Package leaflet: Information for the patient

DERIL 1 mcg capsules

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

Contents of this leaflet:

What DERIL is and what it is used for
What you need to know before taking/giving DERIL to your child
How to take/give DERIL to your child
Possible side effects
How to store DERIL
Contents of the pack and other information

1. What DERIL is and what it is used for

DERIL contains alfacalcidol, a precursor of vitamin D. DERIL is indicated in adults and children weighing over 20 kg for the treatment of:

bone fragility, reduced bone mass, and increased fracture risk in patients with kidney disease (renal osteodystrophy), whether or not undergoing dialysis (a blood filtration system).
reduced function of the parathyroid glands located in the neck (hypoparathyroidism).
bone disorders caused by impaired vitamin D metabolism, including in patients with kidney disease (vitamin D-resistant or vitamin D-dependent rickets and osteomalacia (pseudo-deficiency), rickets and osteomalacia due to other renal actions affecting vitamin D metabolism).
bone density loss after menopause (postmenopausal osteoporosis) (only in postmenopausal adult women).

2. What you should know before taking/giving DERIL to the child

Do not take DERIL

if you are allergic to alfacalcidol or to any of the other ingredients of this medicine (listed in section 6),
if you are pregnant,
if you have high levels of calcium in the blood (hypercalcemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving DERIL to the child.
Throughout the entire treatment period, your doctor will request regular blood tests (calcium and phosphate levels, PTH, alkaline phosphatase, and calcium x phosphate product) and regular monitoring.
An increase in calcium levels in the blood (hypercalcemia) may occur during treatment with DERIL, with symptoms possibly including loss of appetite (anorexia), fatigue, nausea and vomiting, constipation or diarrhea, frequent need to urinate (polyuria), sweating, headache, intense thirst (polydipsia), high blood pressure (hypertension), drowsiness and dizziness (see section 4 Possible side effects).
In particular, inform your doctor if you/the child suffer(s) from:

hardening of the arteries, the large blood vessels in the body (arteriosclerosis), hardening (sclerosis) of heart valves, kidney stones (nephrolithiasis), as in these cases you may develop temporary or permanent kidney damage;
calcium accumulation in the lungs (calcification of lung tissue). This may cause heart disease;
a bone disease caused by kidney problems (renal bone disease) or severely reduced kidney function. Your doctor may prescribe a medicine called a phosphate binder to prevent high levels of phosphate in the blood (hyperphosphatemia) and potential calcium deposition in healthy tissues (metastatic calcification);
an inflammatory disease that may affect the entire body and leads to the formation of nodules (sarcoidosis) or a similar disease;
a kidney disease (chronic renal failure).

Also inform your doctor if you/the child are taking digitalis 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.
Other medicines and DERIL
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you/the child are taking:

anticonvulsants (e.g., barbiturates, phenytoin, carbamazepine, or primidone), medicines used to treat uncontrolled body movements, as higher doses of DERIL may be required;
magnesium-containing antacids, medicines used to treat heartburn;
thiazide diuretics (medicines used to treat high blood pressure) or calcium-containing preparations. Your doctor may request blood tests;
other vitamin D-containing preparations;
aluminum-containing preparations (e.g., aluminum hydroxide, sucralfate);
bile acid sequestrants, such as cholestyramine, medicines used to treat high blood fat levels. Take/give DERIL to the child at least 1 hour before, or 4 to 6 hours after, the bile acid sequestrant.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
DERIL must not be used during pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
Alfacalcidol is excreted in human milk. Your doctor will decide whether you should stop breastfeeding or stop treatment with DERIL, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.
Your doctor will closely monitor the breastfed infant during your treatment with DERIL.
Driving and using machines
Alfacalcidol does not affect or affects negligibly the ability to drive and use machines.
However, dizziness may occur during treatment; therefore, keep this in mind when driving or operating machinery.

3. How to take/give DERIL to the child

Take/give this medicine to the child exactly as directed by the doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
Throughout the treatment period, the doctor will require regular blood tests and check-ups for you/the child.
The recommended dose is 1 mcg daily.
The recommended maintenance dose ranges from 0.25 to 1 mcg daily, depending on the therapy results and laboratory tests that the doctor will request during treatment.
In case of osteoporosis, the doctor will determine the most suitable dose for you based on your health status.
In patients with severe bone dysfunction (except those with renal insufficiency), the doctor may increase the dose to between 1 and 3 mcg daily.
In patients with severe hypocalcemia, the doctor may increase the dose to between 3 and 5 mcg daily. In such patients, the doctor may also prescribe other medicines containing calcium.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you/your child experience any of the following symptoms, stop using DERIL immediately and contact your doctor or go to the nearest hospital, where you will be given appropriate and specific treatment:

High levels of calcium in the blood (hypercalcemia); your doctor will subsequently restart treatment at a halved dose;
High levels of phosphate in the blood (hyperphosphatemia);
High levels of calcium in the urine (hypercalciuria exceeding 6 mg/kg/24 h).

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)
high levels of phosphate in the blood (hyperphosphatemia)
increased levels of calcium in the urine (hypercalciuria)
abdominal pain and discomfort
skin rash (various types of rash have been reported, such as erythematous, maculopapular, and pustular)
itching

Uncommon (may affect up to 1 in 100 people)

headache
diarrhoea
vomiting
constipation
nausea
muscle pain (myalgia)
kidney stones (nephrolithiasis/nephrocalcinosis)
fatigue/weakness/malaise
calcium deposits forming in tissues (calcinosis)

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

dizziness

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

kidney damage (including acute kidney failure)
confusion

Additional side effects in children
The safety profile observed is similar between adults and children.

Reporting of side effects
If you/your child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 DERIL

Keep away from sources of heat, moisture, and light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
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 DERIL contains

The active substance is alfacalcidol 1 mcg.
The other components are: Covi-ox T70 (E306), fractionated coconut oil, gelatin, glycerol, purified water, titanium dioxide (E171), iron oxide (E172).

Description of the appearance of DERIL and package contents
DERIL is presented as capsules.
It is available in a pack containing 30 capsules with 1 mcg of active substance.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro n. 212 – 00141 Rome, Italy

Manufacturer
LABORATORIOS ALCALA‘ FARMA S.L. – C/Nunneaton, 85 – Guadalajara, 19004 Guadalajara – Spain

Primary and secondary packaging
LABORATORIOS ALCALA‘ FARMA S.L. – Avenida De Madrid, 82 – Alcalà De Henares – Madrid 28802 – Spain

Controlled by:
LABORATORIOS ALCALA’ FARMA S.L. - Avenida De Madrid, 82 – Alcalà De Henares – Madrid 28802 – Spain