Patient Information Leaflet

METRONIDAZOLE 200MG & 400MG TABLETS

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 side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Metronidazole is and what it is used for

Metronidazole belongs to a group of medicines called antibiotics.

Metronidazole is used for the treatment of:

•    bacterial infections including infection of the abdomen, brain, blood, lung, bones, pelvic area, intestines and the genital tract

•    certain bacterial and protozoal infection of the genital tract in women

•    ulceration of the gums and other dental infection.

•    infected pressure sores and leg ulcers

•    infections of intestines due to parasitic microorganisms It is also used for the prevention and treatment of bacterial infections after a surgical operation.

2. What you need to know before you take Metronidazole

•    Do not take Metronidazole Tablets if:

•    you are sensitive or allergic to metronidazole, nitroimidazoles or any of the ingredients in your medicine (signs of an allergic reaction include; a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue)

•    you are in the first 3 months of pregnancy or are breastfeeding (see ‘Pregnancy and breastfeeding’ later in this leaflet)

•    Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you:

•    are suffering from, or have suffered from, any liver disease

•    are suffering from any disease of the nervous system

•    are having kidney dialysis

•    are in the 4th-9th month of pregnancy

•    have epilepsy or have ever had fits

•    have porphyria (a genetic disease that can cause skin blisters, abdominal pain and brain/nervous system disorders)

•    have any disorder of the blood and/or blood cells

•    have been exposed to any sexually transmitted disease

•    Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Metronidazole can affect the way some other medicines work, also some other medicines may change the way Metronidazole works.

In particular, tell your doctor if you are taking:

•    anticoagulants ( medicines to thin the blood), such as warfarin

•    lithium (for the treatment of mania in bi-polar patients). If taken at the same time as Metronidazole, your kidneys may be affected

•    medicines used to treat epilepsy, such as phenytoin, phenobarbitone

•    cimetidine (used to treat stomach ulcer)

•    5-flurouracil, busulfan for cancer

•    ciclosporin, to prevent the rejection of organs after transplant

•    disulfiram for alcoholism

•    oestrogen contraceptive

If you are not sure, talk to your doctor or pharmacist before taking metronidazole.

♦ Taking this medicine with food and drink

You are advised not to drink any alcohol whilst taking Metronidazole tablets, and for 48 hours after finishing your course of tablets, as this might cause unpleasant side effect, such as nausea and vomiting, abdominal pain, hot flushes, palpitations and headache.

♦ Pregnancy and breast-feeding

Metronidazole tablets must not be taken during the first 3 months of pregnancy and should not be taken during the rest of the pregnancy.

If you breastfeed you should stop whilst taking

Metronidazole tablets and for 12-24 hours after

the course of tablets has finished before breastfeeding again. Ask your doctor or pharmacist for advice before taking this medicine.

♦    Driving and using machines

While taking Metronidazole you may feel dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems. If this happens, do not drive or use any machinery or tools.

♦    Metronidazole tablet contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose.

♦ Tests

Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days. This medicine may affect the results of some liver function tests (used to tell if your liver is working properly).

3. How to take Metronidazole

Always take metronidazole exactly as your doctor has told you. Check with your doctor if you are not sure. It is important to finish a full course of treatment. The length of a course will depend on your needs and the illness being treated. The tablets should be swallowed whole with water preferably during or after a meal. Do not chew them. Infants and young children will be treated with a liquid form of this medicine.

•    Dosage

The usual dose for adults and children is given below

•    Treatment of bacterial infection

Adults: 800mg initially followed by 400mg every 8 hours, for 7 days.

•    Children up to 12 years of age: Your doctor will advise on the number of tablets to give your child.

•    Bacterial Vaginosis

Adolescents: 400mg twice daily for 5-7 days.

•    Treatment of postoperative infections Children under 12 years: Your doctor will advise on the number of tablets to give your child.

•    Treatment of a genital infection in women Women and girls over 10 years: 400mg twice daily for 7 days or 2g as a single dose.

•    Treatment of Trichomoniasis (infection of the urogenital tract)

Adults and adolescents: 2g as a single dose or 200mg 3 times daily for 7 days or 400mg twice daily for 5-7 days.

Children under 10 years: Your doctor will advise on the number of tablets to give your child.

•    Treatment of Giardiasis (a parasitic infection of the intestines)

Adults, elderly and children over 10 years: 2g once daily for 3 days, or 400mg 3 times daily for 5 days, or 500mg twice daily for 7-10 days.

Children under 10 years: Your doctor will advise on the number of tablets to give your child.

