PATIENT INFORMATION LEAFLET

Transcription

1 DESIFEROL 2000 IU Film Coated Tablets For oral use only PATIENT INFORMATION LEAFLET Active substance(s): Each film coated tablet contains 2000 I.U. (50 ) vitamin D3 (derived from sheep wool). Excipient(s): Microcrystalline cellulose, calcium phosphate dibasic anhydrous (E341), lactose monohydrate (derived from cow's milk), povidone, crospovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol, polyethylene glycol (E1521), talc (E553b), mica and polysorbate 80 (E433) Read this PATIENT INFORMATION LEAFLET carefully before you start using this medicine, because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. If you go to a doctor or hospital during the use of this medicine, inform your doctor about this. Follow the instructions in this leaflet exactly. Do not use higher or lower doses than the dose which was recommended for you. What is in this Leaflet: 1. What DESIFEROL is and what it is used for? 2. Before you use DESIFEROL? 3. How to use DESIFEROL? 4. Possible side effects? 5. How to store DESIFEROL 1. What DESIFEROL is and what it is used for? DESIFEROL contains vitamin D3 (derived from sheep wool). It is marketed in the packaging containing 40 and 50 nacreous whitish color, bright, film coated, rounded tablets with notch in the middle of one side. It is used in the prevention and treatment of Vitamin D deficiency. 2. Before you use DESIFEROL? DO NOT use DESIFEROL If; You are allergic (hypersensitive) to any of the ingredients You have severe high blood pressure (hypertension) You have advanced arteriosclerosis You have active pulmonary tuberculosis (phthisis), then you should not use the drug for a long time at high dosages. 1/7

2 You have D hypervitaminosis (a disorder due to excessive intake or accumulation of vitamin D which has the symptoms of; anorexia, constipation, blurred vision and muscle weakness.) You have hypercalcemia (increased serum calcium concentration above normal levels) or hypercalciuria (increased amount of calcium excreted in the urine) You have nephrolithiasis (calciferous) You are hypersensitive to calcium You have severe kidney failure Use DESIFEROL with CAUTION If; Your mobility is restricted You have been using diuretic agents of benzothiadiazine derivatives. You have a history of renal dysfunction or nephrolithiasis You have sarcoidosis (a chronic, granulomatous disease with involvement in all tissues and organs) You have pseudohypoparathyroidism (a kind of parathyroid gland disorder) You have hepatic impairment You have been on another medication that contains vitamin D or its derivatives. You have gastrointestinal inflammation (enteritis, colitis, diverticulitis and ulcerative colitis) Use in pancreatitis (pancreatitis) and stomach ulcer (peptic ulcer) cases should be carefully evaluated. It should not be used in children under 12 and in infants. Vitamin D has a very low therapeutic index in infants and children. Hypercalcemia leads to mental and physical development retardation in infants in prolonged exposure. In therapeutic (pharmacologic) doses, infants to nursing mothers receiving vitamin D are at increased risk of hypercalcemia. Please consult your doctor, even if these statements were applicable to you at any time in the past. Using DESIFEROL with food and drink No known interaction with food or drinks Pregnancy Ask your doctor or pharmacist for advice before using the medicine. It should not be used during pregnancy unless necessary. If you notice that you are pregnant during treatment, please consult your doctor or pharmacist immediately. Breast-feeding Ask your doctor or pharmacist for advice before using the medicine. DESIFFEROL can be used under medical supervision during breastfeeding period. As DESIFEROL passes into breast milk, use it as recommended by your doctor. Driving and using machines There was no data on the effects on the ability to drive and use machines. 2/7

