Document: leaflet MAH BRAND_PLPI 39467-0199 change

• leaflet MAH BRAND_PLPI 15814-1213
• leaflet MAH BRAND_PLPI 39467-0199

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PACKAGE LEAFLET INFORMATION FOR THE USER

Phenoxymethylpenicillin 125mg/5ml Sugar Free Oral Solution Phenoxymethylpenicillin 250mg/5ml Sugar Free Oral Solution

The name of this product is Phenoxymethylpenicillin 125mg/5ml Sugar Free Oral Solution or Phenoxymethylpenicillin 250mg/5ml Sugar Free Oral Solution but will be called Phenoxymethylpenicillin Oral Solution Sugar Free throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you

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

•    If you have further questions, please ask your doctor or pharmacist (chemist).

•    This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any of the side effects, talk to your doctor or pharmacist, this includes possible side effects not listed in this leaflet. See section 4.

1.    WHAT PHENOXYMETHYLPENICILLIN ORAL SOLUTION SUGAR FREE IS AND WHAT IT IS USED FOR

Phenoxymethylpenicillin Oral Solution Sugar Free is available in two strengths as a powder for reconstitution. The powder for reconstitution is prepared by the pharmacist before dispensing by adding water to the powder to give 100ml of oral solution. The strength you are given will be decided by your doctor.

Phenoxymethylpenicillin, the active ingredient, is an antibiotic, which belongs to a group of medicines called penicillins, which are used to kill bacteria that cause infections in your body.

Your medicine is used to:

•    treat bacterial infections of the ear, throat, respiratory tract, skin and soft tissues

•    prevent infections such as rheumatic fever or chorea recurring

•    prevent pneumococcal infection (e.g. in asplenia and in patients with sickle cell disease).

2.    W HAT YOU NEED TO KNOW BEFORE YOU TAKE PHENOXYMETHYLPENICILLIN ORAL SOLUTION SUGAR FREE

Do not take Phenoxymethylpenicillin Oral Solution Sugar Free if:

•    You have ever had a bad reaction or allergic reaction to any penicillin-type antibiotic including cephalosporin drugs

•    You have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic

•    You are allergic to any of the ingredients contained in this medicine

Warnings and precautions

•    You suffer from any stomach problems, e.g. vomiting

•    You suffer from any kidney problems

•    You suffer from allergies and/or asthma

Other medicines and Phenoxymethylpenicillin Oral Solution Sugar Free:

Your medicine may interfere with other medicines that you may be taking. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines even those not prescribed, including herbal and homeopathic remedies.

Talk to your doctor or pharmacist if you are taking:

•    Methotrexate (a drug used to treat cancers and psoriasis)

•    Some other antibiotics (tetracyclines, erythromycin, neomycin and chloramphenicol have been reported to reduce the effect of penicillin)

•    Sulfinpyrazone or probenecid (medicines used to treat gout)

•    Anti-coagulants (e.g. warfarin - to prevent blood clots)

•    Oral typhoid vaccine (penicillin can stop this from working)

Phenoxymethylpenicillin Oral Solution Sugar Free with food and drink

Guar gum (used as a thickening agent and normally found in puddings and ice-cream and benefiber) can reduce the absorption of phenoxymethylpenicillin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine should not affect your ability to drive or to use machinery.

Important information about some of the ingredients in your medicine

Ponceau 4R (E124) and sunset yellow (E110)

Can cause allergic type reactions including asthma. Such allergies are common in those people who are allergic to aspirin.

Sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE PHENOXYMETHYLPENICILLIN ORAL SOLUTION SUGAR FREE

Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. The pharmacist's label should tell you how much to take and how often. If it does not, or you are not sure, check with your doctor or pharmacist.

How much of your medicine to take

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dose will depend on the patient and will be decided by your doctor.

The usual doses for each age group are as follows:

Adults including the elderly and children over 12 years

250mg to 500mg every six hours (one to two 5ml spoonfuls of 250mg/5ml)

Children

Infants (up to 1 year): 62.5mg every 6 hours

1 - 5 years: 125mg every six hours (one 5ml spoonful of

125mg/5ml)

6 - 12 years: 250mg every six hours (one 5ml spoonful of 250mg/5ml or two 5ml spoonfuls of 125mg/5ml)

For preventing the recurrence of rheumatic fever or chorea:

The usual dose is 250mg twice daily on a continuing basis.

