DISEON 0,25 MCG Kapsułka miękka
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Jak stosować DISEON
DISEON 0.25 mcg soft capsules
DISEON 1 mcg soft capsules
DISEON 2 mcg/ml oral drops, solution
Alfacalcidol
PHARMACOTHERAPEUTIC CATEGORY
Vitamin D and analogues.
THERAPEUTIC INDICATIONS
Osteodystrophy due to renal insufficiency in dialysis or not. Hypoparathyroidism. Rickets and
D-resistant or D-dependent (pseudo-deficient) osteomalacia. Rickets and osteomalacia due to
renal alterations due to vitamin D metabolism. Post-menopausal osteoporosis.
CONTRAINDICATIONS
- Hypersensitivity to the active ingredient or to any of the excipients.
- Hypercalcemia.
- Established vitamin D toxicity/hypervitaminosis.
PRECAUTIONS FOR USE
Since overdose of Diseon can cause hypercalcemia and, in some cases, hypercalciuria, serum calcium
levels should be measured at least twice a week during the dosage adjustment phase. Once the optimal
daily dose has been established, a monthly check of serum calcium is sufficient, which should still be
checked promptly if symptoms suggesting toxicity appear.
Similar monitoring is recommended for infants who are breastfed by mothers receiving pharmacological
doses of 1-alpha-hydroxycholecalciferol.
During treatment with 1-alpha-hydroxycholecalciferol, plasma phosphate concentrations should be
monitored to reduce the risk of ectopic calcifications.
A decrease in alkaline phosphatase values generally precedes the onset of hypercalcemia and may be a
warning symptom of the latter. If hypercalcemia occurs, the drug and any calcium supplement should be
temporarily discontinued until serum calcium levels return to normal, generally quickly.
Treatment can then be resumed at a lower dose. Since Diseon influences the transport of phosphates in the
intestine, kidney and bones, the concomitant administration of phosphate-binding substances should be
adjusted to phosphate levels (normal rates: 2-5 mg/100 ml).
Vitamin D supplementation to the diet may be harmful in people who are already receiving an adequate
intake through diet and sun exposure, as the difference between therapeutic and toxic concentrations is
relatively small.
Since 1-alpha-hydroxycholecalciferol is the most potent form of vitamin D, a greater risk of toxicity could
reasonably be expected.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including
those without a prescription.
Vitamin D or its analogues
Pharmacological doses of vitamin D or its analogues should not be administered during treatment with
1-alpha-hydroxycholecalciferol due to the possibility of an additive effect and an increased risk of
hypercalcemia.
Warfarin
Studies in animals have suggested a possible potentiation of the action of warfarin when administered with
calciferol. Although there is no similar evidence with the use of 1-alpha-OHD, caution should be used when
the two drugs are used simultaneously.
Digitale
Hypercalcemia in patients taking digitalis preparations may exacerbate cardiac arrhythmia. Patients taking
digitalis concurrently with 1-alpha-hydroxycholecalciferol should be carefully monitored.
Anti-epileptics
Some anti-epileptics may increase the requirements for 1-alpha-hydroxycholecalciferol (such as
carbamazepine, phenobarbital, phenytoin and primidone).
Cholestyramine, colestipol, sucralfate, aluminum-based antacids
The absorption of 1-alpha-hydroxycholecalciferol may be impaired by the concomitant use of bile acid
binding agents (Cholestyramine, colestipol), sucralfate or aluminum-based antacids.
Antacids containing magnesium and laxatives
Caution should be exercised when using antacids containing magnesium or laxatives in patients taking
1-alpha-hydroxycholecalciferol, especially those with chronic renal dialysis. Hypermagnesemia may occur.
Preparations containing calcium or phosphate or thiazide diuretics
The risk of hypercalcemia is increased in patients taking preparations containing calcium or phosphate or
thiazide diuretics concurrently with 1-alpha-hydroxycholecalciferol. In these situations, plasma calcium
concentrations should be monitored.
