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Penicillin Vk Capsules 250mg

Document: leaflet MAH BRAND_PL 33414-0079 change

PACKAGE LEAFLET: INFORMATION FOR THE USER


ECONOCIL 125 mg & 250 mg TABLETS

ECONOCIL 250 mg CAPSULES

(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 ECONOCIL is for

2.    Before you take ECONOCIL

3.    How to take ECONOCIL

4.    Possible side effects

5.    How to store ECONOCIL

6.    Further information


1. WHAT ECONOCIL IS FOR


Take special care with ECONOCIL

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

•    allergies

•    asthma

•    kidney problems

•    rheumatic fever

•    prolonged use of antibiotics.

ECONOCIL 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 ECONOCIL tablets or capsules 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.

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

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


ECONOCIL 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 or capsules then please ask your doctor.


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

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

Important information about some of the ingredients of ECONOCIL

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


3. HOW TO TAKE ECONOCIL


2. BEFORE YOU TAKE ECONOCIL


Do not take ECONOCIL

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

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


Always take ECONOCIL 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 or capsules.

If you take more ECONOCIL than you should

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

If you forget to take ECONOCIL

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, ECONOCIL 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 ora 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 or capsules after the expiry date which is stated on the 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 ECONOCIL contains

The active ingredient in this medicine is phenoxymethyl penicillin potassium.

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

The other ingredients in the capsules are lactose, tricalcium phosphate, sodium starch glycollate, gelatin, titanium dioxide (E171) and erythrosine (E172).

What ECONOCIL looks like and contents of the pack

ECONOCIL 125 mg & 250 mg tablets are round white to off-white tablets with no markings.

ECONOCIL 250 mg capsules are white to off-white capsules with the no markings.

This medicine comes in containers of 100 and 500 tablets or capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

Boumpoulinas 11, 3rd Floor,

Nicosia, P.C. 1060, Cyprus

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 amended in May 2009

5. HOW TO STORE ECONOCIL

Keep out of the reach and sight of children.

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