Diserinal

Package leaflet: Information for the patient

DISERINAL 0.25 mcg soft capsules, 1.0 mcg soft capsules

Alfacalcidol
Equivalent medicine
Please read all of this leaflet carefully before you start using 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, 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What DISERINAL is and what it is used for
2. What you need to know before using DISERINAL
3. How to use DISERINAL
4. Possible side effects
5. How to store DISERINAL
6. Contents of the pack and other information

1. What DISERINAL is and what it is used for

DISERINAL contains the active substance alfacalcidol and is a precursor of Vitamin D.
DISERINAL is used for the treatment of:

• Osteodystrophy (bone disorders) due to renal insufficiency, with or without dialysis.
• Hypoparathyroidism (reduced function of the parathyroid glands, which regulate calcium metabolism).
• Rickets and osteomalacia (defective bone mineralization) resistant to or dependent on vitamin D (pseudo-deficiency).
• Rickets and osteomalacia due to renal disturbances affecting vitamin D metabolism.
• Postmenopausal osteoporosis.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking DISERINAL

Do not take DISERINAL

• if you are allergic to vitamin D or to any of the other ingredients of this medicine (listed in section 6).
• in case of hypercalcemia (increased calcium levels in the blood).
• in case of individual hypersensitivity or proven hypervitaminosis related to vitamin D.

Warnings and precautions
Talk to your doctor or pharmacist before taking DISERINAL.
Since an excessive dose of DISERINAL may cause hypercalcemia and, in some cases, hypercalciuria (increased calcium levels in urine), your doctor will perform periodic blood tests to monitor your calcium levels (at least twice weekly during the dose adjustment phase; once monthly once the optimal daily dose has been established). Calcium levels should always be checked promptly if symptoms suggesting toxicity occur. A similar monitoring is recommended for infants breastfed by mothers receiving pharmacological doses of 1-α-hydroxycalciferol. During treatment with 1-α-hydroxycalciferol, your doctor will monitor your plasma phosphate levels to reduce the risk of ectopic calcifications. A drop in alkaline phosphatase levels usually precedes the onset of hypercalcemia and may therefore serve as an early warning sign.
If hypercalcemia develops, the medication and any concomitant calcium supplementation should be temporarily discontinued until blood calcium levels return to normal. Treatment may then be resumed at a lower dose.
Since DISERINAL affects phosphate transport in the intestine, kidney, and bones, the concomitant administration of substances that enhance phosphate absorption should be adjusted according to serum phosphate levels (normal values: 2–5 mg/100 ml).
Supplementing vitamin D in the diet may be harmful if you are already receiving adequate amounts through diet and sun exposure, as the difference between therapeutic and toxic concentrations is relatively small.
Since 1-α-hydroxycalciferol is the most potent form of vitamin D, a higher risk of toxicity might reasonably be expected.
DISERINAL must be used with caution in infants, who may have increased sensitivity to its effects, and in patients with renal impairment, kidney stones, or heart disease, as they may be at greater risk of organ damage should hypercalcemia occur.
Vitamin D and its derivatives must not be administered during treatment with DISERINAL.
Overdosing on any form of vitamin D may lead to severe manifestations. Hypercalcemia caused by excessive doses of vitamin D or its metabolites may even require emergency treatment.
If chronic, hypercalcemia may lead to generalized calcifications in blood vessels, nephrocalcinosis (renal calcifications), and calcifications in other soft tissues. Radiographic examination of body areas prone to calcification may be helpful for early diagnosis.

Other medicines and DISERINAL
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 are taking:

• anticonvulsant medicines such as barbiturates, carbamazepine, phenytoin, and primidone, as they may reduce the response to alfacalcidol, requiring higher doses;
• aluminum-containing preparations. Excessive use may interfere with the effectiveness of the medicine;
• warfarin (a medicine used to thin the blood). Caution is advised when these two medicines are used together;
• medicines containing magnesium or laxatives, as they may lead to hypermagnesemia (increased magnesium levels in blood);
• colestyramine or colestipol (medicines used to lower cholesterol levels), as they may reduce intestinal absorption of fat-soluble vitamins, including DISERINAL;
• sucralfate, a medicine mainly used for the treatment of duodenal ulcers and gastric ulcers, as it may interfere with the effectiveness of DISERINAL;
• vitamin D or its analogs, due to a possible additive effect, increasing the risk of hypercalcemia;
• digitalis (a medicine used in heart failure and atrial fibrillation), as hypercalcemia may worsen cardiac arrhythmias; you will be monitored by your doctor;
• medicines containing calcium, phosphate, or thiazide diuretics, as they may increase the risk of hypercalcemia;
• rifampicin and isoniazid (antibiotics mainly used in the treatment of tuberculosis), as they may reduce the effectiveness of vitamin D;
• corticosteroids (medicines used to treat inflammation), as they may counteract the effects of vitamin D.

