ROVIGON CHEWABLE COATED TABLETS 30 TABLETS

Name
Rovigon chewable coated tablets
Vitamins 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, or malnutrition and related symptomatic conditions. Furthermore, Rovigon, as a balanced association between vitamins A and E, is indicated in functional disorders and degenerative manifestations of tissues of epithelial and mesodermal origin (for example 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.
Women who are pregnant or may 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 patients with heart failure since 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 overdose of vitamin A.
In patients who smoke twenty or more cigarettes a day, prolonged use of the product may increase the risk of developing lung cancer.
During pregnancy, a daily intake of vitamin A up to 10,000 IU has been shown to be safe.
However, doses higher than 15,000 IU/day have been associated with the possibility of malformations in humans. Therefore, during pregnancy, daily doses higher than 10,000 IU should be avoided, especially during the first trimester (see also “Pregnancy and breastfeeding”).
Vitamin A should not be taken together with other drugs containing vitamin A, the synthetic isomers tretinoin and etretinate or beta-carotene, since these compounds, in 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 method of contraception without interruption for the entire duration of treatment and for at least one month after its cessation.
Long-term treatment with vitamin A has been associated with cirrhosis, impaired hepatic circulation, hepatic fibrosis, and hepatotoxicity. Patients with pre-existing liver disease are at increased risk of developing or worsening liver disease due to reduced ability 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 must not be exceeded.
Before prescribing treatment, the intake of vitamin A, isotretinoin, etretinate and beta-carotene from diet and any use of supplements and concomitant medications should be assessed.
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 everybody gets them.

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

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

Hepatobiliary pathologies
Jaundice, hepatomegaly, hepatic steatosis.
Cirrhosis, hepatic fibrosis, and hepatotoxicity have been associated with long-term vitamin A therapy (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 involve 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 through diet or supplements has been associated with increased osteoporosis and risk of hip fracture.
Nervous system disorders
Headache. Sudden onset of headache may be one of the symptoms of pseudotumor cerebri (see “Overdose”).
Skin and subcutaneous tissue disorders
Itching, urticaria, rash, dry skin, exfoliative dermatitis.
Chronic use of vitamin A has been associated with: alopecia, dermatitis, eczema, erythema, skin discoloration, hair structure changes, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.