diltiazem, nifedipine)


• diabetes (tolbutamide), cancer, asthma or bronchitis (theophylline)

Phenytoin may also interact with:

• hormone replacement therapy (oestrogens)


• the pill (oral contraceptive)


• methadone


• halothane (anaesthetic)


• muscle relaxants used in surgery


• ciclosporin (to prevent rejection of organ transplants)


• vitamin supplements such as Vitamin D and folic acid


• the herbal preparation St John’s wort.

Tell your doctor if you are taking, or have recently taken, any other medicines, including ones you have bought yourself.

Phenytoin may also interfere with certain laboratory tests that you may be given.

How Phenytoin Injection Should Be Given

You will be in hospital when you are given this medicine. Your doctor will decide on the dose and how it will be given to you.

A diluted solution will be either injected into one of your veins or, more rarely, into your muscle. The medicine is injected slowly into your vein or given as an infusion (drip) over a period of time.

Your heart rhythm, blood pressure and breathing will be monitored.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell your doctor or nurse if you have any concerns.

Possible Side Effects

As with all medicines, phenytoin may cause some side effects in some patients.

Serious side effects

If any of the following happen, tell a doctor or nurse IMMEDIATELY as you may need urgent medical attention:

• symptoms of a severe hypersensitivity syndrome which may include: itchy rash, swelling of the face, lips, tongue or throat (which may cause difficulty in swallowing or breathing), raised red patches on the skin, joint pain or fever


• irritation or burning sensation at the site of the injection


• rashes, which may be severe, resulting in painful reddening and blistering of the skin, eyes, mouth, anus or genital region and may lead to skin shedding.


• chest pains, palpitations or feeling faint


• joint pains

If you experience any of the following side effects tell your doctor or nurse as soon as possible:

Effects on the nervous system including:

• difficulty in controlling movements


• unsteadiness, shaking, nervousness


• uncoordinated movements


• unusual eye movements


• confusion, dizziness, slurred speech


• pins and needles, twitching muscles


• drowsiness, headaches


• sleeplessness


• loss of feeling in the hands and feet.

These effects may occur when the amount of phenytoin in your blood is too high. If you suffer with kidney or liver disease or are elderly you may experience these side effects at lower doses of phenytoin.

Very high amounts can cause extreme confusion, psychosis or encephalopathy (a brain disease), which may lead to irreversible brain injury. Your doctor should measure the amount of phenytoin in your blood and adjust your dose if necessary.

Effects on the skin:

• minor skin rashes such as measles-like rash or dermatitis.

Tell your doctor if a rash does not clear up, recurs or you show signs of a serious reaction.

Other side effects:

• disorders or swelling of the lymph glands (part of your body’s defence system)


• blood disorders, which may be noticed as bruising, paleness, fever or sore throat


• liver damage or inflammation which may be recognised by yellowing of the eyes and skin


• inflammation of the kidneys


• breathing problems


• feeling sick, vomiting or constipation


• increased levels of blood sugar, decreased levels of folic acid and calcium


• the amount of vitamin D in your body may be altered.

Other rare side effects:

• changes in the hand with difficulty straightening the fingers


• changes to facial features, enlarged gums or lips


• abnormal facial or body hair


• changes to the shape of the penis and painful erection.

Tell your doctor or nurse as soon as possible if you notice these or any side effect not mentioned in this leaflet.

Storing Phenytoin Injection

Keep out of the sight and reach of children.

Keep in the original packaging.

Do not use after the expiry date printed on the carton.

Further Information

What is in this medicine:

Each 5 ml ampoule contains 250mg of the active ingredient phenytoin sodium.

The ampoules also contain propylene glycol, ethanol, sodium hydroxide and water.

What this medicine looks like and contents of the pack:

Phenytoin Injection is a clear liquid. Each pack contains 1 or 50 ampoules.

Marketing authorisation holder:

Beacon Pharmaceuticals Ltd.

