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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 gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctororpharmacist.

In this leaflet:

1.    What Phenoxymethylpenicillin Tablets are and what they are used for

2.    Before you take Phenoxymethylpenicillin Tablets

3.    How to take Phenoxymethylpenicillin Tablets

4.    Possible side effects

5.    How to store Phenoxymethylpenicillin Tablets

6.    Further information

1. WHAT PHENOXYMETHYLPENICILLIN TABLETS ARE AND WHAT THEY ARE USED FOR

Phenoxymethylpenicillin is an antibiotic (antibacterial medicine) for treating infections. It belongs to a group of antibiotics called “Penicillins”. Phenoxymethylpenicillin works by killing the bacteria that can cause infections. Phenoxymethylpenicillin can also be used to prevent infections.

Your doctor has prescribed Phenoxymethylpenicillin Tablets because it can treat a range of infections of the ear, throat, lungs, skin and soft tissues. It may be used to prevent infections such as rheumatic fever and prevention of infection in patients without a spleen or patients with sickle cell disease.

2. BEFORE YOU TAKE

PHENOXYMETHYLPENICILLIN

TABLETS

Do not take Phenoxymethylpenicillin Tablets

• if you are allergic (hypersensitive) to phenoxymethylpenicillin or any of the other ingredients of Phenoxymethylpenicillin Tablets.

•    if you know that you are allergic to penicillin

Take special care with Phenoxymethylpenicillin Tablets

• if you know that you are allergic to cephalosporins, or any other antibiotic or any of the ingredients in yourmedicine

•    if you suffer from kidney problems

•    ifyousufferfromliverproblems

•    if you suffer any blood disorders

•    if you are pregnant, trying for a baby or breast-feeding

•    if you suffer from bronchial asthma or suffer from a tendency to develop allergic conditions

•    if you suffer with persistent diarrhoea or vomiting caused by stomach or intestinal problems.

If any of the above applies to you, let your doctorknow

You should also note that if you test your urine for glucose using a non-enzymatic test phenoxymethylpenicillin tablets may give a false positive result. Please ask your pharmacist for advice on this.

Long term treatment should be monitored as overgrowth of resistant organisms including Pseudomonas or Candida may occur.

Taking othermedicines

Phenoxymethylpenicillin Tablets may occasionally interfere with other medicines, so it is important that you take care about all the medicines you are taking. In particular tell your doctor if you are taking any of the following:

•    any other antibiotics such as erythromycin, neomycin or tetracyclines

•    medicines used to treat gout e.g. probenecid

•    medicine used to treat cancer, psoriasis, rheumatoid arthritis e.g. methotrexate

•    the contraceptive pill (you may need to use extra birth control methods e.g. condoms.)

•    medicine used to prevent clotting of the blood e.g. warfarin

•    medicine used to treat diabetes e.g. guar gum

•    medicines used to treat high blood pressure, water retention or heart conditions e.g. amilorideor spirolactone

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

Taking Phenoxymethylpenicillin Tablets with food and drink

Phenoxymethylpenicillin Tablets are best absorbed when taken on an empty stomach.

Pregnancy and breast-feeding

The effects of phenoxymethylpenicillin in pregnancy have not been adequately studied. If you are pregnant or planning to become pregnant, inform your doctor immediately. Phenoxymethylpenicillin Tablets should be used during pregnancy only if your doctor determines that the potential benefit justifies the potential risk to the unborn baby. Since phenoxymethylpenicillin appears in breast milk, you should consult with your doctor if you plan to breast feed your baby. If this medication is essential to your health, your doctor may advise you to discontinue breast feeding until your treatment is finished.

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

Driving and using machines

Phenoxymethylpenicillin Tablets have not been shown to have any effect on ability to drive and use machines.

Important information about some of the ingredients of Phenoxymethylpenicillin Tablets

Each Phenoxymethylpenicillin 250mg tablet contains 28mg of potassium. This potassium content may be harmful to people on low potassium diets

3. HOW    TO    TAKE

PHENOXYMETHYLPENICILLIN TABLETS

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

Adults and Children (Over12)

It is best to take the doses at evenly spaced times, around the clock and at least 30 minutes before food.

