Thorens 25.000 IU hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Thorens 25,000 IU hard capsules

Colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, 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

Pack contents and additional information

1. What Thorens is and what it is used for

Thorens contains the 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 D promotes calcium absorption in the kidneys and intestines, thereby aiding bone formation. Vitamin D deficiency is the main cause of rickets (inadequate bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Thorens hard capsules are used for the prevention and treatment of vitamin D deficiency in adults.

2. What you need to know before taking Thorens

Do not take Thorens:

• if you are allergic to vitamin D3 or to any of the other ingredients 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 D in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Thorens if you:

• are being treated with certain medicines for heart conditions (e.g., cardiac glycosides such as digoxin);
• have sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D in the body);
• are being treated with diuretics (e.g., benzothiadiazines);
• are immobilized;
• suffer from pseudohypoparathyroidism;
• are being treated with medicines containing vitamin D, or consume vitamin D–enriched foods or milk;
• are likely to be exposed to intense sunlight while using Thorens;
• take other supplements containing calcium. Your doctor should monitor your blood calcium levels to ensure they do not become too high during treatment with Thorens;
• have kidney disease or kidney damage and are prone to developing kidney stones. Your doctor may wish to monitor your blood and urine calcium levels;
• your daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period. In such cases, your doctor should monitor your blood calcium levels through laboratory tests.

Children and adolescents

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

Other medicines and Thorens

Tell 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 conditions, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in blood and urine;
• medicines containing vitamin D or vitamin D–rich foods, such as certain types of vitamin D–fortified milk;
• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D3;
• medicines used to treat tuberculosis, such as rifampicin or isoniazid;
• the following medicines, as they may interfere with the effect or absorption of vitamin D3:
  • antiepileptic drugs (anticonvulsants), barbiturates;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
  • medicines used to lower blood cholesterol levels (e.g., cholestyramine or colestipol);
  • certain weight-loss medicines that reduce fat absorption (e.g., orlistat);
  • certain laxatives (e.g., liquid paraffin).

Taking Thorens with food, drinks, and alcohol

You should preferably take Thorens with food to help the absorption of vitamin D3.

Pregnancy, breastfeeding, and fertility

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

This high concentration is not recommended for use in pregnant or breastfeeding women.

Driving and using machines

Information on possible effects of this medicine on the ability to drive is limited. However, it is unlikely that Thorens will affect your ability to drive or use machines.

3. How to take Thorens

Follow exactly the dosage instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The capsule must be swallowed whole (for example, with water).

Thorens should preferably be taken with food.

Use in adults

The recommended dose is one 25,000 IU capsule per week for the first month. After the first month, a dose reduction may be considered.

This initial treatment may be followed by a maintenance therapy, as directed by your doctor.

Your doctor will adjust the dose according to your individual needs.

Paediatric population

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

Pregnancy and breastfeeding

Thorens is not recommended.

If you take more Thorens than you should

If you take more than prescribed, stop taking the medicine and contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital emergency department and bring the medicine packaging with you.

You may also contact the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken.

The most common symptoms 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) as determined 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. Afterwards, take the next dose at your usual time. However, if it is almost time for your next scheduled dose, do not take the missed dose; instead, take the next dose at the regular time.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Possible adverse effects associated with the use of Thorens may include:

Uncommon (affect up to 1 in 100 people):

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

Rare (affect up to 1 in 1000 people):

• Skin rash (rash or skin eruption)
• Pruritus (itching)
• 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 packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Keep in the original packaging to protect from light.

Do not refrigerate or freeze.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Thorens

• The active substance is colecalciferol (vitamin D3).

One capsule contains: 0.625 mg of colecalciferol (vitamin D3), equivalent to 25,000 IU.

• The other components are:

• Refined olive oil,

• Gelatin,

• Titanium dioxide (E-171),

• Yellow iron oxide (E-172),

• Black iron oxide (E-172).

Description of the product 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 measures 15.9 mm x 5.8 mm. It contains an oily solution and is supplied in aluminum PVC/PVDC blisters packed in cardboard boxes.

Each box may contain 3, 4, 8, 12 or 40 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Abiogen Pharma S.p.A.
Via Antonio Meucci 36
Loc Ospedaletto
Pisa (PI), 56121
Italy

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

Spain: THORENS 25,000 UI hard capsules
UK: THORENS 25,000 IU hard capsules
Ireland: THORENS 25,000 IU hard capsules
Belgium: THORENS 25,000 IU hard capsules
Germany: THORENS 25,000 IU hard capsules
Netherlands: THORENS 25,000 IU hard capsules
Norway: THORENS 25,000 IU hard capsules
Poland: THORENS 25,000 IU hard capsules
Portugal: THORENS 25,000 IU hard capsules
Sweden: THORENS 25,000 IU hard capsules

Date of the most recent review of this leaflet: March 2019

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