📌 COMPOSITION

Each F/C tablet contains: Desloratadine 5.0 mg.

Each 5 ml syrup (teaspoonful) contains: Desloratadine 2.5 mg.

📌 DESCRIPTION

Declarine (Desloratadine) is a long acting histamine antagonist, non‑sedation. It also has selective peripheral H1‑receptor antagonist activity because the drug is effectively excluded from entry to the Central Nervous System (CNS). In addition to antihistaminic activity of Declarine, it has demonstrated antiallergic and anti‑inflammatory activity. Desloratadine is well absorbed, not affected by the presence of food and it can be detected in plasma within 30 minutes of its administration and its maximum concentration achieved after approximately 3 hours. Desloratadine is moderately bound to plasma proteins (83-87%).

📌 INDICATIONS

Declarine is indicated in the following cases:

• Rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge, itching, congestion and ocular itching, tearing and redness, itching of palate and coughing.
• Relief of symptoms associated with urticaria such as itching and the size and numbers of hives.

📌 DOSAGE & ADMINISTRATION

Declarine can be taken with or without meal, once daily as following:

• Adults (12 years and above): 5 mg (one tablet or 10 ml syrup).
• Children: (6-11 years): 2.5 mg (5 ml syrup). (1-5 years): 1.25 mg (2.5 ml syrup).

📌 RESTRICTIONS ON USE

Contraindications

Hypersensitivity to Desloratadine or loratadine.

Precautions

• Desloratadine should be used with caution in case of severe renal insufficiency.
• Efficacy and safety of Desloratadine in children under 1 year have not been established.

Effect on the capacity to drive vehicles or use machines

Desloratadine does not affect the ability to drive vehicles or use machines.

Use in pregnancy and lactation

• Desloratadine is not to be used during pregnancy unless the potential benefits outweigh the risks.
• Desloratadine is not recommended in breast‑feeding women because it is excreted into breast milk.

📌 ADVERSE EFFECTS

The most frequent adverse effects reported in excess of placebo include: fatigue, dry mouth, headache and diarrhoea. In very rare cases include: hypersensitivity reactions, tachycardia, palpitations, elevations of liver enzymes and increased bilirubin.

📌 OVERDOSAGE

In case of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Desloratadine is not eliminated by haemodialysis and it is not known if it is eliminated by peritoneal dialysis.

📌 STORAGE INSTRUCTIONS

• Declarine Tablet: Store below 30°C in a dry place.
• Declarine Syrup: Store below 30°C, protect from light.

📌 PHARMACEUTICAL FORMS

• Declarine Tablet: Blister pack of 20 tablets and hospital packs of different sizes.
• Declarine Syrup: Bottle of 100 ml.