Package Leaflet: Information for the User

Dekristolan 20,000 UI Soft Capsules

Colecalciferol

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Dekristolan 20,000 UI Soft Capsules and what is it used for

2. What you need to know before you start taking Dekristolan 20,000 UI Soft Capsules

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

4. Possible side effects

5. Storage of Dekristolan 20,000 UI Soft Capsules

6. Contents of the pack and additional information

Dekristolan20.000UI soft capsules contain Vitamin D3(also known as colecalciferol) for the regulation of calcium absorption and metabolism and for the integration of calcium in bone tissue.

Dekristolan20.000UI soft capsulesare used in the initial treatment of clinically relevant vitamin D deficiency in adults.

Do not take Dekristolan20,000UI soft capsules

-If you are allergic to colecalciferol, peanuts, soy or any of the other ingredients of this medicine (listed in section 6).

-This medicine contains peanut oil (arachis oil). Do not use in case of allergy to peanuts or soy.

-If you suffer from 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 hypervitaminosis D (high levels of calcium in the blood).

-If you suffer from pseudohypoparathyroidism (hormonal imbalance disorder of the parathyroid glands).

-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 Dekristolan20,000UI soft capsules

-If you are prone to forming kidney stones that contain calcium.

-If you are over 65 years old and have recently fallen.

-If your kidneys do not function correctly and you have problems with calcium and phosphate excretion through the kidneys.The effect of treatment on calcium and phosphate balance must be controlled by your doctor.

-If you are being treated with diuretics (benzotiadiazine derivatives) or if your mobility is severely restricted, as there is a risk in this case of hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).

-If you have sarcoidosis (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 must be controlled by the doctor.

During treatment with Dekristolan20,000UI soft capsules in daily doses above 1,000 UI of vitamin D, the doctor must control blood and urine calcium levels, as well as kidney function.This monitoring is especially important in elderly patients and when treated at the same time with cardiac glycosides (medicines to stimulate heart muscle function) or diuretics (medicines to stimulate urine production). In case of increased blood (hypercalcemia) or urine (hypercalciuria) calcium levels or other signs of kidney function deterioration, the dose must be reduced or the treatment discontinued.

Children and adolescents

Dekristolan20,000UI soft capsules is not recommended for use in pediatric population, including adolescents.

Other medicines and Dekristolan20,000UI soft capsules

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine.

The effect ofDekristolan20,000UI soft capsules may be reduced by the simultaneous use of

-Fenitoin (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)

-Colestiramine (medicine used to reduce high cholesterol levels), paraffin liquid laxatives

-Orlistat (medicine used to treat obesity)

-Actinomycin (medicine used to treat cancer)

-Imidazole (antifungal agent)

The effect/ effects that may increase by the simultaneous use of

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

Must be avoided a combination with Dekristolan20,000UI soft capsules

-diuretics (e.g. thiazide diuretics):

A reduction in calcium elimination through the kidneys may cause an increase in blood calcium levels (hypercalcemia). Therefore, blood and urine calcium levels must be controlled during long-term treatment.

When taken at the same time, Dekristolan20,000UI soft capsules may increase the risk of side effects of

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

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

Use of Dekristolan20,000UI soft capsules with food and drinks

Dekristolan20,000UI soft capsules should be taken preferably with food and drink.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

Dekristolan20,000 UI is not recommended for use in pregnancy and lactation.A low-resistance formulation should be used.

Prolonged hypercalcemia (high blood calcium levels) may lead to physical and mental disability, as well as congenital heart and eye diseases in the child.

Driving and operating machinery

The influence of Dekristolan20,000UI soft capsules on the ability to drive and operate machinery is insignificant.

Dekristolan20,000UI soft capsules contains peanut oil.

This medicine contains peanut oil (arachis oil). Do not use in case of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication 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 a dosage recommendation:

Adults and elderly patients:

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

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

Use in children and adolescents

Dekristolan 20,000 UI soft capsules are not recommended for babies, children, and adolescents under 18 years of age.

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

If you have taken more Dekristolan 20,000 UI soft capsules than you should, consult 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 heartbeats), 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; consult the Toxicological Information Service: Telephone 91 562 04 20.

If you forgot to take Dekristolan 20,000 UI soft capsules 20,000 UI soft capsules soft capsules

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dekristolan 20,000 UI soft capsules 20,000 UI soft capsules soft capsules

Symptoms may reappear or worsen if you discontinue treatment before the recommended time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

You should stop takingDekristolan20.000UI soft capsules and consult a doctor immediately if any of the following symptoms of asevere allergic reactionappear:

-swollen face, lips, tongue, or throat

-difficulty swallowing

-hives and difficult breathing.

The following adverse effects have been observed:

Rare (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)

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

Itching, skin rash, or hives

Unknown frequency (cannot be estimated from available data):

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

Peanut oil may cause severe allergic reactions in rare cases.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use,www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Store the bottle tightly closed.

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

Do not use this medication after the expiration date that appears on the packaging and on the bottle, after EXP. The expiration date is the last day of the month indicated.

Dekristolan 20.000 UI Soft Capsules has a 3-year validity period after the bottle is first opened.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Dekristolan20,000Soft gelatin capsules

-The active ingredient is: Colecalciferol.
One soft gelatin capsule contains 20.0 mg of oily solution of colecalciferol (equivalent to 0.5 mg or 20,000 UI of vitamin D3)

-The other components are:
peanut oil, gelatine, glycerol 85%, medium-chain triglycerides, purified water, all-rac-α-tocopherol (Ph.Eur.)

Appearance of the product and content of the container

Dekristolan20,000UI soft gelatin capsules is a soft gelatin, round, translucent, light yellow capsule.

Dekristolan20,000UI soft gelatin capsules are available in blisters that contain 4, 10, 20 or 50 capsules.

Dekristolan20,000UI soft gelatin capsules are available in glass bottles that contain 20 or 50 capsules.

Only some of the packaging sizes may be marketed.

Marketing Authorization Holder

Mibe Pharma España S.L.U.

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

28045, Madrid

Spain

Responsible for manufacturing (batch liberator)

Mibe GmbH Arzneimittel

Münchener Straße 15

06796 Brehna

Germany

Last review date of this leaflet: 03/2019.

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