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
• 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.

Warnings and precautions

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 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 Metronidazole

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.

Metronidazole with food and drink

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 flushes, palpitations and headaches.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine. You should not take Metronidazole if you are pregnant, planning to become pregnant or are breast-feeding.

Driving and using machines

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 Rosemont contains, methyl, ethyl and propyl parahydroxybenzoates, glucose, sucrose, sorbitol and propylene glycol

• methyl, ethyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may not happen straight away
• glucose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, you must contact you doctor before taking this medicine. It may also be harmful to teeth.
• This medicine contains 113.7 mg sorbitol (E420) in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
• This medicine contains 31.1 mg propylene glycol (E1520) in each ml.
• If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
• If you are pregnant, breast-feeding, suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.