NEODIDRO 0.266 MG Soft capsule

Зміст інструкції

1. NEODIDRO 0.266 mg soft capsules
   1. What is NEODIDRO and what is it used for
   2. What you need to know before taking NEODIDRO
   3. How to take NEODIDRO
   4. Possible side effects
   5. How to store NEODIDRO
   6. Contents of the pack and other information

NEODIDRO 0.266 mg soft capsules

Calcifediol

Generic medicine
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, 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 NEODIDROis and what it is used for
• 2.What you need to know before you take NEODIDRO
• 3.How to take NEODIDRO
• 4. Possible side effects
• 5.How to store NEODIDRO

1. What is NEODIDRO and what is it used for

The medicine contains calcifediol, a form of vitamin D used for the treatment of vitamin D deficiencies and the conditions resulting from them, in cases where it is necessary to start treatment with high doses or to space out its administration over time. Among the functions that vitamin D performs in the human body is that of increasing calcium absorption.

NEODIDROis used:
In adults:
In the treatment of vitamin D deficiency, in cases where initial administration of high doses is necessary or where spaced administration is preferred, such as in the following situations:

• Adjunctive treatment in the care of osteoporosis
• In patients with malabsorption syndrome (difficulty absorbing nutrients)
• Osteodystrophy (bone disease) or calcium deficiency in patients with renal insufficiency
• Bone problems caused by corticosteroids (anti-inflammatory drugs used in the treatment of various diseases).

2. What you need to know before taking NEODIDRO

Do not take NEODIDRO:

• if you are allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from hypercalcemia (calcium levels in the blood >10.5 mg/dl) or hypercalciuria (high levels of calcium in the urine)
• if you suffer from kidney stones
• if you have been diagnosed with hypervitaminosis D (excess of vitamin D in the body).

Warnings and precautions
Talk to your doctor or pharmacist before taking NEODIDRO.

• Do not exceed the recommended daily intake of vitamin D supplements, such as this medicine; taking excessive doses of vitamin D can, in fact, cause poisoning (see section 3, paragraph If you take more NEODIDRO than you should).
• During the intake of this medicine or before starting it, your doctor may advise you to undergo blood and urine tests to check the levels of calcium, phosphorus and other parameters.
• The medicine may have a reduced effect in some patients with liver disease.
• Patients with kidney disease require particular attention and must be subjected to careful medical monitoring and regular tests.
• Patients with heart disease require particular attention and must be subjected to frequent medical monitoring to check calcium levels, especially those undergoing treatment with cardiac glycosides (see within this section, paragraph Other medicines and NEODIDRO) .
• If you suffer from hypoparathyroidism (insufficient synthesis and secretion 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.
• In patients forced to prolonged immobilization, a reduction in the dosage of this medicine may be necessary.
• Some intestinal diseases may involve a reduction in the ability to absorb vitamin D (such as, for example, diseases characterized by frequent diarrhea).
• Patients with sarcoidosis (a disease involving the formation of nodules, particularly at the skin level), tuberculosis or other diseases characterized by the formation of nodules should take this medicine with particular caution as they have a higher risk of developing side effects at doses lower than those recommended. Periodic tests to check calcium and calcium urine levels are recommended.
• In order to avoid a possible overdose, the doctor must inform you and your family and/or caregivers of the importance of adhering to the recommended dosages and the recommendations provided regarding diet and concomitant intake of calcium supplements.
• Interference with laboratory tests: if you are to undergo diagnostic tests (including blood tests, urine tests, skin tests involving the use of allergens, etc ...), inform your doctor that you are taking this medicine; it may, in fact, affect the results, for example, those of cholesterol tests.

Children and adolescents
For use in children and adolescents, it is recommended to administer other dosage forms
with lower dosages.

Elderly patients
Elderly patients generally require an increased need for vitamin D due to, among other
things, the reduced ability of the skin to convert vitamin D into its active forms or the reduced
exposure to the sun. Elderly patients should take the medicine under the supervision of a doctor.

Other medicines and NEODIDRO
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,

NEODIDROor calcifediol, the active ingredient of this medicine, can affect the effectiveness of other
medicines taken at the same time, including the following:

• Medicines used for the treatment of epilepsy (such as phenytoin, phenobarbital and primidone) and other enzyme inducers (which promote a reduction in the effects of NEODIDRO).
• 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 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 proper distance is recommended.
• Some antibiotics (such as penicillin, neomycin and chloramphenicol).
• Magnesium salts.
• Other products containing vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory drugs).

NEODIDRO with food and drink
Some foods and some drinks are supplemented with vitamin D. This should be taken into account as their
effects may add up to those of this medicine and therefore be excessive.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy.
Do not take this medicine if you are breastfeeding.

Driving and operating machinery
NEODIDRO does not impair or negligibly impairs the ability to drive vehicles or operate machinery.

NEODIDRO contains ethanol, sorbitol (E-420) and sunset yellow (E-110).
This medicine contains 1% ethanol (alcohol); this small amount corresponds to 4.98
mg/capsule.
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars,
consult him before taking this medicine.
The medicine contains sunset yellow (E-110) and therefore may cause allergic reactions. It may cause
asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take NEODIDRO

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Do not take this medicine in doses greater than or with a frequency greater than that prescribed by your doctor
(weekly, bi-weekly or monthly). Otherwise, the risk of overdose increases.
The doses vary depending on the person and the indications. Your doctor should periodically monitor your
calcium and vitamin D levels, usually before starting treatment and 3 months after starting
it.
Depending on the indication, the doses will normally be reduced or spaced out more over time once
symptoms improve or vitamin D deficiency has been overcome.
The recommended doses are as follows:

Adults
The recommended dose is one capsule (0.266 mg of calcifediol) once a month.