Tunbridge Wells

Kent

TN1 1YG

Manufacturer:

Laboratorio Reig Jofré, S.A

Spain

Date of approval: 09/09/2008

Efudex Cream

Pronunciation: FLURE-oh-UE-ra-sil
Generic Name: Fluorouracil
Brand Name: Efudex

Efudex Cream is used for:

Treating multiple actinic or solar keratoses (skin growths caused by exposure to sunlight). It may also be used for other conditions as determined by your doctor.

Efudex Cream is an antineoplastic. It works by blocking the growth of certain cells. This causes cell death.

Do NOT use Efudex Cream if:

• you are allergic to any ingredient in Efudex Cream


• you are pregnant or may become pregnant


• you have the metabolic disorder dihydropyrimidine dehydrogenase (DPD) enzyme deficiency

Contact your doctor or health care provider right away if any of these apply to you.

Before using Efudex Cream:

Some medical conditions may interact with Efudex Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if the area of skin being treated is damaged or inflamed, or has open sores

Some MEDICINES MAY INTERACT with Efudex Cream. Because little, if any, of Efudex Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Efudex Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Efudex Cream:

Use Efudex Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use a nonmetallic applicator or wear rubber gloves while applying Efudex Cream.


• Gently wash the area where you will apply Efudex Cream. Rinse well, pat dry with a towel, and wait 10 minutes before applying Efudex Cream.


• Wash your hands immediately after applying Efudex Cream, unless they are part of the treated area.


• Do not bandage or cover the treated area, unless directed to do so by your doctor.


• Efudex Cream is for external use only. Do not get it in your eyes, nose, mouth, or genital area. If you get it in your eyes, rinse with a generous amount of cool water right away and contact your doctor.


• If you miss a dose of Efudex Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Efudex Cream.

Important safety information:

• Complete healing of the lesions may not occur for 1 to 2 months after you stop using Efudex Cream.


• The treated areas may be unattractive during therapy and for several weeks after treatment has stopped.


• Efudex Cream may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Efudex Cream. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Do not use other medicines or products on the treated area without first checking with your doctor.


• Do not use Efudex Cream for future skin problems without first checking with your doctor.


• Lab tests, including biopsies, may be performed while you use Efudex Cream. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Efudex Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Efudex Cream if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Efudex Cream is found in breast milk. Do not breast-feed while taking Efudex Cream.

Possible side effects of Efudex Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; change in skin color; chills; fever; scarring or sores on the treated area; severe or persistent burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Efudex side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Efudex Cream may be harmful if swallowed.

Proper storage of Efudex Cream:

Store Efudex Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Efudex Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Efudex Cream, please talk with your doctor, pharmacist, or other health care provider.


• Efudex Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Efudex Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Efudex resources

• Efudex Side Effects (in more detail)
• Efudex Use in Pregnancy & Breastfeeding
• Efudex Support Group
• 9 Reviews for Efudex - Add your own review/rating

Compare Efudex with other medications

• Actinic Keratosis
• Basal Cell Carcinoma
• Skin Cancer

Hydrocortisone Iodoquinol Cream

Hydrocortisone 1%-lodoquinol 1% Cream

Rx Only

Hydrocortisone Iodoquinol Cream Description

Each gram of Hydrocortisone 1%−Iodoquinol 1% Cream contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a greaseless base of cetyl alcohol, glyceryl monostearate SE, isopropyl myristate, lanolin alcohol, mineral oil, polyoxyl 40 stearate, polysorbate 20, polysorbate 60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate. Paraben free.

Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17, 21- trihydroxy-,(11ß)-] with the molecular formula C21H30O5 and is represented by the following structural formula:

and iodoquinol, 5,7-diiodo-8-quinolinol (C9H5I2NO) is represented by the following structure:

Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent.

Hydrocortisone Iodoquinol Cream - Clinical Pharmacology

Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictor properties. The mechanism of anti-inflammatory activity is unclear. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Iodoquinol has both antifungal and antibacterial properties.

Pharmacokinetics −

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Hydrocortisone can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as a glucuronide.

Indications and Usage for Hydrocortisone Iodoquinol Cream

Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows:

“Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; infantile eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis, bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis, intertrigo. Final classification of the less-than-effective indications requires further investigation.

