TREDEROL 20,000 IU FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Trederol 5,000 IU Film-Coated Tablets.

Trederol 10,000 IU Film-Coated Tablets.

Trederol 20,000 IU Film-Coated Tablets.

colecalciferol (Vitamin D3)

For use in adults

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Trederol and what is it used for
2. What you need to know before you take Trederol
3. How to take Trederol
4. Possible side effects
5. Storage of Trederol
6. Contents of the pack and other information

1. What is Trederol and what is it used for

Trederol contains the active substance colecalciferol.

Vitamin D is present in the diet and is also produced in the skin after exposure to the sun. Your doctor may prescribe you Trederol for the initial treatment of severe vitamin D deficiency. Vitamin D deficiency can occur when your diet or lifestyle does not provide enough vitamin D or when your body requires more vitamin D. This medicine is indicated for adults.

2. What you need to know before you take Trederol

Do not take Trederol

• if you are allergic to colecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6).
• If you have high levels of vitamin D in the blood (hypervitaminosis D)
• If you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria) or if you have a disease or condition that causes hypercalcemia or hypercalciuria.
• if you have kidney stones, kidney calcifications or if your kidney function is severely impaired.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trederol if:

• you have kidney damage or disease. Your doctor will measure your calcium and phosphorus levels in your blood and urine.
• you have a tendency to form kidney stones that contain calcium.

-you suffer from a chronic inflammatory multisystem disease known as sarcoidosis, which can affect your lungs, heart, and kidneys; in that case, there is a high risk of conversion of vitamin D to its active form.

• you take supplements that contain vitamin D or derivatives, foods or drinks enriched with vitamin D.
• you are resistant to parathyroid hormone (pseudo-hypoparathyroidism).

Adequate calcium intake through diet should be ensured. Your doctor may want you to have regular laboratory tests to check the amount of calcium in your blood and urine.

If you take daily doses higher than 1,000 IU of vitamin D through your diet, other medications, or dietary supplements, your doctor will perform certain blood tests. These tests are especially important in elderly patients or those with reduced mobility or in patients who are being treated at the same time with cardiac glycosides or diuretics (see section "Other medicines and Trederol")

Children and adolescents

Trederol should not be used in children and adolescents under 18 years of age.

Other medicines and Trederol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, the following medicines may interact with Trederol:

• Medicines used to treat epilepsy (such as phenytoin) or medicines to help you sleep (barbiturics such as phenobarbital), as these medicines may decrease the effect of vitamin D.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These may decrease the effect of vitamin D.
• Heart medicines (cardiac glycosides such as digoxin). Your doctor will be able to check your heart with an electrocardiogram (ECG) and measure your calcium levels in your blood and urine.
• Laxatives (such as liquid paraffin), a medicine to reduce high cholesterol levels called cholestyramine, or a medicine used to decrease the absorption of fats from your diet called orlistat, which may reduce the absorption of vitamin D.
• Actinomycin (a medicine used to treat some types of cancer) and imidazole-based antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may interfere with the metabolism of vitamin D.
• Rifampicin and isoniazid (used in the treatment of tuberculosis) may reduce the effect of vitamin D.
• Diuretics, medicines that promote urine excretion (such as benzothiadiazine derivatives) may increase the risk of high calcium levels in the blood (hypercalcemia) or in the urine (hypercalciuria).
• Phosphorus administered in high doses may increase the risk of high phosphorus levels in the blood (hyperphosphatemia).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Trederol is not recommended during pregnancy; a product with a lower dose should be used during pregnancy.

Overdoses of vitamin D should be avoided during pregnancy, as prolonged hypercalcemia (elevated blood calcium levels) can lead to physical and mental disability, as well as congenital heart and eye diseases in the child.

Breastfeeding

Vitamin D and its metabolites are excreted in breast milk. If treatment with vitamin D is clinically indicated during breastfeeding, this should be considered when administering additional vitamin D to the child. Trederol is not recommended; products with a lower dose should be used during breastfeeding.

Driving and using machines

Trederol has no effect on the ability to drive and use machines.

This medicinecontains sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Trederol

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The necessary dose will depend on how low your vitamin D levels are. Your doctor will advise you about the dose and the number of tablets you should take and how often you should take them.

The recommended dose is:

• Initial treatment of vitamin D deficiency in adults:

Equivalent to 20,000 IU/week for 4 to 5 weeks.

Trederol 5,000 IU film-coated tablets: 4 tablets per week

Trederol 10,000 IU film-coated tablets: 2 tablets per week

Trederol 20,000 IU film-coated tablets: 1 tablet per week

After 4 or 5 weeks of treatment, a lower maintenance dose should be considered.

The tablets should be swallowed whole with water, preferably with the main meal of the day.

Trederol 20,000 IU film-coated tablets:

The score line is only to facilitate breaking the tablet if you find it difficult to swallow it whole.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

If you take more Trederol than you should

It is important not to exceed the prescribed dose.

If you accidentally take more tablets than you should, consult your doctor or seek medical advice immediately.

