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

Patient leaflet - METRONIDAZOLE TABLETS BP 400 MG

Metronidazole Tablets BP 200mg Metronidazole Tablets BP 400mg

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

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. This includes any possible side effects not listed in this leaflet. See section 4. ____________________________________________________

What is in this leaflet:

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 ARE AND WHAT THEY ARE USED FOR

The name of this medicine is metronidazole. This 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 ulcersand 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 take Metronidazole 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: Further 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 apply 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 apply 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 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 generalised 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. Iftakenatthesametimeas metronidazole, the kidneys may be affected.
Medicines used to treatepilepsy.suchas phenytoin, primidone, phenobarbital
5 fluorouracil for cancer
Busulfan for leukaemia (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.

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 and breast-feeding

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.

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctororpharmacistforadvice before taking any medicine

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 notdriveor use any machinery or tools.

Tests

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

3. how to take metronidazole tablets

Taking your medicine

Always take metronidazole exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist 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.

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 ofyourtreatmentwill depend on the type of illness you have and how bad it is

The recommended dose for adults and children is given below:

To treat bacterial infection

Adults

The initial dose is 800mg
After 8 hours take another dose of 400mg and repeat this dose every 8 hours

Children

Your doctor will work out how much your child should take depending on their weight
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

repeat the dose every 8 hours

To prevent infections from happening after surgery

Adults

Start Taking metronidazole Tablets 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

Children

Start giving your child Metronidazole Tablets 1–2 hours before their operation
Your doctor will workout 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

Othertypes 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, contact your doctor or nearest hospital emergency department immediately. Always take the box, this leaflet and any tablets that are left over with you, if you can. 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, this medicine can cause side effects, although noteverybody 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.
Aserious butvery rare side effect Isa 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 orfeel 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.

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

Yellowing of the skin and eyes. This could bedue 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 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
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
Unpleasanttaste in the mouth
Furred tongue
Feeling sick (nausea), being sick (vomiting), upset stomach, 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 this medicine out of the sight and reach of children.

Store below 25°C in original packing (protect from light)

Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of thatmonth.

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 packand other information

What Metronidazole Tablets contain

Each tablet contains 200mg or 400mg of metronidazole as the active substance.

The other ingredients are povidone, magnesium stearate.colloidal anhydrous silica and maize starch.

What Metronidazole Tablets look like and contents of the pack

The tablets are off-white coloured, round, biconvex and uncoated, engraved with either'MZ 200’ (200mg) or ‚MZ 400‘ (400mg) and a break line on one side whilst plain on the other.

Metronidazole Tablets 200mg are available in containers of 7, 14,15, 21,28,42,56, 70,84,100, 250, 500 and 1000 as well as in bottles containing 50 tablets.

Metronidazole Tablets 400mg are available in containers of 28,30,50,60,84,90,100,112,120,140, 168,180,500 and 1000 tablets.

They are also available in blister packs of 7,14,15,21,28,42,56, 70 and 84 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Milpharm Limited,

Ares, Odyssey Business Park,

West End Road,

South Ruislip, HA46QD

United Kingdom

Manufacturers: