Colecalciferol Alter 50,000 IU hard capsules

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colecalciferol Alter 25,000 IU hard capsules

Colecalciferol Alter 50,000 IU hard capsules

Read all of this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Colecalciferol Alter 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 supporting bone formation. Vitamin D deficiency is the main cause of rickets (defective bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Colecalciferol is used for the prevention and treatment of vitamin D deficiency in adults.

2. What you need to know before taking

Do not take Colecalciferol Alter:

• if you are allergic to vitamin D3 or to 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);
• if you are allergic to peanuts or soy, as it contains soybean oil.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking colecalciferol if you:

• are being treated with certain medicines used 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 medicines containing vitamin D3, or consume foods or milk fortified with vitamin D3;
• are likely to be exposed to significant sunlight while using colecalciferol;
• are taking 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 your blood calcium levels via laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU over a prolonged period.

Children and adolescents

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

Other medicines and Colecalciferol Alter

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:

• medicines used to treat heart or kidney conditions, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in blood and urine;
• medicines containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3-fortified milk;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D3;
• medicines used to treat 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), as they may reduce the effect of vitamin D3;
  • medicines that lower cholesterol levels in blood (e.g., cholestyramine or colestipol);
  • some medicines used for weight loss by reducing the absorption of body fat (e.g., orlistat);
  • some laxatives (e.g., liquid paraffin).

Taking Colecalciferol Alter with food, drinks and alcohol

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

Pregnancy, breast-feeding 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

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

Excipients

Sucrose

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

Soybean oil

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

Orange Yellow S

This medicine may cause allergic-type reactions.

3. How to take Colecalciferol Alter

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

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

Colecalciferol should preferably be taken with food.

For patients who have difficulty swallowing, the capsule may be opened and the dispersible granules poured into half a glass of water to facilitate administration.

Use in adults

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

Higher doses may be required:

50,000 IU/week for 6–8 weeks.

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

Your doctor will adjust the dose for you.

Paediatric population

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

Pregnancy and Lactation

Colecalciferol is not recommended.

If you take more Colecalciferol Alter than you should

If you take more than prescribed, stop taking the medicine and contact your doctor. If you cannot contact your doctor, go to the nearest hospital emergency department and take the medicine pack with you.

You may also contact the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken.

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 (hypercalcaemia and hypercalciuria) as determined by clinical tests.

If you forget to take Colecalciferol Alter

If you forget to take a dose of colecalciferol, take the missed dose as soon as possible. Then 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 everybody gets 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

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colecalciferol Alter

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

Do not use this medicine after the expiry date which is 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. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Colecalciferol Alter

The active substance is colecalciferol (vitamin D3).

One capsule contains:

25,000 IU (0.625 mg) of colecalciferol as concentrated colecalciferol (powder).

50,000 IU (1.250 mg) of colecalciferol as concentrated colecalciferol (powder).

The other components (excipients) are:

Colecalciferol Alter 25,000 IU hard capsules:

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: iron oxide red (E-172), orange yellow S (E-110), titanium dioxide (E-171), gelatin.

Colecalciferol Alter 50,000 IU hard capsules:

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 pack

Colecalciferol Alter 25,000 IU is a hard capsule with a yellow body and light orange cap. The capsule size is 18 mm. It contains a yellowish-white powder and is supplied in blisters made of Polyamide/Aluminum/PVC - Aluminum, packed in cardboard boxes.

Each box may contain 4 or 8 capsules.

Colecalciferol Alter 50,000 IU is a hard capsule with a yellow body and black cap. The capsule size is 24 mm. It contains a yellowish-white powder and is supplied in blisters made of Polyamide/Aluminum/PVC - Aluminum, packed in cardboard boxes.

Each box may contain 4 capsules.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

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

Detailed and up-to-date 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/.