If possible, take the tablets, the medicine packaging, and the leaflet with you to show to the doctor.

In case of ingestion of too many tablets, you may experience nausea, vomiting, constipation, or stomach pain, feel muscle weakness, tiredness, loss of appetite, kidney problems, and in severe cases, you may notice irregular heartbeats.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Trederol

If you forget to take the tablets, take them as soon as possible. Then, take the next dose at the usual time, following your doctor's instructions. 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.

Do not take a double dose to make up for forgotten doses.

If you stop taking Trederol

Keep taking this medicine until your doctor tells you to stop. Do not stop taking this medicine because you feel better. The symptoms may come back or get worse if you stop the treatment too early.

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

4. Possible side effects

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

The side effects of Trederol include:

Uncommon: may affect up to 1 in 100 people:

• high levels of calcium in the blood (hypercalcemia). You may feel sick, lose your appetite, suffer from constipation, stomach pain, be very thirsty, feel muscle weakness, drowsiness, or confusion.
• high levels of calcium in the urine (hypercalciuria)

Rare: may affect up to 1 in 1,000 people:

• skin rash
• itching
• itchy skin rash (urticaria)

Frequency not known: cannot be estimated from the available data:

• constipation
• flatulence
• nausea
• abdominal pain
• diarrhea
• hypersensitivity reactions such as angioedema or laryngeal edema (swelling around the face, nose, throat, and digestive tract or swelling of the larynx).

Tell your doctor or pharmacist if any of the side effects get serious or if you notice any side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Trederol

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

Store below 30°C.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Trederol

• The active substance is colecalciferol (vitamin D3).

Each Trederol 5,000 IU film-coated tablet contains 125 micrograms of colecalciferol (vitamin D3, equivalent to 5,000 IU as colecalciferol concentrated powder).

Each Trederol 10,000 IU film-coated tablet contains 250 micrograms of colecalciferol (vitamin D3, equivalent to 10,000 IU as colecalciferol concentrated powder).

Each Trederol 20,000 IU film-coated tablet contains 500 micrograms of colecalciferol (vitamin D3, equivalent to 20,000 IU as colecalciferol concentrated powder).

• The other ingredients are:

sodium ascorbate (E301), all-rac-α-tocopherol, sodium octenyl succinate starch (from corn) (E1450), sucrose, medium-chain triglycerides, colloidal anhydrous silica (E551), sodium croscarmellose (E468), microcrystalline cellulose (PH 102) (E460), magnesium stearate (E470b), Opadry PVA white (contains polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553B)).

Appearance of the product and pack contents

• Trederol 5,000 IU film-coated tablets are round, white to slightly yellow, marked with "5", approximately 7 mm in diameter.
• Trederol 10,000 IU film-coated tablets are elongated, white to slightly yellow, marked with "10". The tablet dimensions are approximately 13 mm long and 6.7 mm wide.
• Trederol 20,000 IU film-coated tablets are oval, white to slightly yellow, with a double score line. The tablet dimensions are approximately 17 mm long and 9.5 mm wide.

Trederol 5,000 IU film-coated tablets are available in packs of 30, 40, and 60 film-coated tablets in PVC/PVDC/Aluminum blisters.

Trederol 10,000 IU film-coated tablets are available in packs of 10 and 20 film-coated tablets in PVC/PVDC/Aluminum blisters.

Trederol 20,000 IU film-coated tablets are available in packs of 4, 10, and 20 film-coated tablets in PVC/PVDC/Aluminum blisters.

Trederol 5,000 IU film-coated tablets:

Marketing authorization holder and manufacturer

Marketing authorization holder

Wörwag Pharma GmbH & Co. KG

Flugfeld-Allee 24

71034 Böblingen

Germany

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

Trederol 10,000 IU film-coated tablets:

Marketing authorization holder and manufacturer

Marketing authorization holder

Wörwag Pharma GmbH & Co. KG

Flugfeld-Allee 24

71034 Böblingen

Germany

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

Trederol 20,000 IU film-coated tablets:

Marketing authorization holder and manufacturer

Marketing authorization holder

Wörwag Pharma GmbH & Co. KG

Flugfeld-Allee 24

71034 Böblingen

Germany

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

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

Netherlands Trederol 5,000/10,000/20,000 IU film-coated tablets

Austria Trederol 5,000/10,000/20,000 IU film-coated tablets

Bulgaria Soligamma 5,000/10,000/20,000 IU film-coated tablets

Czech Republic Trederol

Estonia Trederol

Spain Trederol 5,000/10,000/20,000 IU film-coated tablets

Hungary Soligamma 5,000/10,000/20,000 IU film-coated tablets

Lithuania Trederol 5,000/10,000/20,000 IU film-coated tablets

Latvia Trederol 5,000/10,000/20,000 IU film-coated tablets

Poland Soligamma

Romania Bonfal 5,000/10,000/20,000 IU film-coated tablets

Slovak Republic Trederol 5,000/10,000/20,000 IU film-coated tablets

Date of last revision of this leaflet: January 2025

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