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Fultium-D3 800 IU Capsules Each capsule contains: 800IU Colecalciferol (equivalent to 20 micrograms vitamin D3 For a full list of excipients see section 6.1 Capsule, soft (Capsule) Blue coloured translucent soft gelatin capsule The prevention and treatment of vitamin D deficiency. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. Fultium-D3 is indicated in adults, the elderly and adolescents. Posology Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)) 1-4 capsules (800-3200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment. Vitamin D insufficiency in adults and the elderly (serum levels 25 50 nmol/l (10-20 ng/mL)) AND long term maintenance therapy following treatment of deficiency in adults and the elderly AND Prevention of vitamin D deficiency 1-2 Capsules (800-1600 IU) daily Vitamin D deficiency or insufficiency in children over 12 years 1 capsule daily depending on the severity of the disease and the patient's response to treatment. Should only be given under medical supervision. As an adjunct to specific therapy for osteoporosis 1 capsule daily Fultium-D3 should not be used in children under 12 years Method of administration Oral The capsules should be swallowed whole (not chewed) with water Hypersensitivity to vitamin D or any of the excipients in the product Hypervitaminosis D Nephrolithiasis Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria Severe renal impairment Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3, contraindications). Caution is required in patients receiving treatment for cardiovascular disease (see Section 4.5 cardiac glycosides including digitalis). Fultium-D3 should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine. Allowances should be made for vitamin D supplements from other sources. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision. Medical supervision is required whilst on treatment to prevent hypercalcaemia. Fultium-D3 should not be given to children. Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D. The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase. There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed, however, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother. Fultium-D3 has no influence on the ability to drive and use machines. Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000,  1/10,000, <1/1,000). Metabolism and nutrition disorders Uncommon: Hypercalcaemia and hypercalciuria. Skin and subcutaneous disorders Rare: Pruritus, rash and urticaria. The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of vitamin D and rehydration. Pharmacotherapeutic group: Vitamin D and analogues ATC code: A11CC05 In its biologically active form vitamin D3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of vitamin D3 PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D3 The pharmacokinetics of vitamin D is well known. Vitamin D is well absorbed from the gastro-intestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycolecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, 25 dihydroxycolecalciferol (calcitriol). The metabolites circulate in the blood bound to a specific a - globin, Vitamin D and its metabolites are excreted mainly in the bile and faeces. Vitamin D is well known and is a widely used material and has been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result. Colecalciferol has been shown to be teratogenic in high doses in animals (4-15 times the human dose). Offspring from pregnant rabbits treated with high doses of vitamin D had lesions anatomically similar to those of supravalvular aortic stenosis and offspring not showing such changes show vasculotoxicity similar to that of adults following acute vitamin D toxicity. Capsule content Maize oil, refined Butylated hydroxytoluene (BHT) (E321) Capsule shell Glycerol (E422) Purified Water Brilliant Blue W. Gelatin (E441) This medicinal product does not require any special temperature storage conditions. Store blister foil in original container in order to protect from light. Opaque, white PVC/PVdC blister tray with aluminium foil Not all pack sizes may be marketed. Any unused product should be disposed of in accordance with local requirements. Internis Pharmaceuticals Ltd., Carradine House, 237 Regents Park Road, London N3 3LF, UK
