1. What Flazol is and what it is used for
The name of this medicine is Flazol. Flazol contains a medicine called metronidazole benzoate. 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 ulcers and pressure sores
• Prevent infections after surgery

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

2. Before you take Flazol
Do not take Flazol 
- If you are allergic (hypersensitive) to metronidazole, nitroimidazoles (e.g. tinidazole) or any of the other ingredients in your medicine.
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not take Flazol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Flazol.
Take special care with Flazol and check with your doctor or pharmacist before using your medicine if:

• You have or have ever had a liver problem.
• You are 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 Flazol 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 of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Flazol and contact your doctor or seek medical attention immediately.

Tell your doctor immediately and stop taking Flazol if you develop:

Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal medicines. This is because Flazol can affect the way some other medicines work. Also, some other medicines can affect the way Flazol works. In particular tell your doctor if you are taking any of the following medicines:

• Medicines used to thin the blood such as warfarin
• Lithium for mental illness
• Phenobarbital or phenytoin for epilepsy
• 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 Flazol.

If you are not sure, talk to your doctor or pharmacist before taking Flazol.
Taking Flazol with food and drink
Do not drink any alcohol while you are taking Flazol and for 48 hours after finishing your course. Drinking alcohol while using Flazol 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 breastfeeding
Tell your doctor before using Flazol if:

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

Driving and using machines
While taking Flazol 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.
Important information about some of the ingredients of this medicine
Sugar intolerance: If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine. It may also be harmful to teeth.
Methyl and propyl parabens: These may cause an allergic reaction. This allergy may not happen straight away.
Tests: If you are taking this medicine for more than 10 days, your doctor may wish to carry out further tests.
If you need any blood or urine tests, tell your doctor you are taking Flazol before the test.
 

3. How to take Flazol
Taking your medicine
Always take Flazol 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.
Flazol Oral Suspension 

• Take Flazol Suspension by mouth
• The dose of Flazol 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
• Your doctor or pharmacist may dilute your Flazol Suspension. In this case the pharmacist’s label on the packaging will tell you how exactly much to take and how often.

The usual dose for adults and children is given below:

Flazol Film Coated Tablets

• 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 Flazol 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

To treat certain bacterial infection
Doses:
Flazol Film Coated Tablets
Adults

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

Flazol Oral Suspension 
Children and infants

• Your doctor will work out how much your child should take depending on his 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

To prevent infections from happening after surgery
Flazol Film Coated Tablets
Adults

• Start Taking Flazol Tablets 24 hours before your operation
• Take 400 mg of Flazol 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

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

Flazol Oral Suspension 
Children

• Give your child Flazol suspension 2-3 hours before their operation
• Your doctor will work out how much your child should take depending on his weight

Other types of infections
For treatment of other infections caused by parasites and some bacteria your doctor will decide how much Flazol 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 exactly how many tablets or how much Flazol Suspension to take and how often.
People having kidney dialysis
Kidney dialysis removes Flazol 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 Flazol than you should
If you take more Flazol than you should, tell your doctor or go to your nearest hospital casualty department straight away.
Take the pack with you. This is so the doctor knows what you have taken.
If you forget to take Flazol
If you forget to take Flazol, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

4. Possible side effects
Like all medicines, Flazol can cause side effects, particularly when you first start taking it, although not everybody gets them.
Stop taking Flazol 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 Flazol.
• 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 Flazol 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 Flazol 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 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)

Not known (frequency cannot be estimated from the available data)

• Numbness, tingling, pain, or a feeling of weakness in the arm 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

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist. 

5. How to store Flazol
Keep out of reach of children.
Store below 30°C.
Flazol Oral Suspension:
After opening, discard any unused suspension after 28 days.
Do not use beyond the expiry date or if the product shows any sign of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.