METRONIDAZOLE 500 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

1. what metronidazole is and what it is used for

Metronidazole is an anti-infective medicine. It is effective against a wide range of micro-organisms. It is used to treat the following:

• Ulcers in the stomach caused by a type of bacteria called Helicobacter pylori
• Genital or urinary tract infections caused by a parasite called Trichomonas
• Infections of the gums and/or teeth
• Bacterial infection of the genitals in females
• Bacterial infections in: the blood, the brain, the bones, the lungs, the stomach lining, the pelvic area after childbirth, a wound after an operation
• A parasitic disease called Giardiasis
• A parasitic disease called Amoebiasis
• Infected leg ulcers or bedsores

Metronidazole can also be used to prevent infections following an operation.

2. what you need to know before you take metronidazole

Do not take Metronidazole:

• if you are allergic to Metronidazole or any of the other ingredients of this medicine (listed in section 6)
• if you are in the first trimester (first three months) of your preganancy
• if you are breast-feeding

Warnings and precautions

Talk to your doctor or pharmacist before

taking Metronidazole:

• if you have kidney disease, especially if you are receiving dialysis treatments
• if you have ever had liver disease
• if you are in the second or third trimester (4th – 9th month) of your pregnancy
• if you have ever suffered from ‘fits’ or if you have been diagnosed with epilepsy
• if you have a genetic disease called porphyria, which can cause: skin blisters, brain disorders, nervous system disorders and abdominal pain
• if you have a blood disorder or disorder of any blood cells
• if you may have been exposed to a sexually transmitted disease
• if you have a nervous system disorder

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.

Serious skin reactions including Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP) have been reported with the use of metronidazole 500mg Film Coated Tablets.

• SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blister on the trunk. Also, ulcers of the mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
• AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blister accompanied by fever. The most common location: mainly localised on the skin folds, trunk and upper extremities.

The highest risk of occurrence of serious skin reactions is within one week, typically, within 48 hours after start of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Metronidazole and contact your doctor or seek medical attention immediately.

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.

Other medicines and Metronidazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Speak with your doctor if you are taking any of the following medications:

• medicines used to prevent blood clotting such as warfarin
• disulfiram, a medicine to treat alcohol addiction
• lithium, a medicine to treat depression
• ciclosporin, a medicine used following organ transplant
• fluorouracil, a medicine used to treat some forms of cancer
• cimetidine, a medicine used to treat stomach ulcers
• oral contraceptive medicines containing oestrogen Metronidazole with food, drink and alcohol

You should not consume alcohol whist taking and 48 hours after finishing your course of Metronidazole.

Pregnancy, breast-feeding and fertility

Metronidazole must not be taken in the first trimester of pregnancy. Metronidazole should not be used in the second and third trimester of pregnancy.

If you are breast-feeding, you should stop whilst you are taking Metronidazole and for 24 hours after the course of tablets has finished.

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

Metronidazole tablets may affect your vision and make you feel dizzy, drowsy and confused or cause hallucinations and fits. You should make sure you do not drive, operate machinery or take part in any activities that could put you or others at risk until you know how Metronidazole affects you.

Metronidazole tablets contain wheat starch

This medicine contains only very low levels of gluten (from wheat starch) and is unlikely to cause problems if you have coeliac disease.

One 500mg tablet contains no more than 164.30 micrograms of gluten.

If you have wheat allergy (different from coeliac disease) you should not take this medicine.

Tests

If you are taking this medicine for more than 10 days, your doctor may wish to carry out further tests. If you need any blood or urine tests, tell your doctor you are taking Metronidazole tablets before the test

3. how to take metronidazole

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Metronidazole should be taken during or after meals. Swallow the tablets whole, do not crush or chew them. The recommended dose will vary depending on the condition being treated. Metronidazole should be taken exactly as directed by your doctor.

For doses less than 500mg (one tablet) an alternative dosage form should be used.

If you are elderly or have liver disease, this may affect the dosage your doctor prescribes.

To treat anaerobic infections

Treatment for 7 days should be satisfactory for most patients but, depending upon clinical and bacteriological assesments, the physician may decide to prolong treatment.

• Children aged 8 weeks to 12 years: 20–30 mg/kg/day as a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection.
• Children under 8 weeks: 15 mg/kg as a single daily dose or divided into 7.5 mg/kg every 12 hours.
• Children under 10 years: a more suitable dosage form should be used.

To prevent infections after surgery

• Adults: 1000 mg as a single dose 24 hours before surgery followed by 400 mg at 8 hourly intervals during the 24 hours after the operation.
• Children under 12 years: 20–30 mg/kg as a single dose given 1–2 hours before surgery.
• Newborns with gestation age less than 40 weeks: 10 mg/kg body weight as a single dose before the operation.
• Children under 10 years: a more suable dosage form should be used.

Treatment of established infections

• Adults and children over 10 years: 800 mg following by 400 mg every 8 hours.
• Children under 10 years: a more suitable dosage form should be used.