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Plivit D3 kapi – Uputa o lijeku Proizvođač: Pliva Samo na recept? DA Primjena: Vitamin D i analozi Skoči na: » opis » primjena » doziranje » mjere opreza Opis Sastav 1 ml (20 kapi) otopine sadržava 4000 i.j. kolekalciferola. Pomoćne tvari: metil parahidroksibenzoat, butilhidroksitoluen, polietoksilirano ricinusavo ulje, propilenglikol. Farmaceutski oblik i veličina pakiranja Kapi, otopina; 10 ml Farmakoterapijska skupina i djelovanje Plivit D3 kapi sadržavaju vitamin D3 (kolekalciferol) u vodenoj otopini. Vitamin D3 je esencijalan za apsorpciju i iskorištavanje kalcija i fosfata u organizmu te za ugrađivanje kalcija u kosti. Zajedno s paratiroidnim hormonom i kalcitoninom regulira serumsku koncentraciju kalcija i fosfata. Osim što stimulira apsorpciju kalcija iz tankog crijeva , također mobilizira kalcij iz kosti. Način i mjesto izdavanja Na recept Rok valjanosti Označen je na pakiranju. Lijek se ne smije rabiti nakon isteka roka valjanosti. Čuvati na hladnom mjestu (8-15 c), zaštićeno od svjetlosti. LIJEK VALJA ČUVATI IZVAN DOSEGA DJECE! Primjena Terapijske indikacije Prevencija rahitisa u dojenčadi i male djece, osobito pri neadekvatnoj prehrani (hrana s premalo vitamina D, smanjena apsorpcija) i kada je izlaganje suncu onemogućeno (zimski mjeseci), te nadoknada povećanih potreba u trudnica i dojilja. Doziranje Doziranje i način uporabe Dojenčad u toku prve godine života: 2-5 kapi (400-1000 i. j.) na dan, ovisno o preporuci liječnika. Djeca starija od jedne godine, trudnice i dojilje: 2 kapi (400 i. j.) na dan. Kapi se uzimaju u žličici soka ili mlijeka. Jedna kap sadržava približno 200 i.j. kolekalciferola. Predoziranje Znakovi predoziranja mogu se pojaviti pri različitim dozama vitamina D, što ovisi o individualnim zanačajkama pojedinca. U odraslih se mogu pojaviti nakon primjene 20000 do 60000 i.j. ili više na dan tijekom nekoliko tjedana ili mj6seci, a u djece nakon primjene 2000 do 4000 i.j. tijekom nekoliko mjeseci, ali i nakon jednokratnog uzimanja velikih količina. Posljedica kroničnog predoziranja vitaminom D3 je hiperkalcemija čiji su rani simptomi opstipacija, mučnina i povraćanje (češće u djece) te proljev, suhoća usta žeđ, gubitak apetita, slabost, glavobolja, češće mokrenje. Hiperkalcemija može rezultirati generaliziranom kalcifikacijom krvnih žila, bubrega i ostalih mekih tkiva s posljedičnom hipertenzijom, srčanim ili bubrežnim zatajenjem. U djece može biti zaustavljen rast. Treba prekinuti uzimanje vitamina D3 uzimati hranu bez kalcija i mnogo tekućine. Te mjere obično su dovoljne, ali vitamin D3 može se zadržati u masnom tkivu, pa simptomi predoziranja mogu perzistirati i tjednima nakon što je unos prekinut. Takvi bolesnici mogu se liječiti glukokortikoidima, a samo teška hiperkalcemija zahtijeva intenzivnu terapiju. Mjere opreza Zbog mogućnosti unošenja prevelikih količina kolekalciferola u organizam, treba voditi računa o ukupnom dnevnom unosu vitamina D iz svih izvora (drugi vitaminski pri pravci, mlijeko obogaćeno vitaminom D, riblje ulje, ribe i jaja su prirodni izvori vitamina D). Ukupni dnevni unos vitamina D ne bi trebao biti viši od 1000 i.j. kako u djece, tako i u trudnica i dojilja. Kontraindikacije Hiperkalcemija. Posebna upozorenja Dojenčad mogu biti jače osjetljiva na učinke vitamina; D3 te ga u ovoj dobnoj skupini valja davati s oprezom. Vitamin D3 valja davati s oprezom osobama s oštećenom bubrežnom funkcijom ili kamencima te srčanim bolesnicima, zbog povećane opasnosti u slučaju hi.perkalcemije. Trudnoća i dojenje Zbog povećane potrebe za vitaminom D, ovaj je lijek indiciran tijekom trudnoće i dojenja, ali propisana se doza ne smije prekoračiti. Nuspojave Nuspojave se nakon uzimanja preporučenih doza Plivita D3 općenito ne javljaju. O svakoj nuspojavi valja obavijestiti svog liječnika ili ljekarnika. Interakcije Istodobna primjena vitamina D3 s pripravcima koji sadržavaju velike količine kalcija ili s tiazidskim diureticima povećava opasnost od hiperkalcemije. Kolestiramin, kolestipol, neomicin i mineralna ulja smanjuju apsorpciju vitamina D3 iz probavnog sustava. Antikonvulzivi (fenitoin, barbiturati) mogu smanjiti djelovanje vitamina D3 Primjena vitamina D3 s antacidima koji sadržavaju magnezij može uzrokovati hipermagnezemiju.