Contraindications

Hydrocortisone 1%−Iodoquinol 1% Cream is contraindicated in those patients with a history of hypersensitivity to hydrocortisone, iodoquinol or any other components of the preparation.

Warnings

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep tube tightly closed.

If irritation develops, the use of Hydrocortisone 1%−Iodoquinol 1% Cream should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. If extensive areas are treated or if the occlusive technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine.

Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Long term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of hydrocortisone or iodoquinol.

In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been conducted with iodoquinol.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C -

Animal reproductive studies have not been conducted with Hydrocortisone 1%−Iodoquinol 1% Cream. It is not known whether Hydrocortisone 1%−Iodoquinol 1% Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Hydrocortisone 1%−Iodoquinol 1% Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers -

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hydrocortisone 1%−Iodoquinol 1% Cream is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence:

Hydrocortisone Iodoquinol Cream Dosage and Administration

Apply to affected area 3 to 4 times daily in accordance with physician’s directions.

How is Hydrocortisone Iodoquinol Cream Supplied

Hydrocortisone 1%−Iodoquinol 1% Cream is available as follows:

1 oz. tube (NDC 45802-930-64)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Manufactured by Perrigo

Bronx, NY 10457

Rev. 11/11

3J700 RC J2

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Hydrocortisone 1%-lodoquinol 1% Cream

Hydrocortisone 1%-lodoquinol 1% Cream Carton Image 1

Hydrocortisone 1%-lodoquinol 1% Cream Carton Image 2

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Hydrocortisone 1%-lodoquinol 1% Cream

Hydrocortisone 1%-lodoquinol 1% Cream Tube Image

HYDROCORTISONE IODOQUINOL  hydrocortisone, iodoquinol  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-930 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg  in 1 g IODOQUINOL (IODOQUINOL) IODOQUINOL 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL   ISOPROPYL MYRISTATE   LANOLIN ALCOHOLS   MINERAL OIL   POLYOXYL 40 STEARATE   POLYSORBATE 20   POLYSORBATE 60   PROPYLENE GLYCOL   WATER   SORBIC ACID   SORBITAN MONOSTEARATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-930-64 1 TUBE In 1 CARTON contains a TUBE 1 28.49 g In 1 TUBE This package is contained within the CARTON (45802-930-64)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		07/14/2008

Labeler - Perrigo New York Inc (078846912)

Revised: 01/2012Perrigo New York Inc

Relistor

1. Name Of The Medicinal Product

Relistor 12 mg/0.6 ml solution for injection

2. Qualitative And Quantitative Composition

Each vial of 0.6 ml contains 12 mg methylnaltrexone bromide.

One ml of solution contains 20 mg methylnaltrexone bromide.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

Clear solution, colourless to pale

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of opioid

4.2 Posology And Method Of Administration

Posology

For adults only.

Relistor should be added to induce prompt bowel movements when response to usual laxative therapy has not been sufficient.

The recommended dose of methylnaltrexone bromide is 8 mg (0.4 ml Relistor) (for patients weighing 38

The usual administration schedule is one single dose every other day. Doses may also be given with longer intervals, as per clinical need.

Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.

Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg. The injection volume for these patients should be calculated:

Dose (ml) = patient weight (kg) x 0.0075

Renal impairment

In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 ml Relistor) for those weighing 62 to 114 kg, or from 0.15 mg/kg to 0.075 mg/kg for those whose weight falls outside the 62 to 114 kg range (see section 5.2). There are no data available from patients with end-stage renal impairment on dialysis, and Relistor is not recommended in these patients (see section 4.4).

Hepatic impairment

No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).

There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and Relistor is not recommended in these patients (see section 4.4).

Paediatric population

No data are available.There is no experience in children under the age of 18 (see section 5.2). Therefore, methylnaltrexone should not be used in the paediatric age group until further data become available.

Elderly population

No dose adjustment is recommended based on age (see section 5.2).

Method of administration

Relistor is given as a subcutaneous injection.

It is recommended to rotate injection sites. It is not recommended to inject into areas where the skin is tender, bruised, red, or hard. Areas with scars or stretch marks should be avoided.

The three areas of the body recommended for injection of Relistor are upper legs, abdomen, and upper arms.

