Colecalciferol CINFA 50.000 UI hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colecalciferol cinfa 50,000 IU hard capsules

Vitamin D3

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Colecalciferol cinfa contains the active substance colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestine, thereby aiding bone formation. Vitamin D deficiency is the main cause of rickets (deficient bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Colecalciferol cinfa is used to treat vitamin D deficiency in adults.

2. What you need to know before starting to take Colecalciferol cinfa

Do not take Colecalciferol cinfa

• If you are allergic to vitamin D3, soybean oil, or any of the other ingredients of this medicine (listed in section 6);
• If you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• If you have kidney stones (renal calculi) or severe renal failure;
• If you have high levels of vitamin D3 in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take colecalciferol if you:

• are being treated with certain medications for heart conditions (e.g., cardiac glycosides such as digoxin);
• have sarcoidosis (an autoimmune disease that may increase vitamin D levels in the body);
• are being treated with diuretics (e.g., benzothiadiazines);
• are immobilized;
• have pseudohypoparathyroidism;
• are being treated with medications containing vitamin D3, or consume foods or milk fortified with vitamin D3;
• are likely to be exposed to significant sunlight while taking Colecalciferol cinfa;
• take other supplements containing calcium. Your doctor should monitor your blood calcium levels to ensure they do not become too high during treatment with colecalciferol;
• have kidney disease or kidney damage and are prone to developing kidney stones. Your doctor may wish to monitor your blood and urine calcium levels;
• your doctor should monitor blood calcium levels via laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.

Children and adolescents

Use is not recommended in children and adolescents under 18 years of age.

Other medicines and Colecalciferol cinfa

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is especially important if you are taking:

• medications used to treat heart or kidney conditions, such as cardiac glycosides (e.g., digoxin) or diuretics. When these are used together with vitamin D3, they may cause a significant increase in blood calcium levels;
• medications containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3-fortified milk;
• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D3;
• medications for tuberculosis, such as rifampicin and isoniazid;
• the following medicines, as they may interfere with the effect or absorption of vitamin D3:
  • antiepileptic drugs (anticonvulsants), barbiturates;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), which may reduce the effect of vitamin D3;
  • medications that lower blood cholesterol levels (such as cholestyramine or colestipol);
  • certain weight-loss medications that reduce fat absorption (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

Taking Colecalciferol cinfa with food, drinks, and alcohol

You should preferably take colecalciferol with food to help absorption of vitamin D3.

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 medicine is not recommended for pregnant or breastfeeding women.

Driving and using machines

Information regarding possible effects of this medicine on the ability to drive is limited. However, it is not expected to affect your ability to drive or operate machinery.

Colecalciferol cinfa contains sucrose, soybean oil, and sunset yellow FCF (E-110)

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.

This medicine contains sunset yellow FCF (E-110). It may cause allergic-type reactions.

3. How to take Colecalciferol cinfa

Dosage

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The amount of colecalciferol will depend on your vitamin D levels and response to treatment. Your doctor will decide the appropriate dose for you.

The recommended dose is one 25,000 IU capsule weekly for the first month. After the first month, a lower dose may be considered.

If deemed necessary by your doctor, higher doses may also be prescribed: 50,000 IU weekly for 6–8 weeks.

This initial treatment may be followed by a maintenance therapy, according to your doctor's instructions.

Paediatric population

Colecalciferol is not recommended in children and adolescents under 18 years of age.

Pregnancy and Breastfeeding

Colecalciferol is not recommended during pregnancy or breastfeeding.

Method of administration

You should take colecalciferol cinfa preferably with food.

The capsule should be swallowed whole (for example, with water).

If you take more Colecalciferol cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call 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 over a 24-hour period, constipation, dehydration, and elevated levels of calcium in blood and urine (hypercalcaemia and hypercalciuria) as determined by clinical tests.

If you forget to take Colecalciferol cinfa

If you forget to take a dose of colecalciferol, take the missed dose as soon as possible. Afterwards, take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose and instead take the following dose at the usual time.

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 may cause adverse effects, although not everyone experiences them.

Possible adverse effects associated with the use of colecalciferol may include:

Uncommon (affects up to 1 in 100 people):

• Excess calcium in the blood (hypercalcemia).
• Excess calcium in the urine (hypercalciuria).

Rare (affects up to 1 in 1,000 people):

• Skin rash (rash or skin eruption).
• Pruritus (itching).
• Urticaria.

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

• Hypersensitivity reactions.
• Weakness, anorexia, anxiety.
• Headache.
• Constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth.
• Accumulation of calcium deposits in the kidneys (nephrocalcinosis), increased urine volume (polyuria), increased sensation of thirst (polydipsia), deterioration or condition in which the kidneys stop functioning (renal failure).

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 may also report them directly through 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 cinfa

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.

Store below 25 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Colecalciferol cinfa

The active substance is colecalciferol (vitamin D3).

Each capsule contains 50,000 IU (1.250 mg) of colecalciferol in the form of concentrated colecalciferol (powder).

The other excipients are:

Contents of the hard capsule:

Gelatin, sucrose, corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol, silicon dioxide.

Capsule composition

Capsule body: quinoline yellow (E-104), orange yellow S (E-110), titanium dioxide (E-171), gelatin.

Capsule cap: black iron oxide (E-172), titanium dioxide (E-171), gelatin.

Appearance of the product and contents of the container

Hard capsule with yellow body and black cap. Capsule size is 24 mm. The capsule contains a white-yellowish powder.

Available in blisters made of Polyamide/Aluminum/PVC-Aluminum containing 2 capsules in cardboard boxes.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: October 2025

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

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/90666/P_90666.html

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