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VITAMINUM A + E GAL



(Retinols Palmitas + int-rac-α-Tocopherylis acetas), IU 30 000 + 70 mg, soft capsule.

Please carefully read the leaflet before you start taking this medicine because this leaflet contains important information for you.

This medication should be taken exactly as described in the leaflet.
Keep this leaflet, you may need to read it again.
If you need more information or advice , ask your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, please consult it with your doctor or pharmacist.
If there is no improvement or the patient feels worse, contact your doctor immediately.

Note: Pregnant women should not use this product.

Contents of this leaflet:

  1. What is the drug VITAMINUM A+E GAL is and what it is used for
  2. Before you take VITAMINUM A+E GAL
  3. How to take VITAMINUM A+E GAL
  4. Possible side effects
  5. How to store VITAMINUM A+E GAL
  6. Package Contents and other information

 

1. What is VITAMINUM A+E GAL and what it is used for:

The drug VITAMINUM GAL A + E combines the activity of vitamin A and vitamin E.
Vitamin A is essential for proper visual processes, reproduction, growth, regeneration and epithelial differentiation steps, as well as bone growth and development and it helps to maintain the integrity of the mucosa.
Vitamin A deficiency leads to blindness after twilight, drying conjunctivitis, softening of the cornea, and in severe cases, to permanent eye damage and blindness.

Vitamin A deficiency can cause skin lesions, hyperkeratosis of the skin, mucous membrane epithelium metaplasia and reduce resistance to infection.

The biological activity of vitamin E is primarily due to its antioxidant properties. Vitamin E prevents the formation of free radicals and lipid peroxides. It protects polyunsaturated fatty acids against oxidation, stabilizes cell membranes and intracellular lipid structure. It affects the biosynthesis of prostaglandins and platelet aggregation.

The drug VITAMINUM GAL A + E is used to treat the clinical symptoms resulting from deficiency of vitamin A and E.

2. Before you take VITAMINUM A+E GAL:

Do not take VITAMINUM A+E GAL:

  • if the patient is hypersensitive to vitamin A, E or other components of the formulation;
  • if you have hypervitaminosis (excess of vitamin A in the body) or malabsorption of fats;
  • if you are allergic to peanuts or soya (medicine contains peanut oil).

Take special care with VITAMINUM A+E GAL

  • in diseases of the liver (cirrhosis, hepatitis), or in case of those with an alcohol abuse problems because of the possibility of further damage to the liver.
  • with concomitant use of anticoagulants ( e.g. dicumarol, warfarin) because they may decrease the effectiveness of VITAMINUM A+E GAL and cause bleeding. During a long-term use of vitamin E it should be regularly monitored for their prothrombin time.
  • during intake of other formulations containing vitamin A (due to possible overdose);
  • if fat malabsorption, and small protein intake (vitamin A absorption is reduced).
  • Carefully apply in the states of deficiency of vitamin K.
  • During treatment, no use of other medicinal products containing vitamin A and (or) vitamin E, due to the possibility of overdose.
  • In the case of long-term use (several weeks to several months), for patients with impaired hepatic, renal , low body weight, hypoproteinaemia, alcohol abuse, due to possible experience of symptoms of overdose.
  • Patients with renal impairment and (or) liver before taking VITAMINUM A+E GAL should consult it with a doctor.

VITAMINUM A + E GAL and other drugs

Cholestyramine, colestipol and neomycin liquid paraffin reduce the effectiveness of the preparation, and other medicaments containing retinoic acid derivatives increase its toxicity. Combination of therapy with retinoids and vitamin A in doses higher than 4000 - 5000 IU a day, can cause symptoms of overdose of vitamin A.
The preparation may potentiate the effects of oral anticoagulants.

Exercise caution with concomitant use of anticoagulants ( e.g. dicumarol, warfarin) because they may decrease their effectiveness and cause bleeding.
Concomitant use of vitamins A + E, iron preparations may inhibit its hematologic effects.

Alcohol enhances the toxicity of vitamin A.
Vitamin E may cause increased absorption of cyclosporine.
You should inform your doctor about all the medicines you are taking or have recently taken, as well as medicines that the patient is planning to take.

VITAMINUM A + E GAL with food and drink
The drug is best when taken with a meal, with a sufficient amount of liquid.

Pregnancy, breastfeeding and fertility

Pregnancy
Before taking any medication, consult your doctor.
Product VITAMINUM GAL A + E is contraindicated in pregnancy. Vitamin A is included in the formulation at a dose dangerous to the fetus. Recommended by the WHO maximum total daily intake of vitamin A for pregnant women is 10 000 IU = 3000 micrograms RE. Preparations containing more than 5000 IU of Vitamin A are not recommended due to possible teratogenic effects.