Relistor can be injected without regard to food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen is contraindicated.

4.4 Special Warnings And Precautions For Use

Cases of gastrointestinal (GI) perforation have been reported in the postauthorisation period in patients using Relistor. Although patients had medical conditions that may be associated with localised or diffuse reduction of structural integrity in the wall of the GI tract (e.g., cancer, peptic ulcer, pseudo-obstruction), the use of Relistor may have contributed to these events.

Use Relistor with caution in patients with known or suspected lesions of the GI tract.

Advise patients to promptly report severe, persistent, and/or worsening symptoms.

The activity of methylnaltrexone bromide has been studied in patients with constipation induced by opioids. Therefore, Relistor should not be used for treatment of patients with constipation not related to opioid use.

If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with Relistor and consult their physician.

Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement.

Methylnaltrexone bromide treatment has not been studied in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.2).

Relistor should only be used in patients who are receiving palliative care. It is added to usual laxative treatment.

Relistor is not recommended in patients with severe hepatic impairment or with end

Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied. Therefore, Relistor should only be administered with caution in these patients.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes. Methylnaltrexone bromide is minimally metabolised by CYP isozymes. In vitro metabolism studies suggest that methylnaltrexone bromide does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate. In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/kg of methylnaltrexone did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.

The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone bromide and an OCT inhibitor was studied in 18 healthy subjects by comparing the single-dose pharmacokinetic profiles of methylnaltrexone bromide before and after multiple 400 mg doses of cimetidine. The renal clearance of methylnaltrexone bromide was reduced following multiple-dose administration of cimetidine (from 31 l/h to 18 1/h). However, this resulted in a small reduction in total clearance (from 107 1/h to 95 l/h). Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to C_max, was observed before and after multiple-dose administration of cimetidine.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data with the use of methylnaltrexone bromide in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Relistor should not be used during pregnancy unless clearly necessary.

Breast-feeding

It is unknown whether methylnaltrexone bromide is excreted in human breast milk. Animal studies have shown excretion of methylnaltrexone bromide in breast milk. A decision on whether to continue/discontinue breast

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However, as a pure peripherally restricted opioid antagonist, the likelihood that Relistor will affect such activities is low.

Dizziness may occur, and this may have an effect on driving and use of machines (see section 4.8).

4.8 Undesirable Effects

The most common drug

The adverse reactions are classified as: Very common (

Nervous system disorders

Common: Dizziness

Gastrointestinal disorders

Very common: Abdominal pain, nausea, diarrhoea, flatulence

Skin and subcutaneous tissue disorders

Common: Injection site reactions (e.g. stinging, burning, pain, redness, oedema), hyperhidrosis

Post Marketing Experience

Cases of gastrointestinal perforation have been reported in patients using Relistor (see section 4.4): frequency unknown.

4.9 Overdose

A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.

In the event of an overdose, signs and symptoms of orthostatic hypotension should be monitored and reported to a physician. Treatment should be initiated as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Peripheral opioid receptor antagonists, ATC code: A06AH01.

Mode of action

Methylnaltrexone bromide is a selective antagonist of opioid binding at the muIn vitro studies have shown methylnaltrexone bromide to be a mu_i] = 28 nM), with 8_i = 230 nM) and much reduced affinity for delta opioid receptors.

As a quaternary amine, the ability of methylnaltrexone to cross the blood

Clinical efficacy and safety

The efficacy and safety of methylnaltrexone bromide in the treatment of opioid

Study 301 compared methylnaltrexone bromide given as a single, double

Study 302 compared double

In both studies, there was no evidence to suggest differential effects of age or gender on safety or efficacy. The effect on race could not be analysed because the study population was predominantly Caucasian (88%).

Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2

The efficacy and safety of methylnaltrexone bromide were also demonstrated in open

The rate of laxation response was maintained throughout the extension studies for those patients who continued treatment.

There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide

Effect on cardiac repolarisation

In a double

5.2 Pharmacokinetic Properties

Absorption

Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (C_max) achieved at approximately 0.5 hours following subcutaneous administration. The C_max and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a dose-proportional manner. Absolute bioavailability of a 0.30 mg/kg subcutaneous dose versus a 0.30 mg/kg intravenous dose is 82 %.

