231-30-40303-C Version: 1

PHENOXYMETHYLPENICILLIN 125 mg/5 ml AND 250 mg/5 ml ORAL SOLUTION SUGAR FREE

PATIENT INFORMATION LEAFLET

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

•    Keep this leaflet. You may need it again.

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

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

IN THIS LEAFLET

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1.    What your medicine is and what it is used for

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Further information

^ WHAT YOUR MEDICINE 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 100 ml 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 bacterial endocarditis in susceptible patients before surgery

•    prevent infection in patients with sickle cell disease.

BEFORE YOU TAKE YOUR MEDICINE

Do not take this medicine 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.

Take special care with your medicine if:

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

•    You suffer from any kidney problems

•    You suffer from allergies and/or asthma.

Taking other medicines:

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.

Inform your doctor 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)

•    The oral contraceptive pill (your medicine may reduce the effectiveness of oral contraceptive pills, in which case you will need to take extra contraceptive measures such as using a condom)

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

In addition:

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

Taking 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

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about one of the ingredients in your medicine 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 YOUR MEDICINE

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.

TO THE PHARMACIST: INSTRUCTIONS FOR RECONSTITUTION OF THE POWDER

1.    Remove the cap and add the correct volume of potable water (87 mls for the 125 mg/5 ml strength of product and 79 mls for the 250 mg/5 ml strength of product).

2.    Replace the cap and shake gently until all powder is dissolved.

3.    Remove the cap once more and place the adaptor (Fig 1) into the bottle opening.The adaptor should not be removed at any stage.

4.    Replace the cap, do not shake any further.

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TO THE PATIENT: INSTRUCTIONS FOR USE OF THE SYRINGE

1.    Remove the cap and if necessary push the adaptor into the neck of the bottle (Fig 1).

2.    Push the plunger of the syringe to remove all the air.

3.    Insert the syringe into the adaptor until it is firmly in place (Fig 2).

4.    While holding the bottle and syringe shake the contents gently.

5.    While holding the bottle, turn the entire assembly upside down. f \

6.    While supporting the syringe draw off the required amount of medicine into the syringe (Fig 3).

7.    Turn the assembly back up the right way and remove the syringe from the bottle.

8.    Replace the cap onto the bottle.    Fig. 1

Administer the dose by introducing the tip of the syringe into the mouth of the infant/child, then apply a

light pressure on the plunger to slowly release the solution. Keep it out of the reach of children.

Note: For subsequent dosage follow steps 3 and 4 above, before shaking in order to prevent leakage.

Fig. 2    Fig. 3

How much of your medicine to take

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

250 mg to 500 mg every six hours (5 ml to 10 ml of 250 mg/5 ml)

Prophylactic use: 250 mg twice daily is recommended for long term prophylaxis of rheumatic fever (5 ml of 250 mg/5 ml).

Children

Infants (up to 1 year): 62.5 mg every 6 hours 1 - 5 years: 125 mg every six hours (5 ml of 125 mg/5 ml)

6 - 12 years: 250 mg every six hours (5 ml of 250 mg/5 ml or 10 ml of 125 mg/5 ml)

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 an hour before food or 2 hours after food.

If you take more of your medicine 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 your medicine

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.

POSSIBLE SIDE EFFECTS

Like all medicines phenoxymethylpenicillin may cause you some problems.

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

•    seizures

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

The following are the more common effects. Tell your doctor or pharmacist if they worry you.

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

The following are other possible side effects:

•    sore mouth

•    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.

HOW TO STORE YOUR MEDICINE

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

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store in original package. Keep the bottle tightly closed.

Dry powder: Store in a dry place below 25°C. Protect from light.

Reconstituted solution: Store 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.

FURTHER INFORMATION

What Phenoxymethylpenicillin Oral Solution Sugar Free contains:

Active ingredient: Each 5 ml of oral solution contains 125 mg or 250 mg of phenoxymethylpenicillin as phenoxymethylpenicillin potassium.

Other ingredients: sodium benzoate (E211), saccharin sodium (E954), sorbitol (E420), disodium edetate, sodium citrite anhydrous (E331) for pH adjustment, citric acid monohydrate (E330) for pH adjustment, colloidal anhydrous silica, xantham gum (E415), lemon flavour, strawberry flavour and menthol flavour.

The product licence holder and manufacturer is:

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.

Your medicine is distributed by:

TEVA UK Limited, Eastbourne, BN22 9AG.

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PL 06453/0052 and PL 06453/0053 This leaflet was last revised January 2013.

TEVA UK LIMITED

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40303-C

PATIENT INFORMATION LEAFLET

In this leaflet

1.    What your medicine is and what it is used for

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Further information