Rifampicin and isoniazid
Rifampicin and isoniazid may reduce the effectiveness of vitamin D.
Corticosteroids
Corticosteroids may counteract the effect of vitamin D.
SPECIAL WARNINGS
DISEON should be used with caution in infants, who may have an increased sensitivity to its effects, and
in patients with impaired renal function or calculi, or heart disease, who are at greater risk of organ
damage if hypercalcemia develops.
Overdosage of any form of vitamin D causes even serious manifestations.
Hypercalcemia caused by an excess dose of vitamin D or its metabolites may also require emergency
therapy. Chronic hypercalcemia could in fact cause widespread vascular calcifications, nephrocalcinosis and
calcifications of other soft tissues. It is therefore necessary to ensure that the figure obtained by multiplying
the value of serum calcium by that of phosphatemia (Ca P) does not exceed 70. Radiographic
examination of the anatomical regions, site of possible calcifications, may be useful for early diagnosis.
Fertility, pregnancy and breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
During pregnancy and breastfeeding, this product may be administered only after careful evaluation of the
risk-benefit ratio.
Effects on the ability to drive and operate machinery
Diseon does not alter or negligibly alters the ability to drive vehicles or operate machinery.
Important information about some excipients
DISEON soft capsules and DISEON oral drops, solution contain small amounts of ethanol (alcohol), less than
100 mg per dose.
DISEON soft capsules and DISEON oral drops, solution contain sorbitol. If your doctor has diagnosed you
with an intolerance to certain sugars, contact him before taking this medicine.
DISEON soft capsules contains peanut oil. Do not use if you are allergic to peanuts or soy.
DISEON oral drops, solution contains hydrogenated castor oil polyoxyethylated. It may cause gastric
disorders and diarrhea.
DISEON oral drops, solution contains methyl parahydroxybenzoate. It may cause allergic reactions (even
delayed).
Doping warning
For those who engage in sports, the use of medicines containing ethyl alcohol may result in positive doping
tests in relation to the alcohol concentration limits indicated by some sports federations.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Suggested starting dose for all indications:
Adults and children over 20 kg of body weight:1 mcg per day.
Children under 20 kg of body weight: 0.05 mcg/kg/day
Subsequently the dose can be adjusted according to the response. Depending on the needs and weight of the
patients.
The specialty is available in soft capsules (0.25 mcg and 1 mcg) and in drops (each drop corresponds to
0.05 micrograms of 1-alpha-hydroxycholecalciferol).
OVERDOSE
Excessive intake of vitamin D leads to the development of hypercalcemia. Symptoms of overdose
include anorexia, fatigue, nausea and vomiting, constipation or diarrhea, polyuria, nocturia,
sweating, headache, thirst, drowsiness and dizziness. The toxicity of vitamin D varies considerably; infants
and children are generally more susceptible to its toxic effect. If toxicity occurs, the vitamin should be
discontinued.
In acute overdose, early gastric lavage and/or administration of mineral oils may reduce absorption and
promote fecal elimination.
In case of severe hypercalcemia due to accidental overdose, after temporarily suspending the drug, diuretics
together with intravenous fluids or corticosteroids can be administered.
In case of accidental ingestion/intake of an excessive dose of Diseon, immediately notify your doctor or go to
the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequencies of adverse reactions are classified according to the following convention: very
common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1.000, <1/100), rare (≥1/10.000,
<1/1.000), very rare (<1/10.000), not known (the frequency cannot be defined on the basis of available
data).
