DEDIOL 0,25 MCG Soft capsule
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Инструкция по применению DEDIOL
Содержание инструкции
DEDIOL 2 mcg/ml oral drops, solution, 0.25 mcg soft capsules
alfacalcidol
Read this leaflet carefully before you take/give this medicine to the child as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed only for you/the child. Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What DEDIOL is and what it is used for
- 2. What you need to know before you take/give DEDIOL to the child
- 3. How to take/give DEDIOL to the child
- 4. Possible side effects
- 5. How to store DEDIOL
- 6. Contents of the pack and other information
1. What DEDIOL is and what it is used for
DEDIOL contains alfacalcidol, a precursor of vitamin D.
DEDIOL is indicated in adults and children for the treatment of:
- fragility and decrease in bone mass and predisposition to fractures in patients with a kidney disease (Renal osteodystrophy) who are undergoing dialysis (a blood filtration system) or not.
- reduced functionality of the parathyroid glands, located in the neck (hypoparathyroidism).
- bone diseases caused by poor vitamin D metabolism, even in patients with a kidney disease (Vitamin D-resistant or D-dependent rickets and osteomalacia (pseudo-deficient), rickets and osteomalacia from other renal actions due to vitamin D metabolism).
- loss of bone consistency after menopause (Postmenopausal osteoporosis) (only in adult women in post menopause).
2. What you need to know before taking/giving DEDIOL to the child
Do not take/give DEDIOL to the child
- if you are allergic to alfacalcidol or any of the other ingredients of this medicine (listed in section 6),
- if you are pregnant,
- if you suffer from high levels of calcium in the blood (hypercalcemia).
Warnings and precautions
Consult your doctor or pharmacist before taking/giving DEDIOL to the child.
Throughout the treatment period, the doctor will ask you/the child to undergo blood tests (calcium and phosphate levels, PTH, alkaline phosphatase and the calcium x phosphate product) and regular checks.
An increase in calcium levels in the blood (hypercalcemia) may occur during treatment with DEDIOL, the symptoms of which may include loss of appetite (anorexia), fatigue, nausea and vomiting, constipation or diarrhea, frequent need to urinate (polyuria), sweating, headache, intense thirst (polydipsia), high blood pressure (hypertension), drowsiness and dizziness (see section 4 Possible side effects).
In particular, inform your doctor if you/the child suffers from:
- hardening of the arteries, the large blood vessels of the body (arteriosclerosis), hardening (sclerosis) of the heart valves, stones (pebbles) in the kidney (nephrolithiasis), as in these cases you may develop transient or permanent kidney damage;
- accumulation of calcium in the lung (calcification of lung tissue). This can cause heart disease;
- a bone disease caused by a kidney problem (renal bone disease) or severely reduced kidney function. The doctor may prescribe a medicine called a phosphate binder to avoid high levels of phosphate in the blood (hyperphosphatemia) and potential calcium deposition in healthy tissues (metastatic calcification);
- an inflammatory disease that can affect the whole body and leads to the formation of nodules (sarcoidosis) or a similar disease;
- a kidney disease (chronic renal failure).
Also inform your doctor if you/the child are taking digitalis glycosides, medicines to treat heart disorders. You may experience increased calcium levels in the blood while taking these medicines and consequently increase the possibility of heart rhythm disturbances.
For athletes
The use of medicines containing ethyl alcohol (DEDIOL oral drops) may result in a positive doping test in relation to the blood alcohol concentration limits indicated by some sports federations.
Other medicines and DEDIOL
Tell your doctor or pharmacist if you/the child are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you/the child are taking:
- anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine or primidone), medicines to treat uncontrolled body movements, as you may need to increase the doses of DEDIOL;
- magnesium-based antacids, medicines to treat heartburn;
- thiazide diuretics (medicines to treat high blood pressure) or preparations containing calcium. The doctor may ask you/the child to undergo blood tests;
- other preparations containing vitamin D;
- preparations containing aluminum (e.g. aluminum hydroxide, sucralfate);
- bile acid sequestrants, such as cholestyramine, medicines to treat high levels of fat in the blood. Take/give DEDIOL at least 1 hour before, or 4 to 6 hours after the bile acid sequestrant.
Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
DEDIOL should not be used during pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
Alfacalcidol is excreted in human milk. The doctor will decide whether to stop breastfeeding or stop therapy with DEDIOL, taking into account the benefit of breastfeeding for the child and the benefit of therapy for you.
