PACKAGE LEAFLET: INFORMATION FOR THE USER

METRONIDAZOLE 200 mg & 400 mg TABLETS

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 Metronidazole is for

2.    Before you take Metronidazole

3.    How to take Metronidazole

4.    Possible side effects

5.    How to store Metronidazole

6.    Further information

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Tests

If you are taking this medicine for more than 10 days, your doctor may wish to carry out regular check-ups and tests, such as blood or urine 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. This is because Metronidazole can affect the way some other medicines work. Also, some medicines can affect the way Metronidazole works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines to stop the blood clotting, such as Warfarin. The dosage of Warfarin may need to be reduced if you are taking this drug

•    Lithium to treat mental health problems. If taken at the same time as Metronidazole, the kidneys may be affected

•    Medicines to treat epilepsy, such as Phenytoin,

Primidone or Phenobarbitone

•    5 Fluorouracil to treat some forms of cancer

•    Busulfan to treat leukaemia

•    Ciclosporin to stop the rejection of organs after transplants

•    Cimetidine to treat stomach ulcers.

1. WHAT METRONIDAZOLE IS FOR

Metronidazole is an antibiotic commonly used to treat:

•    infections of the blood, brain, lung, bone, stomach lining and pelvic area

•    infections after childbirth

•    wound infections after operations

•    trichomoniasis (a urinary or genital infection in men and women caused by a parasite)

•    bacterial vaginosis (a genital infection in women caused by bacteria)

•    intestinal disease and amoebic liver abscess

(a collection of pus in the liver caused by an organism called Entamoeba histolytica)

•    giardiasis (an intestinal infection causing diarrhoea and stomach pain)

•    swollen, painful, bleeding gums or teeth infections

•    infected leg ulcers or pressure sores

•    or prevent infections after operations.

If you are not sure why you have been prescribed this medicine then please ask your doctor.

Taking Metronidazole with food and drink Do not drink alcohol whilst taking this medicine and for 48 hours after finishing the course of tablets, as this might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.

The tablets can be taken with or without food.

Pregnancy and breast-feeding

Metronidazole should not be taken during pregnancy or during breast-feeding. If treatment is considered essential, the short-term high dosage regimens described in section 3 of this leaflet are NOT recommended.

Ask your doctor for advice before taking any medicine.

Driving and using machines

While taking Metronidazole you may feel drowsy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or operate machinery.

2. BEFORE YOU TAKE METRONIDAZOLE

DO NOT take Metronidazole and tell your doctor if you:

•    are allergic to Metronidazole or any of the other ingredients in the tablets (listed in section 6 of this leaflet).

Warning and precautions

Tell your doctor before you take this medicine if you:

•    have kidney problems, particularly if you are undergoing haemodialysis

•    have liver problems

•    have an inherited blood disorder known as porphyria

•    have an active disease of the central nervous system, such as multiple sclerosis or Parkinson's disease.

Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.

If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with metronidazole and afterwards.

Tell your doctor immediately and stop taking metronidazole if you develop:

•    stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.

Important information about some of the ingredients of Metronidazole

Metronidazole 200 mg tablets contain lactose (a type of sugar). If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE METRONIDAZOLE

Always take Metronidazole tablets exactly as your doctor has told you.

For oral use only. Metronidazole tablets should be swallowed, without chewing, with half a glassful of water during or after meals.

Dosage

The usual dose for adults and children is given below:

To treat bacterial infections

Adults and children over 12 years: The initial dose is 800 mg. After 8 hours take another dose of 400 mg and repeat this dose every 8 hours. Treatment is usually for 7 days but will depend upon your condition.

Children under 12 years: Your doctor will work out the exact dose for your child based on your child's weight. The usual dose is 20-30 mg per kilogram of body weight given in a single daily dose, or divided into 7.5 mg per kilogram of body weight doses every 8 hours.

To prevent infections after surgery Adults and children over 12 years: Start taking the tablets 24 hours before your operation. Take 400 mg every 8 hours. After the operation you may be given Metronidazole either through a drip into a vein or rectally as a suppository until you are able to take tablets again.

