Loperamide Hydrochloride BP 2mg
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 questions, please ask your Pharmacist or 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 Tradium capsule is and what it is used for
2. Precautions and warnings before you take Tradium capsule
3. How to take Tradium capsule
4. Possible side effects.
5. Symptoms and treatment of over dosag
6. How to store Tradium capsule
7. Further information
1. WHAT TRADIUM CAPSULE IS AND WHAT IT IS USED FOR
Tradium capsule contains a single active ingredient, Loperamide Hydrochloride which belongs to a class of drugs known as Piperidine derivatives. These are related to opiates, but unlike opioids, they have no physical dependence neither do they have analgesic activity. Loperamide works in your body to ameliorate diarrhoea by acting directly on intestinal mucosal nerve endings to reduce motility or peristalsis.
2. PRECAUTIONS AND WARNING BEFORE YOU TAKE TRADIUM CAPSULE
Contraindication:
• Do not take Tradium capsule if you are allergic or hypersensitive to Loperamide Hydrochloride or any of the ingredients of Tradium capsule.
• If you are a child under age 2 or when constipation must be avoided
• If you have a fever exceeding 38.3 oC or blood is present your stool.
Pregnancy and lactation:
• Do not take Tradium if you are pregnant or breast-feeding.
Take special care with Tradium capsule if:
• You have impaired liver or hepatic function.
Stop taking Tradium capsule:
• At the first sign of blood in the stool.
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
Taking Tradium capsule may cause drowsiness and dizziness, hence impairing your ability to perform tasks requiring alertness. Do not therefore operate machinery.
3. HOW TO TAKE TRADIUM CAPSULE
• You should take the capsule exactly as your Doctor or Pharmacist directs you.
Adults and children over age 12: Initially 4 mg P.O., then 2 mg after each unformed stool. Maximum dose is 16 mg daily.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tradium capsule can cause side effects, although not everybody gets them. Side effects like dizziness, drowsiness, fatigue, nausea, vomiting, constipation, abdominal pain, distension or discomfort, dry mouth, rash and hypersensitivity reactions have been rarely reported.
Possible interactions with food and drugs
Using Tradium together with alcohol can increase CNS side effects like dizziness, drowsiness and difficulty concentrating. Opioid analgesics may cause severe constipation so avoid use together.
5. SYMPTOMS AND TREATMENT OF OVER DOSAGE
Signs and symptoms of overdose include constipation, GI irritation and CNS depression.
Treatment is with activated charcoal if ingestion was recent. If patient is vomiting, activated charcoal may be given in a slurry when patient can retain fluids. Alternatively, gastric lavage may be performed, followed by activated charcoal administration. Treat respiratory depression with naloxone.
6. HOW TO STORE TRADIUM CAPSULE
Keep capsule out of reach or sight of children. Store them below 300c and in the original package. Check the expiry date on the label. Do not use product if the expiry date has passed.
7. FURTHER INFORMATION
Each capsule contains 2mg of Loperamide Hydrochloride BP. Other ingredients in the capsule are: Maize starch, sodium lauryl sulphate, gelatin, methyl paraben, silicon dioxide, talc and magnesium Stearate.
Presentation: Each box contains ten (10) blisters of ten (10) capsules each.
Date of publication / review: Effective June, 2015, this publication is subject to review every two years and upon receipt of new product information.