Distribution

Methylnaltrexone undergoes moderate tissue distribution. The steady

Biotransformation

Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta. Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism. Each of the methyl-6-naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8% of the drug

Elimination

Methylnaltrexone bromide is eliminated primarily as the unchanged active substance. Approximately half of the dose is excreted in the urine and somewhat less in faeces. The terminal disposition half_1/2) is approximately 8 hours.

Special populations

Hepatic insufficiency

The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone bromide has been studied in 8 subjects each, with Child_max of methylnaltrexone. The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.

Renal impairment

In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone bromide. The renal clearance of methylnaltrexone decreased with increasing severity of renal impairment. Severe renal impairment decreased the renal clearance of methylnaltrexone bromide by 8_max was not significantly changed. No studies were performed in patients with end

Paediatric patients

No studies have been performed in the paediatric population (see section 4.2).

Elderly population

In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone bromide at a dose of 24 mg between healthy, young (18 to 45 years of age n=10) and elderly (65 years of age and over n=10) subjects, the effect of age on exposure to methylnaltrexone bromide was found to be minor. The mean steady_max and AUC for the elderly were 545 ng/ml and 412 ng·h/ml, approximately 8.1 % and 20 %, respectively, greater than those for young subjects. Therefore, no dose adjustment is recommended based on age.

Gender

No meaningful gender differences have been observed.

Weight

An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased. The mean methylnaltrexone bromide exposure at 0.15 mg/kg over a weight range of 38 to 114 kg was 179 (range=139-240) ng^·h/ml. This exposure for the 0.15 mg/kg dose can be achieved with a weight-band-based dose adjustment using an 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg, yielding a mean exposure of 187 (range =148-220) ng^·h/ml. In addition, the analysis showed that 8 mg dose for body weight 38 to less than 62 kg and a 12 mg dose for body weight 62 to 114 kg correspond to mean doses of 0.16 (range=0.21

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval). The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.

Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats. Doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) did not affect fertility or general reproductive performance.

There was no evidence of teratogenicity in rats or rabbits. Subcutaneous injections of Relistor at 150/100 mg/kg/day to rats resulted in decreased offspring weights; doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) had no effect on labour, delivery, or offspring survival and growth.

Methylnaltrexone bromide is excreted via the milk of lactating rats.

Studies have been conducted in juvenile rats and dogs. Following intravenous injection of methylnaltrexone bromide, juvenile rats were found to be more sensitive that adults rats to methylnaltrexone-related toxicity. In juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs (incidences of convulsions and labored breathing) occurred at dosages (

Following intravenous injection of methylnaltrexone bromide for 13 weeks, similar methynaltrexone related toxicity was observed in both juvenile and adult dogs. In adult and juvenile dogs given methylnaltrexone bromide at 20 mg/kg/day, clinical signs indicative of CNS toxicity and prolongation of QTc interval were observed. No adverse effects occurred in either juvenile or adult dogs at a dose of 5 mg/kg/day (44 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).

Carcinogenicity studies have not been conducted with Relistor.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Sodium calcium edentate

Glycine hydrochloride

Water for injections

Hydrochloric acid (to adjust pH)

Sodium hydroxide (to adjust pH)

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

3 years.

After withdrawl in the injection syringe:

Due to light sensitivity, the solution for injection should be used within 24 hours.

6.4 Special Precautions For Storage

This medicinal product does not require any special temperature storage conditions.

Keep the vial in the outer carton in order to protect from light.

For storage of the medicinal product in the syringe, see section 6.3.

6.5 Nature And Contents Of Container

Clear, Type I, flint glass, single

Each vial contains 0.6 ml of solution for injection.

The presentations of Relistor are:

1 vial of solution for injection

2 vials of solution for injection

2 sterile 1 ml injection syringes with retractable injection needle

4 alcohol swabs

7 vials of solution for injection

7 sterile 1 ml injection syringes with retractable injection needle

14 alcohol swabs

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Wyeth Europa Ltd.

