DEMILOS 600 MG/1000 IU ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is Demilos and what is it used for

Demilos 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 suitable.

Demilos contains calcium and vitamin D3, both important components in bone formation. Vitamin D3 regulates calcium absorption and metabolism as well as calcium incorporation 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 worsens or does not improve after a few days.

2. What you need to know before you take Demilos

Do not take Demilos

• If you are allergic to calcium, vitamin D, or any of the other ingredients of this medicine (listed in section 6). If you have hypercalcaemia (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 Demilos

• 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 Demilos

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 barbiturics),
• 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 Demilos.

If you take at the same time medicines for

• infections (quinolones)

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

If you take at the same time medicines for

• infections (tetracyclines)

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

If you take at the same time medicines for

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

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

If you take at the same time medicines for

• hypothyroidism (levothyroxine)

you should take Demilos at least four hours apart.

Taking Demilos with Food, Drinks, and Alcohol:

Calcium absorption 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 Demilos 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 1500 mg of calcium and 600 IU of vitamin D. Therefore, it is not recommended to take Demilos during pregnancy.

Demilos 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

Demilos contains 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.

Demilos 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 damage teeth.

3. How to Take Demilos

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

The dose is established by your doctor on an individual basis.

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 Demilos is less than the daily intake usually recommended. Demilos is therefore recommended for 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

Demilos is not indicated in children and adolescents.

If you Take More Demilos than you Should

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

Symptoms of an Overdose of Demilos may Include Loss of Appetite, Thirst, Abnormal Production of Large Amounts of Urine, Nausea, Vomiting, and Constipation.

If you Forget to Take Demilos

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 forgotten 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 must stop taking Demilos 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): hypercalcaemia (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, diarrhoea, pruritus, rash, and urticaria.

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

Other special populations

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 Demilos

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

Keep the container tightly 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 stated.

Store in the original container to protect from light.

Keep the container tightly 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Demilos

The active substances are calcium carbonate 1500mg corresponding to 600mg of calcium 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 (E-463), lactose monohydrate, anhydrous citric acid (E330), orange flavor, stearic acid, all-rac-α-tocopherol (E 307), partially hydrogenated soybean oil, gelatin, sucrose, corn starch, and silicon dioxide.

Appearance of the Product and Contents of the Pack

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

Bottle of 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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

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

Spain: Demilos 600mg/ 1000 UI orodispersible tablets

France: Demilos 600mg/ 1000 UI orodispersible tablets

Italy: Dincrel 600mg/ 1000 UI orodispersible tablets

Ireland: Cadelius 600 mg/1,000 IU orodispersible tablets

Portugal: Demilos 600 mg + 1000 UI orodispersible tablets

Date of the Last Revision of this Leaflet:January 2022

Detailed and 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/).