Thorens 25.000 UI/2,5 ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Thorens 25,000 IU/2.5 ml oral solution

colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 oral solution contains as its active substance colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by the body when the skin is exposed to sunlight. Vitamin D3 promotes calcium absorption in the kidneys and intestine, thereby aiding bone formation. A deficiency in vitamin D3 is the main cause of rickets (defective bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Thorens oral solution is used for the initial treatment of clinically relevant vitamin D deficiency in adults.

2. What you need to know before starting to take Thorens

Do not take Thorens

• if you are allergic to vitamin D3 or to any of the other components of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• if you have kidney stones (renal calculi) or severe renal failure;
• if you have high levels of vitamin D3 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 medicines used for heart conditions (e.g. cardiac glycosides, such as digoxin).

• you suffer from sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D3 in the body).

• you are being treated with medicines containing vitamin D3, or consume foods or milk fortified with vitamin D.

• you are likely to be exposed to sunlight while using this medicine.

• you additionally take supplements containing calcium. Your doctor should monitor your calcium levels to ensure they do not become too high during treatment with Thorens.

• you have kidney disease or kidney damage. Your doctor may monitor your calcium levels in blood and urine.

your doctor should monitor blood calcium levels through laboratory tests if the daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period of time

Children and adolescents

Thorens is not recommended for use in children and adolescents under 18 years of age.

Use of Thorens with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking:

• medicines used to treat heart or kidney diseases, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medicines are used at the same time as vitamin D3, they may cause a significant increase in calcium levels in blood and urine.

• medicines containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3-fortified milk.

• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medicines used to treat fungal diseases). These medicines may interfere with the body's processing of vitamin D3.

• the following medicines, as they may interfere with the effect or absorption of vitamin D3:

  • antiepileptic medicines (anticonvulsants), barbiturates;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), which may reduce the effect of vitamin D3;
  • medicines that lower blood cholesterol levels (such as cholestyramine or colestipol);
  • certain medicines used for weight loss by reducing fat absorption (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

Use of Thorens with food, drinks and alcohol

Thorens should preferably be taken with one of the main meals to help absorption of vitamin D3. It may be taken alone or mixed with cold or lukewarm food to facilitate administration. For more information, see section 3, "How to take Thorens".

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This formulation of Thorens is not recommended for use during pregnancy and breast-feeding due to its high dose of vitamin D3.

Driving and using machines

Information on possible effects of this medicine on the ability to drive is limited. However, it is not expected that your ability to drive or operate machinery will be affected.

3. How to take Thorens

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Shake well before use.

Thorens should preferably be taken with main meals.

This medicine has a mild olive oil flavour. Thorens may be taken alone or by mixing the solution with a small amount of cold or lukewarm food immediately before ingestion. You must ensure that you take the full dose.

Use in adults

The recommended dose is 1 vial (25,000 IU) once weekly for the first month. After the first month, continue with the maintenance dose recommended by your doctor.

Paediatric population

Thorens 25,000 IU is not recommended for children and adolescents under 18 years of age.

Pregnancy and breastfeeding

Thorens 25,000 IU is not recommended during pregnancy and breastfeeding.

If you take more Thorens than you should

Stop taking the medicine and contact your doctor or pharmacist immediately if you take more of this medicine than prescribed. If you are unable to contact them, go to the nearest hospital emergency department and take the medicine packaging with you. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Thorens

If you forget to take a dose of Thorens, take the missed dose as soon as possible and then take the next dose at the usual time. However, if it is almost time for your 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 make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like any other medicine, this medicine may cause adverse effects, although not everyone experiences them.

The possible adverse effects associated with the use of Thorens may include:

Uncommon (affects up to 1 in 100 people):

• excess calcium in the blood (hypercalcemia);
• excess calcium in urine (hypercalciuria).

Rare (affects up to 1 in 1000 people):

• skin rash
• pruritus
• urticaria.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Thorens

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and the outer carton following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Keep the bottle in the outer packaging to protect it from light.

Do not refrigerate or freeze.

Do not use this medicine if the solution appears cloudy.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Thorens contains

• The active substance is colecalciferol (vitamin D3). One single-dose vial of 2.5 ml oral solution contains 25,000 IU of colecalciferol (vitamin D3), equivalent to 0.625 mg. 1 ml of oral solution contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 0.25 mg.
• The other components are: olive oil.

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Appearance of Thorens and Packaging Contents

Thorens 25,000 IU / 2.5 ml is a clear oily solution, ranging from colorless to yellowish-green, free from visible solid particles and/or precipitates. It is supplied in amber glass bottles sealed with a plastic stopper.

Each package contains 1 or 4 single-dose bottles, each containing 2.5 ml of solution.

Marketing Authorization Holder and Manufacturing Responsible

Abiogen Pharma S.p.A.

Via Antonio Meucci 36

Loc Ospedaletto

Pisa (PI), 56121

Italy

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: THORENS 25.000 UI/ml oral solution

UK: THORENS 25.000 IU/ml oral solution

Ireland: THORENS 25.000 IU/ml oral solution

Belgium: THORENS 25.000 IU/ml oral solution

Germany: THORENS 25.000 IU/ml oral solution

Netherlands: THORENS 25.000 IU/ml oral solution

Norway: THORENS 25.000 IU/ml oral solution

Poland: THORENS 25.000 IU/ml oral, solution

Portugal: THORENS 25.000 IU/ml oral solution

Sweden: THORENS 25.000 IU/ml oral solution

Date of the most recent review of this leaflet: January 2018

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).