Patient leaflet - Metronidazole 500 mg tablets

1. What Metronidazole tablets are and what they are used for

Metronidazole 500mg Tablets contain the active substance metronidazole which is an anti-infective medicine. It is eﬀective against a wide range of microorganisms.

It is used to treat the following:

Ÿ Ulcers in the stomach caused by a type of bacteria called Helicobacter

pylori.

Ÿ Genital or urinary tract infections caused by a parasite called

Trichomonas.

Ÿ Infections of the gums and/or teeth.

Ÿ Bacterial infection of the genitals in females.

Ÿ Bacterial infections: in the blood, the brain, the bones, the lungs, the

stomach lining, the pelvic area after childbirth, a wound after an operation.

Ÿ A parasitic disease called Giardiasis.

Ÿ A parasitic disease called Amoebiasis.

Ÿ 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 tablets

Do not take Metronidazole tablets

Ÿ if you are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or

any of the other ingredients of this medicine (listed in section 6) Ÿ if you are in the ﬁrst trimester (ﬁrst 3 months) of your pregnancy Ÿ if you are breast-feeding

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Metronidazole tablets if you:

Ÿ have kidney disease, especially if you are receiving dialysis treatment Ÿ have ever had liver disease

th th Ÿ are in the second or third (4 – 9 month) of your pregnancy Ÿ have ever suﬀered from 'ﬁts' or if you have been diagnosed with

epilepsy

Ÿ have a genetic disease called porphyria, which can cause: skin blisters,

brain disorders, nervous system disorders and abdominal pain Ÿ have a blood disorder or disorder of any blood cells

Ÿ may have been exposed to a sexually transmitted disease Ÿ have a nervous system disorder

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking your medicine. Do this even if they have applied in the past.

Tell your doctor immediately and stop taking Metronidazole tablets if you develop:

Stomach pain, anorexia (loss of appetite), nausea (feeling sick), vomiting (being sick), fever, malaise, fatigue, vertigo (spinning sensation), jaundice, dark urine, putty or mastic coloured stools or itching.

Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with products 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 tablets. Ÿ SJS/TEN can appear initially as reddish target-like spots or circular

patches often with central blisters 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.

Ÿ AGEP appears at the initiation of treatment as a red, scaly widespread

rash with bumps under the skin and blisters 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 tablets and contact your doctor or seek medical attention immediately.

Other medicines and Metronidazole tablets

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Metronidazole tablets can aﬀect the way some other medicines work. Also, some other medicines can aﬀect the way metronidazole works.

Speak with your doctor if you are taking any of the following medications: Ÿ medicines used to prevent blood clotting such as warfarin Ÿ medicines used to treat epilepsy such as phenytoin, phenobarbital, and primidone

Ÿ disulﬁram, a medicine to treat alcohol addiction

Ÿ lithium for mental illness, a medicine to treat depression Ÿ ciclosporin, a medicine used following organ transplant Ÿ ﬂuorouracil, a medicine used to treat some forms of cancer Ÿ busulfan, a medicine used to treat leukaemia (cancer of the blood cells) Ÿ cimetidine, a medicine used to treat stomach ulcers

Ÿ oral contraceptive medicines containing oestrogen

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

Metronidazole tablets with food, drink and alcohol

You should not consume alcohol whilst taking 48 hours after ﬁnishing your course of Metronidazole tablets. Drinking alcohol while using metronidazole 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.

Pregnancy and breast-feeding

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 tablets and for 24 hours after the course of tablets has ﬁnished. This is because small amounts may pass into the mother's milk.

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

While taking Metronidazole tablets you may feel dizzy or experience vertigo (spinning sensation), confusion, hallucinations (seeing or hearing things that are not there), convulsions (ﬁts) or temporary eyesight problems (such as blurred or double vision). 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 tablets aﬀect you.

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 tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important to ﬁnish a full course of treatment.

Metronidazole tablets should be taken during or after meals. Swallow the tablets whole with a drink of water, do not crush or chew them.

The recommended dose and length of a course will vary depending on the condition being treated. Metronidazole tablets should be taken exactly as directed by your doctor.

For doses less than 500 mg (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 on clinical and bacteriological assessments, the physician may decide to prolong treatment.

Ÿ Children 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. Ÿ Children under 8 weeks: 15 mg/kg/day as a single dose or divided into

7.5 mg/kg every 12 hours.

Ÿ Children under 10 years: a more suitable dosage form should be used for this age group.

To prevent infections after surgery

Ÿ 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. Ÿ Children under 12 years: 20 – 30 mg/kg as a single dose 1 – 2 hours before surgery.

Ÿ Newborns with gestation age less than 40 weeks: 10 mg/kg body weight as a single dose before the operation.

Ÿ Children under 10 years: a more suitable dosage form should be used.

Treatment of established infections

Ÿ Adults and children over 10 years: 800 mg followed by 400 mg every 8 hours.

Ÿ Children under 10 years: a more suitable dosage form should be used.

To treat infection caused by Trichomonas

Ÿ 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.

Ÿ 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.

210.00 mm

Genital infections in women

Ÿ Adults: 400 mg taken twice daily for 7 days, or 2000 mg as a single dose

for 1 day only.

Ÿ Adolescents: 400 mg taken twice daily for 5 – 7 days, or 2000 mg as a

single dose.

To treat amoebiasis

Ÿ Adults and children over 10 years: 400 – 800 mg 3 times a day for

5 – 10 days.

Ÿ Children 7 to 10 years: 200 – 400 mg 3 times a day for 5 – 10 days. Ÿ Children 3 to 7 years: 100 – 200 mg 4 times a day for 5 – 10 days. Ÿ Children 1 to 3 years: 100 – 200 mg 3 times a day for 5 – 10 days, or

35 to 50 mg/kg/day in 3 divided doses for 5 – 10 days, not exceeding 2400 mg/day.

