Description

1. Product Overview: Urtinex® is an oral solution formulation of Rupatadine Fumarate 5 mg/5 ml, a second-generation antihistamine used for the treatment of allergic rhinitis and urticaria.

2. Composition: Active Ingredient: Rupatadine Fumarate | Dosage Form: Oral Solution (50 ml)

3. Pharmacological Class: Second-Generation H1 Antihistamine with PAF (Platelet Activating Factor) antagonist activity

4. Mechanism of Action: Rupatadine works by blocking histamine H1 receptors and inhibiting platelet activating factor (PAF), reducing allergic inflammation and providing relief from allergy symptoms.

5. Indications: Seasonal and perennial allergic rhinitis | Chronic idiopathic urticaria (hives) | Allergic skin conditions with itching

6. Dosage & Administration: As prescribed by physician | Oral use | Can be taken with or without food | Shake well before use

7. Clinical Benefits: Relieves sneezing, runny nose, and nasal congestion | Reduces itching and skin rashes | Controls allergic inflammation | Provides long-lasting allergy relief

8. Contraindications: Hypersensitivity to Rupatadine or any component of the formulation

9. Precautions: Use with caution in liver or kidney impairment | May cause drowsiness in some patients | Avoid alcohol during treatment | Use under medical supervision

10. Drug Interactions: May interact with CNS depressants and CYP3A4 inhibitors

11. Special Populations: Not recommended during pregnancy unless advised by physician | Use cautiously during breastfeeding | Pediatric use only under medical guidance

12. Adverse Effects: Drowsiness | Headache | Dry mouth | Dizziness | Fatigue

13. Storage Conditions: Store below 30°C | Protect from light and moisture | Keep out of reach of children

14. Packaging: 50 ml bottle

15. Manufacturer: Everest Pharmaceutical Ltd.