3 Important information about some of the excipients of DESIFEROL Since it contains lactose, if you have previously been told that you were intolerant to certain kinds of sugar contact to your doctor before using DESIFEROL. This medicinal product contains 4.23 mg sodium per tablet. This should be considered in patients on controlled sodium diet. It may contain coloring substances that may cause an allergic reaction. Using with other medicines Concomitant use with anticonvulsant agents (drugs used in seizure treatment), phenytoin, phenobarbital, hydantoin, barbiturates or pyrimydon (medications used in epilepsy), rifampicin (an antibiotic used to treat tuberculosis) and glucocorticoids (hormone-like drugs) may reduce the activity of vitamin D. Concomitant use with medications containing calcitonin, etidronat, gallium nitrate, pamidronate or pliamycin in hypercalcemia (a disease characterized by high calcium levels in the blood) treatment may reduce the effectiveness of these medications. Concomitant use with medications containing high doses of calcium or diuretics calcium concentration in the blood may be elevated above normal level (hypercalcemia risk). Long term treatments require careful monitoring of serum and urinary calcium concentrations. Concomitant use with other products containing vitamin D or derivatives of vitamin D is not recommended due to increased risk of toxicity. Isoniazid (used to treat tuberculosis.) may reduce the activity of vitamin D3. Patients treated with cardiac glycosides (medications used in heart failure) may be susceptible to high calcium levels and therefore should have ECG (electrocardiography) parameters and calcium levels monitored under medical supervision. Drugs that may reduce fat absorption like orlistat (used to treat obesity.), liquid paraffine (mineral oil) and cholestyramine (used to treat high cholesterole.) may reduce the absorption of vitamin D. Actinomycin (cancer drug) and imidazole (fungicide) may affect vitamin D activity in the body. Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. 3. How to use DESIFEROL? Instructions for appropriate method and dose/frequency of administration: Each film coated tablet contains 2000 IU (50 ) Vitamin D3. Use in adults: - In the treatment of vitamin D deficiency: half a tablet-2 tablets ( IU) daily for 10 weeks, followed by half a tablet-1 tablet ( IU) daily as an maintenance therapy depending on the severity of the disease and the patient's response to treatment as recommended by the doctor. Measurements of serum Vitamin D should be performed approximately 3 to 4 months after maintenance therapy for follow-up of target levels. - Prevention of Vitamin D deficiency; half a tablet - 1 tablet ( IU) daily. 3/7

4 Some of the following populations are at high risk for vitamin D deficiency and using of higher doses and monitoring of serum vitamin D levels may be required; Patients requiring care or bedridden patients Patients having dark skin color Patients who are not exposed enough to the sun or who use a sunscreen continuously Patients evaluated for osteoporosis Obese individuals Concomitant use of certain drugs, e.g. anticonvulsant drugs (drugs used in epilepsy), glucocorticoids (hormone-like drugs), anti-retrovirals (drugs used in the treatment of viruses) Patients who are recently treated for vitamin D deficiency and required for maintenance treatment Patients with liver or kidney disease Patients with malabsorption (absorption disorder in the intestine), inflammatory bowel disease and celiac disease (an inflammatory bowel disease caused by susceptibility to wheat products) For the support for the specific treatment of osteoporosis: half a tablet a day (1000 IU) Indication Number of tablets/day Treatment of vitamin D deficiency Prevention of vitamin D deficiency Prophylaxis of vitamin D deficiency due to malabsorption Treatment of Vitamin D deficiency in malabsorption Treatment of osteomalacia due to vitamin D deficiency (a disease caused by mineral depletion in bones) Secondary hyperparathyroidism (high parathyroid hormone levels in the blood) As the support for the specific treatment of osteoporosis Half a tablet-2 tablets Half a tablet-5 tablets Equivalent I.U. vitamin D 3 /day Equivalent Vitamin D 3 /day I.U I.U Half a tablet 1000 I.U. 25 Use in adolescents (12-18 years) Treatment and prevention of Vitamin D deficiency between years; half a tablet (1000 IU) is recommended depending on the severity of the disease and the response of the patient to treatment. It should only be given under medical supervision. Infants and young children (0-12 years) It is not recommended between 0-12 years. Pregnancy and breastfeeding It is not recommended for use in pregnancy unless recommended by your doctor. 4/7

