Your doctor has prescribed you A-Vite to prevent or treat situations where there is a lack of vitamin A.

Vitamin A is a liposoluble vitamin playing an important role in the organism, namely in the retina.

The deficiency in vitamin A causes disturbances in the visual adaptation to dark, as well as degenerative changes in the retina.

Given its role in the maintenance of the structural and functional integrity of the epithelial cells, the deficiency of vitamin A is accompanied by the atrophy of these cells and keratinization which, as far as skin is concerned, causes the appearance of dry skin and scaling.

A decrease in the resistance to infections is also observed.

The intake of vitamin A normalizes the changes caused by its deficiency, exception made regarding irreversible eye injuries.

Do not take A-Vite

– if you are hypersensitive (allergic) to vitamin A or to any other ingrediente of A-Vite,

– if you have hypervitaminosis A (excess of vitamin A),

– if you are pregnant or breastfeeding,

– if you are taking any of the following medicines:

– cholestyramine or colestipol

– neomycin – retinoids (isotretinoin, etretinate)

– warfarin (only if you are taking very high doses of A-Vite)

Take special care with A-Vite

Talk to your doctor on any health problems you may have or may have already had and about your allergies.

Children:

The use of A-Vite in children must be handled with precaution as children have greater sensitivity to high doses and/or to the prolonged administration of vitamin A.

Elderly:

In the elder, the prolonged administration of A-Vite may come with a greater risk of vitamin A overload due to a decrease in the clearance of this substance.

Taking A-Vite with other medicines

Tell your doctor of pharmacist if you are taking, have recently taken, or might take any other medicines including those obtained without prescription. You should also tell any other doctor prescribing you new medication that you are taking A-Vite.

Taking A-Vite together with any of the following medicines may interfere with the absorption of vitamin A and that is why it is so important to tell your doctor if you are taking cholestyramine, colestipol or neomycin.

The administration of certain medicines with A-Vite may lead to adverse reactions that are additive given the interaction with vitamin A. This being so, always tell your doctor if you are taking retinoids (isotretinoin, etretinate).

It is also important to inform your doctor if you are taking anticoagulants (medicines that prevent blood clots, such as warfarin, for instance) since high doses of Vitamin A may increase its effects.

Pregnancy and breastfeeding

Always ask your doctor or pharmacist for advice before taking any medicine.

A-Vite must not be taken by pregnant women, women planning on having a baby or women thinking they might be pregnant. If you get pregnant during treatment with A-Vite, stop treatment and immediately talk to your doctor.

Women who are breastfeeding must not take A-Vite.

Driving and using machines

A-Vite is not likely to interfere with the ability to drive and use machines.

Important information about some of the ingredients of A-Vite

This medicinal product contains Amaranth (E 123). It may cause allergic reactions.

This medicinal product contains castor oil (hydrogenated). It may cause stomach upset and diarrhea.

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take A-Vite as your doctor has told you. Always check with your doctor or pharmacist if you are not sure.

Adults:

The recommended dose is 1 capsule per day. Your doctor may adjust the dose in accordance with your daily intake of vitamin A in your diet. Take A-Vite until your doctor tells you to stop.

Capsules must be swallowed whole with a glass of water.

Children:

Children aged over eight years must only take A-Vite for the treatment of vitamin A deficiency (namely in the case of changes in vision), the recommended dose being the same as in the adult: 1 capsule a day of A-Vite.

Patients with renal and hepatic impairment as well as elderly patients must not take prolonged treatments.

Daily doses must not be exceeded due to the risk of intoxication and hypervitaminosis A, particularly in children and elderly patients.

If you take more A-Vite than you should

If you take an excessive dose of A-Vite, please tell your doctor of pharmacist immediately.

If you forget to take A-Vite

Always take A-Vite as your doctor told you. However, if you forget to take a capsule do not take a double dose to make up for the forgotten one. Then proceed as before resuming treatment following the dose regimen indicated by the doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, A-Vite can cause side effects, although not everybody gets them.

Side effects are described only in the case of overdose (ingestion of very high doses): irritability, vertigo, delusion, coma, vomiting, diarrhea, increase in the intracranial pressure (increase in pressure inside the skull) with hypertension of the fontanel in breastfed children, cephalea (headache) and visual disturbances.

Side effects disappear with the interruption of the treatment.

These effects are more common in children than in adults.

If any of the side effects worsen or if you get any side effects not mentioned in this leaflet, talk to your doctor or pharmacist.

Store in the original package in order to protect from light and moisture.

Keep out the sight and reach of children.

Do not use A-Vite after the expiry date which is stated on the carton after “VAL.”.

The expiry date refers to the last day of that month. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What A-Vite contains

The active substance is axerophthol acetate, 100 mg, equivalent to 50.000 I.U. of vitamin A.

The other ingredients are: sorbitol (E 420); lactose; hydrogenated castor oil; stearic acid; colloidal silica, anhydrous; povidone K 30.

Capsule composition: gelatine; amaranth (E 123); titanium dioxide (E 171).

What A-Vite looks like and contents of the pack

A-Vite comes in capsules (no. 3, green) for oral use and it is available in PVC/Alu blister pack sizes of 20, 60 and 200 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sidefarma – Sociedade Industrial de Expansão Farmacêutica, S.A.

Rua da Guiné, n.º 26

2689-514 Prior Velho

Portugal

Manufacturer

Sofarimex Indústria Química e Farmacêutica, S.A.

Av. das Indústrias, Alto do Colaride

Agualva – 2735-231 Cacém

This leaflet was last revised in October 2012