Package Leaflet: Information for the Patient

Neodiset 100 micrograms soft capsules

calcifediol monohydrate
Read this entire 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, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Neodiset is and what it is used for
What you need to know before taking Neodiset
How to take Neodiset
Possible side effects
How to store Neodiset
Contents of the pack and other information

1. What Neodiset is and what it is used for

It is a medicine containing a form of vitamin D, calcifediol, used for the prevention and treatment of vitamin D deficiency and related conditions. Vitamin D is present in the body and, among its various functions, enhances calcium absorption.
Neodiset is used for the treatment of vitamin D deficiency in adults and for the prevention of vitamin D deficiency in adults who have identified risk factors.
Neodiset is also used for the treatment of certain bone conditions, including 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 to any of the other ingredients of this medicine (listed in section 6);
If you have 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:
Do not exceed the recommended daily intake of vitamin D supplements, such as this medicine,
as it may cause poisoning (see section 3, section If you take more Neodiset than you should).

While taking this medicine or before starting it, your doctor may recommend blood and urine tests to monitor calcium, phosphorus, and other parameters.
Patients with kidney disease require special attention and must be closely monitored by a physician through regular laboratory tests.
Patients with heart disease require special attention and should undergo frequent medical monitoring to check calcium levels, especially those receiving treatment with cardiac glycosides (see within this section, paragraph Other medicines and Neodiset).
If you have hypoparathyroidism (insufficient parathyroid hormone activity), this medicine may be less effective.
If you are prone to developing calcium-containing kidney stones, your doctor should monitor your calcium levels.
Patients who are immobilized for prolonged periods may require lower doses of this medicine. Patients with sarcoidosis (a disease characterized by nodule formation, particularly in the skin), tuberculosis, or other granulomatous diseases should take this medicine with particular caution, as they have an increased risk of developing adverse effects at lower than recommended doses. Periodic testing to monitor calcium levels in blood and urine is advised.
Interference with laboratory tests: if you need to undergo diagnostic tests (including blood and urine analyses, skin tests involving allergens, etc.), inform your doctor that you are taking this medicine, as it may affect test results. For example, cholesterol tests.

Children and adolescents
The use of Neodiset is not indicated in children and adolescents.
Other medicines and Neodiset
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Some medicines may alter the mechanism of action of this medicine. Conversely, Neodiset or its active ingredient, monohydrate calcifediol, may affect the effectiveness of other medicines taken concomitantly.
Therefore, they may interact with the following medicines:

Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing drugs (which may reduce the effects of Neodiset).
Cardiac and/or antihypertensive medicines and cardiac glycosides, thiazide diuretics, or verapamil.
Cholestyramine, colestipol (for cholesterol), orlistat (for obesity). The administration of these medicines and monohydrate calcifediol should be spaced at least 2 hours apart.
Mineral oil or paraffin (laxatives): it is recommended to use another type of laxative or to take the two medicines sufficiently apart.
Certain antibiotics (such as penicillin, rifampicin, isoniazid, neomycin, and chloramphenicol).
Magnesium salts.
Other products containing vitamin D.
Calcium supplements.
Corticosteroids (anti-inflammatory agents).
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 drinks
Some foods and drinks are fortified with vitamin D. This should be taken into account, as their effects may add up to those of this medicine and thus become excessive.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not recommended during pregnancy and breastfeeding.
Calcifediol passes into breast milk. This should be considered when administering vitamin D supplements to breastfed infants.
It is unknown whether calcifediol has any effects on fertility. However, no adverse effects on fertility are expected with normal levels of vitamin D intake.
Driving and using machines
Neodiset does not alter or alters negligibly the ability to drive or operate machinery.
Neodiset contains ethanol, liquid sorbitol (non-crystalline) (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 in this medicine will not have noticeable effects.
This medicine contains 11 mg of sorbitol in the form of liquid sorbitol (non-crystalline) 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 exactly as instructed by 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 with identified risk factors: one capsule once a week.
As an adjunct to specific treatment of osteoporosis: one capsule once a week.

This medicine must not be taken on a daily basis.
Your doctor will periodically monitor your calcium and vitamin D levels, usually before
starting treatment and after 3-4 months.
For oral use.
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 prescribed by your doctor (overdose) and/or take it for prolonged periods,
hypercalcemia (high levels of calcium in the blood) and presence of phosphates in urine and blood may occur, potentially leading to renal failure.
Some symptoms of toxicity may appear early after starting the medicine, while others may develop later. Early symptoms include: weakness, fatigue, headache, loss of appetite, dry mouth, digestive disturbances such as vomiting, abdominal cramps, constipation or diarrhea, increased thirst; increased frequency of urination; muscle pain. Later symptoms may include: itching, weight loss, growth delay in children, kidney disorders, intolerance to sunlight, conjunctivitis, increased cholesterol and transaminase levels, inflammation of the pancreas, calcification (deposits of calcium salts) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disturbances, irregular heartbeat.
Symptoms of overdose usually improve or disappear once treatment is stopped; however, in cases 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 missed capsule.
Take the missed dose as soon as possible, then continue with your regular dosing schedule.
If you stop taking Neodiset
If you have any further questions about the use of this medicine, consult 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 with excessive doses or prolonged use beyond what has been prescribed by the doctor, which may lead to hypercalcemia (increased calcium levels in the blood) and hypercalciuria (increased calcium levels in the urine); see section 3 for a description of symptoms.
Other side effects include allergic reactions such as itching, local swelling, breathing difficulties, and skin redness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via
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 stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Neodiset contains

The active substance 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-crystalline) (E 420), titanium dioxide (E 171) and allura red (E 129).

Description of the appearance of Neodiset and contents of the pack
Neodiset is red, oval, soft gelatin capsules with a longitudinal seam. The capsules are
packaged in PVC/PVDC/Al blisters containing 4, 12, 24 or 48 capsules. The blisters are packed in
a cardboard box.
Marketing Authorization 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 authorized in the EEA Member States under the following names:
Spain: Hidroferol semanal 100 microgramos cápsulas blandas
Portugal: Dvit semanal 100 microgramas cápsula mole
Belgium: Hidroferol Hebdomadaire 100 microgrammes capsules molles
Luxembourg: Hidroferol Hebdomadaire
Italy: Neodiset
This Patient Information Leaflet was last revised on