Adults

The usual dosage is 250 milligrams to 500 milligrams (one to two tablets) every 6 hours. This may vary depending on the type of infection you have. If you have poor kidney function the dose may be lowered.

To prevent recurring rheumatic fever

The usual dosage is 250 milligrams (one tablet)

twice daily on a continuing basis.

To prevent pneumococcal infection (e.g. in asplenia and in sickle cell disease)

The usual dosage is 500 milligrams (two tablet) every 12 hours.

Children funder12f

For children aged between 6 and 12 years of age the usual dosage is 250 milligrams (one tablets) every 6 hours.

To prevent pneumococcal infection (e.g. in asplenia and in sickle cell disease)

The usual dosage is 250 milligrams (one tablet) every 12 hours.

Children with difficulty in swallowing or for infants and children under the age of 6 an oral solution containing phenoxymethylpenicillin is recommended.

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.

If you take more Phenoxymethylpenicillin Tablets than you should

Never take more than the recommended dose each day. If you or someone else swallows several of these tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablet left over with you and also the box, as this will allow easier identification of the tablets.

Symptoms of overdose may include:

Diarrhoea, nausea, vomiting and stomach pain.

If you forget to take Phenoxymethylpenicillin Tablets

If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up fora forgotten dose.

If you stop taking Phenoxymethylpenicillin Tablets

Continue taking Phenoxymethylpenicillin Tablets for the full time of treatment, even if you begin to feel better after a few days. Failure to take a full course of therapy may prevent complete elimination ofthe infection.

If you have any further questions on the use of this product, askyourdoctororpharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Phenoxymethylpenicillin Tablets can cause side effects, although not everybody gets them. If you experience any of the following, stop taking the tablets and tell your doctor IMMEDIATELY:

• an allergic reaction- symptoms such as shortness of breath, skin rash or itching, skin eruptions, swelling of your lips, face or tongue, chills or fever or painful joints

The following side effects have been reported in patients treated with Phenoxymethylpenicillin Tablets. However, frequency estimates for these effects are not available:

•    Diarrhoea

•    Should the diarrhoea be persistent and severe, stop taking your tablets and tell your doctor Immediately.

•    Vomiting or nausea (a feeling of sickness).

•    Inflammation ofthe tongue or mouth.

•    Redness ofthe skin, often itchy, similar to the rash of measles,

•    Thrush or inflammation ofthe vaginal area

•    Changes in white blood cell count, reduction in red blood cell count, reduction in blood platelets, which increases risk of bleeding or bruising.

•    Fever

•    Painful Joints

If any of the side effects get serious or if you

notice any side effects not listed in this leaflet tell

your doctor or pharmacist.

5. HOW TO STORE

PHENOXYMETHYLPENICILLIN

Keep out of the reach and sight of children.

Do not store above 25° C.

Do not use Phenoxymethylpenicillin Film coated Tablets after the expiry date which is stated on the individual blisterand on the carton.

Do not use phenoxymethylpenicillin film coated tablets if you notice visible signs of deteriorations such as colour change of the tablet from white to off-white or yellowish or if patches appear on the tablet.

Medicines should not be disposed of via waste water 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 contains

The active substance is Phenoxymethylpenicillin 250 mg (as Phenoxymethylpenicillin Potassium)

Other ingredients are

Calcium Hydrogen Phosphate Dihydrate Maize Starch

Microcrystalline Cellulose (E460)

Magnesium Stearate (E572)

Film Coat

Basic Butylated Methacrylate

Macrogol6000

Sodium Laurylsulfate (E487)

Stearic acid (E570)

Titanium Dioxide (E171)

What Phenoxymethylpenicillin looks like and contents ofthe pack

Phenoxymethylpenicillin Tablets White, circular, biconvex film coated tablets with break line on one side and '104' on the other.

Blisters (aluminium PVC) of 14 tablets. Packs containing 14, 28, 42, 56, 70, 140 tablets are available.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Morningside Healthcare Ltd 115 Narborough Road Leicester.

LE3 0PAU.K.

Site responsible for batch release

Morningside Pharmaceuticals Ltd 5 Pavilion Way Loughborough.

LE11 5GW. U.K.

This leafletwas last approved in 01/2011.