The doctor will carefully monitor the breastfed baby during your treatment with DEDIOL.
Driving and using machines
Alfacalcidol does not alter or negligibly alters the ability to drive vehicles and use machinery. However, dizziness may occur during treatment and you should therefore take this into account while driving or using machinery.
DEDIOL capsules contains sesame oil
Rarely it may cause serious allergic reactions.
DEDIOL drops contains ethanol, sorbitol, methyl-p-hydroxybenzoate, glycerol polyethylene glycol stearate, sodium
This medicine contains up to 340 mg of ethanol(alcohol) per dose (corresponding to 6 mcg of alfacalcidol), equivalent to 14 vol % of ethanol. The amount of ethanol in this medicine is equivalent to less than 9 ml of beer or 4.5 ml of wine per dose.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 226 mg of sorbitol, as an excipient, in 1 mcg of alfacalcidol (equivalent to 26 drops).
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or the child) take this medicine.
This medicine contains methyl-p-hydroxybenzoate:may cause allergic reactions (even delayed).
This medicine contains glycerol polyethylene glycol stearate: may cause stomach upset and diarrhea.
This medicine contains less than 1 mmol (23 mg) of sodiumper ml, i.e. essentially “sodium-free”.
3. How to take/give DEDIOL to the child
Take/give this medicine to the child always following exactly the instructions of the doctor or the
pharmacist. If you have any doubts consult the doctor or the pharmacist.
During the entire treatment period the doctor will ask you/the child to undergo blood tests and regular checks.
Adults (all indications)
The recommended initial dose is 1 mcg per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose is between 0.25 and 1 mcg per day based on the results
obtained with the therapy and from the laboratory tests that the doctor will ask you to undergo during
the treatment.
In case of osteoporosis, the doctor will indicate the most suitable dose for you based on your state of health.
In patients with severe bone dysfunction (except those with renal insufficiency) the doctor may
increase the dosage between 1 and 3 mcg per day.
In patients with severe hypocalcemia the doctor may increase the dosage between 3 and 5 mcg per day. In such
patients, the doctor may also prescribe other medicines containing calcium.
Children weighing more than 20 kg
The recommended initial dose is 1 mcg per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose is determined by the doctor based on the results obtained with the
therapy and from the laboratory tests that the doctor will ask you to have the child undergo during
the treatment.
Children weighing less than 20 kg
The dose depends on the child's weight.
The recommended initial dose is 0.05 mcg / kg per day, equivalent to approximately 1 drop/kg (e.g., for a
child of 10 kg the dose is 13 drops per day).
To facilitate the calculation of the dosage in these children, an exemplary dose/weight table is reported below:
| Child's weight | Dose | Number of drops |
| 1 kg | 0.050 mcg | 1 gtt |
| 1.5 kg | 0.075 mcg | 2 gtt |
| 2 kg | 0.100 mcg | 2 gtt |
| 2.5 kg | 0.125 mcg | 3 gtt |
| 3 kg | 0.150 mcg | 4 gtt |
| 3.5 kg | 0.175 mcg | 4 gtt |
| 4 kg | 0.200 mcg | 5 gtt |
| 4.5 kg | 0.225 mcg | 6 gtt |
| 5 kg | 0.250 mcg | 6 gtt |
| 5.5 kg | 0.275 mcg | 7 gtt |
| 6 kg | 0.300 mcg | 8 gtt |
| 6.5 kg | 0.325 mcg | 8 gtt |
| 7 kg | 0.350 mcg | 9 gtt |
| 7.5 kg | 0.375 mcg | 10 gtt |
| 8 kg | 0.400 mcg | 10 gtt |
| 8.5 kg | 0.425 mcg | e 11 gtt |
| 9 kg | 0.450 mcg | 11 gtt |
| 9.5 kg | 0.475 mcg | d 12 gtt |
| 10 kg | 0.500 mcg | 13 gtt |
| 11 kg | 0.550 mcg | 14 gtt |
| 12 kg | 0.600 mcg | a 15 gtt |
| 13 kg | 0.650 mcg | 17 gtt |
| 14 kg | 0.700 mcg | n 18 gtt |
| 15 kg | 0.750 mcg | 19 gtt |
| 16 kg | 0.800 mcg | a 21 gtt |
| 17 kg | 0.850 mcg | 22 gtt |
| 18 kg | 0.900 mcg | i 23 gtt |
| 19 kg | 0.950 mcg | l 25 gtt |
| 20 kg | a 1.000 mcg | 26 gtt |
It is recommended not to administer the product directly but to use a teaspoon to correctly dose
the exact number of drops to be administered.
