THORENS

Package leaflet: Information for the user

THORENS, 25,000 IU, hard capsules
Cholecalciferol (vitamin D )
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the 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. How to store THORENS
6. Contents of the pack and other information

1. What THORENS is and what it is used for

THORENS hard capsules contain the active substance cholecalciferol (vitamin D ). Vitamin D
is found in certain foods and is also produced by the body when the skin is exposed to sunlight.
Vitamin D helps the absorption of calcium in the kidneys and intestines and supports the formation of bone tissue. A deficiency of vitamin D is the main cause of rickets (impaired bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).
THORENS hard capsules are used for the initial treatment of clinically significant vitamin D deficiency in adults.

2. Important information before using THORENS

When not to use 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 in the urine (hypercalciuria);
• if the patient has kidney stones (nephrolithiasis) or severe kidney function disorders;
• if the patient has elevated vitamin D levels in the blood (hypervitaminosis D).

Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor, pharmacist or nurse if:

• the patient is taking certain medicines used to treat heart conditions (e.g. cardiac glycosides such as digoxin);
• the patient has sarcoidosis (an immune system disorder which may cause increased vitamin D levels in the body);
• the patient is taking diuretics (e.g. so-called thiazides);
• the patient is immobilized;
• the patient suffers from pseudohypoparathyroidism;
• the patient is taking medicines containing vitamin D or consuming foods or milk fortified with vitamin D;
• the patient may be exposed to strong sunlight during treatment with THORENS;
• the patient is taking additional calcium-containing supplements. During treatment with THORENS, the doctor will monitor calcium levels in the blood to ensure they are not too high;
• the patient has damaged or diseased kidneys, or is prone to developing kidney stones. The doctor may wish to measure calcium levels in blood or urine;
• the patient has been taking a daily dose of vitamin D exceeding 1000 IU for a prolonged period. In such cases, the doctor should monitor blood calcium levels through laboratory tests.

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

THORENS and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take. This is particularly important if the patient is taking:

• medicines affecting the heart or kidneys, such as cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumethiazide). When used concomitantly with vitamin D, these medicines may cause a significant increase in calcium levels in blood and urine;
• medicines containing vitamin D or foods rich in vitamin D, such as certain types of vitamin D-fortified milk;
• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungal medicines (e.g. clotrimazole and ketoconazole, used to treat fungal infections). These medicines may interfere with the way vitamin D is processed in the body;
• medicines used to treat tuberculosis, e.g. rifampicin, isoniazid;
• the following medicines, because they may interfere with the action or absorption of vitamin D:
  • anticonvulsants (antiepileptic drugs), barbiturates;
  • glucocorticosteroids (steroid hormones, such as hydrocortisone or prednisolone). These 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 (such as liquid paraffin).

Taking THORENS with food, drink and alcohol
This medicine should preferably be taken with food to enhance the absorption of vitamin D by the body.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This high-dose formulation is not recommended for use in pregnant or breastfeeding women.

Driving and using machines
There is limited information on the possible effect of this medicine on the ability to drive. However, it is not expected that this medicine will affect the ability to drive vehicles or operate machinery.

3. How to use the medicine THORENS

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The capsule should be swallowed whole (e.g. with water).
THORENS medicine should preferably be taken during a meal.
Use in adults
The recommended dose is one capsule of 25,000 IU once weekly for the first month. After the first month of treatment, lower doses may be considered.
Following this initial treatment, maintenance therapy may be initiated, according to the doctor's recommendations.
The doctor will adjust the dose for the patient.
Children and adolescents
The use of THORENS 25,000 IU medicinal product is not recommended in children and adolescents under 18 years of age.
Pregnancy and breastfeeding
The use of the THORENS 25,000 IU medicinal product is not recommended.
Taking more THORENS medicine than recommended
If more medicine has been taken than recommended, stop taking the medicine and contact a doctor. If it is not possible to contact a doctor, go to the nearest hospital emergency department and take the medicine packaging with you.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production over 24 hours, constipation and dehydration, high calcium levels in blood and urine (hypercalcaemia and hypercalciuria) detected in laboratory tests.
Missed dose of THORENS medicine
If a dose of THORENS medicine is missed, take the missed dose as soon as possible. Then take the next dose at the regular time. However, if it is almost time for the next dose, do not take the missed dose; instead, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions may include:
Uncommon adverse reactions (occurring in fewer than 1 in 100 people)

• too much calcium in the blood (hypercalcaemia)
• too much calcium in the urine (hypercalciuria)

Rare adverse reactions (occurring in fewer than 1 in 1,000 people)

• skin rash
• itching
• urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 pack after:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
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. Ask your pharmacist how to dispose of medicines no longer in use. 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.
• The other ingredients are:
• refined 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 a white cap, with a green band. The capsule measures 15.9 mm x 5.8 mm. The capsule contains an oily solution and is supplied in aluminium-PVC/PVDC blisters packed in cardboard boxes.
The pack contains 3, 4, 8, 12 or 40 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Sweden Deltius 25,000 IU capsules, hard
Norway Deltius 25,000 I.E. capsules, hard
Belgium Thorens 25,000 UI capsules dures
United Kingdom Thorens 25,000 I.U. capsules, hard
Germany Thorens 25,000 IE Hartkapseln
Ireland Thorens 25,000 I.U. capsules, hard
Netherlands Thorens 25,000 IE capsules, hard
Spain Thorens 25,000 IE cápsulas, duras
Portugal Thorens 25,000 IE cápsulas, duras
Other sources of information
Detailed information on this medicinal product is available on the website of the Agency for the Registration of Medicinal Products, Medical Devices and Biocidal Products.