Sefal

Package leaflet: Information for the user

SEFAL 1 microgram capsule

Alfacalcidol
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, consult your doctor or pharmacist.
• 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What SEFAL is and what it is used for
2 What you need to know before taking SEFAL
3 How to take SEFAL
4 Possible side effects
5 How to store SEFAL
6 Contents of the pack and other information

1. What SEFAL is and what it is used for

The active substance of SEFAL is alfacalcidol, also known as 1 alpha-hydroxycholecalciferol, a synthetic
compound derived from vitamin D that exerts the same effects as common vitamin D.
SEFAL may be used for the treatment of the following conditions: renal osteodystrophy
(a condition characterized by bone problems caused by renal insufficiency), hypoparathyroidism (defects in
hormone production by certain glands called parathyroid glands), rickets and osteomalacia (skeletal diseases
that cause bones to become weak and fragile) D-resistant or D-dependent (pseudo-deficient),
rickets and osteomalacia due to renal disturbances related to vitamin D metabolism, postmenopausal
osteoporosis (a disease characterized by weakening of the bones).

2. What you need to know before taking SEFAL

Do not take SEFAL
if you are allergic to alfacalcidol or to any of the other ingredients of this medicine (listed in
section 6);
if you have high levels of calcium in your blood (hypercalcemia);
if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking SEFAL.
Since alfacalcidol is a vitamin D analogue, you must not take vitamin D or its derivatives during treatment with SEFAL, as excessive doses of vitamin D may cause serious harm.
Since excessive doses of SEFAL may increase calcium levels in the blood and sometimes in the urine, your doctor will ask you to undergo regular checks to monitor your blood calcium levels and determine the appropriate SEFAL dose for you.
Elevated calcium levels in the blood may indeed cause serious reactions, which in some cases may require emergency treatment. Moreover, prolonged periods of high calcium levels in the blood may lead to calcification phenomena.
Other symptoms of increased calcium levels in the blood include muscle and bone pain, muscle weakness, confusion, dehydration, anorexia, fatigue, nausea, vomiting, constipation, increased urine production, sweating, headache, intense thirst, increased blood pressure, and drowsiness.
If you develop elevated calcium levels in the blood, your doctor will instruct you to stop treatment with SEFAL until levels return to normal. Afterwards, your doctor may decide to reduce your SEFAL dose.
If you are being treated with digitalis (a medicine derived from a plant containing substances that stimulate the heart muscle), your doctor will exercise caution when prescribing SEFAL, as increased calcium levels due to SEFAL intake may cause disturbances in heart rhythm.
If you are taking phosphate-binding agents, your doctor may decide to adjust their dosage, as SEFAL affects phosphate transport in the intestine, kidneys, and bones.

Other medicines and SEFAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking other medicines while on SEFAL may affect its therapeutic effect.
In particular, concomitant use of SEFAL with the following medicines is not recommended:

• Thiazide diuretics (medicines used to increase urine production) and calcium-containing preparations. These medicines may increase calcium levels in the blood.
• Preparations containing vitamin D. These may increase calcium levels in the blood.
• Anticonvulsants such as barbiturates, phenytoin, carbamazepine, or primidone (medicines used to treat seizures). These medicines may reduce your body's response to SEFAL, possibly requiring a higher dose.
• Magnesium-containing antacids (medicines that counteract stomach acidity). Taking them together with SEFAL may increase magnesium levels in the blood.
• Aluminum-containing preparations, as concomitant administration with SEFAL may increase aluminum levels in the blood.
• Cholestyramine (a medicine used to lower blood cholesterol levels) and orlistat (a medicine used to treat obesity), as they may reduce the intestinal absorption of SEFAL.
• Digitalis (a medicine used for heart problems). This combination must be closely monitored.
• Warfarin (an anticoagulant medicine). This combination requires special caution.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
SEFAL must not be used during pregnancy or while breastfeeding.
If you are a woman of childbearing potential, you must use effective contraception during treatment with SEFAL.

Driving and using machines
SEFAL has no effect or negligible effect on the ability to drive vehicles or operate machinery.
However, you may experience dizziness during treatment with SEFAL.

3. How to take SEFAL

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Regardless of the condition for which you are taking SEFAL, the recommended dose is 1 microgram per day.
Use in children and adolescents
For adolescents weighing more than 20 kg, the recommended dose is 1 microgram per day.
For children weighing less than 20 kg, the recommended dose is 0.05 micrograms per kg per day.
In any case, the recommended dose may be adjusted by the doctor depending on your response to the medicine.
If you take more SEFAL than you should
If you accidentally take too much SEFAL, contact your doctor.
If, as a result of overdose, calcium levels in the blood rise excessively, your doctor will instruct you to stop treatment and will take certain supportive measures.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you take the dose of SEFAL recommended for you, the medicine will generally be well tolerated.
If you take excessive doses of SEFAL, you may experience side effects similar to those caused by an excess of vitamin D and related to calcium accumulation in the blood.
These effects include: increased levels of calcium and phosphate in the blood, confusion, headache, dizziness, nausea, vomiting, diarrhoea, constipation, abdominal pain, skin rash, itching, urticaria, muscle pain, high concentrations of calcium in the urine, kidney stone formation, calcium deposition in the kidneys, renal failure, malaise, fatigue, calcium deposition in tissues.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. 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 SEFAL

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 packaging after "Exp." The expiry date refers to the last day of that month.
Keep the medicine in its outer packaging to protect it from light and moisture.
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 SEFAL contains

• The active substance is alfacalcidol (1α-Hydroxy vitamin D3). Each capsule contains 1 microgram of alfacalcidol.
• 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 SEFAL and contents of the pack
Carton containing 30 soft capsules in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
FARMA GROUP S.r.l.
Via Strampelli, 18
63074 San Benedetto del Tronto (AP)
Responsible manufacturer for batch release:
I.BIR.N. – Istituto Bioterapico Nazionale s.r.l.
Via Vittorio Grassi nn. 9/15
00155 Rome