METRONIDAZOLE 400 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - METRONIDAZOLE 400 MG TABLETS

Metronidazole 200mg Tablets Metronidazole 400mg 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 further questions, please 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Metronidazole tablets are and what they are used for
2. What you need to know before you take Metronidazole tablets
3. How to take Metronidazole tablets
4. Possible side effects
5. How to store Metronidazole tablets
6. Contents of the pack and other information

1. what metronidazole tablets is and what it is used for

The name of this medicinal product is Metronidazole tablets and contains the active substance metronidazole. Metronidazole belongs to a group of medicines called antibiotics.

It works by killing bacteria and parasites that cause infections in your body. It can be used to

Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines
Treat gum ulcers and other dental infections
Treat infected leg ulcers and pressure sores
Prevent infections after surgery

If you need any further information on your illness, speak to your doctor.

2. what you need to know before you take metronidazole tablets do not takemetronidazole tablets if:

You are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients in your medicine (listed in Section 6: Contents of the pack and other information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Do not take metronidazole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking metronidazole.

Warnings and precautions

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

You have or have ever had a liver problem.
You are having kidney dialysis (see section 3: ‚People having kidney dialysis‘)
You have a disease of the nervous system

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

Do this even if they have applied in the past.

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 Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole.

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.
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 for 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, annorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.

Other medicines and Metronidazole tablets

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

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

Anti-coagulants (blood thinning agents), such as warfarin. The dosage of warfarin may need to be reduced when you are taking this drug.
Lithium for mental illness
Medicines used to treat epilepsy, such as phenobarbital, phenytoin, primidone
5 fluorouracil for cancer
Busulfan for leukemia (cancer of the blood cells)
Ciclosporin – to prevent the rejection of organs after transplant
Disulfiram for alcoholism

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

Metronidazole tablets with food and drink

Do not drink any alcohol while you are taking metronidazole and for 48 hours after finishing your course. 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, breast-feeding and fertility

Tell your doctor before using metronidazole if:

You are pregnant, might become pregnant or think you may be pregnant. Metronidazole should not be taken during pregnancy unless considered absolutely necessary.
You are breast-feeding. It is better not to use metronidazole if you are breast-feeding. This is because small amounts may pass into the mother's milk.

Driving and using machines

While taking metronidazole you may feel sleepy, 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 use any machinery or tools.

Tests

Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.

3. how to take metronidazole tabletstaking your medicinealways take metronidazole tablet exactly as your doctor has told you. 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.

Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with a drink of water
Do not crush or chew the tablets
Take these tablets during or just after a meal
The dose of metronidazole will depend on your needs and the illness being treated
The length of your treatment will depend on the type of illness you have and how bad it is

The usual dose for adults and children is given below:

To treat bacterial infection

Adults

The initial dose is 800 mg
After 8 hours take another dose of 400 mg and repeat this dose every 8 hours
Your doctor will work out how much your child should take depending on their weight
Repeat the dose every 8 hours
If your child is a baby under 8 weeks of age, your doctor will give them one daily dose or two separate doses 12 hourly
Start taking Metronidazole 24 hours before your operation
Take 400 mg of metronidazole 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

PHARMACODE

Children

Give your child metronidazole 1–2 hours before their operation
Your doctor will work out how much your child should take depending on their weight
After the operation your child may be given metronidazole either through a drip into a vein or rectally as a suppository until they are able to take tablets again

Other types of infections

For treatment of other infections caused by parasites and some bacteria your doctor will decide how much metronidazole you need to take and how often. This will depend on your illness and how bad it is. The pharmacist's label on the packaging will tell you how many tablets to take and how often to take them.

People having kidney dialysis

Kidney dialysis removes metronidazole from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.

People with liver problems

Your doctor may tell you to use a lower dose or to use the medicine less often.

If you take more Metronidazole tablets than you should

If you take more metronidazole than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the pack and any tablets left with you. This is so the doctor knows what you have taken.

If you forget to take Metronidazole tablets

If you miss a dose, take it as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual. 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 metronidazole and see a doctor or go to a hospital straight away if:

You get 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) This may mean you are having an allergic reaction to metronidazole.
A serious but very rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache, see or hear things that aren't there. You might also have problems using your arms and legs, problems with speaking or feel confused.
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 if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
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 if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
Yellowing of the skin and eyes. This could be due to a liver problem (jaundice).
Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem.
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 10000 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 or flushing
Headache
Darkening of the urine
Feeling sleepy or dizzy
Pains in the muscles or joints
Liver problems including life-threatening liver failure (hepatocellular liver injury)
Numbness, tingling, pain, or a feeling of weakness, in the arms or legs
Unpleasant taste in the mouth
Furred tongue
Feeling sick (nausea), being sick (vomiting), upset stomach, stomach pain or diarrhoea
Loss of appetite
Fever
Feeling depressed
Pain in your eyes (optic neuritis)
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)
Hearing impairment/ hearing loss
Ringing in the ears (tinnitus)
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

5. how to store metronidazole tablets

Keep your medicine in a safe place and out of the sight and reach of children.

No special storage condition is required.

Do not use this medicine after the expiry date shown on the pack.

Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing out with your normal household rubbish. This will help protect the environment.

6. contents of the pack and other informationwhat metronidazole tablets contain:each tablet contains 200 mg, 400 mg or 500 mg of metronidazole as the active substance.

The other ingredients are: anhydrous calcium hydrogenphosphate, pregelatinized maize starch, povidone (PVP K30), maize starch, crospovidone, cellulose microcrystalline, silica colloidal anhydrous and magnesium stearate

The coating of the tablets contains: hypromellose, polyethylene glycol 400

What Metronidazole tablets look like and contents of the pack:

Metronidazole 200mg Tablets are white to off white coloured, caplet shaped (aprox. 14.20 mm x 5.70mm) film coated tablets, debossed “200” on one side & plain on other side.

Metronidazole 400mg Tablets are white to off white coloured, caplet shaped (approx. 17.00mm x 6.00mm) film coated tablets, debossed “400” on one side & plain on other side.

Metronidazole 200mg and 400mg tablets are available in aluminium/PVC blister pack of 14, 21 & 100 tablets.

Marketing Authorisation Holder:

DAWA Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, UK

Manufacturer:

Drugsrus Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, UK

This leaflet was last updated in November 2019.

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