Prospect: information for the user

Demilos 600 mg/1,000 UI chewable tablets

calcium carbonate/colecalciferol

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Content of the prospect

Demilos is used to prevent and treat calcium or vitamin D deficiency3in elderly individuals and as an 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 UI/day of vitamin D3is appropriate.

Demilos contains calcium and vitamin D3, both important components in bone formation. Vitamin D3regulates calcium absorption and metabolism as well as calcium incorporation into bone tissue.

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

You should consult a doctor if you worsen or do not improve after a few days.

Do not take Demilos:

- If you are allergic to calcium, vitamin D, or any of the other components of this medication (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 starting to take Demilos

- If you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).

- If you are taking other medications that contain vitamin D or calcium.

- If your kidneys do not function well or you have a tendency to form kidney stones.

- If you are immobile due to osteoporosis.

Other medications and Demilos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The effect of treatment may be affected if this medication is taken simultaneously with other medications 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 ensure that your doctor knows if you are taking any of the medications listed above. Your dose may need to be adjusted.

If you take simultaneously a medication for

• osteoporosis (bisphosphonates)

you should take it at least one hour before taking Demilos.

If you take simultaneously medications for

• infections (fluoroquinolones)

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

If you take simultaneously medications for

• infections (tetracyclines)

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

If you take simultaneously medications for

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

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

If you take simultaneously medications for

• hypothyroidism (levotiroxine)

you should separate the taking of Demilos by at least four hours.

Taking Demilos 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 most cereals). You should wait at least two hours before taking Demilos if you have taken foods with high oxalic acid or phytic acid content.

Pregnancy, breastfeeding, and fertility:

During pregnancy, the daily intake should not exceed 1500mg 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 additional vitamin D is provided to the infant.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

Demilos contains aspartame

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

Demilos contains lactose and sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. It may harm your teeth

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of doubt, 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 must 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 usual daily recommended intake. Demilos is recommended for patients who need an additional intake of vitamin D, but with a daily intake of 500-1,000 mg of calcium. The recommended calcium dose for you should be established by your doctor.

Children and Adolescents

Demilos is not indicated for 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of a Demilos overdose may include loss of appetite, thirst, abnormal emission 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, omit the missed dose and continue as usual. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medicationmay cause adverse effects, although not everyone will experience them.

You should stop taking Demilos and inform your doctor immediately if you experience severe allergic reaction symptoms such as:

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

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

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

Adverse effects of unknown frequency (frequency cannot be estimated from available data): severe allergic reactions.

Other special populations

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

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 on the safety of this medication.

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

Keep the container perfectly closed.

Do not usethis medication after the expiration date that appears on the container, after CAD. The expiration date is the last day of the month indicated.

Store in the original container to protect it from light.

Keep the container perfectly closed to protect it from moisture.

The expiration is 60 days after its first opening.

Do not use this medication if you observe any visible sign of deterioration.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Demilos

The active principles are calcium carbonate 1500mg corresponding to 600mg of calcium and cholecalciferol 25 micrograms corresponding to 1000 UI of vitamin D3. 3 .

The other components are: maltodextrin, aspartame (E-951), low-substitution hydroxypropylcellulose (E-463), lactose monohydrate, anhydrous citric acid (E-330), orange aroma, stearic acid, DL α-tocopherol (E 307), partially hydrogenated soybean oil, gelatin, sucrose, cornstarch.

Appearance of Demilos and contents of the packaging

White or almost white, circular, bisected buccal tablets.

Bottle of 30 or 60 tablets.

Multiple packaging contains 60 buccal tablets in 2 bottles of 30 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

ITALFARMACO, S.A.

San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN

Tel.: 916572323

Responsible manufacturer:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Tel.: 39 02 6443.1

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

Spain: Demilos 600mg/ 1000 UI buccal tablets

France: Demilos 600mg/ 1000 UI orodispersible tablets

Italy: Dincrel 600mg/ 1000 UI orodispersible tablets

Portugal: Demilos 600 mg + 1000 UI Orodispersible tablets

Revision date of this leaflet: November 2015

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