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Phenoxymethylpenicillin 250mg Tablets

Document: leaflet MAH GENERIC_PL 36722-0064 change

Front of leaflet -148.5mm

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PHENOXYMETHYLPENICILLIN 250mg TABLETS BP

(Phenoxymethylpenicillin potassium)

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 any further questions, ask your doctor or pharmacist

•    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 any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Phenoxymethylpenicillin tablet is and what it is used for

2.    What you need to know before you take Phenoxymethylpenicillin tablet

3.    How to take Phenoxymethylpenicillin tablet

4.    Possible side effects

5.    Howto store Phenoxymethylpenicillin tablet

6.    Contents of the pack and other information

1. WHAT PHENOXYMETHYLPENICILLIN TABLET IS AND WHAT IT IS USED FOR

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

Each tablet contains 250mg of Phenoxymethylpenicillin potassium as the active ingredient.

The strength you are given will be decided by your doctor.

Phenoxymethylpenicillin potassium is used to treat infections caused by bacteria that are sensitive to penicillins. These infections include:

•    Infections of the lungs (such as pneumonia and bronchitis)

•    Ear and throat infections (such as otitis media and pharyngitis)

•    Other infections (such as infections of the skin and soft tissue, respiratory tract, scarlet fever and erysipelas)

Phenoxymethylpenicillin is also used to prevent infections such as:

•    Prevention of recurrent attacks of rheumatic fever or chorea (infection of the nervous system)

•    Prevention of lung infections in patients with no spleen or sickle cell disease

•    Prevention of pneumococcal infection (e.g. in asplenia)

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENOXYMETHYLPENICILLIN TABLET

Do not take Phenoxymethylpenicillin tablet:

•    If you have ever had a bad reaction or allergic to any penicillin or cephalosporin antibiotics, or any of the other ingredients listed in section 6

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

Warnings and precautions

Talk to your doctor or pharmacist before taking

Phenoxymethylpenicillin tablet

•    Have a history of allergies and/or asthma

•    Have kidney disease

•    Have suffered severe diarrhoea following previous treatment with antibiotics and from any stomach problems, e.g. vomiting

•    Are feeling or being sick or are suffering from any gut

disorder which may affect the way your body absorbs the medicine

•    Have a severe illness

•    Have history of antibiotic-associated colitis

Other medicines and Phenoxymethylpenicillin tablet:

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines even those not prescribed, including herbal and homeopathic remedies or might take any other medicines including:

•    Other antibiotics (such as tetracyclines, erythromycin, chloramphenicol, neomycin, sulphonamides, have been reported to reduce the effect of penicillin)

•    Sulfinpyrazone or probenecid (used for the treatment of gout - painful inflammation of the joints)

•    Methotrexate (used in the treatment of severe rheumatoid arthritis, severe psoriasis and cancer) and guar gum (used in the treatment of diabetes)

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

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

•    Phenoxymethyl penicillin may interfere with the way the contraceptive pill works. If you are taking the Pill you should use additional precautions (such as a condom or diaphragm) for the cycle during which you took the antibiotic

Phenoxymethylpenicillin tablet 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 phenoxymethyl penicillin.

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.

Phenoxymethylpenicillin contains lactose

Patients with rare hereditary problems of fructose intolerance, gluclose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. 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. HOWTO TAKE PHENOXYMETHYLPENICILLIN TABLET

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 dosage prescribed will depend upon the type and severity of the infection.

In general the treatment must be continued 2-3 days after improvement of the symptoms. It is important that you complete the entire course of medicine your doctor has prescribed for you.

Treatment of Infection

Adults: 250-500mg every 6 hours or as directed by your doctor. Child 1-5 years of age: 125mg every 6 hours.

Child 6-12 years of age: 250mg every 6 hours or as directed by your doctor.

Prevention of Infection Rheumatic fever: 250mg twice daily.

Lung infection in patients with no spleen or sickle cell disease: Adults: 500mg every 12 hours.

Child aged 6-12 years: 250mg every 12 hours.

Child under 5 years: 125mg every 12 hours.

If you have kidney damage your doctor may give you a different dose. Dosage might be changed by your doctor if you have liver problems along with kidney problem.

Continued, please turn over

When to take your medicine

Phenoxymethylpenicillin contains lactose tablet 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. You should swallow this medicine about half an hour before meals.

If you take more Phenoxymethylpenicillin tablet 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 tablet

If you forget to take your medicine take it as soon as you remember.

Do not take a double dose to make up for a forgotten dose.

If you or a child ever takes too much medicine contact your doctor or local casualty department immediately. Take any remaining tablets and this leaflet to show to your doctor.

If you stop taking Phenoxymethylpenicillin Tablet

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

Do not stop taking the tablets if you feel better, as your infection may come back or get worse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Phenoxymethylpenicillin potassium is generally well tolerated. Occasionally soft stools occur but this does not require interruption of treatment. However, if you develop severe diarrhoea, which may contain blood, you should contact your doctor immediately.

STOP taking the medicine and tell your doctor IMMEDIATELY if

you experience any of the following:

•    Feeling or being sick is a rare reaction

•    Allergic reactions can occur, which may rarely be severe. Stop taking the mixture and contact a doctor immediately if you notice skin rash or itching, hives, which may be itchy raised or red, fever, chills, joint pains, swelling of the face, lips, throat or tongue, breathing difficulties or dizziness. Allergic reactions may also include affects on the blood and kidney

•    Effects on the nervous system occur rarely and are more likely if you have an injection of an antibiotic or have severe kidney damage. If you experience numbness or tingling of the hands or feet, or fits, you should see your doctor

•    Profuse watery diarrhoea usually with blood (pseudomembranous colitis) and mucus, stomach pain and fever

•    unusual bleeding or bruising

•    seizures

•    peeling/blistering of the skin

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

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

•    Jaundice - yellowing of skin or whites of the eyes

•    Convulsions

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

•    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)

•    Thrush (a yeast infection of the vagina, mouth or skin folds) Phenoxymethylpenicillin may alter the number and type of blood cells. If you notice you have more nose bleeds, bruise easily or have frequent infections talk to your doctor who may want to test your blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

Keep this medicine out of the sight and reach of children.

Expiry date

Do not use this medicine after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month.

Storage conditions: Do not store above 25°C. Store in original package. Keep the container tightly closed.

If your doctor decides to stop the treatment, return any tablets left over the pharmacist. Only keep them if your doctor tells you to. Do not use this medicine if you notice visible signs of deterioration. 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.

Important reminder: Do not give your medicine to anyone else, even if they suffer from the same condition as you. This medicine could be harmful to them or interfere with other treatments. Your medicine has been prescribed by your doctor specifically for you.

What Phenoxymethylpenicillin tablet contains:

Active ingredient: Each tablet contains 250mg of phenoxymethylpenicillin as phenoxymethylpenicillin potassium. The Other ingredients are: lactose, talc, magnesium stearate and starch.

What Phenoxymethylpenicillin tablet looks like and contents of the pack

Phenoxymethylpenicillin Potassium tablets are shiny white, flat tablets with bevel edge and embossed with 'K' on one side and breakline on the other and come in bottles of 100, 500 and 1000 tablets and blister packs of 28 and 504 tablets.

Marketing Authorisation Holder:

Special Concept Development (UK) Limited, Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR.

Manufacturer:

Karib Kemi Pharm Limited, Karib House, 63-65 Imperial Way, Croydon, Surrey CRO 4RR, U.K.

This leaflet was last revised in February 2016.

PL 36722/0064

If you would like this leaflet in a different format, please contact the licence holder at the above address.