THORENS 10,000 IU/mL ORAL DROPS IN SOLUTION

Introduction

Package Leaflet: Information for the User

Thorens 10,000UI/ml Oral Drops in Solution

colecalciferol (vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What Thorens is and what it is used for

Thorens oral drops in solution contain 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 D helps the body absorb calcium in the kidneys and intestines, which helps form bones. A deficiency of vitamin D is the main cause of rickets (poor bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Thorens oral drops in solution are used to prevent and treat vitamin D3 deficiency in adults, adolescents, and children with an identified risk of vitamin D3 deficiency.

Thorens oral drops in solution can also be used as an adjunct to specific medication for bone loss.

2. What you need to know before you take Thorens

Do not takeThorens

• if you are allergic to vitamin D3 or any of the other ingredients of this medicine (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 failure;
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before taking Thorens if

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

• you have sarcoidosis (an autoimmune disease that can cause increased levels of vitamin D in the body).
• you are being treated with medicines that contain vitamin D, or you are taking foods or milk enriched with vitamin D.
• you are likely to take the sun while using Thorens.
• you are taking other supplements that contain calcium. 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 should 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 a prolonged period.

UsingThorenswith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is especially important if you are taking:

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

• medicines that contain vitamin D3 or foods rich in vitamin D3, such as some types of milk enriched with vitamin D3.
• actinomycin (a medicine used to treat some types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medicines used to treat fungal diseases). These medicines can interfere with the processing of vitamin D3 in the body.
• the following medicines, because they may interfere with the effect or absorption of vitamin D3:
  • antiepileptic medicines (anticonvulsants), barbiturics;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
  • medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol);
  • certain medicines used to lose weight 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 drops 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Thorens should be taken during pregnancy and breastfeeding only under the recommendation of your doctor.

Vitamin D overdoses should be avoided during pregnancy, as prolonged hypercalcemia can cause physical and mental developmental delays, supravalvular aortic stenosis, and retinopathy in the child.

Driving and using machines

Information on the possible effects of this medicine on the ability to drive is limited. However, it is not expected to affect your ability to drive or use machines.

3. How to take Thorens

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

Shake before use.

Thorens should be taken preferably with the main meals.

This medicine has an olive oil flavor. Thorens can be taken alone or by mixing the prescribed number of drops with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the complete dose.

Use in adults

Recommended doses for vitamin D deficiencyand as a complement to specific medication for bone loss (osteoporosis) are 3-4 drops (600 IU - 800 IU) per day.

For the treatment of vitamin D deficiency, the dose is usually 4 drops (800 IU) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment.

The daily dose should not exceed 4,000 IU (20 drops per day).

Use in children and adolescents

For the prevention of vitamin D deficiency in children (from 0 to 11 years) with an identified risk, the recommended dose is 2 drops (400 IU) per day. For the prevention in adolescents (from 12 to 18 years) with an identified risk, the recommended dose is 3-4 drops (600-800 IU) per day.

For the treatment of vitamin D deficiency in children (from 0 to 11 years) and adolescents (from 12 to 18 years), the dose should be adjusted depending on the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment. The daily dose should not exceed 1,000 IU per day for children under 1 year, 2,000 IU per day for children from 1 to 10 years, and 4,000 IU per day for adolescents.

In children, Thorens can be mixed with a small amount of baby food, yogurt, milk, cheese, or other dairy products. Do not add Thorens to baby bottles or other containers with food that the child will not ingest completely and continuously, to avoid the child not taking the complete dose. You must ensure that the child takes the complete dose. In cases of children who have passed the breastfeeding stage, the prescribed dose should be administered with some main meal.

Do not store any product or food that contains Thorens for later use or in the next meal.

Use during pregnancy and breastfeeding

The recommended dose is 400 IU/day (2 drops). Higher doses may be necessary after confirmation of vitamin D deficiency, but do not take more than your doctor recommends.

Instructions for use of the bottle with independent dropper:

The pack contains a bottle and a dropper. The bottle is closed with a child-resistant cap. The dropper is protected by a plastic ring. To use the medicine, shake the bottle before use and follow the instructions below:

• to open the bottle, press the plastic cap down and turn it at the same time (see Figure 1);

• unscrew the plastic container that contains the dropper (see Figure 2);

• insert the dropper into the bottle to extract the contents. Put the prescribed number of drops into a spoon;

• to close the bottle, remove the dropper from the bottle and put the original cap back on the bottle (see Figure 3);

• Carefully return the dropper to its plastic container and screw it back on.

• Place both the bottle and the dropper in their original box.

Instructions for use of the bottle with included dropper:

The box contains a dropper.

The bottle is closed with a child-resistant cap.

The following are the instructions for opening and use:

• to open the bottle with the included dropper, press and turn the plastic cap at the same time;

• place the bottle in a vertical position and dispense the prescribed number of drops into a spoon;

• once the administration of the drops is complete, return the bottle with the included dropper to a vertical position

• to close the bottle with the included dropper, screw the child-resistant cap back on

• place the bottle in the original carton box.

If you take more Thorens than you should

Stop taking the medicine and contact your doctor or pharmacist immediately if you or your child take more of this medicine than prescribed by your doctor. If it is not possible to talk to your doctor, go to the nearest hospital and take the medicine package with you.

You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

The most frequent symptoms in case of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, dehydration, and high levels of calcium in blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

If you forget to takeThorens

If you forget to take a dose of Thorens, take the next one as soon as possible. Then 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 instead.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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
• itching
• hives.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Thorens

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

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

Do not store above 30°C.

Store in the original package to protect from light.

Do not refrigerate or freeze.

After the first opening of the package, the product can be stored for a maximum period of 6 months.

Do not use this medicine if you notice any visible signs of deterioration, such as turbidity in the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Thorens

• The active substance is colecalciferol (vitamin D3). 1 ml of oral solution (50 drops) contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 0.25 mg. 1 drop contains 200 IU of colecalciferol (vitamin D3).
• The other ingredients are: olive oil.

Appearance of Thorens and contents of the pack

Thorens 10,000 IU/ml oral drops in solution is a clear, colorless to yellow-green oral solution, without visible solid particles and/or precipitates. It is available in:

• Bottle with an independent dropper

Brown glass bottle of 20 ml with a child-resistant cap.

Each pack contains a brown glass bottle containing 10 ml of solution (corresponding to 500 drops) and a dropper, marked with CE 0068.

• Bottle with included dropper

Brown glass bottle of 20 ml with an included dropper and closed with a child-resistant cap.

Each pack contains a bottle with an included dropper for dispensing 10 ml of solution (corresponding to 500 drops).

Not all pack sizes may be available in your country.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Effik, S.A.

c/ San Rafael, 3

28108 Alcobendas, Madrid

Manufacturer

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa (Italy)

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

Spain: THORENS 10,000 IU/ml oral drops, solution

UK: THORENS 10,000 IU/ml oral drops, solution

Ireland: THORENS 10,000 IU/ml oral drops, solution

Belgium: THORENS 10,000 IU/ml oral drops, solution

Germany: THORENS 10,000 IU/ml oral drops, solution

Netherlands: THORENS 10,000 IU/ml oral drops, solution

Norway: THORENS 10,000 IU/ml oral drops, solution

Poland: THORENS 10,000 IU/ml oral drops, solution

Portugal: THORENS 10,000 IU/ml oral drops, solution

Sweden: THORENS 10,000 IU/ml oral drops, solution

Date of the last revision of this leaflet:April 2021

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