Alora 100 mg Film-Coated Tablet

Composition:

Each Alora 100 mg film-coated tablet contains:

• 100 mg of Passiflora extract (standardized to contain 3.5% flavonoids as vitexin)

• Red iron oxide (E172) as a coloring agent.

Indications:

Alora 100 mg film-coated tablets are indicated for the treatment of mild symptoms of psycho-emotional stress and for regulating sleep.

Contraindications:

• Hypersensitivity to any of the components of the product.

Warnings and Precautions:

• Use in children under 12 years of age is not recommended, as sufficient data is not available. Consult a physician before use.

Pregnancy and Lactation:

• There is insufficient data on the use of this product during pregnancy and breastfeeding.

• Use only if the expected benefit to the mother outweighs the potential risk to the child.

Effects on Ability to Drive and Use Machines:

Avoid driving or operating potentially dangerous machinery while using this product.

Dosage and Administration:

For calming (sedative) effects during the day (adults):

• The recommended oral dose is 100 mg, three times daily, taken before meals.

For sleep disturbances (adults):

• The recommended oral dose is 200–300 mg once daily, taken one hour before bedtime.

• Not recommended for children under 12 years of age (see section on Warnings and Precautions).

Overdose:

• No data available on overdose.

• In case of overdose, gastric lavage and symptomatic treatment are recommended.

Storage Conditions:

• Store at a temperature not exceeding 25°C, in its original packaging, protected from light.

• Keep out of reach of children.