To treat infection caused by Trichomonas

• Adults and adolescents: 2000 mg as a single dose or 200 mg 3 times a day for 7 days, or 400 mg twice a day for 5–7 days. Your partner should also be treated.
• Children under 10 years: 40 mg/kg taken orally as a single dose or 15–30 mg/kg/day divided into 2–3 doses taken over 7 days. Doses should not exceed 2000 mg/dose.
• Children under 10 years: a more suitable dosage form should be used.

Genital infections in women

• Adults: 400 mg taken twice daily for 7 days, or 2000 mg as a single dose for 1 day only.
• Adolescents: 400 mg taken twice daily for 5–7 days, or 2000 mg as a single dose.

To treat amoebiasis

• Adults and children over 10 years: 400 to 800 mg 3 times a day for 5–10 days.
• Children 7 to 10 years: 200 to 400 mg 3 times a day for 5–10 days.
• Children 3 to 7 years: 100 to 200 mg 4 times a day for 5–10 days.
• Children 1 to 3 years: 100 to 200 mg 3 times a day for 5–10 days, or 35 to 50 mg/kg daily in 3 divided doses for 5–10 days, not exceeding 2400 mg/day.
• Children under 7 years: a more suitable dosage form should be used.

To treat giardiasis

• Adults and children over 10 years: 2000 mg once a day for 3 days, or 400 mg three times a day for 5 days,

or 500 mg twice daily for 7–10 days.

• Children 7 to 10 years: 1000 mg once a day for

• 3 days.

• Children 3 to 7 years: 600 to 800 mg once a day for

3 days.

• Children 1 to 3 years: 500 mg once a day for 3 days, or 15–40 mg/kg/day divided into 2–3 doses.
• Children under 7 years: a more suitable dosage form should be used.

To treat infections of the gums (for 3 days) or teeth (for 3–7 days)

• Adults and children over 10 years: 200 mg 3 times a day.
• Children under 10 years: a more suitable dosage form should be used.

To treat infected leg ulcers and pressure sores (for 7 days)

• Adults and children over 10 years: 400 mg 3 times a day.

To treat stomach ulcers caused by Helicobacter pylori

• To be taken as part of a combination therapy as directed by your doctor, 20 mg/kg/day, not exceeding 500 mg twice daily for 7–14 days.

If you take more Metronidazole than you should If you or someone else may have swallowed a lot of metronidazole tablets, contact your nearest casualty department or tell your doctor straight away. You should take the package with you even if it is empty. Signs of an overdose include nausea, being sick, loss of appetite, diarrhoea, headache, dizziness, drowsiness, insomnia and metallic taste.

If you forget to take Metronidazole

If you forget to take Metronidazole, do not worry. Take your dose as soon as you remember, unless it is nearly time for your next dose, in which case just continue to take your next dose as normal. Do not take a double dose to make up for a forgotten dose.

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

If you stop taking Metronidazole

If you stop taking Metronidazole tablets your infection may come back. Seek the advice of your doctor before you stop taking Metronidazole tablets.

4. possible side effects

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

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Metronidazole.

Contact your doctor immediately if you notice any of the following serious side effects (it is not known how frequently these side effects occur):

• Allergic reaction: symptoms can include a skin rash (which might be itchy), swelling of the face, lips, tongue or throat, fever or difficulty in breathing

Other Side effects:

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

• increased bruising, nosebleeds, sore throats or infections – this medicine may alter the numbers and types of your blood cells. Your doctor may want you to have a blood test if you experience any of these symptoms
• mental health problems including hallucinations (seeing or hearing things that are not there),
• drowsiness, dizziness, fits, tingling, numbness, pain or a feeling of weakness in the arms or legs
• Encephalopathy (headaches, light sensitivity, confusion, fever, paralysis, a ‘stiff neck’)
• Cerebellar syndrome (poor muscle control coordination, involuntary shaking, uncontrolled eye movements, speech disorders, abnormal walking)
• double vision, short sightedness
• changes in liver function tests, jaundice (yellowing of the skin or whites of the eyes)
• pancreatitis (inflammation of the pancreas causing very severe abdominal pain)
• flushing
• skin rashes, itching, small pus-containing blisters
• muscle and joint pain
• darkening of the urine

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

• bone marrow depression disorders such as aplastic anaemia (causing weakness, bruising and increasing the likelihood of infections)
• urticaria (itchy, pale or red irregular raised patches of skin), fever
• depression
• ‘pins and needles’
• an unpleasant taste in the mouth, changes in taste, furred tongue, mouth ulcers
• feeling or being sick, loss of appetite, diarrhoea, stomach pain and upset stomach
• erythema multiforme (circular, irregular red patches)

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 the MHRA Yellow Card Scheme – Website:.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store metronidazole

Keep blister packs in the outer carton, protected from light.

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

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.

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 contains

• The active substance is Metronidazole 500mg

What Metronidazole looks like and contents of the pack

Metronidazole 500mg Film Coated Tablets are white to yellow, round, biconvex film-coated tablets with ‘M2’ embossed on one side.

Metronidazole is available in packs of 21 tablets.

Marketing Authorisation Holder

Zentiva Pharma UK Limited

• 12 New Fetter Lane

Z0NTIVA 1065027742

Z0NTIVA

Z0NTIVA       1065027742