Colecalciferol Rovi 30000 IU film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Colecalciferol Rovi 30000 IU film-coated tablets

colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Colecalciferol Rovi is and what it is used for
2. What you need to know before taking Colecalciferol Rovi
3. How to take Colecalciferol Rovi
4. Possible side effects
5. How to store Colecalciferol Rovi
6. Contents of the pack and other information

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

The active substance in Colecalciferol Rovi film-coated tablets is vitamin D3.

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

Colecalciferol Rovi is indicated in adults and elderly people.

2. What you need to know before starting to take Colecalciferol Rovi

Do not take Colecalciferol Rovi:

• if you are allergic to vitamin D or to any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium in your blood or urine,
• if you have kidney stones (calculi) or calcium deposits in the kidneys,
• if you have severe renal insufficiency,
• 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 of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting colecalciferol:

• if you are prone to developing kidney stones (calculi),
• if you have cancer or any other condition that may affect your bones,
• if you have a parathyroid hormone imbalance (pseudohypoparathyroidism).

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

• if you are receiving long-term treatment with this medicine,
• if you have kidney problems,
• if you have sarcoidosis, an immune system disorder that may affect the liver, lungs, skin, or lymph nodes.

Taking colecalciferol with other medicines

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

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

• diuretics (water tablets) – your blood calcium levels will be monitored regularly;
• corticosteroids (‘steroids’ e.g. prednisolone, dexamethasone) – your vitamin D dose may need to be increased;
• cholestyramine (a medicine to lower cholesterol) or laxatives (e.g. liquid paraffin) – these reduce vitamin D absorption;
• heart medicines (cardiac glycosides) – you must be monitored by a doctor and your ECG and blood calcium levels may need to be checked;
• anticonvulsants (for treatment of epilepsy), sleeping medicines (e.g. hydantoin, barbiturates) or primidone – these reduce the effects of vitamin D;
• medicines containing high doses of calcium – may increase the risk of high blood calcium levels;
• medicines containing high doses of phosphate – may increase the risk of high blood phosphate levels;
• orlistat (a medicine that helps weight loss) – reduces vitamin D absorption.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are breast-feeding, your doctor will monitor your blood calcium and phosphate levels, or your urinary calcium levels.

Driving and using machines

There are no known effects on the ability to drive or operate machinery.

Colecalciferol Rovi contains lactose and sucrose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Colecalciferol Rovi

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The tablets may be taken with or without food.

Dosage

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

Recommended dose:

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

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

Patients with kidney problems

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

Use in children

Colecalciferol Rovi is not recommended for children under 18 years of age.

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, increased urination, bone pain, kidney problems, and in severe cases, irregular heartbeat, coma, or even death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 missed doses.

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 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 (affects 1 in 100 people):

• Excess calcium in the blood (hypercalcemia) – symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, increased need to drink water, muscle weakness, drowsiness, and confusion.
• Excess calcium in the urine (hypercalciuria).

Rare (affects 1 in 1,000 people):

• Itching, rash, and hives.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colecalciferol Rovi

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

Store below 25°C.

Keep in the original packaging, to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Colecalciferol Rovi

The active substance is colecalciferol (vitamin D3).

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

The other components are:

• Tablet core: cellactose 80 (monohydrate lactose and powdered cellulose (E-460 (ii)), modified starch, corn starch, sodium croscarmellose (E-468), sucrose, anhydrous colloidal silica (E-551), hydrated colloidal silica (E-551), magnesium stearate (E-572), sodium ascorbate (E-301), medium-chain triglycerides, DL-alpha-tocopherol (E-307).
• Tablet coating: 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 contents of the pack

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

Pack: 1, 2 or 4 film-coated tablets in an opaque PVC/PVdC-aluminum blister pack, contained in a carton 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: March 2023

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