Children under 12 years: Your doctor will work out the exact dose for your child based on your child's weight. The usual dose is 20-30 mg per kilogram of body weight, given in a single dose 1-2 hours before surgery.

To treat other types of infections

For the treatment of other infections caused by parasites or some bacteria your doctor will decide how much Metronidazole you need to take and how often, as this will depend upon your condition.

Elderly: It is particularly important to take the medicine exactly as your doctor has told you.

People with liver problems: Your doctor may tell you to take a lower dose or to take the medicine less often.

If you take more Metronidazole than you should

If you or a child accidentally takes too many tablets, contact your doctor or go to a hospital immediately. Take the container, this leaflet and any remaining tablets with you, if possible.

If you forget to take Metronidazole

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.

If you stop taking Metronidazole

It is important that you complete your full course of antibiotics; do not stop taking the tablets early if you feel better.

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

•    pain in the muscles or joints

•    darkening of the urine.

Not known (frequency cannot be estimated from the available data):

•    seizures have been experienced during intensive or prolonged therapy as well as nerve damage which may cause numbness, tingling, pain or a feeling of weakness in the arms or legs

•    patches of skin redness on the face, neck, arm, hands and feet (erythema multiforme)

•    red, raised, itchy lumps (urticaria)

•    unpleasant taste in the mouth, furred tongue, mouth ulcers

•    feeling sick (nausea), being sick (vomiting), stomach pain, diarrhoea

•    loss of appetite.

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.

5. HOW TO STORE METRONIDAZOLE

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.

Do not use the tablets after the expiry date, which is stated on the container.

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

4. POSSIBLE SIDE EFFECTS

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

STOP TAKING this medicine and see a doctor or go to a hospital straight away if you have:

•    an allergic reaction to the medicine. Symptoms of this include a rash, itching, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing

•    a serious but very rare side effect known as encephalopathy (brain disease). Symptoms of this include fever, stiff neck, headache or confusion. You may also have problems with speaking or poor co-ordination or muscle control.

Talk to your doctor straight away if you notice the following side effects:

•    effects on the blood. There may be a slight short-term reduction in the number of white blood cells which may cause chills, fever or infections. Bone marrow depression disorders which may result in low oxygen levels in the blood, infections, bleeding, bruising, paleness, headache, tiredness or irregular periods

•    liver problems such as cholestatic hepatitis (which may result in yellowing of the skin, itching and dark urine) as well as jaundice (yellowing of the skin or whites of the eyes). Abnormal liver function tests may also occur

•    an inflamed pancreas (pancreatitis) which may cause severe pain in the stomach and back.

Tell your doctor or pharmacist if you notice any of the following side effects:

Very rare (affects less than 1 in 10,000 people)

•    mental health problems such as seeing or hearing things that are not there (hallucinations)

•    drowsiness, dizziness, headache, fits (convulsions)

•    eyesight problems such as blurred or double vision

•    skin rashes, itching, small pus-containing blisters

What Metronidazole contains

The active ingredient in Metronidazole 200 mg and 400 mg tablets is metronidazole.

The other ingredients in the 200 mg tablets are lactose, maize starch, pregelatinised maize starch, sodium starch glycollate and magnesium stearate.

The other ingredients in the 400 mg tablets are dicalcium phosphate, maize starch, povidone K25, crospovidone and magnesium stearate.

What Metronidazole looks like and contents of the pack

Metronidazole 200 mg tablets are round white to off-white tablets with the marking MP35 on one side and a break line engraved on the other.

Metronidazole 400 mg tablets are round white tablets with the marking MP36 on one side and a break line engraved on the other.

The tablets come in containers of 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 140, 150, 168, 180, 500, 1000, 5000 and 50000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited,

41 - 43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

Haupt Pharma Berlin GmbH,

Gradestrasse 13, Moosrosenstrasse 5 and Britzer Damm 120, 12347 Berlin, Germany

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

This leaflet was last revised in 11/2016

GE0022-0023/O/PIL/GE2