5 Cholecalciferol and its metabolites are excreted in breast milk. There are no overdoses in infants of suckling mothers, but maternal doses should be taken into consideration when prescribing Vitamin D containing products to children who are breastfed. Route and method of administration: DESIFEROL is administered orally. If your doctor tells you to use ½ (half) tablets, follow the instructions below on how to break DESIFEROL tablets. - Place the tablets on a flat, hard floor (eg table or bench) with the notch facing up. - After placing the index fingers both hands on the edge of notches, then break the tablet by pushing it (Figs. 1 and 2). 1 2 Figures 1 and 2: DESIFEROL notched tablets are easily broken into halves. Different age groups: Use in children: It is not recommended between 0-12 years Use in elderly: No dose adjustment is required. Special conditions: Kidney/liver failure: No dose adjustment is required. The kidney function should be controlled in cases that require continuous use of vitamin D3. It should not be used with calcium in case of severe kidney failure. If you have the impression that the effect of DESIFEROL is too strong or too weak, talk to your doctor or pharmacist. If you used more DESIFEROL than you should: If you may have taken more DESIFEROL than you should, talk to a doctor or pharmacist. If vitamin D is used in high doses for a long time, it causes hypervitaminosis. If you use DESIFEROL in excess amounts, you may develop hypercalcemia (blood calcium level above normal). Symptoms of hypercalcemia include: fatigue, psychiatric symptoms (euphoria [a state of extreme joy, self-confidence, or mania] dizziness, confusion), nausea, vomiting, loss of appetite, loss of weight, thirst, polyurea (frequent urination), kidney stone formation, 5/7

6 nephrocalcinosis (accumulation of salts in kidneys), excessive calcification of bones and kidney failure, ECG (cardiac electrical activity) changes, cardiac arrhytmia, and pancreatitis (inflammation of the pancreas). Treatment: Treatment with D vitamin is discontinued and low calcium diet is applied. Avoid exposure to sunlight. If the drug has recently ingested, perform gastric lavage or vomit. If you forget to use DESIFEROL: Do not take double dose to balance the missed doses of DESIFEROL. Skip the forgotten dose and take the next dose at the usual time. If you stop using DESIFEROL: Discontinuation of the treatment is not expected to cause any side effects. Unless otherwise told by your doctor do not discontinue treatment with DESIFEROL. 4. Possible side effects? Like all medicines, DESIFEROL can cause side effects in people sensitive to the ingredients in its contents. Frequencies of adverse reactions are not known, as no larger clinical trials have been conducted. DESIFEROL in normal doses and duration of treatment rarely has side effects. Administration of vitamin D3 at high doses and extending the duration of treatment in an uncontrolled manner may lead to following side-effects: If any of the following occur stop using DESIFEROL and IMMEDIATELY inform your doctor or go to the nearest emergency department: Hypersensitivity reactions such as itching, rash, white or reddish weals on the skin (urticaria) These are all very serious side effects. If you have any of them, this means you have serious allergy to DESIFEROL. You may need emergency medical care or hospitalization. All of these very serious side effects occur very rarely. Side effects are classified according to frequency of occurrence as follows: Very common: may be seen at least 1 in 10 patients. Common: may be seen less than 1 in 10 patients but more than 1 or 1 in 100 patients Uncommon: may be seen less than 1 in 100 patients but more than 1 or 1 in 1000 patients Rare: may be seen less than 1 in 1000 patients but more than 1 or 1 in patients Very rare: may be seen less than one in patients. Unknown: It cannot be estimated from the available data Uncommon Increased amount of calcium excreted in the urine Amount of calcium in the blood higher than normal (hypercalcemia) Unknown Increased level of residual nitrogen in the blood (established through blood and urine tests.). Constipation 6/7

7 Flatulence Nausea Abdominal pain Diarrhea Excessive urination (polyuria) Excessive thirst (polydipsia) Being unable to void (anuria) Fever If you notice any side effects not mentioned in this leaflet inform your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via clicking Reporting of Drug Side Effects icon on the website or Turkish Pharmacovigilance Center (TUFAM) by calling the phone number for side effects reporting line. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store DESIFEROL Keep DESIFEROL in the original package and out of the reach and sight of children. Store at room temperature below 25 C and away from light. Use in accordance with the expiry date Do not use DESIFEROL after the expiry date which is stated on the package. Do not use DESIFEROL if you notice any damage to the product and/or package. Do not throw away drugs that have expired or are not used! Give to the collection system determined by the Ministry of Environment and Urbanism. Marketing authorization holder: Berko İlaç ve Kimya Sanayi A.Ş. Yenişehir Mah. Özgür Sok. No: Ataşehir/İstanbul-Turkey (Pbx) (Fax) info@berko.com.tr Manufacturer: Berko İlaç ve Kimya Sanayi A.Ş. Adil Mah. Yörükler Sok. No: 2 Sultanbeyli/İstanbul-Turkey (Pbx) (Fax) This patient information leaflet was approved on 12/07/ /7