Immune system disorders
Not known: Hypersensitivity,
Metabolism and nutrition disorders
Common: Hypercalcemia*, hypercalciuria
Rare: Hyperphosphatemia
*Effects associated with hypercalcemia include hypercalciuria, ectopic calcifications, kidney and
cardiovascular damage, weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, bone
and muscle pain, later urinary disorders, conjunctivitis (due to calcification), photophobia, pancreatitis,
rhinorrhea, itching, hyperthermia, decreased libido, albuminuria, hypercholesterolemia, increased SGOT and
SGPT, ectopic calcifications, hypertension, cardiac arrhythmias and rarely psychosis. Because the half-life of
calcitriol is short, normalization of any hypercalcemia occurs within a few days of discontinuing treatment with
Diseon, however more quickly than in the course of vitamin D or its metabolite therapy.
Reporting of side effects.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly via the Website: http://www.agenziafarmaco.gov.it/it/responsabili . By
reporting side effects you can help provide more information on the safety of this medicine.
SHELF LIFE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
Capsules
Store at a temperature below 25°C.
Drops
Store at a temperature not exceeding 25°C in the original container to protect from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
COMPOSITION
DISEON 0.25 micrograms soft capsules
Each capsule contains:
Active ingredient:
1-alpha-hydroxycholecalciferol mcg 0.25
Excipients:
Absolute ethyl alcohol, anhydrous citric acid, propyl gallate, d,l-alpha-tocopherol, peanut oil.
Shell composition:gelatin, glycerol 85%, sorbitolspecial solution (Anidrisorb
85/70), red iron oxide (E172), black ink.
DISEON 1 microgram soft capsules
Each capsule contains:
Active ingredient:
1-alpha-hydroxycholecalciferol mcg 1
Excipients:
Absolute ethyl alcohol, anhydrous citric acid, propyl gallate, d,l-alpha-tocopherol, peanut oil.
Shell composition:gelatin, glycerol 85%, sorbitolspecial solution (Anidrisorb
85/70), yellow iron oxide (E172), titanium dioxide (E171), black ink.
DISEON 2 micrograms/ml oral drops, solution
Each ml (40 drops) contains:
Active ingredient:
1-alpha-hydroxycholecalciferol mcg 2
Excipients:
Hydrogenated castor oil polyoxyethylated, anhydrous citric acid, disodium citrate dihydrate, d,l-alpha-
tocopherol, methyl parahydroxybenzoate, ethyl alcohol, sorbitol70% non-
crystallizable solution, purified water q.s.
Each drop contains 0.05 mcg of 1-alpha-hydroxycholecalciferol.
PHARMACEUTICAL FORM AND CONTENT
Soft capsules: pack of 30 capsules of 0.25 mcg or 1 mcg
Oral drops, solution: bottle of 10 ml
MARKETING AUTHORISATION HOLDER:
THERAMEX IRELAND LIMITED,
3RD FLOOR, KILMORE HOUSE, PARK LANE, SPENCER DOCK, DUBLIN 1, D01 YE64,
IRELAND.
MANUFACTURER
Soft capsules
Teva Pharma B.V. – Swensweg, 5 – 2031 GA Haarlem (Netherlands)
Oral drops, solution
Istituto Biochimico Nazionale Savio S.r.l. - Via del Mare, 36 - Pomezia (Rome)
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- Kraj rejestracji
- Postać farmaceutycznaSoft capsule, 0,25 MCG
- Kod ATCA11CC03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DISEONPostać farmaceutyczna: Soft capsule, 1 MICROGRAMSubstancja czynna: alfacalcidolProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Soft capsule, 0.25 microgramsSubstancja czynna: alfacalcidolProducent: ZENTIVA ITALIA S.R.L.Wymaga receptyPostać farmaceutyczna: Soft capsule, 0.25 MCGSubstancja czynna: alfacalcidolProducent: THERAMEX IRELAND LIMITEDWymaga recepty
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DISEON wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DISEON jest alfacalcidol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DISEON jest produkowany przez THERAMEX IRELAND LIMITED. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie DISEON jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić DISEON w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (alfacalcidol) to m.in. ALFAKALKIDOLO DOK, ALFAKALKIDOLO TSENTIVA, ALPA D3. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
