📌 COMPOSITION

Each kit contains:
2 Omeprazole capsules 20 mg
2 Tinidazole tablets 500 mg
2 Clarithromycin tablets 500 mg.

📌 DESCRIPTION

Tri Cure is a combination medicine used in the treatment of peptic ulcer disease by relieving symptoms such as heartburn, indigestion, stomach pain, and irritation. It works by killing the ulcer‑causing bacteria H. pylori. Tri Cure contains:

• Omeprazole 20 mg capsule works to prevent gastric acid secretion by inhibiting the proton pump H⁺/K⁺-ATPase at the secretory surface of gastric parietal cells, reducing the amount of acid in the stomach, reducing symptoms such as heartburn, difficulty swallowing, prolonged cough and is often used in the treatment of gastro‑oesophageal reflux disease and benign peptic ulcers.
• Tinidazole 500 mg tablet is a substance of the nitroimidazole group with bactericidal effect against anaerobic bacteria, protozoa and H. pylori bacteria.
• Clarithromycin 250 mg tablet is an antibiotic belonging to the macrolide group, has bactericidal effect against many aerobic and anaerobic Gram‑positive, Gram‑negative organisms, including H. pylori.

In the treatment regimens for H. pylori, the three‑drug combination (Omeprazole, Clarithromycin and Tinidazole) gives the best results. Clinical trials have shown that this triple therapy is ideal because the clearance rate for H. pylori is very high (up to 90-100%).

📌 INDICATIONS

• Eradication of H. pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this organism.
• Duodenal ulcer.
• Gastric ulcer.
• Moderate and severe reflux oesophagitis.

📌 DOSAGE & ADMINISTRATION

Tri Cure is produced in the form of a drug set with each set containing 2 omeprazole capsules, 2 tinidazole tablets and 2 clarithromycin tablets. One box has 7 sets, each set for 1 day of treatment and one box of medicine for 7 days, for oral use. With this special packaging, in one day the patient will take 1 omeprazole capsule, 1 clarithromycin tablet and 1 tinidazole tablet in the morning and take another similar dose in the afternoon or evening. After 7 days of treatment with Tri Cure, the patient continues treatment with omeprazole 20 mg twice daily or lansoprazole 30 mg once a day for the next 3 weeks.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to omeprazole, clarithromycin or tinidazole.
• Hypersensitivity to other benzimidazole derivatives (e.g. lansoprazole, pantoprazole or rabeprazole).
• Disorders of haematopoiesis.

Precautions

• Patients using Tri Cure should not drink alcoholic beverages because Tri Cure can cause disulfiram‑like reactions with alcohol.
• Tri Cure should be used with caution in patients with severe hepatic or renal impairment.
• Treatment with proton pump inhibitors and antibiotics, including Tri Cure, may increase the risk of gastrointestinal infections with strains such as Salmonella, Campylobacter and Clostridium difficile.
• Pseudomembranous colitis should be excluded when using Tri Cure.
• Tri Cure should not be used in patients with organic neurological disorders.
• The possibility of a gastrointestinal malignancy must be excluded before treatment with Tri Cure because of possible masking of the disease.

Use in Pregnancy & Lactation

• Do not use Tri Cure in pregnant and lactating women, especially during the first 3 months of pregnancy.
• Tri Cure is not recommended for nursing mothers. Therefore, nursing mothers should decide whether to discontinue Tri Cure or to discontinue breastfeeding during use.

Effect on ability to drive and use machines

Due to side effects that can cause dizziness and fatigue, Tri Cure affects alertness. It is recommended not to drive or operate machinery or perform tasks that require alertness while taking the medicine.

📌 DRUG INTERACTIONS

• Theophylline: Concomitant use with Tri Cure increases theophylline concentration.
• Terfenadine: Concomitant use increases terfenadine concentration, prolonging the QT interval or causing cardiac arrhythmias.
• Oral anticoagulants: Concomitant use may potentiate the effects of oral anticoagulants such as warfarin. Therefore, monitoring of prothrombin time is necessary.
• Carbamazepine, ciclosporin, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin: Concentrations may be increased when co‑administered with Tri Cure.
• Ketoconazole, ampicillin and iron salts: Due to its strong acid‑suppression properties, Tri Cure may interfere with the absorption of these drugs.
• Phenytoin, diazepam, warfarin: Tri Cure delays the excretion of these drugs.

📌 ADVERSE EFFECTS

• Common side effects:
  • Nervous system: Drowsiness, dizziness and headache.
  • Digestive system: Nausea, vomiting, abdominal pain, diarrhoea, constipation and abdominal distension.
• Less common side effects:
  • Nervous system: Insomnia, confusion, dizziness and fatigue.
  • Skin: Urticaria, itching and rash.
  • Hepatic: Elevated liver enzymes (usually reversible after discontinuation).
• Rare side effects:
  • Body and skin: Sweating, peripheral oedema and hypersensitivity (angioedema, fever and anaphylaxis).
  • Blood and lymphatic system: Leukopenia, thrombocytopenia, pancytopenia and agranulocytosis.
  • Nervous system and mental: Reversible confusion, agitation, depression, hallucinations in elderly and seriously ill patients, and hearing disorders.
  • Digestive system: Gastritis, candidal infection, dry mouth, jaundice or non‑jaundice hepatitis and encephalopathy in liver failure.
  • Respiratory system: Bronchospasm.
  • Musculoskeletal system: Joint pain and muscle pain.
  • Renal‑urinary system: Interstitial nephritis.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

Tri Cure: 7 aluminium kits, each kit contains 2 capsules and 4 tablets.