Read this leaflet carefully before you start taking this medicine. (DOWNLOAD)
- Keep this leaflet. You may need to read it again before, during or after use of this medicine. • If you have any further questions, ask your healthcare provider.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please inform your health care provider.
In this leaflet:
- What Metrone Tablet is and what it is used for
- What you need to know before you take Metrone Tablet
- How to use Metrone Tablet
- Possible side effects
- How to store Metrone Tablet
- Contents of the pack and other information
- WHAT METRONE TABLET IS AND WHAT IT IS USED FOR
Metrone Tablet belongs to a group of medicines known as antibiotics. It contains metronidazole and is used for the prevention and treatment of infections caused by certain species of bacteria. It works by killing bacteria and protozoal parasites that cause infections in your body. It is used in adults and children 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.
- WHAT YOU NEED TO KNOW BEFORE YOU TAKE METRONE TABLET Do not take Metrone Tablet 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 applies to you, talk to your doctor or pharmacist before taking this 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 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 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, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Other medicines and Metrone Tablet
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. If taken at the same time as metronidazole, the kidneys may be affected. • Medicines used to treat epilepsy,such as 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.
Metrone Tablet 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 Metrone Tablet 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 breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
While taking Metrone Tablet, 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.
- HOW TO USE METRONE TABLET
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 of your treatment will 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 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 he/she is 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, 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.
- POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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.
- 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.
Talk to your doctor straight away if you notice the following side effects. • 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 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)
Not known (frequency cannot be estimated from the available data)
- 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, 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
Reporting of side effects
If you get any side effects, talk to your healthcare provider. This includes any possible side effects not listed in this leaflet.
By reporting side effects you can help provide more information on the safety of this medicine.
- HOW TO STORE METRONE TABLET
- Keep all medicines out of reach of children.
- Store below 30°C in its original package, protected from light.
- Do not use Metrone Tablet after the expiry date which is stated on the carton and label after ‘Exp. Date’. The expiry date refers to the last day of that month.
- FURTHER INFORMATION.
What Metrone Tablet contains
Metrone 200 Tablet contains Metronidazole 200mg.
Metrone 400 Tablet contains Metronidazole 400mg.
What Metrone Tablet looks like and contents of the pack
Metrone 200 Tablet is packed as 10 x 10 Tablets in sachet placed in a carton with the Patient Information Leaflet.
Metrone 400 Tablet is packed as 10 x 10 Tablets in sachet placed in a carton with the Patient Information Leaflet..
