MINISTRY OF HEALTHCARE OF THE REPUBLIC OF BELARUS

PACKAGE LEAFLET

(Patient information leaflet)

Instructions for use

AYEVIT

Trade name: Ayevit

International non-proprietary name: Vitamin A and E

Formulation: capsules

Description: light yellow to dark yellow soft gelatin capsules of almost spherical shape.

Contents of the capsules – oily liquid of light yellow to dark yellow colour.

Composition: each capsule contains:

Active substance: retinol palmitate (vitamin A) – 100,000 IU; alpha-tocopheryl acetate (vitamin E) – 100 mg.

Excipients: sunflower oil.

Contents of a soft gelatin capsule:

Gelatin, glycerin, methyl parahydroxybenzoate.

Pharmacotherapeutic group: Vitamins. Vitamins combination.

ATC code: A11CA, A11HA03.

 

Pharmacological action

Combination drug, the action of which is defined by properties of its constituents, i.e. fat-soluble vitamins A and E. Retinol (vitamin A) is an essential component for normal functioning of retina: it binds with opsin (retinal red pigment) and generates rhodopsin, also called visual purple, which is necessary for visual adaptation in the dark. Vitamin A is necessary for bones growth, normal functioning of reproduction system, embryonic development, regulation of epithelium splitting and differentiation (enhances skin epithelial cells splitting, rejuvenates cell population, inhibits keratinization processes).

Alpha-tocopherol (vitamin E) functions are still not completely revealed. Being an antioxidant it inhibits development of free radicals reactions, prevents formations of peroxides, damaging cell membranes, which is important for organism growth, normal functioning of the nervous and muscular systems. It improves capillary blood flow, normalizes capillary and tissue permeability, increases tissue resistance to hypoxia.

Indications for use

Combined A and E vitamins deficiency.

Complex therapy in diseases and conditions, requiring long-term administration of high doses of vitamin A combined with vitamin E: skin diseases, accompanied by tissue trophism disorder


(psoriasis, some forms of eczema, ichthyosis, seborrheic dermatitis).

Method of administration and dosing schedule

Per os, irrespective of food intake, 1 capsule per day. Treatment course is 20-30-40 days.

Retreatment is indicated with 3-6 months intervals.

If the drug intake was missed, the dose should be administered as soon as possible, and the next dose – at usual time. However, if it is getting on for administration of the next dose, the missed dose should be omitted. It is not recommended to compensate for the missed dose by doubling the next one.

Use in children. Contraindicated.

Use in elderly patients. Dose adjustment is not required.

Use in patients with liver and/or renal impairment. Dose adjustment is not required.

Side effects

Nervous system disorders: somnolence, irritability, headache, sleep loss.

Gastrointestinal disorders: loss of appetite, pain in epigastrium, dyspeptic disorders (nausea, vomiting, diarrhea).

Immune system disorders: allergic reactions, including pruritus and rash.

Skin and subcutaneous tissue disorders: dry flaky skin.

Others: facial hyperemia, atony, rapid fatigability, rise of temperature; during long-term use – hair loss, pain in lower extremities, aggravation of gallstone disease and chronic pancreatitis, hypervitaminosis A.

In case of any side effects mentioned above or not stated in this leaflet, it is recommended to seek for medical advice.

Contraindications

Hypersensitivity to the components of the drug, gallstone disease, chronic pancreatitis, cardiosclerosis, myocardial infarction, decompensated cardiac insufficiency, high intracranial pressure, treatment with retinoids and their derivatives, pregnancy (especially I trimester) and lactation (it is necessary to stop breast-feeding for the period of treatment), hypervitaminosis A and E, history of sarcoidosis, childhood.

Use with caution: thyrotoxicosis, cholecystitis, conditions, which are accompanied by increased vascular permeability (chronic circulatory failure, chronic glomerulonephritis), liver cirrhosis, viral hepatitis, renal insufficiency, alcoholism, elderly age, hypoprothrombinaemia (associated with vitamin K deficit – can aggravate upon administration of more than 400 IE of vitamin E), elevated risk for thromboembolism, acute or chronic nephritis, severe failure of gastrointestinal tract.

