DUBAS 25,000 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dubas25,000 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.
• 1. 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 symptoms are the same as yours.
• If you experience 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.

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

Dubas is indicated in adults.

2. What you need to know before you take Dubas

Do not takeDubas

• 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 suffer from 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 suffer from kidney disease (renal insufficiency) (see section "Warnings and precautions").

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Dubas.

• If you need to follow a treatment with Colecalciferol for a long 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, calcium levels in the blood and urine should be checked. If you are taking medications that contain vitamin D, vitamin D-enriched foods, or vitamin D-enriched milk.
• If you suffer from a chronic inflammatory disease that can affect all organs called sarcoidosis.
• If you suffer from renal function impairment, vitamin D levels in the body may be altered.
• If you tend 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 medicine for a long time, 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 increased dose as indicated in section 3 "How to take Dubas" may be necessary:

• If you are receiving treatment with medications for epilepsy (anticonvulsants or barbiturates).
  • If you are receiving treatment with medications for inflammation (corticosteroids).
  • If you are receiving treatment with medications to reduce blood fat levels (cholestyramine, colestipol, orlistat, and laxatives such as paraffin oil).
  • If you are receiving treatment with medications to reduce stomach acid production (antacids containing aluminum).
  • If you suffer from obesity.
  • If you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis, or mucoviscidosis).
  • If you suffer from liver disease (liver insufficiency).

Children

Dubas should not be administered to babies and children 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 medicines, as they may reduce or increase the effect of Colecalciferol:

• Other medicines that contain vitamin D.
• Medicines used to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, primidone, etc.
• Medicines to reduce blood fat levels, such as cholestyramine, colestipol, orlistat, and laxatives (such as paraffin oil).
• Antacids that contain aluminum, medications to treat excess stomach acid that can rise to the esophagus.
• Thiazide diuretics, medications to treat high blood pressure, increasing 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.
• Medications for the heart (cardiac glycosides) because they need to be monitored by a doctor, perform an ECG if necessary, and monitor calcium levels.

Taking Dubas with food and beverages and alcohol

Consult your doctor if you are taking other products that contain vitamin D, vitamin D-enriched foods, 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.

Dubas should not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical conditions necessarily require treatment with Colecalciferol in 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 the lack of vitamin D is harmful to 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 baby.

Driving and using machines

Colecalciferol has no influence or insignificant 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 this medicine with food.

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 should consider a lower maintenance dose depending on your condition.

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

If you take moreDubas than you should

If you accidentally take more than the prescribed dose of Colecalciferol, tell your doctor immediately or go to the nearest hospital. In case of overdose, there may be an increase in calcium levels in the blood and urine, whose symptoms are the following: nausea, vomiting, thirst, intense thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.

Other symptoms of overdose are the following:

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

Chronic excessive overdoses can lead to 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 the newborn.

In case of overdose or accidental ingestion, consult the Toxicology Information Service.

Phone 91 562 04 20.

If you forget to take Dubas

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

If you stop takingDubas

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

Dubascontains glycerol

May cause headache, stomach upset, and diarrhea.

May cause allergic reactions.

4. Possible side effects

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

The side effects associated with the use of vitamin D are the following:

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

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

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

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

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

Headache, too much 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System of Medicines 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 Dubas

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 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.

Store below 25°C.

Store in the original package to protect from light.

Do not freeze.

6. Contents of the pack and further information

Composition ofDubas

• The active substance is Colecalciferol (Vitamin D3). Each soft capsule contains: Colecalciferol (Vitamin D3) 0.625 mg corresponding to 25,000 IU.
• The other ingredients are:

Excipients: refined olive oil, butylhydroxytoluene (E321) Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin, and Allura Red (E129).

Appearance of the product and pack contents

The pack contains 1, 2, 4 capsules in a PVC/PVDC and aluminum blister pack, enclosed in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder

Pharmacare Srl

Via Marghera, 29

20149 Milan

Italy

Manufacturer

DOPPEL FARMACEUTICI S.r.l.

Via Martiri delle Foibe, 1

29016 Cortemaggiore (PC)

Italy

This medicine is authorised in the Member States of the EEA under the following names:

Malta: DUBAS 25,000 IU soft capsules

Spain: DUBAS 25,000 IU soft capsules

Date of last revision of this leaflet: November 2022

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/