DISBRON 25,000 IU SOFT GEL CAPSULES

Introduction

Patient Information Leaflet

Disbron 25,000 IU soft capsules

colecalciferol (vitamin D3)

Read this leaflet carefully before starting to take this medicine, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Disbron is and what it is used for
2. What you need to know before taking Disbron
3. How to take Disbron
4. Possible side effects
5. Storage of Disbron
6. Package contents and additional information

1. What Disbron is and what it is used for

Disbron contains vitamin D3, which regulates calcium and phosphate absorption and metabolism, as well as calcium incorporation into bone tissue.

Disbron is used to prevent and treat clinically relevant vitamin D deficiency in adults.

2. What you need to know before taking Disbron

Do not take Disbron:

• if you are allergic to colecalciferol or any of the other ingredients of this medicine (listed in section 6).
• if you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
• if you have hypervitaminosis D (high levels of vitamin D in the blood).
• if you have kidney stones.

If you have any of the above conditions, consult your doctor or pharmacist before taking Disbron.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Disbron.

• if you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• when using other medicines that contain vitamin D at the same time.
• if you have kidney problems or have had kidney stones.
• if you have pseudo hypoparathyroidism.

Children and adolescents

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

Other medicines and Disbron

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• Colestyramine (used to treat high cholesterol).
• Phenytoin or barbiturates (used to treat epilepsy).
• Laxatives that contain paraffin oil.
• Thiazide diuretics (to treat high blood pressure).
• Glucocorticoids (to treat inflammation).
• Cardiac glycosides (to treat heart conditions), e.g., digoxin.
• Actinomycin (chemotherapy).
• Imidazole (antifungal).
• Orlistat (weight loss).

- Products that contain magnesium (such as antacids).

- Products that contain phosphorus.

Taking Disbron with food and drinks

See section 3 "How to take Disbron".

Pregnancy, breastfeeding, and fertility

Daily intake of vitamin D during pregnancy should not exceed 600 IU.

This medicine will only be used during pregnancy if a clinically relevant vitamin D deficiency has been diagnosed.

Disbron can be used during breastfeeding.

Vitamin D3 passes into breast milk. This should be taken into consideration when administering additional vitamin D to the infant. There are no data on the effects of vitamin D3 on fertility.

However, it is not expected that normal levels of vitamin D will have adverse effects on 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 medicine.

Driving and using machines

This medicine has no known effects on the ability to drive or use machines.

Disbron containssorbitol (E420) andPonceau 4R (E124)

This medicine contains 4.8 mg of sorbitol in each soft capsule, equivalent to 0.06 mg/kg/day.

This medicine may cause allergic reactions because it contains Ponceau 4R. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

If you are allergic to the above colorant, consult your doctor or pharmacist.

3. How to take Disbron

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The capsules should be swallowed whole with water.

You should take this medicine preferably with a large meal so that your body absorbs vitamin D3.

Adults

The recommended dose is one 25,000 IU capsule per week.

After the first month, the dose should be reduced.

This initial dose may be followed by a maintenance treatment, as determined by your doctor.

Your doctor will adjust your dose.

Use in children and adolescents

Disbron is not intended for use in children under 18 years of age.

If you take more Disbronthan 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 services to assess the risk and recommendations.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, mental disorders, 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, and high levels of phosphate in the blood.

If you forget to take Disbron

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

If you stop taking Disbron

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should stop taking Disbron and seek immediate medical attention if you experience symptoms of severe allergic reactions, such as:

• Swelling of the face, lips, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing

Uncommon(occurring in less than 1 in 100 people): Hypercalcemia (high levels of calcium in the blood) and hypercalciuria (high levels of calcium in the urine).

Rare(affecting up to 1 in 1,000 people): Itching, skin rash (pruritus/urticaria).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Disbron

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 CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

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

The other ingredients are: all-rac-α-tocopherol (E307), medium-chain triglycerides, glycerol, gelatin (E441), sorbitol (E420), and Ponceau 4R (E124).

Appearance of theproduct andpackage contents

Disbron is a soft, oval-shaped capsule with a transparent red gelatin coating, containing a clear, colorless liquid.

Each pack contains 1, 2, 3, 4, or 8 capsules in blister strips.

Some pack sizes may not be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ferrer Internacional S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Netpharmalab Consulting Services

Carretera de Fuencarral, 22,

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

• Netherlands: Colecalciferol Focus Care 25,000 IU, soft capsules
• Spain:Disbron 25,000 IU soft capsules

Date of the last revision of this leaflet: June 2020

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