LUNDEOS 1,000 IU SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Lundeos 1,000 IU Soft Capsules

Colecalciferol

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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Lundeos and what is it used for
2. What you need to know before taking Lundeos
3. How to take Lundeos
4. Possible side effects
5. Storage of Lundeos
6. Package Contents and Additional Information

1. What is Lundeos and what is it used for

Lundeos contains Vitamin D3, which regulates calcium absorption and metabolism, as well as calcium incorporation into bone tissue.

Lundeos is indicated in the following cases:

• Treatment of vitamin D deficiency in adults and adolescents.
• Prevention of vitamin D deficiency in adults with an identified risk.
• Certain bone disorders, such as thinning of the bone (osteoporosis), when administered along with other medications.

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 the 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 calcium levels in your blood and/or urine to ensure they are not too high.

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

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

Children and Adolescents

This medication is not recommended for children under 12 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 calcium levels in the blood.
• medications used to treat heart conditions (cardiac glycosides, such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure calcium levels in the blood.
• thiazide diuretics, as they may increase the risk of hypercalcemia.
• medications used to treat epilepsy (such as phenytoin) or to induce sleep (barbiturics, 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 (e.g., antacids), should not be taken during treatment with vitamin D due to the risk of high magnesium levels;

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

• 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 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

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.

Do not take this medication during pregnancy without a confirmed vitamin D deficiency.

During pregnancy, higher doses of vitamin D3 are not recommended, which are administered weekly or monthly instead of daily, for safety reasons.

Breastfeeding Lundeos can be used during breastfeeding when a vitamin D deficiency is confirmed. Vitamin D passes into breast milk. This should be taken into account when administering additional vitamin D to the breastfed child. Such supplementation does not replace the administration of vitamin D in newborns.

Driving and Using Machines

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

This medication may cause allergic reactions because it contains tartrazine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to Take Lundeos

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

Treatment of vitamin D deficiency (loading dose) in:

• Adults: 1,000 - 4,000 IU/day (1 to 4 capsules per day)
• Adolescents: 1,000 IU/day (1 capsule per day). Higher doses may be administered according to your doctor's advice, but should not exceed 4,000 IU/day (4 capsules per day).

Depending on your condition, your doctor may change your dose. Any additional treatment with Lundeos should be decided by your doctor.

Prevention of vitamin D deficiency (maintenance dose) in adults: 1,000 IU (1 capsule) per day.

As a complement to specific therapy for patients with osteoporosis: 1,000 IU (1 capsule) per day.

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

Use in Children

This medication is not recommended for children under 12 years of age.

If You Take More Lundeos Than You Should

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

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

The signs and symptoms of an overdose may be 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 the use of 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, have constipation, stomach pain, be very thirsty, have muscle weakness, drowsiness, and confusion.
• Excess calcium in the urine (hypercalciuria).

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

• Skin rash
• itching
• skin rash with high itching (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 Medications: 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. Deposit the packaging and medications you no longer need at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lundeos

• The active ingredient is colecalciferol.
• The other excipients are: medium-chain triglycerides, all-rac-alpha-tocopherol acetate, gelatin (E441), glycerol (E422), sorbitol liquid (E420) (partially dehydrated), tartrazine (E102), and purified water.

Appearance of the Product and Package Contents

Lundeos 1,000 IU are soft gelatin capsules, round, yellow, and transparent, containing clear and colorless liquid.

They are supplied in blisters containing 30 capsules.

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 by contacting 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) (https://www.aemps.gob.es/)