Patient Information Leaflet: Lundeos 1.000 UI Soft Capsules

Colecalciferol

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Lundeos is and what it is used for

2. What you need to know before you start taking Lundeos

3. How to take Lundeos

4. Possible side effects

5. Storage of Lundeos

6. Contents of the pack and additional information

Lundeos contains vitamin D3 that 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 identified risk.
• Certain bone disorders, such as bone thinning (osteoporosis), when administered with other medications.

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 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 that alters the parathyroid gland (pseudohypoparathyroidism)
• have "sarcoidosis", an immune system disorder that may 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 use in children under 12 years old.

Other medications and Vitamin D3

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

• products containing high doses of calcium, which 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 your calcium levels in the blood.
• thiazide diuretics, which may increase the risk of hypercalcemia.
• medications used to treat epilepsy (such as phenytoin) or to induce sleep (barbiturates, such as phenobarbital), which 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 medication that reduces cholesterol called cholestyramine, which may decrease the absorption of vitamin D.
• products containing magnesium (for example, antacids), 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 phosphate levels in the blood.

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

Pregnancy, breastfeeding

Pregnancy

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

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

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

Breastfeeding
Lundeos can be used during breastfeeding when 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 infant. Such supplementation does not replace vitamin D administration in newborns.

Driving and operating machinery

This medication has no known effects on the ability to drive or operate machinery.

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

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

The amount of Lundeos to take 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).

Your doctor may change your dose depending on your condition. 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 supplement 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 old.

If you take more Lundeos than you should

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

A overdose may 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 the missed doses. If you forget to take your capsules, take them as soon as you remember. Then, take the next dose at the usual time following your doctor's instructions. However, if you are close to the time of the next dose, do not take the missed dose and instead take the next dose at the usual time.

If you interrupt treatment with Lundeos

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rarely (affect up to 1 in 100 people)

• Hypercalcemia (excess calcium in the blood). You may feel or be nauseous, lose your appetite, experience constipation, stomach pain, excessive thirst, muscle weakness, drowsiness, and confusion.
• Hypercalciuria (excess calcium in the urine).

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

• Dermatological rash
• Pruritus
• Severe skin eruption with itching (urticaria)

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lundeos

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

Appearance of the product and contents of the packaging

Lundeos 1.000UI are soft gelatin capsules, round, yellow transparent, containing clear and colorless liquid.

It is supplied in blisters containing 30 capsules.

Holder of the marketing authorization

Theramex Ireland Limited

3rdFloor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for manufacturing

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 with the following names:

Last review date of this leaflet: July 2020

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)