Thorens

Leaflet included in the packaging: information for the user

THORENS, 25,000 IU/2.5 ml, oral solution

Cholecalciferol (Vitamin D)

You should carefully read the contents of the leaflet before using the medicine, because

it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you for a specific reason. Do not give it to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is THORENS and what is it used for
• 2. Important information before taking THORENS
• 3. How to take THORENS
• 4. Possible side effects
• 5. How to store THORENS
• 6. Contents of the packaging and other information

1. What is THORENS and what is it used for

THORENS oral solution contains cholecalciferol (Vitamin D). Vitamin D is found in some foods and is also produced by the body when the skin is exposed to sunlight. Vitamin D helps the body absorb calcium in the kidneys and intestines and supports bone tissue formation. A deficiency of Vitamin D is the main cause of rickets (disrupted bone mineralization in children) and osteomalacia (insufficient bone mineralization in adults). THORENS oral solution is used to treat clinically significant Vitamin D deficiency in adults.

2. Important information before taking THORENS

When not to take the medicine:

• if the patient is allergic to Vitamin D or any other component of this medicine (listed in section 6);
• if the patient has elevated calcium levels in the blood (hypercalcemia) or urine (hypercalciuria);
• if the patient has kidney stones (nephrolithiasis) or severe kidney disorders;
• if the patient has elevated Vitamin D levels in the blood (hypervitaminosis D).

Warnings and precautions

Before starting to take THORENS, the patient should discuss it with their doctor or pharmacist if:

• the patient is taking certain heart medications (e.g., digitalis glycosides, such as digoxin);
• the patient has sarcoidosis (an immune system disorder that can cause elevated Vitamin D levels in the body);
• the patient is taking medications containing Vitamin D or foods enriched with Vitamin D;
• there is a possibility of exposure to large amounts of sunlight during THORENS treatment;
• the patient is taking additional calcium supplements. In this case, the doctor will monitor the patient's blood calcium levels to ensure they are not too high during THORENS treatment;
• the patient has damaged or diseased kidneys. In this case, the doctor may decide to monitor the patient's blood or urine calcium levels;
• the patient has been taking Vitamin D for a long time in a daily dose exceeding 1000 IU (1000 international units). In this case, the doctor should monitor the patient's blood calcium levels through laboratory tests.

Children and adolescents

Using this medicine in children and adolescents under 18 years of age is not recommended.

THORENS and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important if the patient is taking:

• medicines that affect the heart or kidneys, such as digitalis glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). These medicines, when taken at the same time as Vitamin D, may cause a significant increase in blood and urine calcium levels;
• medicines containing Vitamin D or foods rich in Vitamin D, such as certain types of Vitamin D-enriched milk;
• actinomycin (a medicine used to treat certain types of cancer) and antifungal medicines that are imidazole derivatives (e.g., clotrimazole and ketoconazole - medicines used to treat fungal infections). These medicines may affect the chemical changes that Vitamin D undergoes in the body;
• the following medicines, as they may affect the effects of Vitamin D or its absorption:
• antiepileptic medicines (anticonvulsants), barbiturates;
• glucocorticoids (steroid hormones, including hydrocortisone and prednisolone). They may reduce the effects of Vitamin D;
• medicines that lower cholesterol levels in the blood (e.g., cholestyramine or colestipol);
• certain weight loss medicines that reduce the amount of fat absorbed from the gastrointestinal tract (e.g., orlistat);
• certain laxatives (e.g., liquid paraffin).

THORENS with food, drinks, and alcohol

This medicine is best taken during a large meal to support Vitamin D absorption by the body. To facilitate taking this medicine, the solution can be mixed with a small amount of cold or warm food. For more information, see section 3 "How to take THORENS".

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine. Using this high-strength preparation is not recommended in pregnant or breastfeeding women.

Driving and using machines

Information on the possible effect of this medicine on the ability to drive and use machines is limited. However, it is unlikely that this medicine will affect the ability to drive and use machines.

3. How to take THORENS

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. Before use, shake the bottle. THORENS is best taken during a meal. This medicine has the taste of olive oil. It can be taken in its original form, directly from the bottle, or mixed with a small amount of cold or warm food immediately before administration. The patient should ensure that the entire dose of the medicine is taken.

Administration to adults

The recommended dose is 1 bottle once a week for the first month of treatment, and then the dose will be determined by the doctor.

Children and adolescents

Using THORENS 25,000 IU in children and adolescents under 18 years of age is not recommended.

Pregnancy and breastfeeding

Using THORENS 25,000 IU is not recommended in pregnant or breastfeeding women.

Taking a higher dose of THORENS than recommended

In case of taking a higher dose of the medicine than prescribed, the patient should stop taking it and contact their doctor. If it is not possible to talk to the doctor, the patient should go to the emergency department of the nearest hospital, taking the leaflet included in the packaging of this medicine. The most common symptoms of overdose are: nausea, vomiting, increased thirst, increased urine production, constipation, and dehydration, elevated calcium levels in the blood and urine (hypercalcemia and hypercalciuria) confirmed by laboratory tests.

Missing a dose of THORENS

In case of missing a dose of THORENS, the patient should take it as soon as possible. The next dose should be taken at the usual time. However, if the time for the next dose is approaching, the patient should not take the missed dose, but only take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, THORENS can cause side effects, although not everybody gets them. Possible side effects may include:

Uncommon(in less than 1 in 100 people)

• excessive calcium in the blood (hypercalcemia)
• excessive calcium in the urine (hypercalciuria)

Rare(in less than 1 in 1000 people)

• skin rash
• itching
• hives

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in the leaflet, they should inform their doctor or pharmacist. Side effects can also be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store THORENS

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month stated. Do not store above 30°C. Do not refrigerate or freeze. Store the bottle in the outer packaging to protect it from light. Do not use this medicine if the solution is discolored. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What THORENS contains

• The active substance is cholecalciferol (Vitamin D).

A single-dose bottle of 2.5 ml oral solution contains 25,000 IU of cholecalciferol (Vitamin D), which corresponds to 0.625 mg. 1 ml of oral solution contains 10,000 IU of cholecalciferol (Vitamin D), which corresponds to 0.25 mg.

• The other ingredient is purified olive oil.

What THORENS looks like and what the packaging contains

THORENS 25,000 IU/2.5 ml, oral solution is a clear and colorless to greenish-yellow oily solution without visible particles and/or sediment. It is supplied in an orange glass bottle with a plastic cap. Each pack contains 1 or 4 bottles of 2.5 ml solution. Not all pack sizes may be marketed.

Marketing authorization holder

Italfarmaco S.p.A. Viale Fulvio Testi, 330, 20126 Milan, Italy

Manufacturer

Abiogen Pharma S.p.A. Via Meucci, 36 – Loc. Ospedaletto, 56121 Pisa, Italy, [email protected]

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

Sweden: Deltius 25,000 IU/2.5 ml oral solution, Norway: Deltius 25,000 I.E./2.5 ml mixture, solution, Belgium: Thorens 25,000 UI/2.5 ml, oral solution, United Kingdom: Thorens 25,000 I.U./2.5ml oral solution, Germany: Thorens 25,000 IE /2.5 ml solution for ingestion, Ireland: Thorens 25,000 I.U./2.5ml oral solution, Netherlands: Thorens 25,000 IE/2.5 ml drink, Spain: Thorens, Portugal: Thorens

Date of last revision of the leaflet:{MM/YYYY}

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.