THORENS 25,000 IU HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Thorens 25,000 IU Hard Capsules

Colecalciferol (Vitamin D3)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package 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. Storage of Thorens

Contents of the pack and additional information

1. What Thorens is and what it is used for

Thorens contains the active ingredient colecalciferol (Vitamin D3). Vitamin D3 can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestines, helping to form bone. Vitamin D deficiency is the main cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Thorens hard capsules are used to prevent and treat 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 any of the other ingredients of this medication (listed in section 6);
• if you have high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria);
• if you have kidney stones (renal calculi) or severe kidney failure;
• if you have high levels of vitamin D in the blood (hypervitaminosis D).

Warnings and precautions

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

• are being treated with certain medications for heart conditions (e.g., cardiac glycosides, such as digoxin).
• have sarcoidosis (an autoimmune disease that can cause increased vitamin D levels in the body).

• are being treated with diuretics (e.g., benzothiadiazine)
• are immobilized
• have pseudohypoparathyroidism
• are being treated with medications that contain vitamin D, or take foods or milk enriched with vitamin D.
• are likely to be exposed to a lot of sunlight while using Thorens
• take other supplements that contain calcium. Your doctor should monitor your blood calcium levels to ensure they are not too high during your treatment with Thorens.
• have kidney disease or kidney damage and have a tendency to form kidney stones. Your doctor may want to monitor your blood and urine calcium levels.
• your doctor should monitor your blood calcium levels through laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU for an extended period.

Children and adolescents.

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

Other medications and Thorens

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication. This is especially important if you are taking:

• medications used to treat heart or kidney diseases, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in blood and urine calcium levels.
• medications that contain vitamin D or foods rich in vitamin D, such as some types of milk enriched with vitamin D.
• actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, which are medications used to treat fungal diseases). These medications can interfere with the processing of vitamin D3 in the body.
• medications used to treat tuberculosis, such as rifampicin and isoniazid
• the following medications, as they may interfere with the effect or absorption of vitamin D3:
  • antiepileptic medications (anticonvulsants), barbiturics;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
  • medications that lower cholesterol levels in the blood (such as cholestyramine or colestipol);
  • certain medications used for weight loss by reducing fat absorption (e.g., orlistat);
  • certain laxatives (such as liquid paraffin).

Taking Thorens with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and using machines

Information on the possible effects of this medication on the ability to drive is limited. However, it is not expected to affect your ability to drive or use machines.

3. How to take Thorens

Follow the instructions for administration of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The capsule should be swallowed whole (e.g., with water)

Thorens should be taken preferably with food.

Use in adults

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

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

Your doctor will adjust the dose for you.

Pediatric population

Thorens is not recommended in 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 the prescribed amount, stop taking the medication and call your doctor. If you cannot contact your doctor, go to the emergency department of the nearest hospital and take the medication package with you.

You can also contact the Toxicology Information Service, phone 915620420, indicating the medication and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for 24 hours, constipation, dehydration, and high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) determined by clinical tests.

If you forget to take Thorens

If you forget to take a dose of Thorens, take the next missed dose as soon as possible. Then, take the next dose at the usual time. However, if it is close to the time of the next dose, do not take the missed dose and take the next dose at the usual time.

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

4. Possible side effects

Like all medications, Thorens can cause side effects, although not everyone gets them.

The possible side effects associated with the use of Thorens may be:

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 1,000 people):

• Skin rash (hives or skin eruption)
• Itching (pruritus)
• Urticaria

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Thorens

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

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Do not store above 30 °C.

Keep in the original package to protect from light.

Do not refrigerate or freeze.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Thorens

• The active ingredient is colecalciferol (Vitamin D3).

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

• The other excipients are:

• Refined olive oil,
• Gelatin,
• Titanium dioxide (E-171),
• Yellow iron oxide (E-172),
• Black iron oxide (E-172).

Appearance 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 size is 15.9 mm x 5.8 mm. It contains an oily solution and is supplied in aluminum PVC/PVDC blisters 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

Marketing authorization holder

Laboratorios Effik, S.A.

c/ San Rafael, 3

28108 Alcobendas, (Madrid)

Spain

Manufacturer

Abiogen Pharma S.p.A.

Via Meucci, 36

Pisa (Italy)

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet:March 2019

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