If you take/give the child more DEDIOL than you should
In case of accidental intake/ingestion of an excessive dose of DEDIOL, immediately inform
the doctor or go to the nearest hospital.
If you forget to take/give the child DEDIOL
Do not take/give the child a double dose to compensate for missing the dose.
If you stop the treatment with DEDIOL
If you have any doubts about the use of this medicine, consult the doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you/the child experience any of the following symptoms, immediately stopusing DEDIOL
and contact your doctor or the nearest hospital where you will undergo appropriate and specific
treatment:
- High levels of calcium in the blood (hypercalcemia); your doctor will then have you resume therapy with a halved dose;
- High levels of phosphorus in the blood (hyperphosphoremia);
- High levels of calcium in the urine (hypercalciuria exceeding 6 mg/kg/24 h).
Possible side effects are listed below according to the following frequency:
common (may affect up to 1 in 10 people)
- high levels of calcium in the blood (hypercalcemia)
- high levels of phosphate in the blood (hyperphosphatemia)
- increased levels of calcium in the urine (hypercalciuria)
- abdominal pain and discomfort
- skin rash (various types of rash have been reported, such as erythematous, maculo-papular and pustular)
- itching uncommon (may affect up to 1 in 100 people)
- headache
- diarrhea
- vomiting
- constipation
- nausea
- muscle pain (myalgia)
- stones (calculi) in the kidney (nephrolithiasis/nephrocalcinosis)
- fatigue/weakness/malaise
- formation of calcium deposits in tissues (calcinosis) rare (may affect up to 1 in 1,000 people)
- dizziness frequency not known(the frequency cannot be estimated based on available data)
- kidney damage (including acute renal failure)
- confusional state
Additional side effects in children
The safety profile observed is similar between adults and children
Reporting of side effects
If you/the child experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
“https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store DEDIOL
Oral drops, solution: store in a refrigerator (2 C – 8 C). Validity after first opening: 4 months.
Capsules: store at a temperature not exceeding 25°C.
Store in the original package to protect the medicine from light.
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 pack after SCAD.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What DEDIOL contains
Oral drops, solution:
- The active ingredient is alfacalcidol 2 mcg/ml
- The other ingredients are glycerol polyethylene glycol stearate; citric acid; sodium citrate; sorbitol; d,l -tocopherol; methylparaben; ethanol(see section 2. DEDIOL drops contains ethanol, sorbitol, methylparaben, glycerol polyethylene glycol stearate, sodium); purified water.
Capsules
- The active ingredient is alfacalcidol 0.25 mcg.
- The other ingredients are: d,l -tocopherol, sesame oil(see section 2. DEDIOL capsules contains sesame oil). The capsule contains:gelatin; glycerol; potassium sorbate; titanium dioxide (E171).
Description of the appearance of DEDIOL and contents of the pack
Oral solution
DEDIOL is presented as a solution contained in a 10 ml bottle.
Capsules
DEDIOL is presented as capsules.
It is available in packs of 30 capsules containing 0.25 mcg of active ingredient.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald (Germany)
Manufacturer
LEO PHARMACEUTICAL PRODUCTS Ltd. - Ballerup - DENMARK
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- Страна регистрации
- Форма выпускаSoft capsule, 0,25 MCG
- Код АТХA11CC03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги DEDIOLФорма выпуска: Soft capsule, 1 MICROGRAMДействующее вещество: Альфа-кальцидолПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Soft capsule, 0.25 microgramsДействующее вещество: Альфа-кальцидолПроизводитель: ZENTIVA ITALIA S.R.L.Отпускается по рецептуФорма выпуска: Soft capsule, 0.25 MCGДействующее вещество: Альфа-кальцидолПроизводитель: THERAMEX IRELAND LIMITEDОтпускается по рецепту
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Действующее вещество DEDIOL — Альфа-кальцидол. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DEDIOL производится компанией CHEPLAPHARM ARZNEIMITTEL GMBH. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения DEDIOL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Другие лекарства с тем же действующим веществом (Альфа-кальцидол) включают ALFAKALKIDOLO DOK, ALFAKALKIDOLO TSENTIVA, ALPA D3. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
