Colecalciferol Teva 25,000 UI soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colecalciferol Teva 25,000 IU soft capsules

Colecalciferol (vitamin D3)

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Colecalciferol Teva is and what it is used for

Colecalciferol Teva contains the active substance colecalciferol (vitamin D3), which regulates the absorption and metabolism of calcium, as well as the incorporation of calcium into bone tissue.

Colecalciferol is used in the initial treatment of clinically relevant vitamin D deficiency in adults.

2. What you need to know before taking Colecalciferol Teva

Do not take Colecalciferol Teva if:

• you are allergic to colecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• you have hypercalcemia (elevated calcium levels in the blood) or hypercalciuria (elevated calcium levels in the urine);
• you have kidney stones;
• you have calcium deposits in the kidneys (nephrocalcinosis);
• you have severe renal insufficiency;
• you have hypervitaminosis D (elevated levels of vitamin D in the blood);
• you are allergic to peanuts or soya.

If you are in any of the above situations, consult your doctor or pharmacist before taking colecalciferol.

Warnings and precautions

Consult your doctor or pharmacist before starting colecalciferol:

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

Your doctor may need to measure calcium levels in your blood or urine and monitor your kidney function. Monitoring is especially important for elderly patients taking concomitant heart medications (glycosides or diuretics) and for patients at higher risk of kidney stones.

Children and adolescents

This medicine is not suitable for use in children and adolescents under 18 years of age.

Other medicines and Colecalciferol Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, particularly any of the following:

• 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 conditions, e.g., digoxin);
• cholestyramine (used to treat high cholesterol);
• orlistat (an anti-obesity agent);
• laxatives, such as paraffin oil;
• actinomycin (chemotherapy);
• imidazole (antifungal);
• rifampicin (antibiotic);
• isoniazid (antibiotic);
• products containing magnesium (e.g., antacids);
• products containing phosphorus in high doses.

Taking Colecalciferol Teva with food and drink

The capsules should be swallowed whole with water, preferably during meals.

Pregnancy, breastfeeding and fertility

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.

This high concentration is not recommended for use in pregnant or breastfeeding women.

Driving and using machines

Colecalciferol has no effect on the ability to drive or operate machinery.

Colecalciferol Teva contains soya lecithin

This medicine contains soya lecithin which may contain soya oil. It must not be used in patients with allergy to peanuts or soya.

3. How to take Colecalciferol Teva

Follow exactly the instructions for use provided by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Your doctor will carefully assess your dietary habits and will take into account the vitamin D content artificially added to certain types of food.

The capsules must be swallowed whole with water.

You should take this medicine preferably with food to help your body absorb Vitamin D3.

Adults

The recommended dose is one 25,000 IU capsule per week during the first month. After the first month, a dose reduction may be considered.

This initial treatment may be followed by a maintenance therapy, according to your doctor's instructions. Your doctor will adjust the dose for you.

Use in children and adolescents

Colecalciferol Teva 25,000 IU is not intended for children and adolescents under 18 years of age. Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.

If you take more Colecalciferol Teva than you should

If you have taken more of this medicine than prescribed, or if a child has accidentally taken this medicine, contact your doctor or emergency department to assess the risk and receive advice.

You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation, dehydration, and elevated levels of calcium in blood and urine (hypercalcemia and hypercalciuria) detected in clinical tests.

If you forget to take Colecalciferol Teva

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

If you stop taking Colecalciferol Teva

Talk to your doctor if you wish to discontinue this medicine.

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.

Stop taking colecalciferol and seek immediate medical help if you experience symptoms of severe allergic reactions (frequency cannot be estimated from available data), such as:

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

Uncommon (affects up to 1 in 100 people):

• hypercalcemia (high levels of calcium in the blood). You may feel unwell, lose your appetite, have constipation, stomach pain, feel very thirsty, or experience muscle weakness, drowsiness or confusion
• hypercalciuria (high levels of calcium in the urine)

Rare (affects up to 1 in 1000 people): itching, rash, hives.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colecalciferol Teva

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25 °C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Colecalciferol Teva

The active substance is colecalciferol (vitamina D3). Each capsule contains 0.625 mg of colecalciferol, equivalent to 25,000 IU of vitamin D3.

The other excipients are:

Capsule filling: medium-chain triglycerides, todo-rac-α-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), caprylic/capric triglycerides, ethanol, glycerides (from sunflower seed oil), oleic acid, ascorbyl palmitate and tocopherol.

Appearance of the product and contents of the pack

Colecalciferol Teva 25,000 IU are yellow, opaque, soft gelatin capsules, oval-shaped, with approximate dimensions of 9 mm x 6 mm.

Packs of 1, 2, 3, 4, 6, 12 and 50 soft capsules in PVC/PVDC/aluminum blisters; unit-dose blisters of 3x1, 4x1, 6x1, 12x1 and 50x1 soft capsules; and clinical packs of 12 and 50 soft capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

The Netherlands

Manufacturer

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen 4042

Hungary

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Date of the most recent revision of this leaflet: June 2024

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/).