Almovitae tab 12.5mg #3

Almovit 12.5 mg Tablets

Composition:

Each tablet contains 12.5 mg of almotriptan, in the form of almotriptan D,L malate.

Indication:

Acute treatment of migraine headaches with or without aura.

Dosage and Administration:

Almotriptan should be taken with liquid as early as possible after the onset of migraine headache. However, it is also effective when taken at later stages.
Almotriptan is not intended for the prophylactic treatment of migraine.
Tablets can be taken with or without food.

Adults (18–65 years):

• The recommended dose is one tablet containing 12.5 mg almotriptan.

• If symptoms recur within 24 hours, a second dose may be taken, with at least a 2-hour interval between doses.

• Controlled studies have not evaluated the effectiveness of a second dose after a non-effective first dose, so if there is no response to the first dose, a second dose should not be taken for the same attack.

• Maximum recommended dose: 2 tablets (25 mg) in 24 hours.

Children and Adolescents (under 18 years):

• There is no available data on the use of almotriptan in children and adolescents, therefore it is not recommended for this age group.

Elderly (over 65 years):

• No dosage adjustment is required. However, safety and efficacy have not been systematically evaluated in patients over 65 years of age.

Renal Impairment:

• No dosage adjustment is required for patients with mild to moderate renal impairment.

• Patients with severe renal impairment should not exceed one 12.5 mg tablet in 24 hours.

Hepatic Impairment:

• There is no available data on the use of almotriptan in patients with hepatic impairment (see section 4.3 Contraindications and 4.4 Special warnings and precautions for use).

Fertility, Pregnancy, and Lactation:

Pregnancy:

• Limited data are available on the use of almotriptan in pregnant women.

• Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonic/fetal development, labor, or postnatal development (see section 5.3).

• Use in pregnancy should be considered only with caution.

Breastfeeding:

• There are no data on the excretion of almotriptan into human breast milk.

• Animal studies indicate that almotriptan and/or its metabolites are excreted in milk.

• Caution is advised during breastfeeding.

• To minimize exposure to the infant, it is recommended to avoid breastfeeding for 24 hours after taking the medication.

Storage:

This product does not require any special storage conditions.