Dekristolan 20.000 IU soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dekristolan 20,000 IU soft capsules

Colecalciferol

Read the entire leaflet carefully before you start 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Dekristolan 20,000 IU soft capsules are and what they are used for
2. What you need to know before taking Dekristolan 20,000 IU soft capsules
3. How to take Dekristolan 20,000 IU soft capsules
4. Possible side effects
5. How to store Dekristolan 20,000 IU soft capsules
6. Contents of the pack and other information

1. What Dekristolan 20,000 IU soft capsules is and what it is used for

Dekristolan 20,000 IU soft capsules contains Vitamin D3 (also known as cholecalciferol) for the regulation of calcium absorption and metabolism, and for calcium incorporation into bone tissue.

Dekristolan 20,000 IU soft capsules is used for the initial treatment of clinically relevant vitamin D deficiency in adults.

2. What you need to know before taking Dekristolan 20,000 IU soft capsules

Do not take Dekristolan 20,000 IU soft capsules

• if you are allergic to colecalciferol, peanut, soy, or any of the other ingredients of this medicine (listed in section 6).
• this medicine contains peanut oil (arachis oil). It should not be used if you are allergic to peanut or soy.
• if you have hypercalcemia (high levels of calcium in the blood).
• if you have hypercalciuria (high levels of calcium in the urine).
• if you have been diagnosed with vitamin D hypervitaminosis D (excess vitamin D leading to high calcium levels in the blood).
• if you have pseudohypoparathyroidism (a disorder of parathyroid hormone balance).
• if you have kidney stones or severely impaired kidney function.
• if you are already taking other medicines containing vitamin D (e.g. multivitamin preparations).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dekristolan 20,000 IU soft capsules

• if you are prone to developing kidney stones containing calcium.
• if you are over 65 years old and have recently fallen.
• if your kidneys do not function properly and you have problems excreting calcium and phosphate through the kidneys. The effect of treatment on calcium and phosphate balance must be monitored by your doctor.
• if you are being treated with medications that increase urine output (benzothiadiazine derivatives) or if your mobility is severely restricted, as there is a risk of hypercalcemia (high blood calcium levels) and hypercalciuria (high urine calcium levels) in such cases.
• if you have sarcoidosis (a granulomatous disease affecting connective tissue in the lungs, skin, and joints), as there is a risk of increased conversion of vitamin D into its active form.

In such cases, calcium levels in blood and urine must be monitored by your doctor.

During treatment with Dekristolan 20,000 IU soft capsules at daily doses exceeding 1,000 IU of vitamin D, your doctor must monitor calcium levels in blood and urine, as well as kidney function. This monitoring is especially important in elderly patients and when concomitantly treated with cardiac glycosides (medicines used to stimulate heart muscle function) or diuretics (medicines that increase urine output). If blood calcium levels (hypercalcemia) or urine calcium levels (hypercalciuria) rise, or if other signs of impaired kidney function appear, the dose should be reduced or treatment discontinued.

Children and adolescents

Dekristolan 20,000 IU soft capsules are not recommended for use in the pediatric population, including adolescents.

Other medicines and Dekristolan 20,000 IU soft capsules

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of Dekristolan 20,000 IU soft capsules may be reduced when taken at the same time as:

• Phenytoin (a medicine used to treat epilepsy) or barbiturates (medicines used to treat epilepsy, sleep disorders, and for anesthesia)
• Glucocorticoids (medicines used to treat certain allergic conditions)
• Rifampicin and Isoniazid (medicines used to treat tuberculosis)
• Cholestyramine (a medicine used to reduce high cholesterol levels), laxatives containing liquid paraffin
• Orlistat (a medicine used to treat obesity)
• Actinomycin (a medicine used to treat cancer)
• Imidazole (an antifungal agent)

The effect/side effects may increase when taken at the same time as:

• metabolites or analogues of vitamin D (e.g. calcitriol):

Combination with Dekristolan 20,000 IU soft capsules should be avoided.

• medicines that increase diuresis (e.g. thiazide diuretics):

Reduced elimination of calcium through the kidneys may lead to increased calcium levels in the blood (hypercalcemia). Therefore, calcium levels in blood and urine should be monitored during long-term treatment.

