BEMETRAZOLE (metronidazole) is an antibiotic and antiprotozoal medicine used to treat certain bacterial infections and to help prevent infection after surgery. It is available as tablets in two strengths: 200 mg and 400 mg of metronidazole. In South Africa, it is a Schedule 4 (S4) medicine, which means it is available on prescription only and should be taken exactly as directed by a healthcare professional.

BEMETRAZOLE works by killing the germs (bacteria and some parasites) that are causing infection in the body. It is often used alone, but for some infections your doctor may prescribe it together with other appropriate antibiotics.

What it is and what it is used for

BEMETRAZOLE contains metronidazole, an antimicrobial agent that fights certain bacteria and parasites. It is used:

To treat infections caused by certain bacteria.
To prevent infections after surgery.

Note: For some conditions, your doctor may combine metronidazole with other antibiotics that target a wider range of germs.

How it works

Metronidazole gets inside susceptible bacteria and parasites and disrupts their DNA, which stops them from growing and reproducing. As a result, the germs die and the infection clears. You may start to feel better before the course ends, but finishing the full course is important to fully clear the infection and reduce the risk of it coming back.

Who should NOT use this medicine

Do not take BEMETRAZOLE if:

You are allergic (hypersensitive) to metronidazole or any of the ingredients in the tablet.
- Signs of allergy include rash, itchy hives, trouble breathing or swallowing, or swelling of the lips, face, throat, or tongue.
You have a blood disease or blood disorder.
You are taking busulfan (a cancer medicine used for blood cell cancers).

If any of the above apply, or if you are not sure, speak to your doctor or pharmacist before taking BEMETRAZOLE.

Warning: Never share your prescription with another person, even if their symptoms seem similar. It may harm them.

Warnings and precautions

Tell your doctor before starting BEMETRAZOLE and take special care if any of the following apply:

Liver problems and brain effects from liver disease:
- If you have hepatic encephalopathy (reduced brain function due to severe liver disease), you require careful medical supervision.
Cockayne syndrome:
- Severe liver toxicity or acute liver failure has been reported with systemic metronidazole in patients with Cockayne syndrome (a rare neurodegenerative disorder).
- Patients with Cockayne syndrome should stop metronidazole and contact a doctor immediately if any symptoms of liver injury appear.
- Liver function tests should be performed during treatment and until liver values return to normal. If liver tests rise, metronidazole should be discontinued.
Effect on syphilis tests:
- Metronidazole has anti-treponemal activity and may mask the immune response in untreated syphilis.
- Contacts of syphilis receiving metronidazole should probably be screened again for 4 to 8 weeks.
Possible persistent gonorrhoea:
- After Trichomonas vaginalis is treated and eliminated, a gonococcal infection may persist. Follow-up testing may be needed.
Severe gut infection risk:
- Pseudomembranous colitis (a serious colon infection) has been reported with metronidazole. Tell your doctor urgently if you develop watery, severe or bloody diarrhoea.
Alcohol:
- Do not drink alcohol (including medicines containing alcohol) while taking BEMETRAZOLE and for 1 to 3 days after finishing. Combining alcohol with metronidazole may cause nausea, vomiting, stomach pain, flushing, palpitations, and headache.
Busulfan combination risk:
- Co-administration with busulfan can cause severe busulfan toxicity and may be fatal — this combination must be avoided.
Monitoring:
- If treatment lasts longer than 10 days, your doctor may carry out tests.

Driving and using machines
BEMETRAZOLE can cause sleepiness, dizziness, confusion, hallucinations, fits (convulsions), and temporary eyesight problems (such as blurred or double vision). If affected, do not drive, cycle, or operate machinery.

Intolerance to sugars
BEMETRAZOLE tablets contain lactose. If you have been told you are intolerant to some sugars, talk to your doctor before taking this medicine.

Pregnancy, planning pregnancy, and breastfeeding

The safety of BEMETRAZOLE in pregnancy and breastfeeding has not been established. Small amounts may pass into breast milk.

Not specified in the source. Speak to your doctor or pharmacist before use.

If you are pregnant, might become pregnant, think you may be pregnant, or are breastfeeding, tell your doctor before using BEMETRAZOLE.