•    Treatment of Amoebiasis (a parasitic infection of the intestines)

Adults and children over 10 years : 400 to 800mg 3 times daily for 5-10 days

Children under 10 years: Your doctor will advise on the number of tablets to give your child.

•    Treatment of Ulcerative Gingivitis (infection of the gums with ulcers)

Adults and children over 10 years: 200mg 3 times daily for 3 days.

Children under 10 years: Your doctor will advise on the number of tablets to give your child.

•    Treatment of infection of gums

Adults and children over 10 years: 200mg 3 times daily for 3-7 days.

•    Treatment of infected leg ulcers

Adults and children over 10 years: 400mg 3 times daily for 3-7 days.

•    Treatment of Helicobacter pylori in children

Your doctor will advise on the number of tablets to give your child. Your child will also be given another medicine at the same time.

If you are elderly or have liver disease, it is particularly important to take this medicine exactly as directed by the doctor.

♦    If you take more tablets than you should

If you or a child accidentally takes too many tablets, contact your nearest hospital casualty department or contact your doctor immediately. Bring any remaining tablets with you to show the doctor.

Signs of an overdose include feeling or being sick, loss of appetite, diarrhoea, metallic taste, headache, dizziness, insomnia or drowsiness.

♦    If you forget to take a dose

Do not worry just take your tablets as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

♦    Stop taking these tablets and see a doctor or go to a hospital straight away if you notice the following serious side effects:

•    swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).

•    a serious but very rare side effect which is a brain disease (encephalopathy). Symptoms include fever, stiff neck, headache, see or hear things that are not there. You might also have problems using your arms and legs, problems with speaking or feel confused.

•    a condition called subacute cerebellar syndrome. Symptoms include lack of muscle co-ordination, problems with speaking or walking, uncontrolled movement of the eyes and tremor

•    bone marrow depression disorders such as aplastic anaemia (causing weakness, bruising, making infections more likely)

•    a group of symptoms together including fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light (meningitis)

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

•    yellowing of the skin and eyes (jaundice).

•    unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness.

•    severe stomach pain which may reach through to your back (pancreatitis).

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

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

•    fits (convulsions)

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

•    problems with your eyesight such as blurred or double vision

•    skin rash and flushing

•    headache, drowsiness or dizziness

•    darkening of the urine

•    pain in the muscles or joints

Not known (frequency cannot be estimated from the

available data):

•    numbness, tingling, pain, or a feeling of weakness, in the arms or legs

•    sore mouth, unpleasant taste in the mouth and furred tongue

•    feeling sick (nausea), being sick (vomiting), upset stomach, or diarrhoea, pain in upper part of abdomen

•    loss of appetite, fever, feeling depressed

•    pain in your eyes (optic neuritis)

•    red skin patches and itching (erythema multiforme)

♦ Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:www .mhra.gov .uk/ yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metronidazole

Keep all medicines out of the sight and reach of children

•    Do not use the tablets after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    Keep container tightly closed.

•    Store in original container.

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.

6. Contents of the pack and other information

•    What Metronidazole tablets contain

Metronidazole 200mg tablets:

•    The active substance is 200mg of Metronidazole.

•    The other ingredients are lactose monohydrate, sodium starch glycollate (Type A), maize starch, micro-crystalline cellulose, colloidal anhydrous silica, macrogol 4000, magnesium stearate (E572) and povidone (E1201).

Metronidazole 400mg tablets:

•    The active substance is 400mg of Metronidazole.

•    The other ingredients are lactose monohydrate, sodium starch glycollate (Type A), maize starch, macrogol 4000, micro-crystalline cellulose, colloidal anhydrous silica, magnesium stearate (E572), povidone (E1201) and aluminium lake quinoline yellow (E104).

See end of section 2 for further information on lactose.

•    What Metronidazole looks like and contents of the pack

•    Metronidazole 200mg tablets are white, biconvex and embossed ‘M/200’ on one side and ‘PV’ on the other side.

•    Metronidazole 400mg tablets are yellow, biconvex and embossed ‘M/400’ on one side and ‘PV’ on the other side.

•    Metronidazole 200mg tablets are available in packs containing “14, 21,100,250 and 500 tablets”

•    Metronidazole 400mg tablets are available in packs containing “14, 21,100,250 and 500 tablets”

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale,

Greenford, Middlesex UB6 7HQ.

Telephone: 0208 997 5444

Fax:_0208 997 5433_

To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.

PL 04556 / 0010 & 04556 / 0011

Reference: 0010110514/03

The leaflet was last revised in May 2014