Package leaflet: Information for the user

THORENS, 25,000 IU/2.5 ml, oral solution
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 them even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What THORENS is and what it is used for
What you need to know before taking THORENS
How to take THORENS
Possible side effects
How to store THORENS
Contents of the pack and other information

1. What THORENS is and what it is used for
THORENS oral solution contains cholecalciferol (vitamin D_), a form of 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 bone tissue formation. Vitamin D_) deficiency is the main cause of rickets (impaired bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).
THORENS oral solution is used in the initial treatment of clinically significant vitamin D_) deficiency in adults.

2. What you need to know before taking THORENS
Do not take THORENS if:

you are allergic to vitamin D_) or any of the other ingredients of this medicine (listed in section 6);
you have elevated levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
you have kidney stones (nephrolithiasis) or serious kidney disorders;
you have elevated levels of vitamin D_) in your blood (hypervitaminosis D_).

Warnings and precautions
Before starting THORENS, discuss with your doctor or pharmacist if:

you are taking certain medicines used to treat heart conditions (e.g. cardiac glycosides such as digoxin);
you have sarcoidosis (an immune system disorder that may cause increased vitamin D_) levels in the body);
you are taking medicines containing vitamin D_) or consuming foods or milk fortified with vitamin D_);
you may be exposed to large amounts of sunlight during treatment with THORENS;
you are additionally taking calcium supplements. In such cases, your doctor will monitor your blood calcium levels to ensure they do not become too high during treatment;
you have impaired or diseased kidneys. In such cases, your doctor may decide to monitor calcium levels in your blood or urine;
you are taking vitamin D_) long-term at daily doses exceeding 1,000 IU (1,000 international units). In such cases, your doctor should monitor your blood calcium levels through laboratory tests.

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

THORENS with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take. This is especially important if you are taking:

medicines affecting the heart or kidneys, e.g. cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumethiazide). These medicines, when taken concurrently with 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_)–fortified milk;
actinomycin (a medicine used in the treatment of certain malignant tumours) and antifungal medicines that are imidazole derivatives (e.g. clotrimazole and ketoconazole – medicines used to treat fungal infections). These medicines may affect the metabolic processes of vitamin D_) in the body;
the following medicines, as they may affect the action or absorption of vitamin D_):
- antiepileptic drugs (anticonvulsants), barbiturates;
- glucocorticoids (steroid hormones, including hydrocortisone and prednisolone). These may reduce the effectiveness of vitamin D_);
- cholesterol-lowering medicines (e.g. cholestyramine or colestipol);
- certain weight-loss medicines that reduce fat absorption from the gastrointestinal tract (e.g. orlistat);
- certain laxatives (e.g. liquid paraffin).

THORENS with food, drink and alcohol
This medicine should preferably be taken during a main meal to enhance vitamin D_) absorption. To facilitate administration, the solution may be mixed with cold or lukewarm food. For further details, see section 3 "How to take THORENS".

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
The use of this high-dose preparation is not recommended in pregnant or breastfeeding women.

Driving and operating machinery
Information on the possible effect of this medicine on the ability to drive and operate machinery is limited. However, no effect on these abilities is expected.

3. How to take THORENS
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Shake well before use.
THORENS is best taken during a meal.
The medicine has an olive oil flavour. It may be taken as supplied (directly from the bottle) or mixed with a small amount of cold or lukewarm food immediately before administration. Ensure the full dose is taken.

Dosage for adults
The recommended dose is 1 bottle once weekly during the first month of treatment. The dose thereafter will be determined by your doctor.

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

Pregnancy and breastfeeding
THORENS 25,000 IU is not recommended during pregnancy or breastfeeding.

If you take more THORENS than you should
If you take more than the prescribed dose, stop taking the medicine and contact your doctor immediately. If you cannot speak to your doctor, go to the nearest hospital emergency department, taking this leaflet with you.
The most common symptoms of overdose include: nausea, vomiting, increased thirst, excessive urine production, constipation and dehydration, and elevated calcium levels in blood and urine (hypercalcemia and hypercalciuria) detected in laboratory tests.

If you forget to take THORENS
If you miss a dose, take it as soon as possible. Take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose; only take the next scheduled dose at the regular 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 side effects

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

Not very common (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 1,000 people)

skin rash
itching
urticaria (hives)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 may also be reported to the responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store THORENS
Keep this medicine out of the 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 stated month.
Do not store above 30°C.
Do not store in a refrigerator or freeze.
Keep the bottle in its outer packaging to protect from light.
Do not use this medicine if the solution appears cloudy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What the medicinal product contains

The active substance is cholecalciferol (vitamin D).

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

The other constituent is refined olive oil.

What Thorens looks like and contents of the pack
Thorens 25,000 IU/2.5 ml oral solution is a clear, colourless to greenish-yellow oily liquid, free from visible solid particles and (or) sediment.
It is supplied in an amber glass bottle closed with a plastic screw cap.
Each pack contains 1 or 4 bottles of 2.5 ml oral solution.
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/2.5 ml oral solution
Norway Deltius 25,000 I.E./2.5 ml. mikstur, oppløsning
Belgium Thorens 25,000 UI/2.5 ml, solution buvable
United Kingdom Thorens 25,000 I.U./2.5ml oral solution
Germany Thorens 25,000 IE /2.5 ml Lösung zum Einnehmen
Ireland Thorens 25,000 I.U./2.5ml oral solution
Netherlands Thorens 25,000 IE/2.5 ml drank
Spain Thorens
Portugal Thorens

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