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Penicillin Tablets 250mg

Document: leaflet MAH GENERIC_PL 17521-0012 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

PENICILLIN 250 mg TABLETS

(PHENOXYMETHYLPENICILLIN POTASSIUM)


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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or


^pharmacist.


THIS LEAFLET CONTAINS


1.    What PENICILLIN is for

2.    Before you take PENICILLIN

3.    How to take PENICILLIN

4.    Possible side effects

5.    How to store PENICILLIN

6.    Further information


Take special care with PENICILLIN

Tell your doctor before you take this medicine if you have a history of:

•    allergies

•    asthma

•    kidney problems

•    rheumatic fever

•    prolonged use of antibiotics.

PENICILLIN may alter the results of some urinary blood sugar level tests.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how PENICILLIN tablets work:

•    Neomycin to treat bacterial infections

•    Methotrexate to treat cancer or skin, joint or gut diseases (psoriasis, rheumatoid arthritis or Crohn's disease)

•    Probenecid or Sulfinpyrazone to treat pain and swelling of the joints (gout)

•    Guar gum to lower blood sugar levels.

PENICILLIN can make birth control pills less effective. An additional form of contraception should be used.


1. WHAT PENICILLIN IS FOR


PENICILLIN belongs to a group of medicines known as the penicillin antibiotics, which help to fight bacterial infections.

This medicine can be used to treat:

•    mild to moderate infections of the upper respiratory tract (the nose, mouth, throat or ear)

•    mild infections of the skin and soft tissues

•    scarlet fever (a red rash accompanied by a sore throat and a red "strawberry" tongue)

•    rheumatic fever (an inflammatory disease which can cause damage to the skin, joints or heart)

•    chorea (uncontrollable, jerky movements).

If you are not sure why you have been prescribed these tablets then please ask your doctor.


If you go into hospital or have treatment for other conditions, tell the doctor that you are taking PENICILLIN.

Pregnancy and breast-feeding

Although this medicine is not known to harm babies, make sure your doctor knows if you are pregnant, planning a pregnancy or breastfeeding and follow his / her advice.

Driving and using machines

PENICILLIN should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of PENICILLIN

If you know you have an intolerance to lactose or other sugars contact your doctor before taking this medicine.


3. HOW TO TAKE PENICILLIN


2. BEFORE YOU TAKE PENICILLIN


Do not take PENICILLIN

•    If you are allergic to PENICILLIN or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    If you are allergic to other penicillin products or antibiotics known as cephalosporins.


Always take PENICILLIN exactly as your doctor has told you.

Take this medicine by mouth. However, if you have severe illness, nausea, vomiting, difficulty swallowing, stomach enlargement or excessive movement of the intestines, treatment by mouth may not be suitable. Follow your doctor's advice.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

Ideally give or take each dose either half an hour before (or at least three hours after) a meal.


The last dose of the day may be doubled to avoid problems sleeping. Do not alter your dose without speaking to your doctor.

Adults and children over 12 years: Typical doses are 125 mg or 250 mg every four to six hours. For severe infections the maximum dose is 1 g every six hours.

Elderly: Same dosage as adults. If you have kidney problems you may require smaller doses. Follow your doctor's advice.

Children under 12 years: The doctor will decide the dose for your child, as it depends on their age.

A liquid form of this medicine is recommended for infants or children who cannot take tablets.

If you take more PENICILLIN than you should

Contact your doctor or pharmacist immediately. Show them the package.

If you forget to take PENICILLIN

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS

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

Allergic reactions have been reported, which may cause:

•    common side effects such as nausea, vomiting, stomach pain, diarrhoea or a black "hairy" tongue

•    other side effects such as chills or fever

•    severe skin rash, itching or peeling (including nettle rash)

•    difficulty breathing or dizziness

•    swelling of the face or throat

•    pain and swelling of the joints (arthritis). Rare side effects:

•    various forms of anaemia (reduction in red blood cells) causing pale skin, weakness, or breathlessness

•    other blood disorders causing excessive bleeding (including blood in your urine or stools), bruising, sore throat, general illness or fever

•    kidney problems

•    nervous system problems causing fits.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Do not use these tablets after the expiry date which is stated on the package or container. The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION

What PENICILLIN contains

The active ingredient in this medicine is phenoxymethyl penicillin potassium.

The other ingredients in the tablets are lactose, maize starch, pregelatinised maize starch, sodium starch glycollate and magnesium stearate.

What PENICILLIN looks like and contents of the pack

PENICILLIN 250 mg tablets are round white to off-white tablets with a score line engraved on one side and MP12 on the other.

The tablets come in blister packs and containers of 14, 15, 21, 28, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited,

15 Runnelfield, Flarrow on the Hill,

Middlesex HA1 3NY

Manufacturer

Next Pharma GmbH,

Hildebrandstrasse 12,

37081 Gottingen, Germany

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last approved in 09/2008

PEN0012/0250T/LEA006

5. HOW TO STORE PENICILLIN

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.