Indications

– Prophylaxis and treatment of Vitamin A deficiency such as xerophthalmia, night blindness.
– Supplement for patients with obstructive biliary cirrhosis that may develop dietary Vitamin A deficiency.
– Certain skin diseases (such as keratosis follicularis, acne, ichthyosis).

Present

Blister of 20 capsules. Box of 10 blisters.

Composition

Retinol acetate………………………………………………………………5000 IU
Excipients s.q. for………………………………………………………1 capsule
(Lactose, Tartrazine, Sunset yellow, Colloidal silicon dioxide, Crospovidone, Talc, Microcrystalline cellulose, Cassava starch).

Actions

Vitamin A is an oil– soluble vitamin that is essential for human vision; growth and development and maintenance of epidermal tissues.

Contra-Indications

– Patients with hypervitaminosis A.
– Hypersensitivity to any ingredient of the medicine.

Side effect

– Adverse effects and toxicity manifestations will occur after prolonged use of high doses or an immediately after an excessive high dose. Common manifestations: anorexia, diarrhea, dizziness, drowsiness,…
Inform your doctor about side– effects when using this medicine.

Precaution

Use with caution while taking other medication that contains Vitamin A.
PREGNANCY AND LACTATION:
– Avoid using Vitamin A or its synthetic analog preparations such as Isotretinoin at large doses for pregnant women because high dosage of Vitamin A (≥ 10,000 IU/day or 25,000 IU/week) may cause birth defects.
– Vitamin A is present in breast milk. Do not give to nursing women in excess of 1 capsule daily.

Interaction

– Neomycin, Cholestyramine, Liquid Paraffin: may decrease Vitamin A absorption.
– Oral contraceptives may increase plasma level of Vitamin A and produce unfavorable conditions for fertilization.
– Concomitant use of Vitamin A containing medicines result in hypervitaminosis. Avoid such as combination as well as high doses of Vitamin A.
OVERDOSAGE:
– Acute toxicity: oral administration of very high dose of Vitamin A may result in acute toxicity with the following manifestations: somnolence, dizziness, nausea, vomiting, irritability, headache, delirium, convulsion, diarrhea,…
Those symptoms appear 6 – 24 hrs after oral administration.
– Chronic toxicity: prolonged use of high doses of Vitamin A may lead to hypervitaminosis. Common symptoms include: fatigue, irritability, anorexia, weight loss, vomiting, GI disturbances, fever, hepatosplenomegaly, skin changes, alopecia, dryness and cracking of hair, fissures of lips, hemorrhagia, anemia, headache, hypercalcemia, skin edema, migratory arthralgia. In children manifestation of chronic toxicity may include increased intracranial pressure, papilledema, vertigo, visual disturbances, painful hyperostosis of the long bones. Symptoms usually disappear within a few days after the drug is discontinued but the bones stop to grow because of premature closure.
– Management: immediate withdrawal of the Vitamin A along with symptomatic and supportive treatment.

Shelf life

24 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC. Protect from light.

Dosage

– As prescribed by physicians.
– Recommended dosage:
+ Prophylaxis of Vitamin A deficiency: Adults and children > 8 years: 1 capsule/daily, for 1 – 2 weeks.
Children ≤ 8 years: 1 capsule once every other day for 1 – 2 weeks.
+ Treatment of Vitamin A deficiency: Adults and children > 8 years: 3 capsules/daily, for 1 – 2 weeks.