LUNDEOS 20,000 IU SOFT GEL CAPSULES

2. What you need to know before taking Lundeos

Do not take Lundeos:

• if you are allergic to colecalciferol or any of the other components of this medication (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you have kidney stones;
• if you have severe kidney problems.

Warnings and Precautions

When you take Lundeos, your doctor will check your blood and/or urine calcium levels to ensure they are not too high.

Consult your doctor or pharmacist before starting to take Lundeos if you:

• have a higher risk of developing kidney stones
• have any condition that may affect your bones
• have a hormonal disorder that affects the parathyroid gland (pseudohipoparathyroidism)
• suffer from "sarcoidosis", an immune system disorder that can affect your liver, lungs, skin, or lymph nodes
• have heart problems
• are already taking additional calcium or vitamin D supplements.

Children and Adolescents

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

Other Medications and Vitamin D3

Tell your doctor if you are taking or have recently taken other medications, such as:

• products containing high doses of calcium, as they increase the risk of high blood calcium levels.
• medications used to treat heart conditions (cardiac glycosides, such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure blood calcium levels.
• thiazide diuretics, as they may increase the risk of hypercalcemia.
• medications used to treat epilepsy (such as phenytoin) or to induce sleep (barbiturates, such as phenobarbital), as these medications may reduce the effect of vitamin D.
• antibiotics used to treat bacterial infections, such as rifampicin and isoniazid.
• laxatives (such as liquid paraffin), orlistat, a medication used to treat obesity, or a cholesterol-lowering medication called cholestyramine, as they may decrease vitamin D absorption.
• products containing magnesium (such as antacids), which should not be taken during vitamin D treatment due to the risk of high magnesium levels;

products containing high amounts of phosphorus. These agents increase the risk of high blood phosphate levels.

• actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (such as clotrimazole and ketoconazole, which are medications used to treat fungal infections). These medications may interfere with vitamin D metabolism.
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D.

Pregnancy, Breastfeeding

Pregnancy

This medication contains a high dose that is not recommended for use in pregnant women.

Breastfeeding

Lundeos can be used during breastfeeding. Vitamin D passes into breast milk. This should be taken into account when administering additional vitamin D to the breastfed child.

Driving and Using Machines

This medication has no known effects on the ability to drive or use machines.

This medication contains 4.8 mg of sorbitol in each soft capsule.

3. How to Take Lundeos

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, ask your doctor or pharmacist.

The amount of Lundeos will depend on your vitamin D levels and response to treatment.

Treatment of vitamin D deficiency (loading dose) in adults: 20,000 IU once a week (1 capsule)

After the first month, the dose may be reduced. Your doctor will decide on any additional treatment with Lundeos.

Swallow the capsule whole (do not chew) with water, preferably with a large meal.

Use in Children and Adolescents

This medication is not recommended for children and adolescents.

If You Take More Lundeos Than You Should

If you have taken more Lundeos capsules than you should, speak to your doctor or pharmacist immediately. Bring the medication with you.

An overdose can lead to an increase in blood and urine calcium levels, as shown by laboratory tests.

The signs and symptoms of an overdose may include loss of appetite, thirst, nausea, vomiting, diarrhea followed by constipation, abdominal pain, headache, muscle and joint pain, muscle weakness, fatigue, confusion, frequent urination with calcium in the urine, kidney problems, and, in severe cases, irregular heartbeats, coma, or even death.

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 medication and the amount used.

If You Forget to Take Lundeos

Do not take a double dose to make up for forgotten doses. If you forget to take your capsules, 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 forgotten dose, and take the next dose at the usual time instead.

If You Stop Taking Lundeos

If you have any doubts about using this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Uncommon (affect up to 1 in 100 people)

• Excess calcium in the blood (hypercalcemia). You may feel or be sick, lose your appetite, experience constipation, stomach pain, have excessive thirst, muscle weakness, or drowsiness.
• Confusion.
• Excess calcium in the urine (hypercalciuria).

Rare (affect up to 1 in 1,000 people)

• Skin rash
• Itching
• Itchy skin rash (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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lundeos

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

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

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Lundeos Composition

• The active ingredient is colecalciferol.
• The other excipients are: medium-chain triglycerides, all-rac-alpha-tocopherol, acetate, gelatin (E441), glycerol (E422), and sorbitol liquid (E420) (partially dehydrated), and purified water.

Product Appearance and Packaging Contents

Lundeos 20,000 IU are soft gelatin capsules, round, light yellow, and transparent, containing clear and colorless liquid.

They are supplied in blisters containing 4, 5, 10, or 14 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

NetPharma Lab Consulting Services

Carretera de Fuencarral, 22

28051 – Alcobendas

Madrid

Spain

You can request more information about this medication from the local representative of the marketing authorization holder:

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

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: July 2020

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