Disbron 25,000 IU soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Disbron 25,000 IU soft capsules
colecalciferol (vitamin D3)
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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Disbron is and what it is used for
- What you need to know before taking Disbron
- How to take Disbron
- Possible side effects
- How to store Disbron
- Contents of the pack and other information
1. What Disbron is and what it is used for
Disbron contains vitamin D3, which regulates the absorption and metabolism of calcium and phosphate, as well as the incorporation of calcium into bone tissue.
Disbron is used to prevent and treat clinically significant vitamin D deficiency in adults.
2. What you need to know before starting to take Disbron
Do not take Disbron:
- if you are allergic to colecalciferol or to any of the other ingredients of this medicine (listed in section 6).
- if you have hypercalcemia (increased calcium levels in blood) or hypercalciuria (increased calcium levels in urine).
- if you have hypervitaminosis D (increased vitamin D levels in 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
Talk to your doctor or pharmacist before starting to take Disbron:
- if you have sarcoidosis (a specific type of connective tissue disease affecting the lungs, skin, and joints).
- when simultaneously using other medicines containing vitamin D.
- if you have kidney problems or have previously had kidney stones.
- if you have pseudohypoparathyroidism.
Children and adolescents
This medicine is not suitable for use in children and adolescents under 18 years of age.
Other medicines and Disbron
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, particularly:
- Cholestyramine (used to treat high cholesterol).
- Phenytoin or barbiturates (used to treat epilepsy).
- Laxatives containing paraffin oil.
- Thiazide diuretics (used to treat high blood pressure).
- Glucocorticoids (used to treat inflammation).
- Cardiac glycosides (used to treat heart conditions), e.g., digoxin.
- Actinomycin (chemotherapy).
- Imidazole (antifungal).
- Orlistat (for weight loss).
- Products containing magnesium (such as antacids).
- Products containing phosphorus.
Taking Disbron with food and drinks
See section 3 “How to take Disbron”.
Pregnancy, breastfeeding, and fertility
During pregnancy, daily intake of vitamin D should not exceed 600 IU.
This medicine should only be used during pregnancy if vitamin D deficiency has been clinically diagnosed.
Disbron may be used during breastfeeding.
Vitamin D3 passes into breast milk. This should be taken into account when administering additional vitamin D to the infant. There are no data regarding the effects of vitamin D3 on fertility.
However, normal levels of vitamin D are not expected to have adverse effects on 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.
Driving and using machines
This medicine has no known effects on the ability to drive or operate machinery.
Disbron contains sorbitol (E420) and Ponceau 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 may provoke asthma, especially in patients allergic to acetylsalicylic acid.
If you are allergic to the above dye, consult your doctor or pharmacist.
3. How to take Disbron
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The capsules should be swallowed whole with water.
You should take this medicine preferably with a substantial meal to help your body absorb vitamin D3.
Adults
The recommended dose is one 25,000 IU capsule per week.
After the first month, a dose reduction should be considered.
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 Disbron than 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 potential risk and receive recommendations.
In case of overdose or accidental ingestion, contact 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 frequent symptoms of overdose are: nausea, vomiting, excessive thirst, mental disturbances, production of large amounts of urine over 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 forget to take Disbron
Do not take a double dose to make up for the missed 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 adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. You should stop taking Disbron and seek immediate medical help 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 (occur in less than 1 in 100 people): Hypercalcemia (increased levels of calcium in blood) and hypercalciuria (increased levels of calcium in urine).
Rare (affect up to 1 in 1,000 people): Itching, skin rash (pruritus/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 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 Disbron
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
The active substance is colecalciferol (vitamin D3). Each soft capsule contains 0.625 mg colecalciferol, equivalent to 25,000 IU of vitamin D3.
The other components are: all-rac-α-tocoferol (E307), medium-chain triglycerides, glycerol, gelatin (E441), sorbitol (E420), and Ponceau 4R (E124).
Appearance of the product and contents of the pack
Disbron is a soft, oval, transparent red gelatin capsule containing a clear, colourless liquid.
Each carton 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 medicinal product is authorized in the European Economic Area (EEA) member states under the following names:
- Netherlands: Colecalciferol Focus Care 25,000 IU, zachte capsules
- Spain: Disbron 25,000 IU soft capsules
Date of the most recent review of this leaflet: June 2020
Detailed and up-to-date 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/