Package leaflet: Information for the patient

OSTIDIL-D3 0.25 microgram capsules, 1 microgram capsules

Alfacalcidol
Equivalent medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OSTIDIL-D3 is and what it is used for
What you need to know before taking OSTIDIL-D3
How to take OSTIDIL-D3
Possible side effects
How to store OSTIDIL-D3
Contents of the pack and other information

1. What OSTIDIL-D3 is and what it is used for

OSTIDIL-D3 contains the active substance alfacalcidol, a precursor of vitamin D3.
OSTIDIL-D3 is used to treat:

bone fragility, decreased bone mass, and increased risk of fractures in patients with kidney disease (renal osteodystrophy) undergoing dialysis or not.
reduced function of the parathyroid glands, which regulate calcium metabolism (hypoparathyroidism).
bone disorders characterized by defective bone mineralization (caused by impaired vitamin D metabolism and resistant to vitamin D (vitamin D-resistant or vitamin D-dependent rickets and osteomalacia (pseudo-deficient type)).
rickets and osteomalacia due to renal disturbances in vitamin D metabolism.
loss of bone density after menopause (postmenopausal osteoporosis).

2. What you need to know before taking OSTIDIL-D3

Do not take OSTIDIL-D3:

if you are allergic or hypersensitive to vitamin D or to any of the other ingredients of this medicine (listed in section 6)
if you are pregnant or breastfeeding
if you have high levels of calcium in the blood (hypercalcemia)
if you have confirmed vitamin D toxicity or excessive vitamin intake (hypervitaminosis).

Warnings and precautions
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Talk to your doctor or pharmacist before taking OSTIDIL-D3.
Throughout the treatment period, your doctor will request blood tests to monitor the following values:

calcium levels, as OSTIDIL-D3 may cause elevated calcium levels in the blood (hypercalcemia) and increased calcium excretion in the urine (hypercalciuria). This allows your doctor to determine the most appropriate dosage for you and monitor for potential drug toxicity in case of symptoms. Inform your doctor if you are breastfeeding, as infants should also be monitored. If high calcium levels (hypercalcemia) occur, your doctor will suspend treatment until levels return to normal, which usually happens quickly. Your doctor will then prescribe a lower dose of the medicine.
phosphate levels, to reduce the risk of calcium deposition in bones (ectopic calcifications).
alkaline phosphatase levels, as they may anticipate the onset of hypercalcemia.

Additionally, inform your doctor if you or the child are taking:

cardiac glycosides, medicines used to treat heart disorders. You may experience increased calcium levels in the blood while taking these medicines, thereby increasing the risk of heart rhythm disturbances.
phosphate-binding agents, as OSTIDIL-D3 influences phosphate transport in the intestine, kidney, and bones; concomitant administration should be evaluated by the doctor based on serum phosphate levels (phosphatemia).
an adequate intake of vitamin D from diet and sun exposure, as additional vitamin D supplementation may be harmful in such cases.

Inform your doctor before taking OSTIDIL-D3 if:

you are breastfeeding, as infants may be sensitive.
you have kidney disease (renal impairment or kidney stones), or
you have heart disease.
you are taking vitamin D or its derivatives, as vitamin D overdose may cause serious effects, including increased calcium levels in the blood (hypercalcemia), which, if chronic, could lead to generalized calcifications in blood vessels, renal calcifications (nephrocalcinosis), and calcification of other soft tissues, possibly requiring emergency treatment.

Other medicines and OSTIDIL-D3
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you or the child are taking:

anticonvulsants (e.g. barbiturates, phenytoin), medicines used to treat uncontrolled body movements, as higher doses of OSTIDIL-D3 may be required;
magnesium-containing drugs, to avoid increased magnesium levels in the blood (hypermagnesemia);
medicines for high blood pressure (thiazide diuretics) or calcium-containing preparations, as these may increase calcium levels in the blood. Your doctor may request blood tests;

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other vitamin D-containing preparations, due to the possibility of additive effects and increased risk of elevated calcium levels in the blood (hypercalcemia);
aluminum-containing preparations, as they may interfere with the drug's effectiveness;
bile acid sequestrants such as cholestyramine, medicines used to treat high blood fat levels, as they may reduce intestinal absorption of OSTIDIL-D3;
an anticoagulant medicine called warfarin, as its effect may be enhanced;
drugs used for infectious diseases (rifampicin and isoniazid), as they may reduce the effectiveness of vitamin D;
drugs used for inflammation (corticosteroids), as they may counteract the effect of vitamin D.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This product should be administered during pregnancy and breastfeeding only if clearly needed and under strict medical supervision, which will assess the benefit-risk balance.