Ÿ Children under 7 years: a more suitable dosage form should be used.

To treat giardiasis

Ÿ Adults and children over 10 years: 2000 mg once a day for 3 days, or

400 mg 3 times a day for 5 days, or 500 mg twice daily for 7 – 10 days. Ÿ Children 7 to 10 years: 1000 mg once a day for 3 days. Ÿ Children 3 to 7 years: 600 – 800 mg once a day for 3 days. Ÿ Children 1 to 3 years: 500 mg once a day for 3 days, or

15 – 40 mg/kg/day divided into 2 – 3 doses.

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

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

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

To treat stomach ulcers caused by Helicobacter pylori

Ÿ 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 tablets than you should If you or someone else may have swallowed more Metronidazole tablets than you should, contact your nearest hospital 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 tablets

If you forget to take a dose, 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 stop taking Metronidazole tablets

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

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

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 tablets.

Stop taking Metronidazole tablets and see a doctor or go to a hospital straight away if you notice any of the following serious side eﬀects – you may need urgent medical treatment:

Ÿ You have an allergic reaction. The signs may include: swelling of the

hands, feet, ankles, face, lips or throat which may cause diﬃculty in swallowing or breathing, an itchy, lumpy rash (hives) or nettle rash (urticaria).

Ÿ A serious but very rare side eﬀect is a brain disease (encephalopathy).

Symptoms vary but you might get a fever, stiﬀ neck, headache, or see or hear things that aren't there. You might also have problems using your arms and legs, problems with speaking or feel confused. Ÿ You develop skin rashes including Stevens-Johnson syndrome or toxic

epidermal necrolysis. These can appear as reddish target-like spots or circular patches often with central blisters on the trunk, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and can be preceded by fever and ﬂu-like symptoms. Stop using Metronidazole tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See section 2.

Ÿ You develop a red, scaly widespread rash with bumps under the skin

and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Metronidazole tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See section 2.

Ÿ Yellowing of the skin and eyes. This could be due to a liver problem

(jaundice).

Ÿ Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe

tiredness. This could be caused by a blood problem.

Ÿ Severe stomach pain which may reach through to your back

(pancreatitis).

Other side eﬀects

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

Ÿ 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.

Ÿ Mental health problems including hallucinations (seeing or hearing

things that are not there).

Ÿ Drowsiness, dizziness, ﬁts (convulsions), tingling, numbness, pain or a feeling of weakness in the arms or legs.

Ÿ Encephalopathy (headaches, light sensitivity, confusion, fever, paralysis, a 'stiﬀ neck').

Ÿ Cerebellar syndrome (poor muscle control co-ordination, involuntary shaking, uncontrolled eye movements, speech disorders, abnormal walking).

Ÿ Double or blurred vision, short sightedness.

Ÿ Changes in liver function tests, jaundice (yellowing of the skin or whites of the eyes).

Ÿ Pancreatitis (inﬂammation of the pancreas causing very severe abdominal pain).

Ÿ Flushing.

Ÿ Skin rashes, itching, small pus-containing blisters.

Ÿ Muscle and joint pain.

Ÿ Darkening of the urine.

Ÿ Liver problems including life-threatening liver failure (hepatocellular liver injury).

Not known (frequency cannot be estimated from the available data) Ÿ Numbness, tingling, pain, or a feeling of weakness, in the arms or legs. Ÿ Acute liver failure in patients with Cockayne Syndrome (see section 2

“Warnings and precautions”).

Ÿ Bone marrow depression disorders such as aplastic anaemia (causing weakness, bruising and increasing the likelihood of infections). Ÿ Urticaria (itchy, pale or red irregular raised patches of skin). Ÿ Fever.

Ÿ Depression.

Ÿ Pain in your eyes (optic neuritis).

Ÿ 'Pins and needles'.

Ÿ An unpleasant taste in the mouth, changes in taste, furred tongue, mouth ulcers.

Ÿ Feeling or being sick, loss of appetite, diarrhoea, stomach pain and upset stomach.

Ÿ Erythema multiforme (circular, irregular red patches). Ÿ A group of symptoms together including: fever, nausea, vomiting, headache, stiﬀ neck and extreme sensitivity to bright light. This may be caused by an inﬂammation of the membranes that cover the brain and spinal cord (meningitis).

Ÿ Hearing impairment/hearing loss.

Ÿ Ringing in the ears (tinnitus).

Ÿ Vertigo (spinning sensation).

Ÿ You get a rash or skin discolouration with or without raised areas which often reoccurs at the same location each time the drug is taken.

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 Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects, you can help provide more information on the safety of this medicine.

5. How to store Metronidazole tablets

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Keep this medicine out of the sight and reach of children. No special storage conditions are required.

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 to protect the environment.

6. Contents of the pack and other information What Metronidazole tablets contain

Ÿ Each tablet contains 500 mg of the active substance, metronidazole. Ÿ The other ingredients are: anhydrous calcium hydrogen phosphate

(E341), pregelatinised maize starch, povidone (PVP K30) (E1201), maize starch, crospovidone, cellulose, microcrystalline, silica colloidal anhydrous and magnesium stearate.

Ÿ The coating of the tablets contains: Hypromellose, polyethylene glycol 400 and puriﬁed water.

What Metronidazole tablets look like and contents of the pack

Metronidazole 500mg tablets are white to oﬀ white, round convex shaped (approx. 13.00 mm) ﬁlm coated tablets, debossed “500” on one side and plain on the other side.

Metronidazole 500mg tablets are available in aluminium/PVC blister packs of 14, 15, 21 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

DAWA Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited,