METRONIDAZOLE

Do not take Metronidazole and tell your doctor if:

• you are allergic to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients of this medicine(listed in section 6). Signs of an allergic reaction include a rash, itching or shortness of breath
• treating infections, including infections of your blood, brain, lungs, bones, lining of your abdomen, pelvis and infections following childbirth or around the area where you had an operation
• you are pregnant, think you are pregnant or breast feeding. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metronidazole.

Talk to your doctor before taking Metronidazole if:

• you have liver problems
• you have a disease of the nervous system
• you are having haemodialysis.

• If you are on this medicine for more than 10 days, your doctor may give you some tests.
• If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Metronidazole.
• 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 exanthematouspustulosis (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 ¬u-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.

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

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

• warfarin – used to thin your blood
• lithium – used to treat depression
• phenobarbital, phenytoin or carbamazepine – used to treat epilepsy
• 5-¬fluorouracil – used to treat cancer
• busulfan – used to treat leukaemia
• ciclosporin or tacrolimus – used after organ transplants
• disulfiram – used to treat alcoholism.

Do not drink alcohol whilst taking Metronidazole and for 48 hours after finishing the treatment. Drinking alcohol may cause unpleasant side effects such as nausea, vomiting, pain in and around your stomach area (the abdomen), hot ushes, palpitations and headaches.

Metronidazole may make you feel drowsy, dizzy or confused. It may cause you to see and hear things that are not there (hallucinations), have fits or give you blurred or double vision. If you are affected, do not drive or operate machines. Metronidazole Powder For Oral Suspension contains, sodium Benzoate, Bronopol, MethylPeraben, PropylPeraben, Sugar, Citricacid, Menthol, sodium Sacharine, ZenthanGum, Aspartame, water.

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor orpharmacist if you are not sure. The different routines you might follow are shown below.

Taking this medicine

• This medicine contains 125mg of metronidazole in each 5ml.
• Take this medicine by mouth.
• Always shake the bottle before use.
• Complete the full course of this medicine.

• Your doctor may prescribe a lower dose than that given to adults. This is because you may be more sensitive to the medicine.

Like all medicines, Metronidazole 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 a brain disease (encephalopathy) which is a serious but very rare side effect. Symptoms vary but you mightget a fever, stiff neck, headache, see or hear things that aren’t there. You might also have problems using yourarms and legs, problems with speaking or feeling confused
• you get a group of symptoms together including: fever, nausea, vomiting, headache, stiff neck and extreme sensitivityto bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord(meningitis)
• 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 or nettle rash. This may mean you are having an allergic reaction toMetronidazole
• blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also ¬flu-like symptoms and fever.
• This may be something called `Steven Johnson Syndrome’ which is a severe blistering rash where layers of theskin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell,fever, chills and aching muscles. Sometimes called Toxic epidermal necrolysis.
• you develop a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at theinitiation of treatment (acute generalised exanthematouspustulosis). Stop using Metronidazole if you developthese symptoms and contact your doctor or seek medical attention immediately. See also section 2.

What Metronidazole Powder For Oral Suspension contains

• The active substance is metronidazole benzoate. Each 5ml contains 320mg metronidazole benzoate. This is equivalent to 125mg metronidazole.

What Metronidazole Powder For Oral Suspension looks like and contents of the pack

• A white color powder filled in a white plastic bottle.