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PACKAGE LEAFLET: INFORMATION FOR THE USER

Phenoxymethylpenicillin potassium solution 125mg/5ml

Phenoxymethylpenicillin potassium

^ Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Phenoxymethylpenicillin potassium is and what it is used for

2.    Before you take Phenoxymethylpenicillin potassium

3.    How to take Phenoxymethylpenicillin potassium

4.    Possible side effects

5.    How to store Phenoxymethylpenlcillin potassium

6.    Further information

1.    What Phenoxymethylpenicillin potassium is and what it is used for

Phenoxymethylpenicillin Potassium is one of a group of antibiotic medicines called penicillins. They are used to treat infections caused by bacteria that are sensitive to penicillins.

Phenoxymethylpenicillin Potassium is used to treat a range of bacterial infections:

•    Chest (bronchitis or pneumonia) infections

•    To treat ear and throat infections (such as otitis media and pharyngitis)

•    To treat skin and soft tissue infections such as scarlet fever and erysipelas

•    To prevent recurrent attacks of rheumatic fever

•    To prevent lung infections in patients with no spleen or sickle cell disease.

2.    Before you take phenoxymethylpenicillin potassium Do not take Phenoxymethylpenicillin potassium:

•    If you are allergic (hypersensitive) to Phenoxymethylpenicillin Potassium or any of the other ingredients in this medicine (see Section 6 for a full list of ingredients).

•    If you are allergic (hypersensitive) to cephalosporin antibiotics

Take special care with Phenoxymethylpenicillin potassium

Tell your doctor before you start to take this medicine if you:

•    Have a history of allergies

•    Have been treated for kidney problems

•    Have suffered severe diarrhoea following previous treatment with antibiotics

•    Have a severe illness

•    If you have your urine tested for glucose using a non-enzymatic test, then Phenoxymethylpenicillin Potassium Solution may give a false positive result.

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Taking other medicines

Please tell your doctor or pharmacist if you are taking or haverecently taken any other medications including medicines obtained without a prescription.

Please tell your doctor if you are taking any of the following medicines:

•    Other antibiotics (such as tetracyclines, erythromycin, chloramphenicol, sulphonamides, neomycin).

^ • Coumarin or phenindione used to thin the blood.

•    Sulfinpyrazone or probenecid used to treat gout.

•    Methotrexate used in the treatment of severe rheumatoid arthritis, severe psoriasis and cancer

•    Guar gum used in the treatment of diabetes.

•    Contraceptive Pill as phenoxymethylpenicillin potassium may reduce the effect of the Pill. You should therefore take additional contraceptive precautions such as using a condom, or diaphragm with spermicide.

Please tell your doctor or pharmacist, if you have recently been given or are due to receive a typhoid vaccination.

Pregnancy and Breast feeding

Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant discuss this with your doctor before taking any medicine.

Small amounts of phenoxymethylpenicillin potassium may enter the breast milk and can occasionally cause diarrhoea or mouth infections in infants. Infants may become allergic to penicillin. If you are breast feeding, discuss this with your doctor before you take phenoxymethylpenicillin potassium.

Important information about some of the ingredients of Phenoxymethylpenicillin Potassium

This medicine contains sodium benzoate (E211) this may increase the risk of jaundice in newborn babies.

3. How to take Phenoxymethylpenicillin potassium

Always take Phenoxymethylpenicillin potassium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You should take your medicine half an hour before food, use the cup provided.

In general the treatment must be continued 2-3 days after improvement of the symptoms. It is important that you complete the entire course of medicine your doctor had prescribed for you.

The usual oral dose:

All doses are measured out using the cup provided.

Adults dose including elderly patients:

10-20 ml every 6 hours

Prevention of infection in patients with no spleen or sickle cell disease:

Adults: 20 ml every 12 hours

Children 6-12 years old: 10 ml every 12 hours

Children under 5 years old: 5 ml every 12 hours

Prevention of recurrence of rheumatic fever:

10 ml twice a day.

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Childrens Dosage (up to 12 years of age):

Children under 1 year old: 2.5 ml every 6 hours Children aged 1-5 years old: 5 ml every 6 hours Children aged 6-12 years old: 5-10 ml every 6 hours.

To avoid late complications (rheumatic fever), infections with p-haemolytic streptococci should be treated for 10 days.

Patients with kidney problems may have a lower dose recommended by their doctor.

The treatment of acute otitis media with penicillin V should be limited to 5 days. However, 5-10 days treatment may be recommended in patients with potential for complications

If you take more Phenoxymethylpenicillin Potassium than you should

If you (or someone else) swallow a lot of the solution all at once, or if you think a child has swallowed any of the solution, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining solution and the container with you to the hospital or doctor so that they know which solution was consumed.

If you forget to take Phenoxymethylpencillin Potassium

If you forget to take your medicine take it as soon as you remember. Do NOT take a double dose to make up for a forgotten dose.

If you stop taking Phenoxymethylpenicillin Potassium

Do not stop taking Phenoxymethylpenicillin Potassium just because you feel better. If you stop before the end of the course the infection may come back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Phenoxymethylpencillin potassium can cause side effects, although not everybody gets them.

Allergic (hypersensitive) reactions may occur commonly during treatment with Phenoxymethylpenicillin potassium but severe allergic reactions are rare. If any of the following happen, stop taking this medicine and tell your doctor immediately. You may need urgent medical attention or hospitalisation.

•    Itchy skin, rash, swollen face, breathing difficulty

•    Fever

•    Joint pains

•    Swelling of the face, lips, throat or tongue

•    Dizziness

•    Allergic reactions may also cause effects to the blood and kidneys.

Other side effects that may occur are:

•    Soft stools

•    Nausea or vomiting.

If you notice any of the following side effects you should contact your doctor:

•    Severe diarrhoea, which may contain blood

•    Fits or convulsions (usually following high doses or if you suffer from severe kidney damage)

•    Numbness or tingling of the hands and feet

•    Blood disorders. Possible symptoms might include unexplained bruising and bleeding, sore throat, fever or other infections.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5.    How to store Phenoxymethylpenicillin potassium

Keep out of the reach and sight of children.

Store in the original packaging.

Do not use after the expiry date shown on the carton. The expiry date refers to the last day of the month.

Phenoxymethylpenicillin potassium powder: Do not store above 25 °C. Keep in a dry place.

The reconstituted solution: Store in a refrigerator (2-8°C) and use within 7 days after reconstitution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further Information

What Phenoxymethylpenicillin potassium contains:

The active ingredient is phenoxymethylpenicillin potassium. 5ml of the reconstituted soultion contains 125 mg of phenoxymethylpenicillin potassium. The other ingredients are sodium saccharin, citric acid, sodium citrate, sucrose, banana flavour, E211 sodium benzoate (preservative) and E 127 erythrosine (colouring).

What Phenoxymethylpenicillin potassium looks like and contents of the pack:

The product comes in 60ml or 100ml bottles either as a powder or as a solution after reconstituted.

Not all pack sizes may be marketed.

This leaflet was last revised: July 2012 PL 21880/0038

POM

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