For the prevention of infection in patients without a spleen or patients with sickle cell disease:

For adults and children over 12 years, the dosage is 500mg every 12 hours.

For children aged between 6 and 12 years, the dosage is 250mg every 12 hours and for children below 5 years, the dosage is 125mg every 12 hours.

For children over 12 years the dose should not exceed the maximum adult doses.

For elderly, the dosage is as for the adult. The dosage should be lowered in poor renal function.

Patients with kidney and liver problems

•    If you have kidney problems the dose might be changed by your doctor.

•    Dosage might be changed by your doctor if you have liver problems along with kidney problem.

When to take your medicine

Phenoxymethylpenicillin Oral Solution Sugar Free is usually prescribed to be taken four times a day. It is best to take it as evenly spaced as possible.

Take this medicine when your stomach is empty. This means at least 30 mins before food and preferably not less than two hours after food.

If you take more Phenoxymethylpenicillin Oral Solution Sugar Free than you should

If you accidentally take too much medicine, contact your doctor or pharmacist who will recommend what action you should take.

If you forget to take Phenoxymethylpenicillin Oral Solution Sugar Free

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.

DO NOT take a double dose to make up for the dose you have missed.

If you stop taking your medicine

Keep taking this medicine until your doctor tells you to stop.

Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse.

4.    POSSIBLE SIDE EFFECTS

Like all medicines phenoxymethylpenicillin can cause side effects although not everybody gets them.

STOP taking the medicine and tell your doctor IMMEDIATELY if you experience any of the following:

•    an allergic reaction - symptoms may include: shortness of breath, skin rash or itching, hives, swelling of the skin (especially of the lips, face or tongue), chills or fever, painful joints

•    severe peeling/blistering of the skin

•    Serum sickness-like reactions (characterised by fever, chills, joint pains and oedema)

•    seizures

•    profuse watery diarrhoea usually with blood and mucus, stomach pain and fever

Tell your doctor or pharmacist if you notice any of the following and they worry you.

•    stomach pain or cramps, nausea (feeling sick), vomiting (being sick) and diarrhoea

•    sore mouth

•    hepatitis

•    convulsions

•    black hairy tongue

•    pins and needles or numbness

•    sore throats, infections, or fever (may be caused by low white blood cells)

•    problems with blood clotting (unusual bleeding or bruising)

•    anaemia (may cause lack of energy or tiredness)

•    kidney problems, which might cause blood in the urine or reduced amounts of urine

•    jaundice - yellowing of skin or whites of the eyes

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE PHENOXYMETHYLPENICILLIN ORAL SOLUTION SUGAR FREE

Keep out of the sight and reach of children.

Do not use your medicine after the expiry date shown on the label. The ‘expiry' on the label refers to the last day of that month.

Dry powder: Do not store above 25^oC. Store in the original container. Keep container tightly closed. Protect from moisture. Protect from light. Store in a dry place. Reconstituted solution: Store for 7 days at 2^oC - 8^oC in a refrigerator. Store in the original container. Keep container tightly closed.

Do not throw away any medicines via wastewater or household waste. Ask your Pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

If your doctor tells you to stop your treatment return any left over to the pharmacist. Only keep it if your doctor tells you to.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Phenoxymethylpenicillin Oral Solution Sugar Free contains:

Powder for reconstitution.

Each 5ml of oral solution contains 125mg of Phenoxymethylpenicillin (as Phenoxymethylpenicillin potassium).

Each 5ml of oral solution contains 250mg of Phenoxymethylpenicillin (as Phenoxymethylpenicillin potassium).

Other ingredients: sodium benzoate, saccharin sodium, trusil orange flavour, orange colour (containing sunset yellow (E110) and ponceau 4R (E124)), sorbitol (E420) and ammonium glycyrrhizate.

What Phenoxymethylpenicillin looks like and contents of the pack

The unreconstituted powder is an off-white, granular powder. The reconstituted oral solution is a clear orange solution with an orange odour and flavour.

Available in pack containing 100ml bottle and a spoon. Manufacturer

Athlone Pharmaceuticals Limited, Ballymurray,

Co. Roscommon, Ireland.

Procured from within the EU by PL Holder PilsCo Ltd,

10-16 Colvilles Place, East Kilbride, G75 0SN.

PL 39467/0199 Phenoxymethylpenicillin 125mg/5ml Sugar Free Oral Solution

PL 39467/0200 Phenoxymethylpenicillin 250mg/5ml Sugar Free Oral Solution

POM

This leaflet was last revised 04/07/2016