Leaflet: information for the user

Thorens 10.000UI/ml oral drops in 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 drops solution contain colecalciferol (vitamin D3). Vitamin D3can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes the absorption of calcium in the kidneys and intestine, aiding in bone formation. Vitamin D deficiency is the main cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Thorens oral drops solution is used to prevent and treat vitamin D3deficiency in adults, adolescents, and children with identified risk of vitamin D3deficiency.

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

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 D 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 D levels in the body).

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

-you are likely to take the sun while using Thorens.

-you take other supplements containing calcium. 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 should 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 a prolonged period.

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 indicated for the treatment of heart disease or kidney disease, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumetazide). When these medications are used at the same time as 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 diseases caused by fungi). 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 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, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Prolonged hypercalcemia should be avoided during pregnancy, as it can cause physical and mental developmental delays, aortic stenosis, and retinopathy in the child.

Driving and operating machinery

The information on possible effects of this medication on driving ability is limited. However, it is not expected to affect driving ability and the use of machinery.

Follow exactly the administration instructions of 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 taste of olive oil. 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. Make sure to take the complete dose.

Use in adults

The recommended dose forthevitamin D deficiencyand as a complement to specific medication for bone loss (osteoporosis) is 3-4 drops (600 IU - 800 UI) per day.

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

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

Use in children and adolescents

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

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

In children, Thorens can be mixed with a small amount of children's 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 consume completely uninterrupted, in order to avoid the child not taking the complete dose. Make sure the child takes the complete dose. In cases of children who have surpassed the lactation stage, the prescribed dose should be administered with some main meal.

Do not store any product or food containing Thorens for later use or for the next meal.

Use during pregnancy and lactation

The recommended dose is 400 UI/day (2 drops).You may need higher doses after confirming vitamin D deficiency, but do not take more than your doctor recommends.

Instructions for use of the bottle with independent dosing dropper:

The package contains a bottle and a child-resistant dropper cap. The bottle has a child-resistant cap. The dropper is protected by a plastic ring. To use the medication, shake the bottle before use and follow the instructions below:

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

b.Remove the plastic container that contains the dosing dropper (see Figure 2);

c.Insert the dropper cap into the bottle to extract the content. Put the prescribed number of drops in a spoon;

d.To close the bottle, remove the dosing dropper from the bottle and replace the original cap (see Figure 3);

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

f.Place both the bottle and the dosing dropper in their original box.

Instructions for use of the bottle with dosing dropper included:

The box contains a dosing dropper.

The bottle is closed by a child-resistant cap.

The following are the instructions for opening and using:

a.To open the bottle with the included dosing dropper, press and turn the plastic cap at the same time;

b.Place the bottle in a vertical position downwards and dispense the prescribed number of drops in a spoon;

c.Once the administration of the drops is finished, return the bottle with the included dosing dropper to a vertical position

d.To close the bottle with the included dosing dropper, screw the child-resistant cap back on

e.Place the bottle in the cardboard box of the original packaging.

If you take more Thorens than you should

Stop taking the medication and immediately call your doctor or pharmacist if you or your child take more of this medication than prescribed by your doctor. If it is not possible to speak with the doctor, go to the nearest hospital and bring the packaging with the medication.

You can also consult the Toxicological Information Service, phone 915620420, indicating the medication and the amount taken.

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

If you forgot to takeThorens

If you forget to take a dose of Thorens, take it as soon as possible. Then take the next dose at the usual time. However, if you are very 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 the 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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Store in the original packaging to protect it from light.

Do not refrigerate or freeze.

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

Do not use this medication if you observe any visible sign of deterioration, such as turbidity in the solution.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Thorens

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

Appearance of Thorens and contents of the packaging

Thorens10,000UI/ml oral drops in solutionis a transparent, colorless to yellow-green oily oral solution, without visible solid particles and/or precipitates. It is presented in:

• Bottlewith a separate dosing dropper

Bottleof topaz-colored glass of 20 ml with a child-resistant cap.

Each package contains a topaz-colored glass bottle containing 10ml of solution (corresponding to 500 drops) and a dropper, with CE marking 0068.

• Bottle with dosing dropper included

Bottle of 20 ml with a dosing dropper included and closed with a child-resistant cap.

Each package contains a dosing dropper included) to dispense the 10 ml of solution (corresponding to 500 drops).

Not all presentations may be available on the market

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

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 10,000 UI/ml oral drops in 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

Last review date of this leaflet:April 2021

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