Singulair Paediatric 4 mg 14 chewable tablets

Singulair Paediatric 4 mg 14 chewable tablets

Composition:

Each chewable tablet contains:
Montelukast sodium — 4 mg.
Excipients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red iron oxide, sodium croscarmellose, cherry flavor, aspartame, magnesium stearate.

Product Description:

• Montelukast is a highly active anti‑asthmatic agent, non‑steroidal.
• Blocks the development of bronchospasm.
• Reduces eosinophil count in airways and peripheral blood.
• Improves inflammatory markers in bronchial asthma.

Indications for Use:

• Prevention and long‑term treatment of bronchial asthma in children aged 2–5 years.
• Control of daytime and nighttime asthma symptoms.
• Relief of allergic rhinitis symptoms in children aged 2–5 years.
• Treatment of allergic rhinitis in patients with bronchial asthma.

Method of Administration and Dosage:

• Oral use, once daily regardless of food intake.
• For asthma: take in the evening.
• For allergic rhinitis: may be taken at any time of day.
• Children 2–5 years: 1 chewable tablet (4 mg) daily.
• Therapeutic effect develops within the first day.
• Continue treatment during both controlled and exacerbation phases of asthma.
• Not for immediate relief of acute asthma attacks.
• May be added to therapy with bronchodilators and inhaled corticosteroids.

Contraindications:

• Children under 2 years.
• Hypersensitivity to components.
• Phenylketonuria.
• Pregnancy and breastfeeding.

Precautions:

Not recommended for treatment of acute asthma attacks.
Patients should always carry rescue medication (short‑acting inhaled β2‑agonists).
No dose adjustment required for elderly patients, those with renal impairment, or mild to moderate hepatic dysfunction.

Adverse Reactions / Side Effects:

• Nervous system: dizziness, drowsiness, fatigue.
• Hematologic: increased bleeding tendency.
• Gastrointestinal: diarrhea, nausea, vomiting, pancreatitis, hepatitis.
• Allergic: hypersensitivity reactions, itching, rash, urticaria.
• Psychiatric: anxiety, depression, attention and memory disorders, insomnia.
• Cardiovascular: palpitations, nosebleeds.
• Musculoskeletal: arthralgia, myalgia, muscle cramps.
• Other: edema.

Pregnancy and Lactation:

Contraindicated.

Storage Conditions:

Keep out of reach of children.

Packaging:

Carton box containing 14 chewable tablets and leaflet.