Breast-feeding
Before taking any medication, consult your doctor.
Vitamin A is excreted in breast milk. During treatment with VITAMINUM A + E GAL women should not breastfeed.
For women who are breastfeeding, if it is necessary to take the drug VITAMINUM A + E GAL exactly according the daily dose determined by their doctor.

3. How to take VITAMINUM A+E GAL:

This medicine should only be used as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose VITAMINUM A + E GAL: Adults : 1 capsule daily with a meal.
If in doubt, ask your doctor or pharmacist.

In case you take more than the recommended dose of VITAMINUM A + E GAL, you should immediately contact your doctor or pharmacist.
Symptoms of acute poisoning (for vitamin A) may occur after 6 hours once a dose of 1 000 000 IU of vitamin A. They are characterized by somnolence, delirium, headache, dizziness, coma, or irritability, nausea, vomiting and diarrhea.

With long-term use of vitamin A in large doses patients may have symptoms of chronic toxicity (see section 4. Possible side effects).
Treatment for overdose of vitamin A is to discontinue its use and, if necessary, start symptomatic treatment. Symptoms usually disappear within 1-4 weeks after discontinuation of consumption of vitamin A.
Vitamin E usually does not cause symptoms of toxicity.

If you forget taking VITAMINUM A + E GAL
Do not take a double dose to make up for the forgotten dose.

If you stop taking VITAMINUM A + E GAL
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects:

With long-term adoption of vitamin A in large doses greater than 3000 mg (10 000 IU) there may occur hypervitaminosis A, and the symptoms are: malaise, weakness, anorexia, excessive irritability or depression, increased intracranial pressure, drowsiness, itching, dry skin, brittle nails, skin discoloration, hair loss, headaches, stomach, nausea, vomiting, mild fever, enlarged liver and spleen, nystagmus, optic disc edema, bone pain and joint, photophobia, cracking and bleeding lips, alopecia, erythema.

Long-term intake of vitamin A can cause liver damage.

The use of vitamin E in doses greater than 300 units (220 mg) daily may rarely cause nausea, diarrhea, cramps , fatigue, emotional disturbances, fatigue, thrombophlebitis, headache, blurred vision, rash, breast tenderness, creatine kinase, increased cholesterol and triglyceride levels and a decrease in the concentration of thyroxine and triiodothyronine in serum, increased levels of estrogens and androgens in the urine.
These symptoms resolve after discontinuation of vitamin E.

For some people, while taking VITAMINUM A + E GAL with any other medication patient may experience other side effects.
Like all medicines, this medicine can cause side effects, although not everybody will suffer from them.

In case of long-term use of the drug in doses exceeding the recommended doses hypervitaminosis A can occur. Its symptoms are: malaise, weakness, anorexia, excessive irritability or depression, itching and dry skin, brittle nails, skin discoloration, hair loss, headache, enlarged liver and spleen, swelling of the optic disc.

Long-term intake of vitamin A can cause liver damage.
This medicine may cause allergic reactions.

Reporting of adverse reactions

If you experience any side effects, including any side effects not listed in this leaflet, please inform your doctor about this. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Action Office for Registration of Medicinal Products for Human Medicinal Products, Medical Devices and Biocidal Products

ul. Ząbkowska 41, 03-736 Warsaw
Tel: 22 49 21 301 , fax: 22 49 21 309 , e- mail: adr@urpl.gov.pl .
E- mail: adr@urpl.gov.pl.

Thanks to the reporting of adverse events more information about the safety of this medicine can be  gathered and spread to other patients using this product.

5. How to store VITAMINUM A+E GAL:

Keep at temperatures below 25°C, in the original package in order to protect from light.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date given on the packaging.

Package contents and other information

What does the drug VITAMINUM A+E GAL contain

  • The active substance is a Retinol palmitate and all-rac-α-tocopheryl acetate
  • The other ingredients (excipients) are peanut oil, gelatin, glycerol 99,5%, ethyl parahydroxybenzoate and purified water.

How does VITAMINUM A+E GAL packaging look like and what are the contents of the packaging
60 capsules in blisters of Aluminium/PVC foil and carton

Authorisation holder and Manufacturer

Specjalistyczne Przedsiębiorstwo Rolno-Przetwórcze „GAL”
L.P.M.Ł. Marek s.j.
ul. Krótka 4, 61-012 Poznań

Leaflet was last revised: November 2013.