Pregnancy and breastfeeding
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.
You may take this medicine during pregnancy and breastfeeding only after careful evaluation by your doctor of the benefit-risk ratio.

Driving and using machines
DISERINAL does not affect or affects negligibly the ability to drive and use machines.

3. How to take DISERINAL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended initial dose suggested for all indications:
Adults and adolescents above 20 kg body weight:
1 mcg per day.
Use in children
Children below 20 kg body weight:
0.05 mcg/kg per day.
The dose may subsequently be adjusted according to your response to the medicine.
If you take more DISERINAL than you should
If you take more DISERINAL than prescribed by your doctor, contact your doctor or
pharmacist immediately.
Excessive intake of vitamin D leads to the development of hypercalcemia (increased calcium levels in the
blood). Symptoms of overdose include: anorexia, fatigue, nausea and vomiting, constipation or diarrhea,
polyuria, nocturia, sweating, headache, thirst, drowsiness and dizziness. If toxicity occurs, your doctor will
instruct you to stop treatment with DISERINAL and will adopt certain supportive measures.
In case of severe hypercalcemia due to accidental overdose, you must stop taking the medicine and go to the
nearest hospital, where diuretics will be administered along with intravenous fluids or cortisone and similar
agents.
If you stop treatment with DISERINAL
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:

Common (may affect up to 1 in 10 people):

• Hypercalcemia (increased calcium levels in the blood)*
• Hypercalciuria (increased calcium levels in the urine)

Rare (may affect up to 1 in 1,000 people)

• Hyperphosphatemia (increased phosphate levels in the blood)

Frequency not known (cannot be estimated from the available data)

• Hypersensitivity

*Side effects similar to those occurring in vitamin D excess may appear, such as a hypercalcemic syndrome (due to elevated calcium levels) or calcium-related toxic manifestations (depending on the severity and duration of hypercalcemia). These manifestations can be both acute and chronic. The former include hypercalciuria, ectopic calcifications, kidney and cardiovascular damage, weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, bone and muscle pain. Later symptoms may include disturbances in urination, conjunctivitis (due to calcification), photophobia (light intolerance), pancreatitis, rhinorrhea (runny nose), pruritus, increased body temperature, decreased libido, albuminuria (loss of albumin in urine), hypercholesterolemia (increased cholesterol levels in blood), increased transaminases (SGOT and SGPT), ectopic calcifications (outside typical sites), increased blood pressure, cardiac arrhythmias (irregular heartbeats), and, rarely, psychosis. Normalization of any hypercalcemia usually occurs within a few days after discontinuation of DISERINAL treatment.

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 can 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 DISERINAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This date applies to the product in its original, undamaged packaging, properly stored.
Keep away from heat sources, moisture, and light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DISERINAL contains
DISERINAL 0.25 mcg soft capsules

• The active substance is alfacalcidol. Each capsule contains 0.25 mcg of alfacalcidol (1-α-hydroxy vitamin D3).
• The other components are: Mixture of tocopherols (E306), Medium-chain triglycerides, Gelatin, Glycerol, Purified water, Titanium dioxide (E171), Iron oxide (E172).

DISERINAL 1.0 mcg soft capsules

• The active substance is alfacalcidol. Each capsule contains 1.0 mcg of alfacalcidol (1-α-hydroxy vitamin D3).
• The other components are: Mixture of tocopherols (E306), Medium-chain triglycerides, Gelatin, Glycerol, Purified water, Titanium dioxide (E171), Iron oxide (E172).

Description of the appearance of DISERINAL and contents of the pack
DISERINAL 0.25 mcg soft capsules – Pack of 30 capsules of 0.25 mcg.
DISERINAL 1.0 mcg soft capsules – Pack of 30 capsules of 1.0 mcg.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome – Italy

Manufacturer
Curtis Health Caps S.A.
ul. Batorowska 52, Wysogotowo
62-081 Przeźmierowo – Poland
Special Product’s Line
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)