Driving and using machines
OSTIDIL-D3 does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

3. How to take OSTIDIL-D3

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents:
over 20 kg body weight: 1 microgram per day.
Children:
under 20 kg body weight: 0.05 micrograms/kg per day.
Subsequently, the dose may be adjusted according to the response, depending on the patient's needs and body weight.

If you take more OSTIDIL-D3 than you should
If you take more OSTIDIL-D3 than prescribed by your doctor, contact your doctor or pharmacist immediately.
Excessive intake of vitamin D leads to increased calcium levels in the blood (hypercalcemia).
Symptoms of overdose include: loss of appetite (anorexia), fatigue, nausea and vomiting, constipation or diarrhea, increased urine production (polyuria), need to urinate at night (nocturia), sweating, headache, thirst, drowsiness and dizziness. If toxicity occurs, your doctor will instruct you to stop treatment with OSTIDIL-D3 and will implement supportive measures.
In case of severe increase in blood calcium levels (hypercalcemia) due to accidental overdose, you must stop taking the medicine and go immediately to the nearest hospital, where you will be given diuretics, intravenous fluids, or corticosteroids and similar agents.
In acute overdose, the doctor may consider treatment with gastric lavage and/or administration of mineral oils to reduce absorption and promote fecal elimination.
Hypercalcemia caused by excessive doses of vitamin D or its metabolites may also require emergency treatment.
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If you forget to use OSTIDIL-D3
If you forget to take OSTIDIL-D3, do not take a double dose to make up for the missed dose.

If you stop using OSTIDIL-D3
If you have any doubts about the use of Alfacalcidol, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the dosage corresponds to individual requirements, OSTIDIL-D3 is well tolerated. Otherwise, since the product has vitamin D activity, side effects may occur similar to those caused by an excess of vitamin D (hypervitaminosis D), i.e. a syndrome due to increased calcium levels (hypercalcemia), or calcium-related toxic manifestations depending on the severity and duration of hypercalcemia.
The 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)
increased levels of calcium in the urine (hypercalciuria)
rare (may affect up to 1 in 1,000 people)
high levels of phosphate in the blood (hyperphosphatemia)
frequency not known (frequency cannot be estimated from the available data)
allergic reactions

Symptoms of high calcium levels in the blood (hypercalcemia) may be either acute or chronic. Early symptoms include increased calcium levels in the urine (hypercalciuria), ectopic calcifications, kidney and cardiovascular damage, weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, bone and muscle pain. Later symptoms may include urinary disturbances (difficulty in urination), conjunctivitis (due to calcification), light intolerance (photophobia), inflammation of the pancreas (pancreatitis), rhinorrhea (runny nose), pruritus, hyperthermia (increased body temperature), decreased libido, albuminuria (loss of albumin in urine), hypercholesterolemia (increased blood cholesterol levels), increased SGOT and SGPT (liver enzymes), calcium deposition in bones outside their normal sites (ectopic calcification), increased blood pressure (hypertension), heart rhythm disorders (cardiac arrhythmias), and, rarely, altered perception of reality (psychosis). Since the half-life of calcitriol is short, any hypercalcemia normalizes within a few days after discontinuation of OSTIDIL-D3 treatment, and more rapidly than during therapy with vitamin D or its metabolites.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: 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 OSTIDIL-D3

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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, correctly stored
away from sources of heat, moisture and light.
Do not dispose of any medicine 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 OSTIDIL-D3 contains
OSTIDIL-D3 0.25 mcg soft capsules:
Each capsule contains:
Active substance: Alfacalcidol (1α-hydroxy vitamin D3) 0.25 mcg.
Excipients: Mixture of tocopherols (E306), medium-chain triglycerides, gelatin, glycerol, purified water, titanium dioxide (E171), iron oxide (E172).

OSTIDIL-D3 1.0 mcg soft capsules:
Each capsule contains:
Active substance: Alfacalcidol (1α-hydroxy vitamin D3) 1.0 mcg.
Excipients: Mixture of tocopherols (E306), medium-chain triglycerides, gelatin, glycerol, purified water, titanium dioxide (E171), iron oxide (E172).

Description of the appearance of OSTIDIL-D3 and pack sizes
OSTIDIL-D3 0.25 mcg soft capsules – 30 capsules of 0.25 mcg.
OSTIDIL-D3 1.0 mcg soft capsules – 30 capsules of 1.0 mcg.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
Laboratorio Farmaceutico SIT S.r.l. – Via Cavour, 70 – 27035 Mede (PV), Italy

MANUFACTURERS
Curtis Health Caps S.A.
ul. Batorowska 52, Wysogotowo
62-081 Przeźmierowo
Poland

Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

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