Prospect: information for the user

Colecalciferol Rovi 30000 UI coated tablets

colecalciferol (vitamin D3)

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Colecalciferol Rovi

4.Possible adverse effects

5.Storage of Colecalciferol Rovi

6. Contents of the package and additional information

The active ingredient of Colecalciferol Rovi 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 Colecalciferol Rovi to treat severe vitamin D deficiency. Vitamin D deficiency can occur when your diet or lifestyle do not provide enough vitamin D or when your body requires more vitamin D. Colecalciferol Rovi is indicated for adults.

Colecalciferol Rovi is indicated for adults and the elderly.

Do not take Colecalciferol Rovi:

• if you are allergic to vitamin D or any of the other components of this medication (listed in section 6),
• if you have high levels of calcium in your blood or urine,
• if you have kidney stones or calcium deposits in your kidneys,
• if you have severe kidney failure,
• if you are already taking additional doses of vitamin D (for example, 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 hormone parathyroid imbalance (pseudohipoparathyroidism)

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

• if you are on prolonged treatment with this medication,
• 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

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

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

• diuretics (water-removing tablets) – your calcium levels in blood will be regularly monitored;
• corticosteroids (‘steroids’ for example: prednisolone, dexamethasone) – you may need to increase your vitamin D dose;
• colestiramine (cholesterol-lowering medication) or laxatives (for example, paraffin oil) - reduce vitamin D absorption;
• heart medications(cardiac glycosides) – you should be monitored by a doctor and possibly your ECG and calcium levels in blood, should be controlled;
• anticonvulsants (for epilepsy treatment), sleep medications (for example, 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 blood;
• medications containing high doses of phosphorus – may increase the risk of high phosphate levels in blood;
• orlistat (weight loss medication) – reduces vitamin D absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

No known effects on the ability to drive or operate machinery.

Colecalciferol Rovi contains lactose and saccharose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, 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 your response to treatment.

Recommended dose:

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

After this initial treatment, you may need maintenance treatment with a dose determined by your doctor. Additionally, follow national recommendations for vitamin D treatment.

Patients with kidney problems

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

Use in children

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

If you take more Colecalciferol Rovi than you should

You may experience 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Colecalciferol Rovi

Do not take a double dose to make up for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

You should discontinue colecalciferol intake and consult your doctor immediately if you experience severe allergic reaction symptoms, such as:

• Swelling of the face, lips, tongue, or throat.
• Difficulty swallowing.
• Urticaria and difficulty breathing.

Infrequent(affects 1 in 100 people):

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

Rare(affects 1 in 1,000 people):

• Pruritus, rash, and urticaria.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication..

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

Store below 25°C.

Store in the original packaging to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofColecalciferol Rovi

The active ingredient is colecalciferol (vitamin D3).

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

The other components are:

• Tablet core: Cellactose 80 (lactose monohydrate and cellulose in powder(E-460 (ii))modified starch, cornstarch, croscarmellose sodium(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 package

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 a PVC/PVdC-aluminum opaque blister pack, packaged in a box.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Farmacéuticos Rovi, S.A.

Julián Camarillo, 35

28037 Madrid

Spain

Responsible 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 with the following names:

Last review date of this leaflet:March 2023

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/