NODIGAP 1000 IU Софт капсула
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Инструкция по применению NODIGAP
Содержание инструкции
NODIGAP soft capsules 1,000 I.U. (25 micrograms), soft capsules 10,000 I.U. (250 micrograms), soft capsules 20,000 I.U. (500 micrograms), soft capsules 50,000 I.U. (1250 micrograms)
Cholecalciferol
Read this leaflet carefully before taking this medicine 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet
- 1. What NODIGAP is and what it is used for
- 2. What you need to know before you take NODIGAP
- 3. How to take NODIGAP
- 4. Possible side effects
- 5. How to store NODIGAP
- 6. Contents of the pack and other information
1. What is NODIGAP and what is it used for
The active ingredient of NODIGAP is vitamin D3. Vitamin D promotes calcium absorption
by the body and improves bone formation.
This medicine is recommended in the following cases:
- prevention and treatment of vitamin D deficiency.
Capsules 1,000 I.U.
NODIGAP is indicated in adults and adolescents from 12 to 18 years of age.
Capsules 10,000, 20,000, 50,000 I.U.
NODIGAP is indicated in adults and the elderly.
2. What you need to know before taking NODIGAP
Do not take NODIGAP:
- if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6)
- if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria)
- if you have severe kidney problems (severe renal impairment)
- if you have high levels of vitamin D in the blood (hypervitaminosis D)
- if you have kidney stones or deposits of calcium in the kidneys.
Warnings and precautions
Talk to your doctor or pharmacist before taking NODIGAP if:
- You are predisposed to the formation of kidney stones.
- You have cancer or any other condition that may have affected your bones.
- If you have an imbalance of the parathyroid hormone (pseudohypoparathyroidism).
If you have any of the following conditions, your doctor will check the levels of calcium or phosphate in your
blood or the level of calcium in your urine:
- if you are being treated for a long time with this medicine
- if you have kidney problems
- if you suffer from ‘sarcoidosis’, a disorder of the immune system that can affect the liver, lungs, skin or lymph nodes.
Children
NODIGAP is not indicated for use in children under 12 years of age.
Other medicines and NODIGAP
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
This is particularly important if you are taking:
- diuretics, as the doctor will need to regularly check the levels of calcium in your blood
- corticosteroids (‘steroids’ e.g. prednisolone, dexamethasone), because the dose of vitamin D may need to be increased
- cholestyramine (a medicine to lower cholesterol) or laxatives (e.g. paraffin oil), because they reduce the absorption of vitamin D
- medicines for the heart (cardiac glycosides), because you will need to be monitored by a doctor, possibly have an ECG and check calcium levels
- anticonvulsants (for the treatment of epilepsy), cytotoxic agents, antimycotics derived from imidazole and actinomycin, sleeping pills (e.g. hydantoin, barbiturates) or primidone, because they reduce the effect of vitamin D
- calcitonin, etidronate, gallium nitrate, pamidronate or plicamycin, because they reduce the levels of calcium in the blood
- products containing high doses of calcium, because they increase the risk of high levels of calcium in the blood
- products containing magnesium (e.g. antacids), because they should not be used during treatment with vitamin D due to the risk of high levels of magnesium
- products containing high doses of phosphorus, because, at high doses, they increase the risk of high levels of phosphates in the blood
- other products containing vitamin D such as multivitamin products and dietary supplements containing vitamin D should be avoided.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. These
formulations can be used during pregnancy, but only if a vitamin D deficiency has been diagnosed and after consulting a doctor.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
NODIGAP contains:
Sorbitol:If your doctor has told you that you have an intolerance to some sugars, contact your doctor
before taking this medicine. This medicine contains 16.5 mg of sorbitol in each capsule.
Sunset Yellow:NODIGAP 10,000 I.U. capsules contain sunset yellow. It may cause
allergic reactions.
3. How to take NODIGAP
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Adults
NODIGAP 1,000 I.U.:
The doctor generally prescribes 1-4 capsules a day for a maximum period of 3 months, followed by
a maintenance and prevention therapy of 1 capsule a day. In severe vitamin D deficiencies
in adults and the elderly, the amount will depend on vitamin D levels and response to
treatment.
NODIGAP 10,000 I.U.:
The doctor generally prescribes 2 capsules a week for a period of 1-3 months, followed by a
maintenance and prevention therapy of 1 capsule every 2 weeks. In severe vitamin D deficiencies
in adults and the elderly, the amount will depend on vitamin D levels and response to
treatment.
NODIGAP 20,000 I.U.:
The doctor generally prescribes 1 capsule a week for a period of 1-3 months, followed by a
maintenance and prevention therapy of 1 capsule a month. In severe vitamin D deficiencies
in adults and the elderly, the amount will depend on vitamin D levels and response to
treatment.
NODIGAP 50,000 I.U.:
The doctor generally prescribes 1 capsule a week for a period of 6-8 weeks, followed by
a maintenance and prevention therapy of 1 capsule every 2 months. In severe vitamin D deficiencies
in adults and the elderly, the amount will depend on vitamin D levels and response to
treatment.
