Mebendazole 100mg USP / 5ml
Read all of this leaflet carefully before you take this medicine.
• Keep this leaflet. You many need to read it again.
• If you have further question, please ask your Pharmacist or your Doctor.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Trazole Suspension is and what it is used for.
2. Precautions and warning before you take Trazole Suspension
3. How to take Trazole Suspension
4. Possible side effects.
5. Symptoms and treatment of over dosage
6. How to store Trazole Suspension
7. Further information
1. WHAT TRAZOLE SUSPENSION IS AND WHAT IT IS USED FOR
Trazole Suspension is a single dose medicine containing the active drug called mebendazole. This belongs to a group of compounds known as benzimidazoles. It is used to treat a broad spectrum of gastro-intestinal worm infestations that include pinworms, roundworms, whipworms and hookworms. Mebendazole kills susceptible worms by inhibiting their uptake of glucose and other low molecular weight nutrients; depleting the glycogen stores they need for survival and reproduction.
2. PRECAUTIONS AND WARNING BEFORE YOU TAKE TRAZOLE
SUSPENSION
Contraindication:
• Do not take Trazole Suspension if you are allergic (hypersensitive) to mebendazole or any of the ingredients of Trazole Suspension
Pregnancy and lactation
• Take special care with Trazole suspension if you are pregnant or breast feeding as studies in animals have revealed adverse effects on the fetus, but in humans, this has not yet been proven.
Taking other medicines:
Please inform your Pharmacist or Doctor if you are taking or about to take any other medicine including those obtained without a prescription.
Driving and using Machines
Trazole Suspension is not likely to affect you being able to drive, use tools or machines.
3. HOW TO TAKE TRAZOLE SUSPENSION
You should take the suspension exactly as your Doctor or Pharmacist directs you.
The suspension can be mixed with food. Laxatives, enemas or dietary restrictions are unnecessary.
Children over age 2 and adults take the same single dose of 500 mg P.O or 100 mg P.O b.i.d for 3 days. Repeat treatment if infection persists after 3 weeks.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trazole Suspension can cause side effects, although not everybody gets them. Occasional, transient abdominal pain and diarrhea have been reported, in cases of massive infestation and expulsion of worms. Rarely, fever and hypersensitivity reactions like rash, itching have been reported.
5. SYMPTOMS AND TREATMENT OF OVER DOSAGE
Signs and symptoms of overdose may include GI disturbances and altered mental status. Treatment is non specific and usually supportive. Induced emesis with ipecac syrup or gastric lavage followed by activated charcoal may be employed if need be.
6. HOW TO STORE TRAZOLE SUSPENSION
Keep bottle out of reach or sight of children and in the original package. Store product below 300C and away from light. Always check the expiry date on the label and do not use product if the expiry date has passed.
7. FURTHER INFORMATION
Each 30ml bottle contains Mebendazole 600mg USP.
The excipients in Trazole Suspension are: Sucrose, Sodium methyl paraben, Sodium benzoate, Sodium carboxymethyl cellulose, Sodium saccharin, Sorbitol, Citric acid, Polysorbate-80, Tartrazine and Banana flavor.
Date of publication / review: This publication is subject to review every two years (effective January, 2016) and upon receipt of new product information.
The Manufacturer:
Tradewinds Chemist Limited
PLT 9B BLK1, Ayigya industrial area
Kumasi