Huntercombe Lane South

Taplow, Maidenhead

Berkshire SL6 0PH

UK

Tel: +44 1628 604 377

Fax +44 1628 666 368

8. Marketing Authorisation Number(S)

EU/1/08/463/001

EU/1/08/463/002

EU/1/08/463/003

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 02 July 2008

10. Date Of Revision Of The Text

3 September 2010

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.

Boots Paracetamol and Codeine Extra

Boots Paracetamol and Codeine Extra

(Caffeine, Codeine Phosphate, Paracetamol)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• This medicine can only be used for the short term treatment of acute moderate pain such as headache, migraine, rheumatic pain, neuralgia, toothache and period pain that is not relieved by aspirin, ibuprofen or paracetamol alone


• 
  You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice


• 
  This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it


• 
  If you take this medicine for headaches for more than 3 days it can make them worse


• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Codeine and Paracetamol which belong to a group of medicines called analgesics which act to relieve pain. It also contains Caffeine which helps to increase the pain relief.

It can be used for the short term treatment of acute moderate pain such as headache, migraine, rheumatic pain, neuralgia, toothache and period pain that is not relieved by aspirin, ibuprofen or paracetamol alone.

Before you take this medicine

• 
  This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it


• 
  If you take a painkiller for headaches for more than 3 days it can make them worse
  
  This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• 
  If you are allergic to any of the ingredients


• 
  If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sorbitol)

Talk to your pharmacist or doctor:

• If you have severe kidney problems


• If you have severe liver problems (including a disease caused by drinking alcohol)


• If you are on a low salt (sodium) diet (each tablet contains 362 mg of sodium, which may be harmful to you)


• If you are pregnant or breastfeeding

Other important information

Driving and using machines: This medicine may cause drowsiness or dizziness. You should not drive or use machines until you are sure you are not affected.

Drinking large amounts of tea, coffee or cola (or other caffeine containing products) with this medicine may make you feel more tense and irritable.

If you take other medicines

This medicine contains paracetamol. Do not take with any other paracetamol-containing products.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)


• Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)


• Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet.

Dissolve the tablets in a glass of water and then drink the solution.

Adults and children of 12 years and over: Take two tablets dissolved in water every 4 hours, if you need to, up to 4 times in 24 hours. Don’t take more than 8 tablets in any 24 hours.

Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist.

Do not give to children under 12 years.

Do not take more than the amount recommended.

If symptoms persist consult your doctor.

If you take too many tablets: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible withdrawal effects when stopping treatment

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Possible side effects

Most people will not have problems, but some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10 am – 2 pm Monday-Friday) or fill in a paper form available from your local pharmacy.

If you get any of these serious side effects, stop taking the tablets. See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)


• Severe stomach pain, which may reach through to the back. This may be a sign of pancreatitis, which is very rare

These other effects are less serious. If they bother you talk to a pharmacist:

• Constipation, feeling sick, being sick, stomach upset


• Drowsiness, dizziness, feeling light headed, headache - do not drive or use machines if you feel drowsy or dizzy


• Difficulty in passing urine


• Confusion, nervousness, irritability


• Feeling shaky or shaking, fast heart rate


• Difficulty sleeping


• Other allergic reactions (e.g. skin rash)


• Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

• You need to take the medicine for longer periods of time


• You need to take more than the recommended amount


• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

How to store this medicine

Do not store above 30°C. Store in the original package to help protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each effervescent tablet contains Caffeine 30 mg, Codeine Phosphate 8 mg, Paracetamol 500 mg which are the active ingredients.

As well as the active ingredients, the tablets also contains sorbitol (E420), saccharin sodium, sodium bicarbonate, povidone, sodium laurilsulfate, citric acid anhydrous, sodium carbonate, dimeticone.

This pack contains 32 flat white tablets with bevelled edges, plain on one side, scored on the other side.

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by

Fawdon Manufacturing Centre

Edgefield Avenue

Fawdon

Newcastle Upon Tyne

NE3 3TT

UK

Marketing Authorisation held by

Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

UK

Leaflet prepared December 2009

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

2885aeMC