THORENS 25,000 IU/2.5 ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Thorens 25,000UI/2.5ml Oral Solution

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, consult 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What Thorens is and what it is used for

Thorens oral solution contains the active ingredient colecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D3 promotes calcium absorption in the kidneys and intestines, helping to form bone. A deficiency of vitamin D3 is the main 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.

2. What you need to know before taking Thorens

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 the blood (hypercalcemia) or urine (hypercalciuria);
• if you have kidney stones (renal calculi) or severe kidney failure;
• if you have high levels of vitamin D3 in the blood (hypervitaminosis D).

Warnings and Precautions

Consult your doctor or pharmacist before taking Thorens if

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

• you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D3 in the body).
• you are being treated with medications that contain vitamin D3, or you are taking foods or milk enriched with vitamin D.
• you are likely to be exposed to the sun while using this medication.
• you are also taking calcium supplements. Your doctor should monitor your calcium levels to ensure they are not too high during your treatment with Thorens.
• you have kidney disease. Your doctor may need to monitor your blood and urine calcium levels.

Your doctor should monitor your blood calcium levels 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.

UsingThorenswith Other Medications

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

• medications for heart or kidney conditions, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in blood and urine calcium levels.

• medications that contain 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 infections). These medications can interfere with the processing of vitamin D3 in the body.
• the following medications, as they may interfere with the effect or absorption of vitamin D3:
  • antiepileptic medications (anticonvulsants), barbiturics;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
  • medications that lower cholesterol levels in the blood (such as cholestyramine or colestipol);
  • certain medications used for weight loss by reducing fat absorption (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

UsingThorenswith Food, Drinks, and Alcohol

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

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.

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

Driving and Using Machines

Information on the possible effects of this medication on the ability to drive is limited. However, it is not expected that your ability to drive and use machines will be affected.

3. How to Take Thorens

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Shake before use.

Thorens should be taken preferably with the main meals.

This medication has a mild olive oil flavor. Thorens can be taken alone or mixed with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the complete dose.

Use in Adults

The recommended dose is 1 vial (25,000 IU) per week for the first month. After the first month, continue with the maintenance dose recommended by your doctor.

Pediatric Population

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

.

Pregnancy and Breastfeeding

Thorens 25,000 IU is not recommended during pregnancy and breastfeeding.

If You Take More Thorens Than You Should

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

The most common symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, dehydration, and high 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 it is close to the time of the next dose, do not take the missed dose and take the next dose at the usual time.

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

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

4. Possible Side Effects

Like any other medication, this medication can cause side effects, although not everyone will experience them.

The possible side effects associated with the use of Thorens may be:

Uncommon (affect up to 1 in 100 people):

• excess calcium in the blood (hypercalcemia);
• excess calcium in the urine (hypercalciuria).

Rare (affect up to 1 in 1,000 people):

• skin rash
• pruritus
• urticaria.

Reporting Side Effects

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

5. Storage of Thorens

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

Do not use this medication after the expiration date stated on the vial and carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep the vial 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

What Thorens Contains

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

Appearance of Thorens and Package Contents

Thorens 25,000 IU / 2.5 ml is a clear, colorless to yellow-green oily solution, without visible solid particles and/or precipitates. It is presented in amber glass vials sealed with a plastic cap.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Effik, S.A.

c/ San Rafael, 3

28108 Alcobendas, Madrid (Spain)

Manufacturer

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa (Italy)

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

Spain: THORENS 25,000 IU/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

Date of the Last Revision of this Package Leaflet:January 2018

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