ROVIGON 30CPR RIV MAST

ROVIGON MASTICAL RIVESTATES

active ingredients

A chewable coated tablet contains: retinol 30,000 UI (such as vitamin A palmitate 1.7 MUI/g with BHA/BHT), d–α–tocoferil acetate 70 mg (such as vitamin E 50 CWS/S). For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosio, anidro glucose, mannitolo, cocoa powder, lean milk powder, cocoa butter, K30 povidone, glycerol, etilvanillin, caramel aroma, rice starch, talc, dried nebulized arabic rubber, sodium carmellose, β–carotene (E 160a) 10% CWS, solid paraffin, light liquid paraffin.

Therapeutic indications

Rovigon is indicated in all deficiencies from mal absorption, lipid species, or from malnutrition and related symptomatic paintings. In addition, Rovigon, as a balanced association between vitamin A and E, is indicated in functional disorders and degenerative manifestations of tissues of epithelial and mesodermal origin (e.g. degenerative retinopathy, internal ear disorders, etc.), especially in middle-age and elderly people.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. A. Children under 12 years of age. Pregnant women or pregnant women.

Population

For oral use. Unless otherwise prescribed by your doctor, the recommended dose is 1 tablet daily for up to 4 weeks. The therapeutic cycle can be repeated over the year, according to the doctor. Posology should be regulated, based on the serum levels of vitamin A and vitamin E. Rovigon is contraindicated in children under 12 years of age (see paragraph 4.3).

Conservation

This medicine does not require any special condition of conservation.

Warnings

In order to avoid the appearance of signs and symptoms of hyperdosage use the product under medical control and for the period of time considered strictly necessary. The preparations containing vitamin E must be used carefully in diabetics and in subjects with heart failure since this vitamin can reduce insulin and digital requirements. In very prolonged therapies, especially if for several years, do not exceed in the number and duration of the therapeutic cycles recommended for each year, in order not to incur in the risk of chronic hyperdose of vitamin A. For the presence of betacarotene in the composition, prolonged use of the product can increase the risk of lung cancer on the strong smokers (ventive or more cigarettes per day). During pregnancy, a daily intake of vitamin A up to 10,000 IU was proven safe. However, doses greater than 15,000 IU/days were associated with the possibility of malformation in humans. Therefore, during pregnancy, daily doses of more than 10,000 IU must be avoided, especially during the first quarter (see also paragraph 4.6). Vitamin A should not be taken along with other medicines containing vitamin A, synthetic isomers tretinoin and hetretin or beta-carotene, since these compounds, at high doses, are considered harmful to the fetus. In women in fertile age it is necessary to ensure that: • the patient is not pregnant when treatment begins (negative pregnancy test) • the patient understands the teratogenic risk • the patient agrees to adopt an effective contraceptive method without interruption throughout the duration of treatment and for at least one month after its cessation. Long-term treatments with vitamin A have been associated with cirrhosis, alterations of liver circulation, liver fibrosis and hepatotoxicity. Patients with pre-existing liver disease are at greater risk of developing or meeting a worsening of liver disease due to the reduced capacity of protein binding retinol. Patients taking high doses of vitamin A (up to 2,500 UI/Kg per day) for a prolonged period without interruption must be kept under control for the appearance of signs of hypervitaminosis A. A maximum daily dose of 5,000 UI/Kg should not be exceeded prior to the prescription of treatment, vitamin A, isotrenitoin, etretinate and beta-carotene from the diet and the possible use of supplements and concomitant drugs must be evaluated. High doses of vitamin A have been associated with osteoporosis and osteosclerosis. This product contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance or galactose, lactase deficiency, glucose–galactose mal absorption or saccarase–isomaltase deficiency should not take this medicine.

Interactions

Vitamin E can enhance the action of digital or insulin. Avoid concomitant use with other drugs or supplements containing retinoids and antibiotics belonging to the tetracycline class.

