Rovigon chewable coated tablets
Vitamins A+E
30 tablets
Therapeutic Category
Rovigon belongs to the therapeutic category of vitamin preparations based on vitamin A and vitamin E.
Therapeutic Indications
Rovigon is indicated in all deficiency states due to malabsorption, particularly lipid malabsorption, or malnutrition, and related symptomatic conditions. Furthermore, Rovigon, as a balanced combination of vitamin A and vitamin E, is indicated in functional disorders and degenerative manifestations of epithelial and mesodermal tissue (e.g. degenerative retinopathies, inner ear disorders, etc.), especially in middle-aged and elderly individuals.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Hypervitaminosis A.
Children under 12 years of age.
Pregnant women or women in whom pregnancy may occur.
Precautions for Use
To avoid the onset of signs and symptoms of overdose, use the product under medical supervision and only for the time strictly considered necessary.
Preparations containing vitamin E should be used with caution in diabetic patients and in subjects with heart failure, as this vitamin may reduce insulin and digitalis requirements.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Vitamin E may enhance the action of digitalis or insulin.
Avoid concomitant use with other drugs or supplements containing retinoids and with antibiotics belonging to the tetracycline class.
Special Warnings
In very prolonged therapies, especially over several years, do not exceed the recommended number and duration of treatment cycles per year, to avoid the risk of chronic vitamin A overdose.
In patients who smoke twenty or more cigarettes per 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 exceeding 15,000 IU/day have been associated with the possibility of congenital malformations in humans.
Therefore, during pregnancy, daily doses exceeding 10,000 IU should be avoided, especially during the first trimester (see also “Pregnancy and Lactation”).
Vitamin A should not be taken together 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 adopt an effective contraceptive method continuously throughout the duration of treatment and for at least one month after its discontinuation.

Long-term treatments with vitamin A have been associated with cirrhosis, alterations in hepatic circulation, hepatic fibrosis, and hepatotoxicity. Patients with pre-existing liver disease are at higher risk of developing or worsening liver disease due to reduced capacity to produce retinol-binding protein. Patients taking high doses of vitamin A (exceeding 2,500 IU/kg per day) for a prolonged uninterrupted period 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 from concomitant supplements and medications should be evaluated. High doses of vitamin A have been associated with osteoporosis and osteosclerosis.

Pregnancy and Lactation
Consult your doctor or pharmacist before taking any medicine.
Pregnancy
During pregnancy, a daily intake of vitamin A up to 10,000 IU has been shown to be safe.
However, doses exceeding 15,000 IU/day have been associated with the possibility of congenital malformations in humans.
Therefore, during pregnancy, daily doses exceeding 10,000 IU should be avoided, especially during the first trimester.
Vitamin A should not be taken together 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 adopt an effective contraceptive method continuously throughout the duration of treatment and for at least one month after its discontinuation.

Lactation
Adequate information on the excretion of vitamin A and vitamin E in human and animal milk is not available, and therefore a risk to the infant cannot be excluded. The decision whether to discontinue breastfeeding or to discontinue retinol/tocopherol therapy should be made taking into account the benefit of breastfeeding for the newborn and the benefit of retinol/tocopherol therapy for the mother.

