Colecalciferol Teva B.V.

Patient Information Leaflet

Colecalciferol Teva B.V. 25,000 IU Soft Capsules

colecalciferol (Vitamin D)
Please read all of 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, ask 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, because it could 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:

1. What Colecalciferol Teva B.V. is and what it is used for
2. What you need to know before taking Colecalciferol Teva B.V.
3. How to take Colecalciferol Teva B.V.
4. Possible side effects
5. How to store Colecalciferol Teva B.V.
6. Contents of the pack and other information

1. What Colecalciferolo Teva B.V. is and what it is used for

Colecalciferolo Teva B.V. contains the active substance colecalciferol (vitamin D ), which regulates
the absorption and metabolism of calcium, as well as the incorporation of calcium into bone tissue.
Colecalciferolo Teva B.V. is used for the initial treatment of clinically significant vitamin D deficiency
in adults.

2. What you need to know before taking Colecalciferol Teva B.V.

Do not take Colecalciferol Teva B.V. if:

• you are allergic to colecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6);
• you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• you suffer from kidney stones;
• you have calcium deposits in the kidneys (nephrocalcinosis);
• you have severe kidney impairment;
• you have vitamin D intoxication (excess vitamin D levels in the blood);
• you are allergic to peanuts or soya.

If any of the conditions listed above apply to you, consult your doctor or pharmacist before taking
Colecalciferol Teva B.V.
Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferol Teva B.V. if:

• you have sarcoidosis (a specific type of connective tissue disease affecting the lungs, skin, and joints);
• you are taking other medicines or dietary supplements containing vitamin D or related substances;
• you have kidney problems;
• you suffer from pseudohypoparathyroidism.

Your doctor may consider it necessary to measure calcium levels in your blood or urine and monitor
kidney function. Monitoring is particularly important in elderly patients who are concurrently taking
heart medications (cardiac glycosides or diuretics) and in patients at increased risk of kidney stones.
Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
Other medicines and Colecalciferol Teva B.V.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, especially:

• thiazide diuretics (used to treat high blood pressure);
• phenytoin or barbiturates (used to treat epilepsy);
• glucocorticoids (used to treat inflammation);
• cardiac glycosides (used to treat heart disorders, such as digoxin);
• cholestyramine (used to treat high cholesterol);
• orlistat (a medication for obesity treatment);
• laxatives, such as liquid paraffin;
• actinomycin (chemotherapy);
• imidazole (antifungal);
• rifampicin (antibiotic);
• isoniazid (antibiotic);
• products containing magnesium (e.g. antacids);
• products containing high doses of phosphorus.

Colecalciferol Teva B.V. with food and drink
The capsules should be swallowed whole with some water, preferably during meals.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Administration of this high-dose formulation is not recommended in pregnant or breastfeeding women.
Driving and using machines
Colecalciferol Teva B.V. has no known effect on the ability to drive vehicles or operate machinery.
Colecalciferol Teva B.V. contains soya lecithin
Colecalciferol Teva B.V. contains traces of soya lecithin, which may contain soya oil. If you are
allergic to peanuts or soya, do not take this medicine.

3. How to take Colecalciferolo Teva B.V.

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will carefully evaluate your dietary habits and take into account the vitamin D content artificially added to certain types of food.
The capsules must be swallowed whole with a little water.
You should take this medicine preferably during meals to enhance the absorption of vitamin D by the body.

Adults
The recommended dose is one capsule (25,000 IU) once a week for the first month. After the first month, lower doses may be considered.
This initial treatment may be followed by a maintenance therapy established by your doctor. Your doctor will determine the appropriate dose for you.

Use in children and adolescents
Colecalciferolo Teva B.V. 25,000 IU capsules are not indicated for children and adolescents under 18 years of age. Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

If you take more Colecalciferolo Teva B.V. than you should
If you take more of this medicine than prescribed, or if a child accidentally ingests it, contact your doctor or go to the emergency department for risk assessment and advice.
The most common symptoms of overdose are: nausea, vomiting, intense thirst, production of large amounts of urine over 24 hours, constipation and dehydration, high levels of calcium in the blood (hypercalcemia), and hypercalciuria detected in laboratory tests.

If you forget to take Colecalciferolo Teva B.V.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Colecalciferolo Teva B.V.
If you wish to discontinue taking this medicine, consult your doctor.
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 everyone experiences them.
Stop taking Colecalciferolo Teva B.V. and contact a doctor immediately if symptoms of serious allergic reactions occur (available data do not allow the frequency to be estimated), such as:

• swelling of the face, lips, tongue or throat;
• difficulty swallowing;
• difficulty breathing.

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

• hypercalcaemia (high levels of calcium in the blood). You may feel unwell or become sick, lose your appetite, experience constipation, stomach ache, excessive thirst, muscle weakness, drowsiness or confusion;
• hypercalciuria (increased levels of calcium in the urine).

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

• itching, rash, urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Colecalciferolo Teva B.V.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging to protect the medicine from moisture.
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. Pack contents and other information

What Colecalciferolo Teva B.V. contains
The active substance is colecalciferol (vitamin D). Each soft capsule contains 0.625 mg of
colecalciferol, equivalent to 25,000 IU of vitamin D.
The other components are:

• Capsule contents: medium-chain triglycerides, alpha-tocopherol E307.
• Capsule shell: gelatin E441, glycerol E422, purified water, titanium dioxide E171, and yellow iron oxide E172. It also contains traces of medium-chain triglycerides, lecithin/phosphatidylcholine (from soybean seeds), caprylic/capric triglycerides, ethanol, glyceride (from sunflower seed oil), oleic acid, ascorbyl palmitate, and tocopherol.

Description of the appearance of Colecalciferolo Teva B.V. and pack contents
Colecalciferolo Teva B.V. 25,000 IU capsules are soft gelatin capsules, oval, yellow, opaque,
approximately 9 mm x 6 mm in size.
Blister packs in PVC/PVDC/aluminum containing 1, 2, 3, 4, 6, 12 and 50 soft capsules; unit-dose blister packs of 3x1, 4x1, 6x1, 12x1 and 50x1 soft capsules; and hospital packs containing 12 and 50 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
TEVA Gyógyszergyár Zrt.
Pallagi út 13
Debrecen 4042
Hungary
Merckle GmbH
Ludwig-Merckle-Strasse 3,
Blaubeuren 89143
Baden-Wuerttemberg
Germany

This medicinal product is authorised in the European Economic Area countries under the
following names:
Germany: Colecalciferol-ratiopharm 25.000 I.E. Weichkapseln
The Netherlands: Vitamine D3 Teva 25.000 IE, zachte capsules
Italy: Colecalciferolo Teva B.V.
Spain: Colecalciferol Teva 25.000 UI cápsulas duras