PACKAGE LEAFLET: Information for the patient. VITAMINE D2 Solution for injection IU / 1 ml (Ergocalciferol)

Transcription

1 PACKAGE LEAFLET: Information for the patient VITAMINE D2 Solution for injection IU / 1 ml (Ergocalciferol) Read this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets worse or if you notice any side effect not listed in this leaflet, please inform your doctor or pharmacist. What is in this leaflet 1. What Vitamine D2 is and what it is used for 2. What you need to know before you take Vitamine D2 3. How to take Vitamine D2 4. Possible side effects 5. How to store Vitamine D2 6. Other information 1. WHAT VITAMINE D2 IS AND WHAT IT IS USED FOR Vitamin D is a fat - soluble vitamin. The term vitamin D is used for a range of closely related sterol compounds which may treat or prevent rickets. Natyral resources of vitamin D in humans depend on the ultraviolet (UV) radiation, which converts 7 dehydrocholesterol (provitamin D) to cholecalciferol (vitamin D3) or ergosterol to ergocalciferol (vitamin D2). Vitamin D deficiency develops when there is inadequate exposure to sunlight or a lack of this vitamin in the diet. Vitamin D deficiency causes rickets in children and osteomalacia in adults. 1

2 Vitamine D2 is indicated in: prevention and treatment of vitamin D deficiency resulting from lack of vitamin D dietary intake and its decreased synthesis (unbalanced diet with no fat, lack of sun exposure, and disorders of absorption of this vitamin from intestines); prevention and treatment of rickets and osteomalacia; spasmophilia in children and tetany. Your doctor may have prescribed Vitamine D2 for other purposes. Ask your doctor if you need to know why this medicine has been prescribed to you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAMINE D2 Do not take Vitamine D2: if you are hypersensitive to ergocalciferol or ethyl oleate; if you have nephritis; if you have renal lithiasis; if you have degenerative and cardiovascular disease; if you have hypercalcemia; if you have metastatic calcification. If you think you have any of the conditions mentioned above, consult your doctor first and follow the given advice. Take special care with Vitamine D2 Vitamin D should be used with caution in patients with renal impairment, renal calculi, or heart disease, because they are at increased risk of organ damage if hypercalcaemia occurs. Plasma phosphate concentrations should be controlled during vitamin D therapy to reduce the risk of ectopic calcification. It is advised that patients receiving pharmacological doses of vitamin D should have their plasma - calcium concentration monitored at regular intervals, especially at the beginning of treatment and if symptoms of toxicity occur. Mothers who take pharmacologic doses of vitamin D are advised not to breast feed their infants, because it may cause hypercalcemia in the infant. 2

3 Vitamin D should be used with caution in infants, because they have increased sensitivity to its effects. Interindividual tolerance to vitamin D varies considerably; infants and children are generally more susceptible to its toxic effects. The difference between the therapeutic and toxic concentrations is small, thus caution is advised when taking this vitamin. Other medicines and Vitamine D2 There is an increased risk of hypercalcaemia if vitamin D is given with thiazide diuretics, calcium, or phosphate. Plasma - calcium concentrations should be monitored in such situations. Some antiepileptics may increase vitamin D requirements (e.g. carbamazepine, phenobarbital, phenytoin, and primidone). Rifampicin and isoniazid may reduce the effectiveness of vitamin D. Corticosteroids may counteract the effect of vitamin D. Ask your doctor or pharmacist for advice if you are taking the above mentioned medicines concomitantly with vitamin D. Taking Vitamine D2 with food and drinks Not applicable. Pregnancy Inform your doctor or pharmacist if you are pregnant or planning a pregnancy and ask for advice on the use of this medicine during pregnancy. Hypercalcaemia during pregnancy may produce congenital disturbances in the offspring, and hypoparathyroidism in the neonate. Avoidance of this medicine during pregnancy is recommended. 3

4 Breast - feeding Inform your doctor or pharmacist if you are breast - feeding and ask for advice on the use of this medicine during breast - feeding. Vitamin D is distributed into breast milk. Mothers who take pharmacologic doses of vitamin D are advised not to breast feed their infants, because it may cause hypercalcemia in the infant. Driving and using machines No available data. 3. HOW TO TAKE VITAMINE D2 Children, rickets prophylaxis, by intramuscular injection: 1 ml ( IU); this dose may be repeated after 3 5 weeks. Rickets treatment: 1 ml ( IU), this dose may be repeated after 3 5 weeks. Higher doses are suitable for use when signs of severe rickets occur, and when the child has severe acute disease (pneumonia, febrile illness). In case of tetany in children as a result of rickets, it is necessary that vitamin D2 be combined with calcium. In case of tetany from primary hypoparathyroidism in adults, doses up to IU (10 mg) are used daily for the first days, concomitantly with oral calcium. If you take more Vitamine D2 than you should If you take more Vitamine D2 than you should or if the children have taken this medicine by mistake, contact your doctor or the nearest hospital or call the emergency service to ask for the risks and advice on actions that should be taken. If you forget to take Vitamine D2 If you forget to take one dose, take the next dose at the next prescribed time. Do not take a double dose to make up for a forgotten dose. 4

5 If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine may cause side effects. Sometimes they are serious and sometimes not. Excessive use of vitamin D leads to the development of hypercalcaemia or hyperphosphataemia. Associated effects of hypercalcaemia include hypercalciuria, ectopic calcification, and renal and cardiovascular damage. Symptoms of overdosage include anorexia, lassitude, nausea and vomiting, constipation or diarrhoea, polyuria, nocturia, sweating, headache, thirst, somnolence and vertigo. Hypersensitivity reactions have also occurred. The vitamin should be withdrawn if toxicity occurs. Inform your doctor if any of the side effects mentioned above occurs. If you notice side effects not mentioned in this leaflet, inform your doctor or pharmacist. 5. HOW TO STORE VITAMINE D2 Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging. Store below 25 C! Keep in the original packaging protected from light and humidity. 6. OTHER INFORMATION What Vitamine D2 contains The active substance is ergocalciferol. Each ampoule of 1 ml contains IU ergocalciferol. The excipient is ethyl oleate. Content of the pack Carton box with 10 ampoules; Carton box with 100 ampoules (for hospital use). 5

6 Marketing Authorisation Holder and Manufacturer PROFARMA Sh.a. Rruga Myslym Keta Tel.: Tirana - Albania This leaflet was last revised in December