PHENOXYMETHYLPENICILLIN 125 MG / 5ML SUGAR FREE ORAL SOLUTION - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

(phenoxymethyl­penicillin)

The name of your medicine is Phenoxymethyl­penicillin 125mg/5ml Sugar Free Oral Solution, but will be referred to as 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.

In this leaflet

• 1. What Phenoxymethyl­penicillin Oral Solution Sugar Free is and what it is used for

• 2. What you need to know before you take Phenoxymethyl­penicillin Oral Solution Sugar Free

• 3. How to take Phenoxymethyl­penicillin Oral Solution Sugar Free

• 4. Possible side effects

• 5. How to store Phenoxymethyl­penicillin Oral Solution Sugar Free

• 6. Contents of the pack and other information

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. what 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 This medicine contains sorbitol and sodium benzoate .

The 125mg/5ml solution contains 792.93 mg of sorbitol in each 5 ml dose.

The 250 mg/5ml solution contains 800.00 mg of sorbitol in each 5 ml dose. This medicine contains less than 1 mmol sodium (23mg) per unit volume, that is essentially to say ‘sodium-free’.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to four weeks old). This medicine contains 16 mg Sodium benzoate in each 5ml Dose which is equivalent to 320 mg/100 ml unit volume.

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 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. 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 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
• 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
• teeth may appear stained, usually returning to normal with brushing (this has been reported in children).

6. contents of the pack and other information

What Phenoxymethyl­penicillin Oral Solution Sugar Free contains: Active ingredient: Each 5ml spoonful of oral solution contains 125mg of phenoxymethyl­penicillin as phenoxymethyl­penicillin potassium.

Other ingredients: sodium benzoate (E211), saccharin sodium, trusil orange flavour, quinoline yellow (E104), sorbitol (E420), and ammonium glycyrrhizate.

What Phenoxymethylpenicillin looks like and contents of the pack

Unconstituted powder: A pale yellow, granular powder.

Reconstituted solution: A clear orange solution with an orange odour and flavour.

Phenoxymethyl­penicillin Oral Solution is available in bottles containing 100 ml on reconstitution.

Manufactured by Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland and procured from within the EU and repackaged in the UK by the Product Licence holder: CD Pharma Ltd, 4 Cairn Court, East Kilbride, G74 4NB.

Phenoxymethyl­penicillin 125mg/5ml Sugar Free Oral Solution

PL: 20492/0581

POM

Blind or partially sighted? Is this leaflet hard to see or read? Call 01355 204 448 to obtain a leaflet in a format suitable for you.

Date of preparation: 18th January 2022

5. HOW TO STORE PHENOXYMETHYLPENICILLIN ORAL SOLUTION SUGAR FREE

KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN

Expiry date

Do not use your medicine after the expiry date which is stated on the label. The expiry date, listed as “expiry” on the label, refers to the last day of that month.

Storage conditions

Phenoxymethyl­penicillin Oral Solution Sugar Free should be stored for up to 7 days in a refrigerator. Store in the original container. Keep the bottle tightly closed.

If your medicine becomes discoloured or shows any signs of deterioration consult your pharmacist who will advise you what to do.

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.