Effects on the Ability to Drive and Use Machines
The product may cause visual disturbances. If this occurs, do not drive or operate machinery.
Important Information on Some Excipients
This product contains sucrose and glucose. Patients with rare hereditary problems of fructose or galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.
Dosage, Method, and Duration of Administration
For oral use.
Unless otherwise prescribed by the physician, the recommended dose is one tablet per day for a maximum of 4 weeks. The treatment cycle may be repeated within the year, at the physician’s discretion.
Dosage should be adjusted based on serum levels of vitamin A and vitamin E.
Rovigon is contraindicated in children under 12 years of age (see “Contraindications”).
Overdose
In case of accidental ingestion/overdose of Rovigon, contact your doctor immediately or go to the nearest hospital.
Acute hypervitaminosis A: ingestion of excessive doses of retinol may cause acute vitamin A intoxication.
Factors influencing acute retinol toxicity reactions include age, nutritional status, type of preparation taken, and route of administration. However, the risk may increase in cases of renal or liver disease, low body weight, protein malnutrition, hyperlipoproteinemia, alcohol consumption, or vitamin C deficiency.
Acute retinol toxicity is characterized by severe headache, dizziness, hepatomegaly, vomiting, irritability, drowsiness, and papilledema. Within 24 hours, generalized skin desquamation may occur. Cutaneous reactions associated with retinol toxicity include cheilitis, facial dermatitis, exfoliative dermatitis, mucosal dryness, alterations in hair structure, hair thinning, localized alopecia, generalized alopecia, skin rash, pruritus, and skin fragility.
Other manifestations of massive acute overdose include gastrointestinal symptoms (abdominal pain, nausea, vomiting) and pseudotumor cerebri (increased intracranial pressure with symptoms: headache, dizziness, lethargy, papilledema, and in neonates, transient bulging of fontanelles), followed within a few days by generalized skin desquamation.
Generally, signs and symptoms of vitamin A toxicity resolve rapidly upon discontinuation of intake.
Chronic hypervitaminosis A: prolonged intake of vitamin A at daily doses 10 to 20 times higher than the maximum recommended may lead to the onset of hypervitaminosis A. The actual toxic dose depends on age, single 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 appear with chronic daily dietary intake of 10 mg of retinol.
Symptoms of chronic vitamin A poisoning are varied and include headache, nausea, and vomiting due to increased intracranial pressure, bone pain, signs and symptoms affecting mucous membranes and skin, hepatomegaly, hypercalcemia, and hematological abnormalities. Dry and itchy skin, erythematous dermatitis, lip fissures, anorexia, edema, hemorrhage, irritability, and asthenia may also occur. Other possible symptoms include night sweats, abdominal discomfort, growth retardation, premature epiphyseal closure, vertigo, alopecia, skin desquamation, increased skin pigmentation, inflammation of the tongue, lips, and gums.
Hepatotoxic reactions are present in about half of the cases of chronic hypervitaminosis A. In addition to clinical signs such as hepatosplenomegaly, spider angioma, leukonychia, palmar erythema, and jaundice, an increase in liver transaminases (aspartate and alanine aminotransferase) is observed. Alkaline phosphatase may be markedly elevated, and cholestasis with hyperbilirubinemia may occur. A reversible portal hypertension syndrome with ascites may manifest.
The only diagnostic laboratory finding is an increase in serum retinol levels, primarily in the form of retinyl esters.
Generally, signs and symptoms of vitamin A toxicity regress rapidly once intake is discontinued. In patients with impaired liver function and hepatomegaly, the prognosis is usually favorable. However, if portal hypertension with ascites has developed, the syndrome may persist.
Vitamin E overdose: Vitamin E is usually non-toxic. However, high doses (more than 300 units per day) have rarely caused nausea, diarrhea, intestinal cramps, asthenia, weakness, headache, blurred vision, skin rash, gonadal dysfunction, creatinuria, increased serum levels of creatine kinase and creatine phosphokinase, increased cholesterol and serum triglycerides, increased urinary estrogens and androgens, and decreased serum thyroxine and triiodothyronine levels. These effects disappeared upon discontinuation of treatment.
A meta-analysis has shown that, in patients with chronic disease, dosages equal to or exceeding 400 units per day for one year or more were associated with an increased risk of all-cause mortality. The results of this data analysis were unclear regarding the risks and benefits of lower vitamin E doses.
However, a dose-response analysis demonstrated a statistically significant relationship between vitamin E dosage and all-cause mortality, with increased risk at dosages exceeding 150 units. These conclusions are controversial and remain a subject of debate within the medical and scientific community.
Very high doses of vitamin E (exceeding 800 units per day for long periods) have also been associated with increased bleeding tendency in patients with vitamin K deficiency, alterations in hormonal metabolism (thyroid, pituitary, and adrenal), alterations in immune response, impairment of sexual function, and increased thromboembolic risk in predisposed patients.
If you have any doubts about the use of Rovigon, consult your doctor or pharmacist.
Undesirable Effects
Like all medicines, Rovigon can cause undesirable effects, although not everyone experiences them.
The following undesirable 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, 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 affect the skin, respiratory tract, gastrointestinal system, and cardiovascular system.
Diagnostic investigations
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 dietary or supplemental intake of vitamin A has been associated with increased osteoporosis and hip fracture risk.
Nervous system disorders
Headache. Sudden onset of headache may be one of the symptoms of pseudotumor cerebri (see “Overdose”).
Skin and subcutaneous tissue disorders
Pruritus, urticaria, skin rash, dry skin, exfoliative dermatitis.
Chronic use of vitamin A has been associated with alopecia, dermatitis, eczema, erythema, skin discoloration, alterations in hair structure, hypotrichosis, mucosal dryness, skin fragility, cheilitis. Skin changes are often among the first signs of hypervitaminosis A.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.
Expiry and Storage
Expiry: see the date on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
Composition
One chewable coated tablet contains retinol 30,000 IU (as vitamin A palmitate 1.7 MUI/g with BHA/BHT), dl-α-tocopheryl acetate 70 mg (as vitamin E 50% CWS/S).
Excipients: sucrose, anhydrous glucose, mannitol, cocoa powder, skimmed milk powder, cocoa butter, povidone K30, glycerol, ethyl vanillin, caramel flavor, rice starch, talc, spray-dried dried gum arabic, sodium carmellose, β-carotene (E 160a) 10% CWS, solid paraffin, light liquid paraffin.
Pharmaceutical Form and Contents
Chewable coated tablets.
Box of 30 tablets
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TEOFARMA SRL
VIA FRATELLI CERVI, 8
27010 VALLE SALIMBENE
PAVIA (PV)
Manufacturer: Dragenopharm Apotheker Puschl GmbH Tittmoning (Germany).