• Vitamin D insufficiency: administration of one capsule (0.266 mg of calcifediol) per month for 2 months is recommended.
• Vitamin D deficiency: initial administration of one capsule (0.266 mg of calcifediol) per month for 4 months is recommended.
• As an adjunct to the treatment of osteoporosis in patients with vitamin D deficiency: administration of one capsule (0.266 mg of calcifediol) per month for 3-4 months is recommended. There are populations at high risk of vitamin D deficiency in whom, if the doctor deems it appropriate, the administration of higher doses or for longer periods of time may be necessary depending on the degree of deficiency ascertained by performing the relevant blood tests and subsequent regular checks of the corresponding levels:
• Renal osteodystrophy: taking one capsule (0.266 mg of calcifediol) once a week or every two weeks is recommended.
• Corticosteroid-induced bone diseases: taking one capsule (0.266 mg of calcifediol) once a month is recommended.
• In patients with more severe vitamin D deficiency or malabsorption syndrome, it is recommended to repeat the initial dose one week after starting treatment and then continue with the administration of one capsule once a month for four months, providing for regular monitoring of the plasma concentration of 25-OH-cholecalciferol. Depending on the serum levels found, it may be necessary to increase the dosage or frequency of administration. Once the concentration value has stabilized within the expected range, therapy will be discontinued or the frequency of administration reduced. For oral use.

If you feel that the effect of this medicine is too strong or too weak, consult your
doctor or pharmacist.

If you take more NEODIDRO 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 the urine and blood may occur, with a possible consequent risk of
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, growth retardation in children, kidney disorders, intolerance to sunlight,
conjunctivitis, increased cholesterol and transaminases, inflammation of the pancreas, calcification
(formation of calcium deposits) of blood vessels and other tissues such as tendons and muscles, increased
blood pressure, mental disorders, irregular heartbeat. Overdose symptoms usually
improve or disappear once treatment is stopped; however, in case of severe poisoning, they may manifest
renal or cardiac failure.

If you forget to take NEODIDRO
Do not take a double dose to make up for the missed dose.
Take the missed dose as soon as possible; then resume the normal assumption of the dosage
established.

If you stop taking NEODIDRO
If you have any 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.
In general, side effects are not common (may affect up to 1 in 100 people) when the doses are adjusted
according to the recommendations. However, important adverse reactions may occur in case of treatment
with excessive doses or for longer periods than prescribed by the doctor, which may result in the
development of hypercalcemia (increased calcium levels in the blood).
The following side effects may occur:
Nausea, vomiting, dry mouth, constipation, taste alterations with a metallic taste, abdominal cramps,
anorexia (loss of appetite).
In case of moderate hypercalcemia (increased calcium levels), weakness, fatigue, drowsiness, headache
and irritability may occur.
In case of hypercalcemia, arrhythmias (heart rhythm disturbances) may occur.
In case of hypercalcemia, bone and muscle pain may occur and calcifications (calcium deposits) in soft
tissues may appear. Nephrocalcinosis (formation of calcium deposits in the kidneys), impaired kidney
function with polyuria (increased frequency of urination), polydipsia (increased thirst), nocturia
(repeated need to urinate during the night) and proteinuria (presence of protein in the urine) may also
occur.
In rare cases (may affect up to 1 in 1000 people), at very high doses, photophobia (eye intolerance to
light) and conjunctivitis with corneal calcifications (calcium deposits) may occur.
Other possible side effects reported include: rhinorrhea (runny nose), itching, hyperthermia (fever) and
decreased libido (sexual desire), pancreatitis (inflammation of the pancreas), increased blood urea
nitrogen, albuminuria (presence of albumin in the urine), hypercholesterolemia (increased blood
cholesterol) and hypercalcemia (increased calcium in the blood).
In the presence of high calcium levels in the blood, an increase in transaminases (SGOT and SGPT) may
occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NEODIDRO

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 special storage conditions.
Do not store in a refrigerator.
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 NEODIDRO contains

• The active ingredient is calcifediol. Each capsule contains 0.266 mg of calcifediol (equivalent to
• 15,960 IU of vitamin D).
• The other ingredients are: anhydrous ethanol, medium chain triglycerides; the capsule components are: gelatin, glycerol, sorbitol (E-420), titanium dioxide (E171) and sunset yellow (E-110).

Description of the appearance of NEODIDRO and contents of the pack
NEODIDRO is presented as soft gelatin capsules, orange in colour and oval in shape,
containing a clear, low viscosity liquid, free from particles, packaged in PVC/PVDC-Al blisters
containing 5 or 10 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bruno Farmaceutici S.p.A.
Via delle Ande 15, 00144 Rome
Italy
Manufacturer responsible for batch release
Faes Farma, S.A.
C/ Máximo Aguirre, 14
Leioa
48940 Bizkaia
Spain

This medicinal product is authorised in the Member States of the EEA
under the following denominations:>