Інструкція із застосування NEODISET
Зміст інструкції
Neodiset 100 micrograms soft capsules
calcifediol monohydrate
Read this leaflet carefully before you start to take 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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Neodiset is and what it is used for
- 2. What you need to know before you take Neodiset
- 3. How to take Neodiset
- 4. Possible side effects
- 5. How to store Neodiset
- 6. Contents of the pack and other information
1. What is Neodiset and what is it used for
It is a medicine that contains a form of vitamin D, calcifediol, used for the prevention and the
treatment of vitamin D deficiency and problems related to it. Vitamin D is present
in the body and, among its various activities, increases calcium absorption.
Neodiset is used for the treatment of vitamin D deficiency in adults and the prevention of
vitamin D deficiency in adults who present identified risks.
Neodiset is also used for the treatment of some bone conditions, including the thinning of
the bones (osteoporosis) in adults.
2. What you need to know before taking Neodiset
Do not take Neodiset:
- If you are allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6);
- If you suffer from hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine);
- If you suffer from kidney stones;
- If you have been diagnosed with hypervitaminosis D (excess vitamin D in the body).
Warnings and precautions
Talk to your doctor or pharmacist before taking Neodiset if:
You do not exceed the recommended daily intake of vitamin D supplements, such as this medicine,
because it can cause poisoning (see section 3, section
If you take more Neodiset than you should
- During the intake of this medicine or before it begins, your doctor may advise you to undergo blood and urine tests to check the levels of calcium, phosphorus and other parameters.
- Patients with kidney disease need particular attention and must be subjected to careful medical monitoring, through regular tests.
- Patients with heart disease need particular attention and must be subjected to frequent medical monitoring to check calcium levels, especially patients undergoing treatment with cardiac glycosides (see within this section, paragraph Othermedicines and Neodiset).
- If you suffer from hypoparathyroidism (insufficient activity of parathyroid hormone), this medicine may be less effective.
- If you are prone to developing calcium-containing kidney stones, your doctor must monitor your calcium levels.
- Patients forced to prolonged immobilization may need lower doses of this medicine. Patients with sarcoidosis (a disease involving the formation of nodules, particularly on the skin), tuberculosis or others characterized by nodules will need to take this medicine with particular caution, as they have a higher risk of developing undesirable effects at doses lower than those recommended. Periodic tests to check calcium levels in the blood and urine are recommended.
- Interference with laboratory tests: if you are to undergo diagnostic tests (including blood tests, urine tests, skin tests involving the use of allergens, etc.), tell your doctor that you are taking this medicine as it may affect the results. For example, in cholesterol tests.
Children and adolescents
The use of Neodiset is not indicated in children and adolescents.
Other medicines and Neodiset
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Some medicines can alter the mechanism of action of this medicine. Conversely, Neodiset or its
active ingredient calcifediol monohydrate can affect the effectiveness of other medicines taken in
combination.
Therefore, they can interact with the following medicines:
- Medicines used for the treatment of epilepsy (such as phenytoin, phenobarbital and primidone) and other enzyme-inducing drugs (which promote the reduction of the effects of Neodiset).
- Cardiac and/or antihypertensive medicines and cardiac glycosides, thiazide diuretics or verapamil.
- Cholestyramine, colestipol (for cholesterol), orlistat (for obesity). The intake of these medicines and that of calcifediol monohydrate should be at least 2 hours apart.
- Mineral oil or paraffin (laxatives): the use of another type of laxative or the intake of the two medicines at a suitable distance is recommended.
- Some antibiotics (such as penicillin, rifampicin, isoniazid, neomycin and chloramphenicol).
- Magnesium salts.
- Other products containing vitamin D.
- Calcium supplements.
- Corticosteroids (anti-inflammatory drugs).
- Verapamil (antihypertensive).
- Medicines that inhibit cytochrome P-450 (e.g. atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole).
Neodiset with food and drink
Some foods and some drinks are supplemented with vitamin D. This must be taken into
consideration as their effects may add to those of this medicine and
result, therefore, in excessive amounts.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine is not recommended during pregnancy and breastfeeding.
Calcifediol passes into breast milk. This must be taken into consideration when
administering vitamin D supplements to breastfed babies.
No effects of calcifediol on fertility are known. However, no adverse effects on
fertility are expected with the intake of normal levels of vitamin D.
Driving and operating machinery
Neodiset does not alter or negligibly alters the ability to drive vehicles or operate machinery.
Neodiset contains ethanol, liquid sorbitol (non-crystallizing) (E 420) and allura red (E 129)
The medicine contains 2 mg of alcohol (ethanol) in each soft capsule. The amount contained in each
capsule of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol
contained in this medicine will not have noticeable effects.
This medicine contains 11 mg of sorbitol in the form of liquid sorbitol (non-crystallizing) in
each soft capsule, equivalent to 0.04 mg/mg.
