DUBAS 20,000 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for thepatient

Dubas 20,000 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Dubas and what is it used for
2. What you need to know before you take Dubas
3. How to take Dubas
4. Possible side effects
5. Storage of Dubas
6. Contents of the pack and further information

1. What is Dubas and what is it used for

Dubas contains the active substance colecalciferol, also known as Vitamin D3.

Colecalciferol is indicated for the treatment of vitamin D deficiency in adults.

Colecalciferol is indicated in adults.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Dubas

Do not take Dubas

• If you are allergic to colecalciferol (Vitamin D3) or any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria)
• If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
• If you have high levels of vitamin D in the body (hypervitaminosis D).
• If you have kidney disease (renal insufficiency) (see section "Warnings and precautions").

Colecalciferol should not be administered to infants and children under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Dubas:

• If you need to follow a treatment with colecalciferol for a prolonged period and in high doses.
• If you are an elderly patient and are taking medications for heart conditions (cardiac glycosides or diuretics). In this case, you should have your calcium levels in the blood and urine checked.
• If you are taking medications that contain vitamin D, foods fortified with vitamin D, or vitamin D-enriched milk.
• If you have a chronic inflammatory disease that can affect all organs, called sarcoidosis.
• If you have impaired renal function, as vitamin D levels in the body may be altered.
• If you have a tendency to form kidney stones, which contain calcium.
• If you have severe renal insufficiency: in this case, other forms of vitamin D should be used.
• If you take this medication for long-term treatment, especially if you are an elderly patient. In this case, your doctor will monitor your calciuria and renal function. If necessary, your doctor will reduce the dose.
• If you have a hormone imbalance (pseudohypoparathyroidism)

Tell your doctor if you have any of the following conditions, as an increase in dose as indicated in section 3 "How to take Dubas" may be necessary:

• If you are being treated with medications for epilepsy (anticonvulsants or barbiturates).
• If you are being treated with medications for inflammation (corticosteroids).
• If you are being treated with medications that lower blood fat levels (cholestyramine, colestipol, orlistat, and laxatives such as paraffin oil).
• If you are being treated with medications used to treat excessive stomach acid production (antacids containing aluminum).
• If you are obese.
• If you have digestive disorders (intestinal malabsorption, cystic fibrosis, or mucoviscidosis).
• If you have liver disease (liver insufficiency).

Children and adolescents

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

Other medicines and Dubas

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

In particular, consult your doctor if you are taking the following medications, as they may reduce or increase the effect of colecalciferol:

• Other medications that contain vitamin D.
• Medications used to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, primidone, etc.
• Medications to reduce blood fat levels, such as cholestyramine, colestipol, orlistat, and laxatives (such as paraffin oil).
• Antacids containing aluminum, medications to treat excessive stomach acid that can rise to the esophagus.
• Thiazide diuretics, medications to treat high blood pressure, which increase urine production.
• Digitalis, a medication to treat certain heart conditions.
• Medications used to treat tuberculosis, such as rifampicin or isoniazid.
• Antifungal agents such as imidazole (such as ketoconazole), medications used to stop the growth of fungal organisms.
• Warfarin, a medication used to thin the blood.
• Heart medications (cardiac glycosides) because they need to be monitored by a doctor, have an electrocardiogram if necessary, and check calcium levels.

Taking Dubas with food, drinks, and alcohol

Consult your doctor if you are taking other products that contain vitamin D, foods with added vitamin D, or if you are using vitamin D-enriched milk, so that they can take into account the total dose of vitamin D and avoid excessive doses.

Consuming large amounts of alcohol over a long period (chronic alcoholism) decreases vitamin D deposits in the liver.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Colecalciferol should not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical conditions necessarily require treatment with colecalciferol at lower doses.

Pregnancy

Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if it is strictly necessary, due to the risk of harmful effects on the fetus (see section 3: "If you take more Dubas than you should").

However, since vitamin D deficiency is harmful to both the fetus and the mother, when necessary, your doctor will prescribe vitamin D during pregnancy at lower doses.

Breastfeeding

When necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding. This does not replace the administration of vitamin D to the breastfed infant.

Driving and using machines

Colecalciferol has a negligible influence on the ability to drive and use machines.

3. How to take Dubas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose and duration of treatment will be evaluated by your doctor based on your health conditions.

Do not exceed the dose recommended by your doctor.

Take the dose orally.

Take Dubas with meals.

Adults

The amount of colecalciferol will depend on your vitamin D levels and response to treatment.

Treatment of vitamin D deficiency (initial dose) in adults: 1 capsule every week. After the first month of treatment, your doctor may consider a lower dose depending on your condition.

Any additional treatment with Dubas should be decided by your doctor.

If you take more Dubas than you should

If you accidentally take more of this medicine than you should, tell your doctor immediately or go to the nearest hospital. You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

In case of overdose, high levels of calcium in the blood and urine may occur, with symptoms such as nausea, vomiting, thirst, intense thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.

Other symptoms of overdose are:

Diarrhea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and kidney disease.

Chronic excessive overdoses can cause deposits of calcium salts in blood vessels and organs.

Taking too much vitamin D in the first 6 months of pregnancy can cause serious harm to the fetus and newborn.

If you forget to take Dubas

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

If you stop taking Dubas

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

Dubas contains glycerol

It can cause headache, stomach upset, and diarrhea.

It can cause allergic reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects reported with the use of vitamin D are:

Uncommon side effectsthat may affect up to 1 in 100 people:

• Allergic reactions, weakness, loss of appetite (anorexia), high levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Rare side effectsthat may affect up to 1 in 1,000 people:

• Drowsiness, confusion, constipation, gas (flatulence), stomach pain, nausea, vomiting, diarrhea, metallic taste, dry mouth, skin rash, itching, hives.

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

• Headache, excess calcium in the kidneys (nephrocalcinosis), increased urine production (polyuria), intense thirst (polydipsia), kidney disease (renal insufficiency).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dubas

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

Do not store above 25°C.

Store in the original package to protect from light.

Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Dubas

• The active substance is colecalciferol (Vitamin D3). Each soft capsule contains: 0.500 mg of colecalciferol equivalent to 20,000 IU.
• The other excipients are:

Filling: refined olive oil, butylhydroxytoluene (E321)

Coating: glycerol 98% (E422), titanium dioxide (E171), gelatin, and red allura #40 (E129).

Appearance of the product and pack contents

Dubas 20,000 IU are soft capsules, burgundy red in color, size 3, oval, containing a clear, colorless, or yellowish-green solution.

They are available in packs containing 4, 5, and 10 capsules in a PVC/PVDC and aluminum blister pack.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmacare Srl

Via Marghera, 29

20149 Milan

Italy

Manufacturer

DOPPEL FARMACEUTICI S.r.l.

Via Martiri delle Foibe, 1

29016 Cortemaggiore (PC)

Italy

Date of last revision of this leaflet:May 2025

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