Leaflet: information for the user

Thorens 25.000UI/2,5ml oral solution

colecalciferol (vitamin D3)

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

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

1.What Thorens is and for what it is used

2.What you need to know before starting to take Thorens

3.How to take Thorens

4.Possible side effects

5.Storage of Thorens

6.Contents of the pack and additional information

Thorens oral solution contains colecalciferol (vitamin D3) as its active ingredient. Vitamin D3can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D3promotes the absorption of calcium in the kidneys and intestines, aiding in bone formation. Deficiency of vitamin D3is the primary cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Thorens oral solution is used for the initial treatment of clinically relevant vitamin D deficiency in adults.

Do not takeThorens

-if you are allergic to vitamin D3 or any of the other components of this medication (listed in section 6);

-if you have high levels of calcium in your blood (hypercalcemia) or urine (hypercalciuria);

-if you have kidney stones (renal calculi) or severe kidney insufficiency;

-if you have high levels of vitamin D3 in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Thorens if

• you are being treated with certain medications for heart disease (e.g., cardiac glycosides, such as digoxin).

-you have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D3 levels in the body).

-you are being treated with medications containing vitamin D3, or you take foods or milk enriched with vitamin D.

-you are likely to be taking the sun while using this medication.

-you are taking additional calcium supplements. Your doctor should monitor your calcium levels to ensure they are not too high while you are taking Thorens.

-you have kidney disease or renal damage. Your doctor may monitor your calcium levels in your blood and urine.

Your doctor should monitor your calcium levels in your blood through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for an extended period.

Children and adolescents

Thorens is not recommended for use in children and adolescents under 18 years of age.

Use ofThorenswith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is especially important if you are taking:

• medications used to treat heart or kidney diseases, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetazide). When these medications are used with vitamin D3, they can cause a significant increase in calcium levels in your blood and urine.

-medications containing vitamin D3 or foods rich in vitamin D3, such as some types of milk enriched with vitamin D3.

-actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medications used to treat fungal diseases). These medications can interfere with the processing of vitamin D3 in your body.

-the following medications, as they may interfere with the effect or absorption of vitamin D3:

Use ofThorenswith foods, beverages, and alcohol

You should take Thorens preferably with one of your main meals to help with the absorption of vitamin D3. You can take it alone or mix the solution with cold or lukewarm food to facilitate administration. For more information, see section 3 "How to take Thorens".

Pregnancy, breastfeeding, and fertility

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

This presentation of Thorens is not recommended for use during pregnancy and breastfeeding due to its high dose of vitamin D3.

Driving and operating machinery

The information on possible effects of this medication on your ability to drive is limited. However, it is not expected that your ability to drive and operate machinery will be affected.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Shake before use.

Thorens should be taken preferably with main meals.

This medication has a mild olive oil flavor. Thorens can be taken alone or by mixing the solution with a small amount of cold or lukewarm food immediately before ingestion. Make sure to take the complete dose.

Adult Use

The recommended dose is 1 bottle (25,000 UI) per week during the first month. After the first month, continue with the maintenance dose recommended by your doctor.

Pediatric Population

Thorens 25,000 UI is not recommended for children and adolescents under 18 years of age.

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Pregnancy and Lactation

Thorens 25,000 UI is not recommended during pregnancy and lactation.

If You Take More Thorens Than You Should

Stop taking the medication and immediately call your doctor or pharmacist if you take more than the prescribed amount of this medication. If you cannot contact them, go to the nearest hospital emergency service and bring the medication packaging with you. You can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The most frequent symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for up to 24 hours, constipation, dehydration, and elevated levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) determined by clinical analysis.

If You Forget to TakeThorens

If you forget to take a dose of Thorens, take the missed dose as soon as possible and take the next dose at the usual time. However, if you are close to the time of the next dose, do not take the missed dose and instead take the next dose at the usual time.

Do not take a double dose to compensate for missed doses.

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

Like any other medication,this medicationmay cause adverse effects, although not all people will experience them.

The possible adverse effects associated with the use ofThorensmay be:

Rare (affect up to 1 in 1000 people):

-hypercalcemia (excess calcium in the blood);

-hypercalciuria (excess calcium in the urine).

Uncommon (affect up to 1 in 100 people):

-cutaneous rash

-pruritus

- 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.

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

Do not store at a temperature above 30°C.

Store the bottle in the outer packaging to protect it from light.

Do not refrigerate or freeze.

Do not use this medication if the solution appears cloudy.

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

What Thorens contains

• The active principle is colecalciferol (vitamin D3). A single-dose vial of 2.5ml oral solution contains 25,000 UI of colecalciferol (vitamin D3) equivalent to 0.625 mg. 1ml of oral solution contains 10,000UI of colecalciferol (vitamin D3), equivalent to 0.25mg.
• The other components are: olive oil.

Appearance of Thorens and contents of the packaging

Thorens 25,000 UI / 2.5 ml is a transparent, colorless to yellow-green oily solution, without visible solid particles and/or precipitates. It is presented in topaz-colored glass vials sealed with a plastic stopper.

Each package contains 1 or 4 single-dose vials containing 2.5ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Effik, S.A.

c/ San Rafael, 3

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa (Italy)

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:THORENS 25,000 UI/ml oral solution

UK:THORENS 25,000 IU/ml oral solution

Ireland:THORENS 25,000 IU/ml oral solution

Belgium: THORENS 25,000 IU/ml oral solution

Germany: THORENS 25,000 IU/ml oral solution

Netherlands: THORENS 25,000 IU/ml oral solution

Norway: THORENS 25,000 IU/ml oral solution

Poland: THORENS 25,000 IU/ml oral solution

Portugal: THORENS 25,000 IU/ml oral solution

Sweden: THORENS 25,000 IU/ml oral solution

Last review date of this leaflet:January 2018

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