Bemetrazole 200 mg/400 mg Tablets

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

Do not take BEMETRAZOLE:

• If you are hypersensitive (allergic) to metronidazole or any of the other ingredients of BEMETRAZOLE (listed in section 6) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• If you have a disease or disorder, especially of the blood
• If you are taking the medicine, busulfan (treatment for cancer of blood cells).

Do not take BEMETRAZOLE if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before receiving BEMETRAZOLE. Do this even if they have applied in the past.

Warnings and precautions

Take special care with BEMETRAZOLE:

• If you 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 have severe liver toxicity /acute liver failure with Cockayne syndrome (neuro degenerative disorder characterised by growth failure, no development of the nervous system, abnormal sensitivity to sunlight, eye disorders and premature aging) have been reported with systemic use Patients with Cockayne syndrome should report any symptoms of potential liver injury to their physician and stop taking metronidazole.
• If a liver function test must be performed throughout treatment until liver function is within normal range.
• If liver function is elevated during treatment, metronidazole should be discontinued.
• Metronidazole has anti-treponemal activity and may mask the immune response seen in untreated syphilis.
• Contacts of syphilis receiving metronidazole should probably be screened for an additional 4 to 8 weeks.
• If possibly after trichomonas vaginalis has been eliminated a gonococcal infection might persist.
• Alcohol beverages and medicines containing alcohol should not be consumed during therapy and at least 1 to 3 days afterwards. (see taking BEMETRAZOLE with food and drink).
• If pseudomembranous colitis (infection of the colon) has been reported with the use of BEMETRAZOLE.
• Co-administration with busulfan (treatment for cancer of blood cells) may lead to severe busulfan toxicity and death.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before receiving BEMETRAZOLE. Do this even if they have applied in the past.

Taking your medicine:

Do not share medicines prescribed for you with any other person. Always take BEMETRAZOLE exactly as your doctor has instructed you. It is important to finish a full course of treatment. Check with your doctor or pharmacist if you are not sure.

The usual dose is as below:

Anaerobic infections

a) Treatment:

Metronidazole may be given alone or concurrently with other bacteriologically-appropriate antibacterial agents. They should be given for 7 days or longer depending on clinical and bacteriological assessments of the patient's condition.

Adults: Initially, 800 mg followed by 400 mg by mouth every 8 hours.

Children and infants: 7,5 mg/kg body mass by mouth every 8 hours daily during or after meals.

b) Prevention:

Adults: Administered in doses similar to those used for the treatment of established infection. 400 mg may be given every 8 hours in the 24 hours before surgery followed postoperatively by intravenous or rectal administration until oral therapy is possible. Shorter pre-operative courses and oral doses of up to 1 g have been used.

Children: as for treatment (a).

Treatment of Helicobacter pylori-associated gastritis and duodenal ulcer

The following regimens have been used:

a) BEMETRAZOLE 200 - 250 mg – 4 - 5 times a day for 14 days in combination with other medicines.

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 and length of your treatment will depend on the type and severity of your condition. Your doctor will tell you how long your treatment with BEMETRAZOLE will last.

Do not stop treatment early because you are feeling well. If you have the impression that the effects of BEMETRAZOLE is too strong or too weak, tell your doctor or pharmacist.

Tests: Your doctor may wish to carry out some tests if you have been using BEMETRAZOLE for more than 10 days.

If you take more BEMETRAZOLE 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. Take the carton and bottle with you. This is so the doctor knows what you have taken.

If you forget to take BEMETRAZOLE: If you forget to take BEMETRAZOLE, 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.

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

If any of the following happens, stop taking /using BEMETRAZOLE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• a serious but rare side effect is a brain disease (encephalopathy). Symptoms vary but you might get a fever, stiff neck, headache and see or hear things that are not there. You might also have problems using your arms and legs, problems with speaking or feel confused.
• if you get swelling of the hands, feet, ankles, face, lips or throat, which may cause difficult in swallowing or breathing. You could also notice an itchy, nettle rash (urticaria). This may mean that you are having an allergic reaction to BEMETRAZOLE.
• Fainting.

These are very serious side effects. If you have them, you may have had a serious reaction to BEMETRAZOLE. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of 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 also be felt in your back (pancreatitis).

These are serious side effects. You may need urgent medical attention. Tell your doctor or pharmacist if you notice any of the following side effects:

Frequent side effects:

• 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).
• stomatitis (sore mouth, mouth ulcers and cold sores).

Less frequent side effects:

• 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.
• weakness.
• dizziness.
• drowsiness.
• skin rash.
• headache.
• darkening of the urine.
• feeling sleepy or dizzy.
• unable to sleep.
• pseudomembranous colitis (watery and severe diarrhoea, which may also be bloody).

Frequency unknown side effects:

• low white blood cell count.
• weight loss.
• 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, stomach pain or diarrhoea.
• loss of appetite.
• fever.
• feeling depressed.
• pain in your eyes (optic neuritis).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BEMETRAZOLE.

• 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).