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Folavit 5 Mg Tablets 1. NAME OF THE MEDICINAL PRODUCT Folavit 1 mg tablets Folavit 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Folavit 1 mg tablets Each tablet contains 1 mg folic acid. Excipients with known effect: each tablet contains 72,2 mg lactose (as monohydrate) and 8,3 mg sucrose. For the full list of excipients, see section 6.1. Folavit 5 mg tablets Each tablet contains 5 mg folic acid. Excipients with known effect: each tablet contains 68,4 mg lactose (as monohydrate) and 8,3 mg sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Folavit 1 mg tablets Light yellow or light yellow orange speckled, round, biconvex tablet of 7 mm with a score-line on one side. The tablet can be divided into two equal doses. Folavit 5 mg tablets Yellow or yellow orange speckled, round, biconvex tablet of 7 mm with a score-line on one side. The tablet can be divided into two equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Folavit is indicated in adults and children. - Reduction of side effects in patients receiving low-dose methotrexate therapy for rheumatoid arthritis, psoriasis and inflammatory bowel disease. - Prevention or treatment of folate deficiency, which may cause macrocytic anemia. Folate deficiency is associated with elevated homocysteine levels. Various conditions can cause folate deficiency: - Inadequate dietary intake (e.g. malnutrition in the elderly) - Malabsorption (e.g. coeliac disease, bariatric surgery, inflammatory bowel disease, alcoholism) - Increased utilization (e.g. pregnancy, lactation, hemolytic anemia) - Increased loss (e.g. hemodialysis) 1 - Intake of medications (e.g. certain antiepileptic drugs, sulphasalazine, pemetrexed). Folic acid supplementation reduces the hematological toxicity of pemetrexed. - Prevention of neural tube defects. Women at high risk include: - Previous pregnancy affected by a neural tube defect or woman or partner are affected by a neural tube defect themselves - Family history of neural tube defects - Use of antiepileptic drugs - Diabetes mellitus (type 1 and type 2) - Obesity - Malabsorption (e.g. coeliac disease, bariatric surgery) - Thalassemia or sickle cell anemia - Use of sulphasalazine - Use of proguanil 4.2 Posology and method of administration Posology - Reduction of side effects during low-dose methotrexate therapy: 5 to 10 mg once a week (24h after methotrexate intake, see section 4.5) or 1 mg daily. Other dosage regimens can be justified. - Prevention or treatment of folate deficiency: 0,5-5 mg daily; higher doses may be necessary in some patients e.g. in malabsorption states. Folic acid doses > 1 mg/day should be avoided during treatment with certain antiepileptic drugs (see section 4.4 and 4.5). - Reduction of side effects of pemetrexed therapy: 1 mg daily. At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed (unless prescribed otherwise) and daily dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. - Prevention of neural tube defects in women at high risk: 5 mg daily, starting at least 1 month before conception and continuing during the first trimester of pregnancy. - Prevention of neural tube defects in women at no elevated risk: 0,5 mg daily, starting at least 1 month before conception and continuing during the first trimester of pregnancy. Paediatric population - Reduction of side effects low-dose methotrexate therapy: similar doses as adults. - Prevention or treatment of folate deficiency: - Neonates: 50 µg folic acid once daily - Children aged less than 1 year: 0,5 mg folic acid/kg once daily - Children aged 1 – 18 years: similar doses as adults. Method of administration Oral use. 2 The tablets can be taken with or without food, with a glass of water. 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Vitamin B12 deficiency unless simultaneous folic acid deficiency can be documented and administered with adequate amounts of cobalamine. Folic acid should never be given alone in the treatment of pernicious anemia and other vitamin B12 deficiency states (see section 4.4). - Megaloblastic anaemia of unknown origin, unless vitamin B12 deficiency can be excluded (see section 4.4). - Patients with malignant disease, unless prevention or treatment of folate deficiency associated hematological disorders is advisable (see section 4.4). 