Overdose

In acute hypervitaminosis A and E due to immediate intake of high doses, which exceed manifold the therapeutic ones, the following events may develop: severe headache, dizziness, somnolence, confused consciousness, elevated intracranial pressure, cardiac insufficiency, visual disturbances, seizures, incoercible vomiting, intractable diarrhea, severe dehydration; on the second day the following develops: extended rash with subsequent heavy peeling, starting from the face; palpation of long bones is strongly painful due to subperiosteal haemorrhage, changes in bones, soft tissues, creatinuria, diarrhea, pain in epigastrium, decrease in working capacity.

In case of prolonged administration of the medicinal product, development of chronic hypervitaminosis A and E is possible.


 

Symptoms of chronic vitamin A intoxication: anorexia, pain in bones, skin crevices and dryness, dryness of lips, dryness of oral mucosa, gastralgia, vomiting, hyperthermia, asthenia, headache, photosensibilisation, pollakiuria, nycturia, polyuria, irritability, hair loss, marigold yellow spots on plantae, palms and in the nasolabial triangle region, hepatotoxic events, increase of intraocular pressure, oligomenorrhea, portal hypertension, hemolytic anemia, changes in the bones on X-ray pictures, seizures.

Symptoms of vitamin E overdose: in case of prolonged administration of 400-800 U/day – blurred vision, dizziness, headache, nausea, diarrhea, gastralgia, asthenia; in case of prolonged administration of more than 800 U/day – elevation of haemorrhage risk in patients with hypovitaminosis K, thyroid hormones metabolism disorder, sexual function disorder, thrombophlebitis, thromboembolism, necrotizing colitis, sepsis, hepatomegaly, hyperbilirubinemia, renal insufficiency, retinal haemorrhage, hemorrhagic stroke, ascites.

Treatment: drug withdrawal; symptomatic therapy.

Precautions

In order to prevent hypervitaminosis A and E, you should not exceed the recommended doses. The drug should not be administered together with other medicinal products, which include vitamin A and its synthetic analogues due to risk of hypervitaminosis A development.

During the drug usage, you should keep in mind that it contains great amount of vitamin A (100, 000 IE), and that it is therapeutic agent and not a preventive one. A diet with increased selenium and sulphur-containing amino acids content reduces the demand in vitamin E.

Pregnancy and lactation. Use in pregnancy (especially in I trimester) and lactation (it is necessary to stop breast-feeding) is contraindicated. Teratogenic effect of high retinol doses also persists after discontinuation of the drug, therefore pregnancy may be planned only after 6-12 months.

Effects on ability to drive and use other potentially dangerous mechanisms. No effects.

Interaction with other medicinal products.

The drug should not be used together with other vitamin A derivatives due to risk of overdose and hypervitaminosis A.

Vitamin A weakens the effect of calcium medications, elevates hypercalcemia development risk. Cholestyramine, colestipol, mineral oils, neomycin reduce vitamins A and E absorption (dose elevation may be required). Oral contraceptives increase vitamin A concentration in blood plasma. Isotretinoin increases risk of vitamin A intoxication. Concomitant use of high doses of tetracycline and vitamin A (50,000 U and over) increases risk of intracranial hypertension.

Vitamin E enhances the effect of glucocorticosteroids, non-steroidal anti-inflammatory agents, antioxidants, increases the efficacy and decreases the toxicity of vitamins A and D, cardiac glycosides. Administration of vitamin E in high doses may cause vitamin A deficit. Vitamin E increases the efficacy of antiepileptic drugs in patients with epilepsy (with increased blood level of lipids peroxidation products). Simultaneous use of vitamin E in the dose exceeding 400 U per day with anticoagulants (coumarin and indandione derivatives) increases the risk for hypoprothrombinaemia and haemorrhage. High doses of Fe enhance oxidative processes, which increase the

demand in vitamin E.

The drug should not be administered concomitantly with nitrites, disturbing vitamin A absorption.

Retinol reduces anti-inflammatory action of glucocorticoids.

Storage conditions

Store in a dry place protected from light at temperature from 15°C up to 25°С.

Keep out of reach of children.

Shelf life

2 years.

Do not use after expiration date, stated on the packaging.

Packaging

10 capsules per blister container. 5 blister containers together with the leaflet are placed into a pack.

Prescription status

Prescription only.

 

Manufacturer:

Belmedpreparaty RUE

30 Fabritsius Str., 220007 Minsk, Republic of Belarus,

Tel./fax: (+375 17) 220 37 16,

e-mail: medic@belmedpreparaty.com,

http://www.belmedpreparaty.com