When taken simultaneously, Dekristolan 20,000 IU soft capsules may increase the risk of side effects of:

• cardiac glycosides (medicines used to improve heart muscle function):

The risk of heart rhythm disturbances may increase due to elevated calcium levels in the blood during vitamin D treatment. In such cases, the responsible doctor should perform ECG monitoring, as well as monitor calcium levels in blood and urine and blood levels of the cardiac glycoside.

Use of Dekristolan 20,000 IU soft capsules with food and drink

Dekristolan 20,000 IU soft capsules should preferably be taken with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Dekristolan 20,000 IU is not recommended during pregnancy and breastfeeding. A low-dose formulation should be used instead.

Vitamin D overdose should be avoided during pregnancy, as prolonged hypercalcemia (elevated calcium levels in the blood) may lead to physical and mental disabilities, as well as congenital heart and eye disorders in the child.

Driving and using machines

The effect of Dekristolan 20,000 IU soft capsules on the ability to drive and operate machinery is negligible.

Dekristolan 20,000 IU soft capsules contain peanut oil.

This medicine contains peanut oil (arachis oil). It should not be used if you are allergic to peanut or soy.

3. How to take Dekristolan 20,000 IU soft capsules

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is taken orally. The capsules must be swallowed whole with sufficient water, preferably with the main meal of the day.

The following information will serve as dosage recommendations:

Adults and elderly patients:

1 capsule per week (equivalent to 20,000 IU/week).

After the first month, continue with the maintenance dose recommended by your doctor.

Use in children and adolescents

Dekristolan 20,000 IU soft capsules are not recommended in infants, children, and adolescents under 18 years of age.

If you take more Dekristolan 20,000 IU soft capsules than you should

If you have taken more Dekristolan 20,000 IU soft capsules than you should, consult your doctor or pharmacist immediately.

In case of overdose, you may experience nausea, vomiting, initial diarrhea progressing to constipation, loss of appetite, fatigue, headache, muscle and joint pain, arrhythmia (irregular heartbeat), azotemia (high levels of nitrogen in the blood), increased thirst, increased frequency of urination, and—in the final stage—dehydration.

In case of overdose or accidental ingestion, contact the Toxicology Information Service: Telephone 91 562 04 20.

If you forget to take Dekristolan 20,000 IU soft capsules

Do not take a double dose to make up for forgotten doses.

If you stop taking Dekristolan 20,000 IU soft capsules

Symptoms may reappear or worsen if you stop treatment prematurely.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You must stop taking Dekristolan 20,000 UI soft capsules and consult a doctor immediately if you experience any of the following symptoms of a severe allergic reaction:

• swollen face, swollen lips, tongue or throat
• difficulty swallowing
• hives and breathing difficulties.

The following adverse effects have been observed:

Uncommon (may affect up to 1 in 100 people):

Hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine)

Rare (may affect up to 1 in 1,000 patients):

Itching, skin rash or urticaria

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

Gastrointestinal problems (constipation, flatulence, nausea, abdominal pain or diarrhea)

Peanut oil may rarely cause severe allergic reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dekristolan 20,000 IU Soft Capsules

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Keep the container tightly closed.

Store the container in the outer packaging to protect it from light and moisture.

Do not use this medicine after the expiry date stated on the packaging and on the bottle, following EXP. The expiry date refers to the last day of the month indicated.

Dekristolan 20,000 IU soft capsules have a shelf life of 3 years after the bottle has first been opened.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s Sigre collection point. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dekristolan 20,000 IU soft capsules

• The active substance is: Colecalciferol. One soft capsule contains 20.0 mg of oily solution of colecalciferol (equivalent to 0.5 mg or 20,000 IU of vitamin D3).
• The other components are: peanut oil, gelatin, glycerol 85%, medium-chain triglycerides, purified water, all-rac-α-tocopherol (Ph.Eur.)

Appearance of the product and contents of the pack

Dekristolan 20,000 IU soft capsules are round, translucent, light yellow soft gelatin capsules.

Dekristolan 20,000 IU soft capsules are available in blisters containing 4, 10, 20 or 50 capsules.

Dekristolan 20,000 IU soft capsules are also available in glass bottles containing 20 or 50 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Manufacturer (Batch Release Responsible)

Mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Date of the most recent revision of this leaflet: 03/2019.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).