Flagyl 200 mg/5 ml Tablets

FLAGYL contains metronidazole, and it works by killing bacteria and parasites that cause infections in your body. It can be used to:

• Treat infections caused by certain bacteria
• Prevent infections after surgery.

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

Do not take FLAGYL if:

• You or your child are allergic (hypersensitive) to metronidazole or any of the other ingredients in FLAGYL. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You or your child are taking the medicine, busulfan (treatment for cancer of blood cells). (See TAKE SPECIAL CARE WITH FLAGYL and TAKING OTHER MEDICINES WITH FLAGYL).

If you are not sure, talk to your doctor or pharmacist before taking or giving FLAGYL to your child.

Take special care with FLAGYL: You should tell your doctor or pharmacist before taking or giving FLAGYL to your child:

• If you or your child have blood dyscrasias (disease of the blood with low/lack of certain blood cells) or active or chronic disease of the central (nerves of the brain and spinal cord) and peripheral (nerves outside the brain and spinal cord) nervous system.
• If you or your child have hepatic encephalopathy (worsening of brain function that occurs when the liver is no longer able to remove toxic substances in the blood).
• If you or your child receives treatment for cancer of blood cells. Co-administration with busulfan may lead to severe busulfan toxicity and death.

Do not take alcohol beverages and medicine containing alcohol during therapy and for at least 1 to 3 days afterwards (see TAKING FLAGYL WITH FOOD AND DRINK).

Do not share medicines prescribed for you with any other person. Taking your medicine: Always take FLAGYL exactly as your doctor has instructed you or your child. 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. You should check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of FLAGYL is too strong or too weak, tell your doctor or pharmacist.

TABLETS

• Swallow the tablets whole with a little water
• Do not crush or chew the tablets
• Take these tablets during or just after a meal
• The dose of FLAGYL 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.

SUSPENSION

• Shake well before use
• Take FLAGYL SUSPENSION by mouth
• Take the suspension at least 1 hour before food
• The dose of FLAGYL 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.

If you or your child take more FLAGYL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take FLAGYL: If you or your child forget to take FLAGYL, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

FLAGYL can have side effects. Not all side effects reported for FLAGYL are included in this leaflet. Should you or your child’s general health worsen or if you experience any untoward effects while taking FLAGYL, please consult your doctor, pharmacist or other healthcare professional for advice.

Blood and the lymphatic system disorders:

• Less frequent: Agranulocytosis, neutropenia and thrombocytopenia (blood problems with unexpected infections, mouth ulcers, bleeding or bruising more easily than normal)
• Frequency unknown: Leucopenia (lack of white blood cells)

Immune system disorders:

• Less frequent: Anaphylaxis (sudden life-threatening allergic reaction)
• Frequency unknown: Angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), urticaria (pinkish, itchy, lumpy rash called hives or nettle rash)

Metabolism and nutrition disorders:

• Frequency unknown: Anorexia (loss of appetite)

Psychiatric (mental) disorders:

• Less frequent: Psychotic disorders including confusion, irritability and hallucinations (seeing or hearing things that are not there), changes in mood or mental state such as depression or confusion

Nervous system disorders:

• Less frequent: Weakness, dizziness, drowsiness, insomnia (sleep disorder). Reports of encephalopathy (brain disease, symptoms of which vary but you may get a fever, stiff neck, headache and see or hear things that are not there) and subacute cerebellar syndrome (where you encounter problems with coordination of movement of your arms and legs, problems speaking or feel confused)
• Frequency unknown: Peripheral neuropathy (a disorder of the nerves), usually presenting as numbness, tingling, or a feeling of weakness in the arms or legs and, fits (convulsions) are serious adverse effects on the nervous system that have been associated especially with high doses of FLAGYL of prolonged treatment

Eye disorders:

• Less frequent: Vision disorders such as diplopia (double vision) and myopia (short sightedness)

Respiratory, thoracic and mediastinal (breathing and chest) disorders:

• Frequency unknown: Nasal congestion (blocked/stuffy nose)

Gastrointestinal (stomach and intestines) disorders:

• Frequent: Gastrointestinal disturbances, especially nausea (feeling sick) and taste disorders; nausea is sometimes accompanied by headache, and vomiting (being sick). Diarrhoea, dry mouth, a furred tongue, oral mucositis (sore/red mouth) and stomatitis (sore mouth, mouth ulcers and cold sores)
• Less frequent: Pseudomembranous colitis (watery and severe diarrhoea, which may also be bloody)

Hepato-biliary (liver-bile duct) disorders:

• Less frequent: Increase in liver enzymes (liver problem) and inflammation of the liver sometimes with jaundice (liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine)
• Frequency unknown: Pancreatitis (inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting) and raised liver enzyme values (liver problem)

Skin and subcutaneous tissue (under the skin) disorders:

• Less frequent: Pustular eruptions (breakouts of blisters, containing pus, on the skin), mild erythematous eruptions (mild redness) with fleeting (brief) joint pains resembling serum sickness (allergic reaction to an injection of serum)
• Frequency unknown: Skin rashes, fever, flushing (reddening of skin), and pruritus (itching)

Musculoskeletal (muscle and skeleton), connective tissue (body packing tissue) and bone disorders:

• Frequency unknown: Myalgia (pains in the muscles) and arthralgia (pains in the joints)

Renal (kidney) and urinary (bladder) disorders:

• Less frequent: Urethral (bladder) discomfort and darkening of the urine

General disorders and administration site conditions:

• Frequency unknown: Fever

The frequency of the following side effects is unknown:

Nervous system disorders:

• Headache, aseptic meningitis (inflammation of the membranes around the brain and spinal cord with fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light)

Eye disorders:

• Eyesight problems such as blurred vision, decreased in visual acuity (sharpness of vision), changes in colour vision
• Optic neuritis (pain in your eyes and increasingly blurred vision)

Gastrointestinal (stomach and intestines) disorders:

• Epigastric pain (pain in the upper central region of the stomach)

Hepato-biliary (liver and bile-duct) disorders:

• Mixed hepatitis and hepatocellular liver injury (liver diseases)
• Cases of liver failure requiring liver transplant have been reported in patients treated with FLAGYL in combination with other antibiotic medication

Store all medicines out of reach of children. Store at or below 25 °C. Store your medicine in the original packaging in order to protect from light. Do not use this medicine after the expiry date shown on the packaging. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).