Interactions

Always inform your healthcare professional about all medicines you take, including prescription, over-the-counter, complementary, or traditional medicines. The following interactions are noted in the source:

Disulfiram (for alcohol dependence): Taking with metronidazole can cause acute confusion.
Alcohol or alcohol-containing medicines: Avoid during treatment and for 1–3 days after (see above).
Warfarin and other blood thinners: Metronidazole can intensify the effect, increasing the risk of uncontrolled bleeding.
Lithium (for mental health conditions): Metronidazole may increase lithium blood levels.
Phenytoin or phenobarbital (for epilepsy): These may reduce the effectiveness of metronidazole.
5-Fluorouracil (cancer treatment): Metronidazole may intensify harmful effects of 5-fluorouracil.
Busulfan (leukaemia): Do not combine — risk of severe toxicity and death.
Ciclosporin (post-transplant): Metronidazole may increase ciclosporin levels.
Cimetidine (stomach ulcers): May intensify the effects of metronidazole.

Practical tip: Do not start, stop, or change any medicine while on BEMETRAZOLE without medical advice.

How to take (Step-by-step)

General directions

Take BEMETRAZOLE exactly as your doctor has instructed.
Swallow tablets whole with a little water. Do not crush or chew.
Take during or just after a meal.
Finish the full course, even if you start feeling better. Stopping early may allow the infection to return.
If the effect feels too strong or too weak, speak to your doctor or pharmacist.

Doses from the source

Anaerobic infections

a) Treatment

Adults:
- Initial dose: 800 mg by mouth once, then 400 mg every 8 hours.
- Duration: 7 days or longer, depending on your doctor’s clinical and laboratory assessments.
- May be given alone or with other appropriate antibacterial agents, as advised by your doctor.
Children and infants:
- 7.5 mg per kg body mass by mouth every 8 hours, during or after meals.

b) Prevention (pre-operative use)

Adults:
- 400 mg every 8 hours in the 24 hours before surgery, followed post-operatively by intravenous or rectal administration until oral therapy is possible.
- The source notes that shorter pre-operative courses and oral doses up to 1 g have been used (as guided by your doctor).
Children:
- As for treatment (a) above (your doctor will calculate the dose by weight).

Helicobacter pylori-associated gastritis and duodenal ulcer (used in combination regimens)

BEMETRAZOLE 200–250 mg 4–5 times a day for 14 days, in combination with other medicines (your doctor will prescribe the full regimen).

Missed dose

If you forget a dose, take it as soon as you remember.
If it is almost time for your next dose, skip the missed dose and take the next one at the usual time.
Do not take a double dose to make up for a missed dose.

Overdose

In case of suspected overdose, seek medical help immediately: contact your doctor, pharmacist, the nearest hospital, or a poison control centre.
Take the carton and bottle with you so healthcare providers know exactly what you took.

Monitoring during longer courses

If you use BEMETRAZOLE for more than 10 days, your doctor may order tests.

Note: The maximum daily dose is not specified in the source. Your doctor will tailor dosing to your condition.

Dosing table

Important: Doses below come directly from the source. If your doctor gives you a different schedule based on your condition, follow their advice.

Indication	Age/weight band	Dose	Frequency	When to take	Duration	Maximum daily dose
Anaerobic infections – Treatment (Adults)	Adults	800 mg initial, then 400 mg	Every 8 hours	During or just after meals	7 days or longer, as directed	Not specified in the source
Anaerobic infections – Treatment (Children/Infants)	By weight	7.5 mg/kg	Every 8 hours	During or just after meals	As directed by doctor	Not specified in the source
Anaerobic infections – Prevention (Adults)	Adults	400 mg	Every 8 hours	As directed (pre-op oral dosing)	In the 24 hours before surgery, then IV or rectal post-op until oral possible	Not specified in the source
Anaerobic infections – Prevention (Children)	By weight	As for treatment (7.5 mg/kg)	Every 8 hours	During or just after meals	As per surgical plan	Not specified in the source
H. pylori-associated gastritis/duodenal ulcer (Adults)	Adults	200–250 mg	4–5 times daily	As directed	14 days, with other medicines	Not specified in the source

Possible side effects

Like all medicines, BEMETRAZOLE can cause side effects, although not everyone gets them. Stop the medicine and seek urgent medical help if you develop serious symptoms listed below.

Serious — seek urgent help

Stop BEMETRAZOLE and contact your doctor immediately or go to the nearest casualty if you notice:

Brain disease (encephalopathy): fever, stiff neck, headache, seeing or hearing things that are not there, problems speaking, problems using arms/legs, or confusion.
Severe allergic reaction: swelling of hands, feet, ankles, face, lips, or throat causing difficulty swallowing or breathing, with itchy nettle-like rash (urticaria).
Fainting.
Yellowing of the skin or eyes (jaundice) — may indicate liver problems.
Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness — may indicate a blood problem.
Severe stomach pain that may also be felt in the back — may indicate pancreatitis.

These events may require urgent medical attention or hospital care.

