OSMILLE D 600 MG/1000 IU ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Osmille D 600 mg/1,000 IU Orodispersible Tablets

Calcium carbonate/colecalciferol

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Osmille D is and what it is used for

Osmille D is used to prevent and treat calcium or vitamin D3 deficiency in elderly people and as additional treatment in osteoporosis in patients at risk of vitamin D or calcium deficiency, when a dietary supplement of 600 mg/day of calcium and 1,000 IU/day of vitamin D3 is appropriate.

Osmille D contains calcium and vitamin D3, both important components in bone formation. Vitamin D3 regulates the absorption and metabolism of calcium as well as the incorporation of calcium into bone tissue.

Ask your doctor or pharmacist if you have any questions and always follow their instructions.

You should consult a doctor if it gets worse or does not improve after several days.

2. What you need to know before you take Osmille D

Do not take Osmille D

• If you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6).
• If you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
• If you have hypervitaminosis D (high levels of vitamin D in the blood).
• If you have kidney stones.
• If you have kidney failure.
• If you are allergic to soy or peanuts.

Warnings and precautions

Consult your doctor or pharmacist before taking Osmille D

• if you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• if you are taking other medicines that contain vitamin D or calcium.
• if your kidneys do not work well or you have a tendency to form kidney stones.
• if you are immobilized due to osteoporosis.

Other medicines and Osmille D

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

The effect of treatment may be affected if this medicine is taken at the same time as other medicines for:

• high blood pressure (thiazide diuretics)
• heart problems (cardiac glycosides such as digoxin)
• high cholesterol (cholestyramine)
• constipation (laxatives such as liquid paraffin)
• epilepsy (phenytoins or barbiturates)
• inflammatory diseases/immunosuppression (corticosteroids)
• obesity (orlistat)

Please make sure your doctor knows if you are taking any of the medicines listed above. Your dose may need to be adjusted.

If you take at the same time a medicine for

• osteoporosis (bisphosphonates)

you should take it at least one hour before taking Osmille D.

If you take at the same time medicines for

• infections (quinolones)

you should take them two hours before or six hours after taking Osmille D.

If you take at the same time medicines for

• infections (tetracyclines)

you should take them two hours before or six hours after taking Osmille D.

If you take at the same time medicines for

• dental caries (sodium fluoride)
• anemia (iron)

you should take these medicines at least three hours before taking Osmille D.

If you take at the same time medicines for

• hypothyroidism (levothyroxine)

you should take Osmille D at least four hours apart.

Taking Osmille D with food, drinks, and alcohol

The absorption of calcium may be inhibited by foods containing oxalic acid (present in spinach and rhubarb) or phytic acid (present in whole grains). You should wait at least two hours before taking Osmille D if you have taken foods with high oxalic acid or phytic acid content.

Pregnancy, breast-feeding, and fertility

During pregnancy, the daily intake should not exceed 1,500 mg of calcium and 600 IU of vitamin D. Therefore, it is not recommended to take Osmille D during pregnancy.

Osmille D can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when vitamin D is additionally administered to the infant.

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

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Osmille Dcontains aspartame

This medicine contains 8.67 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Osmille D contains lactose and sucrose

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

3. How to take Osmille D

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The dose is established by your doctor individually.

The recommended dose is 1 tablet per day.

The tablets should be dissolved in the mouth. They should not be swallowed whole.

The tablets should be taken preferably after meals.

The amount of calcium in Osmille D is less than the daily intake usually recommended. Osmille D is therefore recommended in patients who need an additional intake of vitamin D, but with a daily intake of 500-1,000 mg of calcium per day. The dose of calcium recommended for you should be established by your doctor.

Use in children and adolescents

Osmille D is not indicated in children and adolescents.

If you take moreOsmille Dthan you should

If you have taken more Osmille D than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

The symptoms of an overdose of Osmille D may include loss of appetite, thirst, abnormal emission of large amounts of urine, nausea, vomiting, and constipation.

If you forget to take Osmille D

Take it as soon as you remember. Then take the next dose as usual. However, if it is already time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for missed doses.

If you have any further questions on 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.

You should stop taking Osmille D and inform your doctor immediately if you experience symptoms of severe allergic reactions such as:

• Swelling of the face, lips, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing.

Uncommon side effects (may affect up to 1 in 100 people):hypercalcemia (elevated calcium levels in serum) and/or hypercalciuria (elevated calcium levels in urine).

Rare side effects (may affect up to 1 in 1,000 people):constipation, flatulence, nausea, abdominal pain, diarrhea, pruritus, rash, and urticaria.

Side effects with unknown frequency (frequency cannot be estimated from the available data):severe allergic reactions.

Other special populations

Patients with renal insufficiency may have a potential risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of Osmille D

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

Keep the container perfectly closed.

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

Store in the original container to protect from light. Keep the container perfectly closed to protect from moisture.

The shelf life after first opening is 60 days.

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

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on the disposal of unused medicines, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Osmille D

• The active ingredients are calcium carbonate and colecalciferol (vitamin D3). Each tablet contains 1,500 mg of calcium carbonate equivalent to 600 mg of calcium and 1,000 IU of colecalciferol equivalent to 0.025 mg.
• The other ingredients are: maltodextrin, aspartame (E951), low-substituted hydroxypropylcellulose (E463), lactose monohydrate, anhydrous citric acid (E330), orange flavor, stearic acid, all-rac-α-tocopherol (E307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch, silicon dioxide.

Appearance of the product and contents of the pack

Osmille D is presented in the form of white or almost white, circular, beveled orodispersible tablets.

Bottles of 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

ITALFARMACO, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Tel.: 91 657 23 23

Manufacturer

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

20126 Milan

Italy

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

Laboratorios EFFIK S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Tel: 91 358 52 73

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

Spain Osmille D 600 mg/1,000 IU orodispersible tablets

Italy Natemille 600 mg/1,000 IU orodispersible tablets

Date of the last revision of this leaflet:January 2022

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