4.4 Special warnings and precautions for use - Folic acid treatment can mask a concurrent vitamin B12 deficiency, or the development of such, as it may resolve the megaloblastic anemia due to vitamin B12 deficiency. However, it does not prevent aggravation of neurological symptoms, which may result in irreversible nerve damage (see section 4.3). - Caution should be taken when treating patients which may have folate dependant tumour disease. Folic acid supplements may increase growth of already existing malignity (see section 4.3). - Folic acid supplementation should be avoided during treatment with fluorouracil or its prodrugs as it may increase fluorouracil toxicity (see section 4.5). - Folic acid supplementation should be avoided during treatment with raltitrexed as it may possibly interfere with the action of raltitrexed (see section 4.5). - Folic acid doses > 1 mg/day should be avoided during treatment with certain antiepileptic drugs in order to avoid decreased seizure control (see section 4.5) except for prevention of neural tube defects where 5 mg/day should be taken. - Folate deficiency due to high-dose (antitumoral) methotrexate, pyrimethamine or trimethoprim (dihydrofolate reductase inhibitors) should be treated with folinic acid instead of folic acid (see section 4.5). - This medicinal product contains lactose and sucrose. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, sucrase- isomaltase insufficiency or glucose-galactose malabsorption should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction - Folic acid may increase toxicity of fluorouracil (pyrimidine analogue) and its prodrugs capecitabine and tegafur. Folic acid supplementation should be avoided. On the other hand, folinic acid may be used therapeutically in combination with fluorouracil (prodrugs) as adjuvant (see section 4.4). In this case, the dose of the cytostatic drug should be decreased. - Folic acid may interfere with the action of raltitrexed. Folic acid supplementation should be avoided (see section 4.4). - Intake of certain antiepileptic drugs may cause subnormal serum folate levels (in particular phenytoin, phenobarbital and primidone, possibly also carbamazepine and valproate). Conversely, if folic acid supplements are given to treat folate deficiency, the serum antiepileptic drug levels may fall, leading to decreased seizure control in some patients. Therefore, high dose folic acid supplementation (> 1 mg/day) should be avoided and levels of antiepileptic drugs (phenytoin, phenobarbital, primidone, pheneturide and carbamazepine) should be monitored in 3 case folic acid supplements are administered (see section 4.2). The antiepileptic drug dose should be adjusted if necessary. - High folic acid dose (i.e. dosage regimen of 5 to 10 mg folic acid once a week) should not be taken on the same day as methotrexate. Instead, it should be taken the day after methotrexate intake in order to avoid potential interference with methotrexate efficacy (see section 4.2). - Folate antagonists including high-dose (antitumoral) methotrexate, pyrimethamine and trimethoprim may cause hematological toxicity due to folate deficiency. Administration of folinic acid is the appropriate treatment (see section 4.4). - Treatment with cholestyramine or colestipol may interfere with folate absorption and cause folate deficiency. Folic acid supplements should be taken at least 1 h before or 4-6 h after cholestyramine or colestipol administration. - Treatment with sulphasalazine may cause folate deficiency. - Chronic alcoholism may cause folate deficiency. - Oral contraceptive use may cause reduced serum folate levels. - Treatment with triamterene may cause folate deficiency. Moreover, folic acid and triamterene may inhibit each other’s absorption. - Folic acid may increase the antidepressant action of fluoxetine. Antibiotics may interfere with the microbiological assay for folic acid concentrations and may cause falsely low results. 4.6 Fertility, pregnancy and lactation Pregnancy There are no known hazards to the use of folic acid in pregnancy. Pregnant women have higher folate requirements associated with the growth of fetal and maternal tissue and the active transfer of folate to the fetus. Periconceptional folic acid supplementation decreases the risk of a pregnancy affected by a neural tube defect. Breastfeeding Folic acid is actively secreted in human breast milk. Breast milk folate concentrations are maintained at the expense of maternal folate reserves and are not affected by low maternal folate intake, unless women are severely folate deficient (see section 5.2). Folate requirements are increased during lactation. There are no known adverse events in breast fed infants whose mothers were receiving folic acid supplements. Fertility There is no evidence for a negative effect of folic acid supplementation on male or female fertility. 4.7 Effects on ability to drive and use machines Folavit has no or negligible influence on the ability to drive and
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