Lysagor

LYSAGOR^®
Pizotifen
tablet

Composition
Each tablet contains:
Pizotifen malate equivalent to Pizotifen 0.5 mg

Pharmacology
LYSAGOR® prevents migraine attack by 2 mechanisms:

1. LYSAGOR® has anti serotonin and antihistamine properties, which inhibit the permeability-increasing effect of these amines on the affected cranial vessels, thereby checking transudation of plasmakinin and, as a result, maintaining the pain threshold of the receptors at normal levels.
2. LYSAGOR® inhibits the re uptake of serotonin by the blood platelets, thus maintaining plasma serotonin and preventing the loss of tone in the extra cranial arteries.

LYSAGOR® also has a weak anti cholinergic effect and mild sedative properties.

Indications
Prophylactic of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia).

Contraindications
- Patients with closed angle glaucoma or with urinary retention.
- Hypersensitivity to pizotifen.

Warnings and precautions

1. LYSAGOR® may cause drowsiness. Patients should be informed and cautioned against driving vehicles and operating machinery. Concomitant administration of CNS depressants (hypnotics, sedatives, other antihistamines, etc) may have additive effects.
2. Clinical data with pizotifen in pregnancy are limited. It should be administered in pregnancy only if the expected benefits outweigh any potential risks.
3. Use in nursing mothers is not recommended.
4. The central effects of alcohol may be enhanced by LYSAGOR®.
5. Patients who sensitive to an antihistamine may have a cross-sensitivity to LYSAGOR®.
6. Use in migraine attack is not recommended, because it is not effective. 
7. Use in children: experience in children is still limited.
8. Dosage adjustment may be necessary in patients with renal impairment.

Adverse reactions

• The most commonly occurring side-effects are drowsiness, lassitude, nausea, dizziness and dryness of the mouth.
• Less common reactions include oedema, headache, hypo tension, skin rashes, muscle pain, paraesthesiae and impotence.

Drug Interactions
Central effects of sedatives, hypnotics, antihistamines, including certain common cold preparations, and alcohol may be enhanced.

Dosage and administration Adults:
Start with 0.5 mg daily, and increase the dosage gradually to an average of 1 .5 mg daily, which may be taken in one dose at night or 3 times a day. Dosage of 0.5 - 3 mg daily may be given for prophylaxis of migraine. Up to 3 mg may be given as a single daily dose at night.

Presentation
LYSAGOR® 0.5 mg: Box of 3 strips x 10 tablets Reg. No. DKL8911610210A1

Store below 30°C. 
Protect from direct light.

ON MEDICAL PRESCRIPTION ONLY.

PT KALBE FARMA Tbk.
Bekasi - Indonesia

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