Aphrofemine

Trade name:

Aphrofemine

Composition

Each film coated tablet contains:

Active ingredient:

Flibanserin 100 mg

Inactive ingredients:

Lactose monohydrate, microcrystalline cellulose, Croscamellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol, purified talc, titanium dioxide

Indications

Aphrofemine (flibanserin) tablets are indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

A co-existing medical or psychiatric condition

Problems with the relationship or

Dosage and administration

1)Recommended dosage:

The recommended dosage of Aphrofemine is 100 mg administered orally once per day or at bedtime. Aphrofemine is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation).

2)Missed Dose:

Contraindications

Aphrofemine is contraindicated :

With use of alcohol.

With concomitant use with moderate or strong CYP3A4 inhibitors.

Side effects

Hypotension and syncope

CNS depression

Dizziness, nausea, insomnia, somnolence, anxiety

Storage

Store at temperature not exceeding 30°C, in a dry place

Package:

Carton box containing 1,2 or 3 strips each of 10 film coated tablet and inner leaflet.