Product Information for the User

Colecalciferol Teva 25.000 U.I. Soft Capsules

Colecalciferol (Vitamin D3)

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

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

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

Do not take Colecalciferol Teva if:

• you are allergic to colecalciferol or any of the other components of this medication (listed in section 6);
• you have hypercalcemia (elevated levels of calcium in the blood) or hypercalciuria (elevated levels of calcium in 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 soy

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take colecalciferol:

• if you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• when using other medications or dietary supplements that contain vitamin D or related substances.
• if you have kidney problems.
• if you have pseudohypoparathyroidism.

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

Children and adolescents

This medication is not suitable for use in children and adolescents under 18 years old.

Other medications and Colecalciferol Teva

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

• thiazide diuretics (to treat high blood pressure)
• phenytoin or barbiturates (used to treat epilepsy)
• glucocorticoids (to treat inflammation)
• cardiac glycosides (to treat heart conditions, for example, digoxin)
• cholestyramine (used to treat high cholesterol)
• orlistat (weight loss agent)
• laxatives, for example, mineral oil
• actinomycin (chemotherapy)
• imidazole (antifungal)
• rifampicin (antibiotic)
• isoniazid (antibiotic)
• products containing magnesium (for example, antacids)
• products containing high doses of phosphorus

Taking Colecalciferol Teva with food and drinksandbeverages

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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

Colecalciferol Teva contains soy lecithin

This medication contains soy lecithin, which may contain soy oil. It should not be used in case of allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Your doctor will carefully evaluate your dietary habits and take into account the artificially added vitamin D content in certain types of foods.

The capsules should be swallowed whole with water.

You should take this medication preferably with food to help the body absorb Vitamin D3.3.

Adults

The recommended dose is one 25,000 UI capsule per week for the first month. After the first month, the dose may be reduced.

This initial treatment may be followed by a maintenance therapy, as indicated by your doctor. Your doctor will adjust the dose for you.

Use in children and adolescents

Colecalciferol Teva 25,000 UI is not intended for children and adolescents under 18 years old. Other forms of this medication 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 medication than indicated, or if a child has accidentally taken this medication, contact your doctor or emergency unit to assess the risk and receive advice.

You may also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Colecalciferol Teva

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

If you interrupt treatment with Colecalciferol Teva

Speak with your doctor if you wish to stop taking this medication.

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

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

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

• swollen face, lips, tongue, or throat
• difficulty swallowing
• difficulty breathing

Infrequent(affect up to 1 in 100 people):

• hypercalcemia (elevated calcium levels in the serum). You may feel or be nauseous, lose your appetite, experience constipation, stomach pain, feel very thirsty, experience muscle weakness, drowsiness, or confusion
• hypercalciuria (elevated calcium levels in the urine)

Rare(affect up to 1 in 1000 people):itching, rash, urticaria.

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 Medicinal Products for Human Use:https://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 use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Colecalciferol Teva

The active ingredient is colecalciferol (vitamin D 3 ). Each capsule contains 0.625 mg of colecalciferol equivalent to 25,000 UI of vitamin D 3 .

The other excipients are:

Capsule filler: medium-chain triglycerides, all-rac-α-tocopherol (E307)

Capsule coating: 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 packaging

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

PVC/PVDC/aluminum blister packs containing 1, 2, 3, 4, 6, 12, or 50 soft capsules; single-dose blisters containing 3x1, 4x1, 6x1, 12x1, or 50x1 soft capsules; and clinical packs containing 12 or 50 soft capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg, 5

2031 GA Haarlem

Netherlands

Responsible manufacturer

Teva Gyógyszergyár Zrt.

Pallagi út 13

Debrecen 4042

Hungary

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

You can request more information about this medication by contacting 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)

Last review date of this leaflet: June 2024

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