This medicine contains allura red (E 129) which may cause allergic reactions.
3. How to take Neodiset
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses are as follows:
- Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients who present identified risks: one capsule once a week.
- As an adjunct to specific treatment of osteoporosis: one capsule once a week.
This medicine should not be taken with daily frequency.
Your doctor will monitor calcium and vitamin D levels periodically, usually before
the start of treatment and after 3-4 months.
Orally.
Neodiset can be taken on an empty stomach or with a meal, swallowed whole and taken with water, milk or
fruit juice.
If you take more Neodiset than you should
If you take a dose of this medicine higher than that prescribed by your doctor (overdose) and/or if you
take it for prolonged periods of time, hypercalcemia (high levels of calcium in the
blood) and the presence of phosphates in urine and blood may occur, leading to possible renal failure.
Some symptoms of toxicity may appear from the beginning of taking the medicine, others
may appear later. Initial symptoms include: weakness, fatigue, headache, loss of appetite, dry mouth, digestive disorders such as vomiting, abdominal cramps, constipation or
diarrhea, increased thirst; increased frequency of urination, muscle pain. Symptoms that
may appear later include: itching, weight loss, delayed growth in
children, kidney disorders, intolerance to sunlight, conjunctivitis, increased cholesterol, transaminases, inflammation of the pancreas, calcification (calcium salt deposits) of blood vessels and
other tissues such as tendons and muscles, increased blood pressure, mental disorders, irregular heartbeat.
The symptoms of overdose usually improve or disappear once treatment is stopped, however,
in case of severe intoxication, renal or cardiac failure may occur.
If you forget to take Neodiset
Do not take a double dose to make up for the forgotten capsule.
Take the forgotten dose as soon as possible; then, resume the normal administration of the established dosage.
If you stop taking Neodiset
If you have any other doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions may occur in case of treatment with excessive doses or for periods of time
longer than prescribed by the doctor, which may cause hypercalcemia (increased levels of calcium
in the blood) and hypercalciuria (increased levels of calcium in the urine), see paragraph 3 for the description
of the symptoms.
Other side effects include allergic reactions such as itching, local swelling, difficulty
breathing and redness of the skin.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. 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 Neodiset
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 EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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.
6. Contents of the pack and other information
What Neodiset contains
- The active ingredient is calcifediol monohydrate. Each capsule contains 100 micrograms of calcifediol monohydrate (equivalent to 96 micrograms of calcifediol).
- The other ingredients are: anhydrous ethanol, medium chain triglycerides and the capsule components are: gelatin, glycerol, liquid sorbitol (non-crystallized) (E 420), titanium dioxide (E 171) and Allura Red (E 129).
Description of the appearance of Neodiset and contents of the pack
Neodiset are soft gelatin capsules, red, oval-shaped with a longitudinal join. The capsules are
packaged in PVC/PVDC/Al blisters containing 4, 12, 24 or 48 capsules. The blisters are packaged in
a cardboard box.
Marketing Authorisation Holder
Faes Farma, S.A.
Autonomia Etorbidea 10,
Leioa, 48940 Bizkaia
Spain
Manufacturer
Faes Farma, S.A.
Maximo Agirre Kalea, 14
48940 Leioa (Bizkaia)
Spain
Faes Farma S.A.
Parque Científico y Tecnológico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain
This medicinal product is authorised in the Member States of the EEA under the following denominations:
Spain: Hidroferol semanal 100 micrograms soft capsules
Portugal: Dvit semanal 100 micrograms soft capsule
Belgium: Hidroferol Hebdomadaire 100 micrograms soft capsules
Luxembourg: Hidroferol Hebdomadaire
Italy: Neodiset
- Країна реєстрації
- Лікарська формаSoft capsule, 100 MICROGRAMS
- Код АТХA11CC06
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до NEODISETЛікарська форма: Oral drops, solution, 0.15 MG/MLДіюча речовина: calcifediolВиробник: BRUNO FARMACEUTICI S.P.A.Потрібен рецептЛікарська форма: Oral drops, solution, 0.266 MG/0.5 MLДіюча речовина: calcifediolВиробник: FARMACEUTICI CABER S.R.L.Потрібен рецептЛікарська форма: Oral drops, solution, 0,266 MG/0,5 MLДіюча речовина: calcifediolВиробник: I.B.N. SAVIO S.R.LПотрібен рецепт
Аналоги NEODISET в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог NEODISET у Іспанія
Аналог NEODISET у Польща
Аналог NEODISET у Україна
Лікарі онлайн щодо NEODISET
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на NEODISET онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
NEODISET потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у NEODISET — calcifediol. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
NEODISET виробляється компанією FAES FARMA S.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування NEODISET з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати NEODISET у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (calcifediol) включають DIDROGYL, ERKAL, KALED. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















