Thorens

Package Leaflet: Information for the User

THORENS, 25,000 IU, Hard Capsules

Cholecalciferol (Vitamin D)

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• -Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed 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 pack and other information

1. What is THORENS and what is it used for

THORENS hard capsules contain the active substance 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 formation. A deficiency of vitamin D is the main cause of rickets (impaired bone mineralization in children) and osteomalacia (insufficient bone mineralization in adults). THORENS hard capsules are used to treat clinically significant vitamin D deficiency in adults.

2. Important information before taking THORENS

When not to take THORENS:

• if the patient is allergic to vitamin D or any of the other ingredients 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 dysfunction;
• if the patient has elevated vitamin D levels in the blood (hypervitaminosis D).

Warnings and precautions

Before taking this medicine, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient is taking certain heart medications (e.g., cardiac 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 diuretics (e.g., thiazides);
• the patient is immobilized;
• the patient has pseudohypoparathyroidism;
• the patient is taking vitamin D supplements or consuming foods enriched with vitamin D;
• there is a possibility of exposure to strong sunlight during THORENS treatment;
• the patient is taking additional calcium supplements. During THORENS treatment, the doctor will monitor calcium levels in the blood to ensure they are not too high;
• the patient has kidney damage or disease, or is prone to kidney stone formation. The doctor may want to measure calcium levels in the blood or urine;
• the patient has been taking high doses of vitamin D (over 1000 IU per day) for a long time. In this case, the doctor should monitor calcium levels in the blood through laboratory tests.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

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:

• heart or kidney medications, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When taken with vitamin D, these medicines may cause a significant increase in calcium levels in the blood and urine;
• vitamin D supplements or foods enriched with vitamin D, such as certain types of vitamin D-enriched milk;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal medicines (e.g., clotrimazole and ketoconazole, used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D;
• tuberculosis medications, such as rifampicin and isoniazid;
• the following medicines, as they may interfere with the action or absorption of vitamin D:
• antiepileptic medicines (anticonvulsants), barbiturates;
• glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone). They may reduce the effectiveness of vitamin D;
• cholesterol-lowering medicines (such as cholestyramine or colestipol);
• certain weight loss medicines that reduce fat absorption (e.g., orlistat);
• certain laxatives (e.g., liquid paraffin).

Taking THORENS with food, drink, and alcohol

This medicine should be taken with food to support the absorption of vitamin D by the body.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. This high-dose medicine is not recommended for use in pregnant or breastfeeding women.

Driving and using machines

There is limited information on the possible effects of this medicine on the ability to drive or operate machines. However, it is not expected to affect the ability to drive or operate machines.

3. How to take THORENS

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The capsule should be swallowed whole (e.g., with water). THORENS is best taken with food.

Adults

The recommended dose is one capsule of 25,000 IU per week for the first month. After the first month of treatment, smaller doses may be considered. After this initial treatment, maintenance therapy may be started, as directed by the doctor. The doctor will adjust the dose for the patient.

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Pregnancy and breastfeeding

This medicine is not recommended for pregnant or breastfeeding women.

Overdose of THORENS

In case of overdose, the patient should stop taking the medicine and contact their doctor. If it is not possible to contact the doctor, the patient should go to the nearest hospital emergency department and take the medicine packaging with them. The most common symptoms of overdose are: nausea, vomiting, excessive thirst, production of large amounts of urine per day, constipation, and dehydration, high calcium levels in the blood and urine (hypercalcemia and hypercalciuria) shown in laboratory tests.

Missing a dose of THORENS

In case of a missed dose, the patient should take the missed dose as soon as possible. Then, they should take the next dose at the usual time. However, if the time for the next dose is near, the patient should not take the missed dose, but 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 further doubts about taking 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 side effects(occurring in less than 1 in 100 people)

• high calcium levels in the blood (hypercalcemia)
• high calcium levels in the urine (hypercalciuria)

Rare side effects(occurring in less than 1 in 1000 people)

• skin rash
• itching
• hives

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store THORENS

Keep the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date refers to the last day of the month stated. Do not store above 30°C. Store in the original packaging to protect from light. Do not freeze. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What THORENS contains

• The active substance is cholecalciferol (vitamin D). One capsule contains: 0.625 mg cholecalciferol (vitamin D), equivalent to 25,000 IU.
• Other ingredients are:
• purified olive oil,
• gelatin,
• titanium dioxide (E 171),
• yellow iron oxide (E 172),
• black iron oxide (E 172).

What THORENS looks like and contents of the pack

THORENS 25,000 IU is a hard capsule with a transparent body and white cap, with a green band. The capsule size is 15.9 mm x 5.8 mm. The capsule contains an oily solution and is supplied in aluminum-PVC/PVDC blisters in cardboard boxes. The box contains 3, 4, 8, 12, or 40 capsules. 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 IE hard capsules, Norway: Deltius 25,000 I.E. hard capsules, Belgium: Thorens 25,000 UI hard capsules, United Kingdom: Thorens 25,000 I.U hard capsules, Germany: Thorens 25,000 IE hard capsules, Ireland: Thorens 25,000 I.U hard capsules, Netherlands: Thorens 25,000 IE hard capsules, Spain: Thorens 25,000 IE hard capsules, Portugal: Thorens 25,000 IE hard capsules

Date of last revision of the leaflet: 10.03.2022

Other sources of information

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