COLECALCIFEROL ROVI 30,000 IU FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Colecalciferol Rovi 30000 IU Film-Coated Tablets

colecalciferol (vitamin D3)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Colecalciferol Rovi and what is it used for
2. What you need to know before taking Colecalciferol Rovi
3. How to take Colecalciferol Rovi
4. Possible side effects
5. Storage of Colecalciferol Rovi
6. Package Contents and Additional Information

1. What is Colecalciferol Rovi and what is it used for

The active ingredient of Colecalciferol Rovi film-coated tablets is vitamin D3.

Vitamin D can be found in some foods and is produced by the body when the skin is exposed to sunlight. Your doctor may prescribe you Colecalciferol Rovi to treat severe vitamin D deficiency. Vitamin D deficiency can occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires more vitamin D. Colecalciferol Rovi is indicated in adults.

Colecalciferol Rovi is indicated in adults and the elderly.

2. What you need to know before taking Colecalciferol Rovi

Do not take Colecalciferol Rovi:

• if you are allergic to vitamin D or any of the other ingredients of this medication (listed in section 6),
• if you have high levels of calcium in the blood or urine,
• if you have kidney stones or calcium deposits in the kidneys,
• if you have severe kidney failure,
• if you are already taking additional doses of vitamin D (e.g., multivitamins or dietary supplements containing vitamin D).
• if you are under 18 years old.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take colecalciferol:

• if you have a tendency to form kidney stones
• if you have cancer or any other condition that may affect your bones
• if you have a parathyroid hormone imbalance (pseudo-hypoparathyroidism)

If any of the following situations apply to you, your doctor will monitor your calcium or phosphate levels in the blood, or your calcium levels in the urine:

• If you are taking this medication for a prolonged period,
• If you have kidney problems,
• If you have sarcoidosis, an immune system disease that can affect the liver, lungs, skin, or lymph nodes.

Use of colecalciferol with other medications

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

In particular, inform your doctor if you are taking any of the following medications:

• diuretics (water pills) - your calcium levels in the blood will be regularly monitored;
• corticosteroids (e.g., prednisolone, dexamethasone) - your vitamin D dose may need to be increased;
• cholestyramine (a medication to lower cholesterol) or laxatives (e.g., paraffin oil) - reduce the absorption of vitamin D;
• heart medications (cardiac glycosides) - you should be monitored by a doctor and possibly your ECG and calcium levels in the blood should be checked;
• anticonvulsants (for the treatment of epilepsy), sleeping pills (e.g., hydantoin, barbiturates), or primidone - these reduce the effects of vitamin D;
• medications containing high doses of calcium: may increase the risk of high calcium levels in the blood;
• medications containing high doses of phosphorus - may increase the risk of high phosphate levels in the blood;
• orlistat (a medication to help with weight loss) - reduces the absorption of vitamin D.

Pregnancy, Breastfeeding, and 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 medication.

If you are breastfeeding, your doctor will monitor your calcium and phosphate levels in the blood, or your calcium levels in the urine.

Driving and Using Machines

There are no known effects on the ability to drive or use machines.

Colecalciferol Rovi contains lactose and sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Colecalciferol Rovi

Follow the administration instructions of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The tablets can be taken with or without food.

Dose

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

Recommended dose:

1 tablet of Colecalciferol Rovi 30000 IU per week. After the first month, lower doses may be considered.

After this initial treatment, maintenance treatment with a dose determined by your doctor may be necessary. Additionally, national recommendations for vitamin D treatment may be followed.

Patients with kidney problems

Your doctor may establish routine blood and/or urine tests.

Use in children

Colecalciferol Rovi is not recommended in children under 18 years old.

If you take more Colecalciferol Rovi than you should

You may develop the following symptoms: loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, frequent urination, bone pain, kidney problems, and in severe cases, irregular heartbeats, coma, or even death.

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 medication and the amount ingested.

If you forget to take Colecalciferol Rovi

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You should stop taking colecalciferol and consult your doctor immediately 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(affect 1 in 100 people):

• Excess calcium in the blood (hypercalcemia) - symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness, and confusion.
• Excess calcium in the urine (hypercalciuria).

Rare(affect 1 in 1,000 people):

• Itching, rash, and hives.

Reporting side effects:

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

5. Storage of Colecalciferol Rovi

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

Store below 25°C.

Store in the original package, protected from light.

Do not use this medication after the expiration date stated on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofColecalciferol Rovi

The active ingredient is colecalciferol (vitamin D3).

Each film-coated tablet contains 300 mg of colecalciferol concentrate (in powder form) (equivalent to 750 μg of colecalciferol = 30,000 IU of vitamin D3).

The other ingredients are:

• Core of the tablet: cellactose 80 (lactose monohydrate and cellulose powder (E-460 (ii)) modified starch, corn starch, croscarmellose sodium (E-468), sucrose, colloidal anhydrous silica (E-551), colloidal hydrated silica (E-551), magnesium stearate (E-572), sodium ascorbate (E-301), medium-chain triglycerides, DL-alpha-tocopherol (E-307).
• Coating of the tablet: Opadry II yellow 85F 32659, consisting of: polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol, talc (E-553b), quinoline yellow (E-104), yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Film-coated tablet, yellow, round, 13.2 mm in diameter with a smooth convex surface on both sides.

Package: 1, 2, or 4 film-coated tablets in an opaque PVC/PVdC-aluminum blister pack, packaged in a box.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Manufacturer

Pharma Patent Ltd.

Váci út 36-38. 4. em

1132 Budapest

Hungary

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

Date of the last revision of this package leaflet:March 2023

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