DEKRISTOLAN 20,000 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Dekristolan 20,000 IU Soft Capsules

Colecalciferol

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Dekristolan 20,000 IU Soft Capsules are and what they are used for
2. What you need to know before you take Dekristolan 20,000 IU Soft Capsules

soft capsules

1. How to take Dekristolan 20,000 IU Soft Capsules
2. Possible side effects
3. Storage of Dekristolan 20,000 IU Soft Capsules
4. Contents of the pack and further information

1. What Dekristolan 20,000 IU Soft Capsules are and what they are used for

Dekristolan20,000 IU Soft Capsules contain Vitamin D3 (also known as Colecalciferol) for the regulation of calcium absorption and metabolism and for the integration of calcium into bone tissue.

Dekristolan20,000 IU Soft Capsules are used for the initial treatment of clinically relevant vitamin D deficiency in adults.

2. What you need to know before you take Dekristolan 20,000 IU Soft Capsules

Do not take Dekristolan20,000UI 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 in case of peanut or soy allergy.
• if you suffer from hypercalcaemia (high levels of calcium in the blood).
• if you have hypercalciuria (high levels of calcium in the urine).
• if you have been diagnosed with hypervitaminosis D (high levels of calcium in the blood).
• if you suffer from pseudo-hypoparathyroidism (a disorder of parathyroid hormone balance).
• if you have kidney stones or if your kidney function is severely impaired.
• if you are already taking other medicines that contain vitamin D (e.g. multivitamin preparations)

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Dekristolan 20,000 IU Soft Capsules

• If you tend to form kidney stones (stones) that contain calcium.
• If you are over 65 years old and have recently fallen.
• If your kidneys do not function properly and you have problems with calcium and phosphate excretion through the kidneys. The effect of treatment on calcium and phosphate balance should be monitored by your doctor.
• If you are being treated with medicines to increase urine production (benzothiadiazine derivatives) or if your mobility is severely restricted, as there is a risk in this case of hypercalcaemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).
• If you have sarcoidosis (a granulomatous disease that affects the connective tissue of the lungs, skin, and joints), as there is a risk of increased conversion of vitamin D to its active form.

In such cases, blood and urine calcium levels should be monitored by the doctor.

During treatment with Dekristolan 20,000 IU Soft Capsules in daily doses above 1,000 IU of vitamin D, the doctor should monitor blood and urine calcium levels, as well as kidney function. This monitoring is especially important in elderly patients and when treated simultaneously with cardiac glycosides (medicines to stimulate heart muscle function) or diuretics (medicines that stimulate urine production). In case of increased calcium levels in the blood (hypercalcaemia) or urine (hypercalciuria) or other signs of impaired kidney function, 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 Dekristolan20,000UI Soft Capsules

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

The effect of Dekristolan 20,000 IU Soft Capsules may be reduced by the simultaneous use of

• 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)
• Colestyramine (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(s) that may increase with the simultaneous use of

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

Combination with Dekristolan 20,000 IU Soft Capsules should be avoided

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

A reduction in calcium excretion through the kidneys may cause an increase in blood calcium levels (hypercalcaemia). Therefore, blood and urine calcium levels should be monitored during long-term treatment.

When taken at the same time, Dekristolan 20,000 IU Soft Capsules may increase the risk of side effects of

• Cardiac glycosides (medicines used to increase heart muscle function):

The risk of cardiac arrhythmias may increase as a result of increased calcium levels in the blood during treatment with vitamin D. In such cases, the responsible doctor should perform ECG monitoring, as well as monitoring of blood and urine calcium levels and medicine levels in the blood.

Use of Dekristolan20,000UI Soft Capsules with Food and Drinks

Dekristolan20,000 IU Soft Capsules should be taken preferably with food and drink.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Overdoses of vitamin D should be avoided during pregnancy, as prolonged hypercalcaemia (elevated blood calcium levels) can lead to physical and mental disability, as well as congenital heart and eye diseases in the child.

Driving and Using Machines

The influence of Dekristolan 20,000 IU Soft Capsules on the ability to drive and use machines is negligible.

Dekristolan20,000UI Soft Capsules contain peanut oil.

This medicine contains peanut oil (arachis oil). It should not be used in case of peanut or soy allergy.

3. How to take Dekristolan 20,000 IU Soft Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

The following information will serve as a dosage recommendation:

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 for use in infants, children, and adolescents under 18 years of age.

If you take more Dekristolan20,000UI Soft Capsules than you should

If you have taken more Dekristolan 20,000 IU Soft Capsules than you should, talk to your doctor or pharmacist immediately.

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

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

If you forget to take Dekristolan20,000UI Soft Capsules

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

If you stop taking Dekristolan20,000UI Soft Capsules

The symptoms may reappear or worsen if you stop treatment prematurely.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Dekristolan 20,000 IU Soft Capsules and seek immediate medical attention if you experience any of the following symptoms of a severe allergic reaction:

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

The following side effects have been observed:

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

Hypercalcaemia (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 hives

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

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

Peanut oil can rarely cause severe allergic reactions.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System, www.notificaram.es. By reporting side 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 bottle tightly closed.

Keep the bottle in the outer packaging to protect it from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Dekristolan 20,000 IU Soft Capsules have a shelf life of 3 years after first opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Dekristolan20,000UI 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 ingredients are: peanut oil, gelatine, 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 a soft gelatine capsule, round, translucent, light yellow in color.

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

Dekristolan 20,000 IU Soft Capsules are available in glass bottles containing 20 or 50 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mibe Pharma España S.L.U.

C/Amaltea 9, 4ª planta, letra B,

28045, Madrid

Spain

Manufacturer (Batch Release)

Mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Date of Last Revision of this Leaflet: 03/2019

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