Effects

The adverse reactions listed below derive from spontaneous signalling and there is therefore no organization for frequency categories. Pathologies of the eye Visual disturbances. Gastrointestinal diseases Gastrointestinal and abdominal pain, nausea, vomiting, diarrhea. Hepatobiliary diseases Ittero, hepatomegalia, hepatic steatosis. Cirrhosis, liver fibrosis and hepatotoxicity have been associated with long-term therapies with vitamin A (See paragraph 4.4.). Immune system disorders Allergic reaction, allergic edema, anaphylactic reaction, anaphylactic shock. Hypersensitivity reactions and clinical and laboratory manifestations include mild to moderate reactions that may affect the skin, respiratory tract, gastrointestinal apparatus and cardiovascular apparatus. Diagnostic examinations Anomaly in liver function tests, increased aspartate and alanine aminotransferase, increased triglycerides in blood. Disorders of metabolism and nutrition Hypercalcemia, lipid metabolism disorder. Diseases of musculoskeletal system and connective tissue Bone pain and osteoporosis; high intake of vitamin A with diet or by means of supplements has been associated with an increase in osteoporosis and the risk of hip fracture. Diseases of the nervous system Cephalea. An improvised onset of cephalea may be one of the symptoms of cerebri pseudotumor (see paragraph 4.9). Pathologies of skin and subcutaneous tissue Prurito, hives, rash, skin dryness, exfoliatory dermatitis. They have been associated with the chronic use of vitamin A: alopecia, dermatitis, eczema, erythema, skin discoloration, alterations of the hair structure, hypotrics, dry mucosa, skin fragility, cheylitis. Skin alterations are often among the first signs of hypervitaminosis A. Reporting of suspected adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Pervitamins Acute: ingestion of excessive doses of retinol can cause acute intoxication by vitamin A. Factors affecting acute toxicity reactions from retinol include age, nutritional status, type of preparation taken and route of administration. However, the risk may increase in case of kidney or liver disease, low body weight, protein malnutrition, hyperlipoproteinemia, alcohol consumption or vitamin C deficiency. The toxicity acute by retinol is characterized by intense headache, dizziness, hepatomegaly, vomiting, irritability, drowsiness and papylledema. After 24 hours, generalized dequamation of the skin may occur. Skin reactions associated with retinol toxicity include cheylitis, facial dermatitis, exfoliatory dermatitis, mucous membrane dryness, hair structure alterations, hair thinning, area alopecia, generalized alopecia, skin rash, itching, skin fragility. Other manifestations of a massive acute overdose consist of gastrointestinal symptoms (abdominal pain, nausea, vomiting) and cerebri pseudotumor (increasing intracranial pressure with the following symptoms: cephalea, capogiro, torpore, papilledema and, in newborns, transitory protrusion of the fountains), followed within a few days by generalized skin dequamation. Generally, signs and symptoms of vitamin A toxicity disappear quickly with the cessation of intake. Pervitamins Chronic: prolonged intake of vitamin A at daily doses from 10 to 20 times the recommended maximum can determine the occurrence of hypervitaminosis A. The actual toxic dose depends on age, individual doses and duration of administration. In adults hypervitaminosis A generally results from chronic intake of more than 30 mg of retinol per day; however, mild symptoms may already occur with a daily chronic intake with the diet of 10 mg of retinol. Symptoms of chronic vitamin A poisoning are various and include headache, nausea and vomiting for increased endocranial pressure, bone pain, signs and symptoms dependent on mucosa and skin, hepatomegalia, hypercalcemia, hematological alterations. Dry and itching skin, herimatous dermatitis, lip fissuration, anorexia, edema, hemorrhage, irritability and astenia can also occur. Other possible symptoms are night sweats, abdominal discomfort, growth delay, premature closure of epiphysis, dizziness, alopecia, skin dequamation, increased skin pigmentation, inflammation of the tongue, lips and gums. Hepatotoxic reactions are present in about half the cases of chronic hypervitaminosis A. In addition to clinical signs, such as hepatosplenomegalia, stellar angioma, leuconichia, palmar erythema and jaundice, an increase of hepatic transaminasis (aspartate and alanine aminotransferase). The increase in alkaline phosphatease can be very marked and there can be cholestasis with hyperbilirubinemia. A reversible syndrome of portal hypertension can occur with ascites. Histopathological characteristics include hypertrophy and hyperplasia of star cells (Ito) with accumulations of perisinusoidal lipocytes associated with fibrosis. Hepatocytic atrophy and cirrhosis were reported. It is also possible to find a picture of hepatitis and steatosis. The risk can be increased in case of kidney or liver disease, low body weight, protein malnutrition, hyperlipoproteinemia, alcohol consumption or vitamin C deficiency. The only diagnostic laboratory finding is the increase in serum retinol levels, mainly in the form of ester retinil. The concentration of the binding protein retinol (RBP) is normal and the excess retinol circulates linked to a lipoprotein. Generally the signs and symptoms of vitamin A toxicity quickly regress once the intake ceases. In patients with impairment of liver function and hepatomegaly, prognosis is usually favorable. However, if you have developed portal hypertension with ascites, the syndrome may persist. Overdose of vitamin E: vitamin E is usually not toxic. However, high doses (more than 300 units per day) have caused, in rare cases, nausea, diarrhea, intestinal cramps, astenia, weakness, headache, blurred vision, rash, gonad dysfunction, creatinuria, increased serum levels of creatinin–chinasis and creatinin–phospho-kinase, increased cholesterol and triglycerides in serum. These effects have disappeared from the suspension of treatment. Methanalysis revealed that, in patients with chronic disease, dosages equal to or greater than 400 units per day for a year or more were associated with an increase in mortality for any cause. The results of this data analysis were not clear about the risks and benefits of lower vitamin E dosages. However, a dose–response analysis showed a statistically significant relationship between the dose of vitamin E and mortality for any cause, with an increase in the risk of dosages greater than 150 units. These conclusions are controversial and are still a subject of debate in the medical and scientific community. Very high vitamin E doses (superior to 800 units per day for long periods) have also been associated with increased bleeding tendency in patients with vitamin K deficiency, alterations of hormonal metabolism (thyroid, hypophysis and adrenal), alterations of immune response and impairment of sexual function and can increase the thromboembolic risk in patients prepared.

Pregnancy

During pregnancy, a daily intake of vitamin A up to 10,000 IU was proven safe. However, doses greater than 15,000 IU/days were associated with the possibility of malformation in humans. Therefore, during pregnancy, daily dosages of more than 10,000 IU must be avoided, especially during the first quarter. Vitamin A should not be taken along with other medicines containing vitamin A, synthetic isomers tretinoin and hetretin or beta-carotene, since these compounds, at high doses, are considered harmful to the fetus. In women in fertile age it is necessary to ensure that: • the patient is not pregnant when treatment begins (negative pregnancy test) • the patient understands the teratogenic risk • the patient agrees to adopt an effective contraceptive method without interruption throughout the duration of treatment and for at least one month after its cessation.

Food

There is no adequate information on the excretion of vitamin A and vitamin E in human and animal breast milk and it is therefore not possible to exclude a risk for infants. The decision whether to stop breastfeeding or retinol/tocopherol therapy should be taken taking into account the benefit of breastfeeding for the newborn and the benefit of retinol/tocopherol therapy for the mother.

Source: Farmadati