PHENOXYMETHYLPENICILLIN 250 MG / 5ML SUGAR FREE ORAL SOLUTION - patient leaflet, side effects, dosage

Patient Information 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.

Your medicine is called Phenoxymethyl­penicillin 250mg/5ml Sugar Free Oral Solution but will be referred to as Phenoxymethyl­penicillin Sugar Free throughout this leaflet. Pease note that the leaflet also contains information about other strengths of the medicine Phenoxymethyl­penicillin 125mg/5ml Sugar Free Oral Solution.

IN THIS LEAFLET

/ij What Phenoxymethyl­penicillin Sugar Free is and what it is used for

^ 2 what you need to know before you take phenoxymethylpenicillin sugar free

How to take Phenoxymethyl­penicillin Sugar Free

Possible side effects

j 5| how to store phenoxymethylpenicillin sugar free

Contents of the pack and other information

j)

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 Sugar Free, 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) What you need to know before you take Phenoxymethylpenicillin Sugar Free

Do not take Phenoxymethyl­penicillin 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 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 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.

Fab How to take Phenoxymethylpenicillin 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 125 mg/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.

Patient Information Leaflet (continued)

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 30mins before food and preferably not less than two hours after food.

If you take more Phenoxymethyl­penicillin Sugar Free than you should

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

If you forget to take Phenoxymethyl­penicillin 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.

3

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

[ft How to store Phenoxymethylpenicillin Sugar Free

Do not use your medicine after the expiry date shown on the label.

Keep out of the sight and reach of children.

Keep container tightly closed. Do not store above 25°C.

Store in a dry place. Store in the original container. Protect from light. Phenoxymethyl­penicillin Sugar Free Oral Solution should be stored for up to 7 days at 2°C-8°C in a refrigerator.

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.

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.

[ft Contents of the pack and other information

What Phenoxymethyl­penicillin Sugar Freecontains:

Active ingredient: Each 5ml spoonful of oral solution contains 250mg of phenoxymethyl­pencillin as phenoxymethyl­penicillin potassium.

Other ingredients: sodium benzoate (E211), saccharin sodium, trusil orange flavour, orange colour (containing sunset yellow (E110) and ponceau 4R (E124), sorbitol (E420) and ammonium glycyrrhizinate.

What Phenoxymethylpenicillin Sugar Free looks like and contents of the pack

Phenoxymethyl­penicillin Sugar Free is a an off-white, granular powder in natural high density polyethylene 100ml bottle with a polypropylene tamper evident or HDPE/polypropylene, tamper evident/child resistant cap.

Each pack contains 1 bottle.

Manufacturer and Licence Holder

Manufactured by Athlone Laboratories Limited, Ballymurray, Co.

Roscommon, Ireland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1945

Revision date: 16/05/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you.

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.