ROVIGON*30CHEWABLE COATED TABLETS

Rovigon film-coated chewable tablets
Vitamin A+E 30 tablets

What it is and what it is used for
Rovigon is indicated in all deficiency states due to malabsorption, especially lipid malabsorption, or malnutrition and related symptomatic conditions. Furthermore, Rovigon, as a balanced combination of vitamin A and E, is indicated in functional disorders and degenerative manifestations of epithelial and mesodermal tissues (e.g., degenerative retinopathies, inner ear disorders, etc.), especially in middle-aged and elderly people.

What you need to know before taking the medicine
Hypersensitivity to the active substance or to any of the excipients.
Hypervitaminosis A.
Children under 12 years of age.
Pregnant women or women who could become pregnant.

Warnings and precautions
In order to avoid the appearance of signs and symptoms of overdose, use the product under medical supervision and for the period of time deemed strictly necessary.
Preparations containing Vitamin E should be used with caution in diabetics and in patients with heart failure, as this vitamin may reduce the need for insulin and digitalis.
In very prolonged therapies, especially if for several years, do not exceed the number and duration of therapeutic cycles recommended for each year, in order to avoid the risk of chronic vitamin A overdose.
In patients who smoke twenty or more cigarettes a day, prolonged use of the product may increase the risk of lung cancer.
During pregnancy, a daily intake of vitamin A up to 10,000 IU has been shown to be safe.
However, doses greater than 15,000 IU/day have been associated with the possibility of malformations in humans. Therefore, during pregnancy, daily doses greater than 10,000 IU should be avoided, especially during the first trimester (see also "Pregnancy and breastfeeding").
Vitamin A should not be taken with other drugs containing vitamin A, the synthetic isomers tretinoin and etretinate, or beta-carotene, as these compounds, at high doses, are considered harmful to the fetus.
In women of childbearing age, it is necessary to ensure that:
• the patient is not pregnant when starting treatment (negative pregnancy test)
• the patient understands the teratogenic risk
• the patient agrees to use an effective contraceptive method without interruption for the entire duration of treatment and for at least one month after its cessation.
Long-term treatments with vitamin A have been associated with cirrhosis, altered hepatic circulation, hepatic fibrosis, and hepatotoxicity. Patients with pre-existing liver disease are at higher risk of developing or experiencing worsening liver disease due to reduced capacity to produce retinol-binding protein.
Patients taking high doses of vitamin A (greater than 2,500 IU/kg per day) for a prolonged period without interruption should be monitored for signs of hypervitaminosis A.
A maximum daily dose of 5,000 IU/kg should not be exceeded.
Before prescribing treatment, the intake of vitamin A, isotretinoin, etretinate, and beta-carotene from diet and any concomitant supplements and drugs should be evaluated.
High doses of vitamin A have been associated with osteoporosis and osteosclerosis.

Possible side effects
Like all medicines, Rovigon can cause side effects, although not everyone gets them.

The following side effects have been reported in association with the use of Rovigon.

Eye disorders
Visual disturbances.
Gastrointestinal disorders
Gastrointestinal and abdominal pain, nausea, vomiting, diarrhea.

Hepatobiliary disorders
Jaundice, hepatomegaly, fatty liver.
Cirrhosis, hepatic fibrosis, and hepatotoxicity have been associated with long-term vitamin A therapies (See "Warnings").
Immune system disorders
Allergic reaction, allergic edema, anaphylactic reaction, anaphylactic shock.
Hypersensitivity reactions and their clinical and laboratory manifestations include mild to moderate reactions that may affect the skin, respiratory tract, gastrointestinal tract, and cardiovascular system.Diagnostic tests
Abnormal liver function tests, increased aspartate and alanine aminotransferase, increased blood triglycerides.
Metabolism and nutrition disorders
Hypercalcemia, lipid metabolism disorder.
Musculoskeletal and connective tissue disorders Bone pain and osteoporosis; high intake of vitamin A from diet or supplements has been associated with an increased risk of osteoporosis and hip fracture.
Nervous system disorders
Headache. A sudden onset of headache may be one of the symptoms of pseudotumor cerebri (see "Overdose").
Skin and subcutaneous tissue disorders
Pruritus, urticaria, rash, dry skin, exfoliative dermatitis.
Chronic use of vitamin A has been associated with: alopecia, dermatitis, eczema, erythema, skin discoloration, changes in hair structure, hypotrichosis, dry mucous membranes, skin fragility, cheilitis. Skin changes are often among the first signs of hypervitaminosis A.
Following the instructions in the package leaflet reduces the risk of side effects.
If any of the side effects get worse, or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.