Prospect: information for the patient

Disbron 25.000 UI soft capsules

colecalciferol (vitamin D3)

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

-Keep this prospect, as you may need to read it again

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isDisbronand for what it is used

2. What you need to know before starting to takeDisbron

3. How to takeDisbron

4. Possible adverse effects

5. Storage ofDisbron

6. Contents of the package and additional information

Disbroncontains vitamin D3, which regulates the absorption and metabolism of calcium and phosphate, as well as the incorporation of calcium into bone tissue.

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

Do not takeDisbron:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to takeDisbron.

• if you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• when using other medications that contain vitamin D simultaneously.
• if you have kidney problems or have had kidney stones
• if you sufferpseudohipoparatiroidismo

Children and adolescents

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

Other medications and Disbron

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

- Colestiramina (used to treat high cholesterol).

- Phenobarbital or barbiturates (used to treat epilepsy).

- Laxatives containing paraffin oil.

- Thiazide diuretics (to treat high blood pressure).

- Glucocorticoids (to treat inflammation).

- Cardiotonic glucosides (to treat heart conditions), e.g. digoxin.

- Actinomycin (chemotherapy).

- Imidazole (antifungal).

- Orlistat (weight loss).

- Products containing magnesium (such as antacids).

- Products containing phosphorus.

Disbron with food and drinks

See section 3 “How to takeDisbron”.

Pregnancy, breastfeeding, and fertility

During pregnancy, daily vitamin D intake should not exceed 600 UI.

This medicationwill only be used during pregnancy if a clinical deficiency of vitamin D has been diagnosed.

Disbroncan be used during breastfeeding.

VitaminD3passes into breast milk. This should be taken into account when administering additional vitamin D to the infant.There are no data on the effects of vitaminD3on fertility.

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

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medicationhas no known effects on the ability to drive or operate machinery

Disbron containscontains sorbitol (E420) andPonceau (E124)

This medication contains4.8mg of sorbitol in each soft capsule, equivalent to 0.06mg/kg/day.

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

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

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

The capsules should be swallowed whole with water.

This medication should be taken preferably with a full meal so that your body can absorb vitamin D3.

Adults

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

After the first month, the dose should be evaluated for reduction.

This initial dose may be followed by a maintenance treatment, as established 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 old.

If you take more Disbron than you should

If you have taken a greater amount of this medication than prescribed, or if a child has accidentally taken this medication, contact your doctor or emergency services to evaluate the existing risk and recommendations.

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

The most frequent symptoms of overdose are: nausea, vomiting, excessive thirst, mental disturbances, the production of large amounts of urine during 24 hours, constipation, and dehydration, elevated levels of calcium in the blood (hypercalcemia and hypercalciuria) detected in laboratory tests, and high levels of phosphate in the blood.

If you forgot to take Disbron

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Disbron

If you have any other doubts 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.You should discontinue takingDisbronand seek immediate medical helpif you experience severe allergic reaction symptoms, such as:

• Swelling of the face, lips, tongue, or throat

• Difficulty swallowing

• Urticaria and difficulty breathing

Infrequent(occur in less than 1 in 100 people): Hypercalcemia (elevated calcium levels in blood) and hypercalciuria (elevated calcium levels in urine).

Rare(affect up to 1 in 1,000 people):Itching, skin rash (pruritus/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.Reporting adverse effects can help provide more information about 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.

This medication does not require any special storage conditions.

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.

The active principle is colecalciferol (vitamin D3). Each soft capsule contains 0.625 mg of colecalciferol, which corresponds to 25,000 UI of vitamin D3.

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

Appearance of the product and contents of the packaging

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

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

Some packaging sizes may not be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ferrer Internacional S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

Netpharmalab Consulting Services

Carretera de Fuencarral, 22,

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

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

Last review date of this leaflet: June 2020

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