Common

Gastro-intestinal disturbances: nausea, taste disorders (metallic or altered taste), vomiting
Diarrhoea
Dry mouth
Furred tongue
Oral mucositis (sore/red mouth)
Stomatitis (mouth soreness, ulcers, or cold sores)
Headache

Less common

Mental problems such as confusion or hallucinations
Vision problems such as blurred or double vision
Weakness
Dizziness
Drowsiness
Skin rash
Darkening of the urine
Sleep problems (unable to sleep)

Additional side effects

Low white blood cell count
Weight loss
Numbness, tingling, pain, or weakness in arms or legs
Unpleasant taste
Upset stomach, stomach pain, loss of appetite
Fever
Feeling depressed
Eye pain (optic neuritis)
Meningitis-like symptoms: fever, nausea, vomiting, headache, stiff neck, extreme sensitivity to bright light
Hearing impairment or hearing loss
Ringing in the ears (tinnitus)
Rash or skin discolouration that may recur in the same spot when the drug is taken again
Nasal congestion
Skin rashes
Joint pain
Muscle pain

What to do about side effects

Mild symptoms (like nausea or metallic taste) often improve as your body adjusts. Mention them at your next check-in.
Severe, persistent, or worrying symptoms (especially those under “Serious”) need urgent medical attention.
You can report side effects to SAHPRA using the “6.04 Adverse Drug Reaction Reporting Form” found under SAHPRA’s publications.

Note: Not all possible side effects are listed in the source. If your general health worsens, speak to your healthcare professional.

Storage and disposal

Keep out of the reach of children.
Store at or below 25 °C.
Keep in the original packaging to protect from light.
Do not use after the expiry date on the packaging.
Return all unused medicine to your pharmacist.
Do not dispose of unused tablets in toilets, drains, or sewerage systems.

What the medicine contains

Active ingredient:Metronidazole
- BEMETRAZOLE 200: each tablet contains metronidazole 200 mg
- BEMETRAZOLE 400: each tablet contains metronidazole 400 mg
Other ingredients (excipients):
Lactose monohydrate 200 mesh, magnesium stearate, maize starch, pregelatinised starch, purified talc.
Lactose content per tablet:
- 200 mg tablet: lactose 100 mg
- 400 mg tablet: lactose 80 mg

Note: If you have a known lactose intolerance, consult your doctor before use.

Pack information and appearance

Appearance: Round, biconvex, scored tablets (both strengths).
Packs — BEMETRAZOLE 200 mg:
- Securitainers of 21’s, 100’s, or 500’s; patient-ready packs of different sizes.
Packs — BEMETRAZOLE 400 mg:
- Securitainers of 10’s, 100’s, or 500’s; 500’s in HDPE containers; patient-ready packs of different sizes.

Holder of Certificate of Registration: Ranbaxy Pharmaceuticals (Pty) Ltd.

FAQs

1) Can I drink alcohol while taking BEMETRAZOLE?
No. Do not drink alcohol during treatment and for 1–3 days after finishing. Alcohol may cause nausea, vomiting, stomach pains, flushing, palpitations, and headache.

2) Is it safe to drive or use machines?
Not if you are affected. BEMETRAZOLE may cause sleepiness, dizziness, confusion, hallucinations, fits, or blurred/double vision. If these occur, do not drive or operate machines.

3) I forgot a dose. What should I do?
Take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not take a double dose.

4) I’m on warfarin. Can I take BEMETRAZOLE?
Tell your doctor. Metronidazole can intensify warfarin’s effect and may lead to uncontrolled bleeding. Close monitoring may be needed.

5) I take lithium. Is there a problem?
Tell your doctor. Metronidazole may increase lithium levels.

6) I have epilepsy and use phenytoin or phenobarbital.
These medicines may reduce the effectiveness of metronidazole. Your doctor will advise you.

7) I’m on disulfiram for alcohol dependence.
Do not combine with BEMETRAZOLE as it can cause acute confusion.

8) I have Cockayne syndrome. Can I use this medicine?
Use only under close medical supervision. There is a risk of severe liver toxicity/acute liver failure; stop the medicine and seek medical advice immediately if liver injury symptoms occur. Liver tests should be monitored during treatment.

9) I have lactose intolerance.
BEMETRAZOLE contains lactose (100 mg per 200 mg tablet; 80 mg per 400 mg tablet). Consult your doctor before use.

10) How long must I take it?
Your doctor decides based on your infection. For anaerobic infections, 7 days or longer may be required. For H. pylori regimens, 14 days together with other medicines are used.

Militian Inessa Mesropovna

Education:
Sochi Medical College 2014 – 2017

Work experience:
2017 – to date Sochi Pharmacy – Pharmacist