Adolescents
NODIGAP 1,000 I.U.:
The doctor generally prescribes 1-4 capsules a day for a maximum period of 3 months, followed by
a maintenance and prevention therapy of 1 capsule a day. In severe vitamin D deficiencies, the amount will depend on vitamin D levels and response to treatment. Do not take more than 4
capsules a day.
Use in children
NODIGAP is not indicated in children under 12 years of age.
Method of administration
Swallow the capsules whole with water, without chewing.
NODIGAP with food and drinks
NODIGAP can be taken with or without food.
If you take more NODIGAP than you should
You may experience the following symptoms: loss of appetite, thirst, nausea, vomiting, constipation, abdominal
pain, muscle weakness, fatigue, confusion, need to urinate more than usual, bone
pain, kidney problems and in severe cases, irregular heartbeat, coma or death.
If you take too many capsules, contact your doctor immediately or go to the nearest hospital.
Bring the package and any remaining capsules with you.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
If you forget to take NODIGAP
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking NODIGAP and see a doctor if you have symptoms of a serious allergic reaction, such as:
- swelling of the face, lips, tongue or throat
- difficulty swallowing
- hives and difficulty breathing.
The side effects of NODIGAP may include:
Common (may affect up to 1 in 10 people):
- nausea, constipation, flatulence, stomach pain, diarrhoea.
Uncommon (may affect up to 1 in 100 people):
- excessive amount of calcium in the blood (hypercalcemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, needing to urinate more than usual, muscle weakness, drowsiness and confusion
- excessive amount of calcium in the urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people):
- skin rash (itching, hives)
- itching.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store NODIGAP
Keep this medicine out of the sight and reach of children.
This medicine does not require particular precautions for storage.
Do not use this medicine after the expiry date that is reported on the label after EXP. The date
of expiry refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What NODIGAP contains
- The active ingredient is cholecalciferol: Each 1,000 IU capsule contains 1,000 IU of cholecalciferol, equivalent to 25 micrograms of vitamin D3. Each 10,000 IU capsule contains 10,000 IU of cholecalciferol, equivalent to 250 micrograms of vitamin D3. Each 20,000 IU capsule contains 20,000 IU of cholecalciferol, equivalent to 500 micrograms of vitamin D3. Each 50,000 IU capsule contains 50,000 IU of cholecalciferol, equivalent to 1250 micrograms of vitamin D3.
- The other ingredients are: Capsule: medium-chain triglycerides and vitamin E acetate (α-tocopherol acetate). Capsule shell 1,000 IU: gelatin, glycerol, partially dehydrated liquid sorbitol (E420), brilliant blue (E133), quinoline yellow (E104) and purified water. Capsule shell 10,000 IU: gelatin, glycerol, partially dehydrated liquid sorbitol (E420), sunset yellow (E110) and purified water. Capsule shell 20,000 IU: gelatin, glycerol, partially dehydrated liquid sorbitol (E420) and purified water. Capsule shell 50,000 IU: gelatin, glycerol, partially dehydrated liquid sorbitol (E420), quinoline yellow (E104) and purified water.
Description of the appearance of NODIGAP and contents of the pack
- The 1,000 IU vitamin D3 capsules are transparent, rounded gelatin capsules of green color containing a colorless transparent liquid.
- The 10,000 IU vitamin D3 capsules are transparent, rounded gelatin capsules of orange color containing a colorless transparent liquid.
- The 20,000 IU vitamin D3 capsules are transparent, rounded gelatin capsules of light yellow color.
- The 50,000 IU vitamin D3 capsules are transparent, rounded gelatin capsules of yellow color containing a colorless transparent liquid. NODIGAP is available in HDPE bottles containing 60 capsules (1,000 IU) and in blisters containing 10 capsules (10,000 IU), 5 capsules (20,000 IU) and 2 capsules (50,000 IU).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fidia Farmaceutici S.p.A, Via Ponte della Fabbrica, 3/A, 35031 Abano Terme, Padova, Italy
Manufacturer:
Geryon Pharma Limited, 18 Owen Drive, Liverpool, United Kingdom, L24 1YL
This medicinal product is authorised in the member states of the EEA under the following names:
Denmark: DIPRIMIS, capsule, soft 1,000, 10,000, 20,000 and 50,000 IU
Italy: NODIGAP 1,000, 10,000, 20,000 and 50,000 IU soft capsules
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- Страна регистрации
- Форма выпускаSoft capsule, 1000 IU
- Код АТХA11CC05
- 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 NODIGAPФорма выпуска: Film-coated tablet, 1000 IUДействующее вещество: colecalciferolПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Film-coated tablet, 800 IUДействующее вещество: colecalciferolПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Soft capsule, 10,000 IUДействующее вещество: colecalciferolПроизводитель: PHARMACARE S.R.L.Отпускается по рецепту
Аналоги NODIGAP в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог NODIGAP в Испания
Аналог NODIGAP в Польша
Аналог NODIGAP в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
NODIGAP требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество NODIGAP — colecalciferol. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
NODIGAP производится компанией FIDIA FARMACEUTICI S.P.A.. 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 NODIGAP с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить NODIGAP в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (colecalciferol) включают ANNEXXO, ANNOVA, ANORSIA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
