Patient Information Leaflet

Demilos 600 mg/ 2,000 IU Buccal Tablets

Calcium / Colecalciferol

Read this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do 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, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet (see section 4).

Contents of the leaflet:

This medication is used to treat calcium and vitamin D deficiency in adults.

This medication contains calcium and vitamin D3, both important components in bone formation. Vitamin D3 regulates calcium absorption and metabolism, as well as calcium incorporation into bones.

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

You should consult a doctor if it worsens or does not improve in a few days.

Do not take Demilos 600 mg/ 2.000 UI :

• If you are allergic (hypersensitive) 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 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 pregnant.
• This medication contains partially hydrogenated soybean oil. Do not use in case of allergy to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Demilos 600 mg/ 2.000 UI

• 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 bedridden due to osteoporosis.

Children and adolescents

Demilos 600mg/ 2.000 UI is not recommended for use in children or adolescents.

Other medications and Demilos 600 mg/ 2.000 UI :

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The treatment effect may be affected if this medication is taken simultaneously with other medications used for:

• High blood pressure (thiazide diuretics).
• Heart problems (cardiac glycosides such as digoxin).
• High cholesterol (cholestyramine).
• Constipation (laxatives such as liquid paraffin).
• Epilepsy (phenytoin or barbiturates).
• Inflammatory diseases / immunosuppression (corticosteroids).
• Obesity (orlistat).

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

If you are taking simultaneously medications for:

• Osteoporosis (bisphosphonates). You should take them at least 3 hours before taking Demilos 600 mg/ 2.000 UI.

If you are taking simultaneously medications for:

• Some infections (quinolones). You should take them 2 hours before or 6 hours after taking Demilos 600 mg/ 2.000 UI.

If you are taking simultaneously medications for:

• Some infections (tetracyclines). You should take them 2 hours before or between 4 and 6 hours after taking Demilos 600 mg/ 2.000 UI.

If you are taking simultaneously medications for:

• Dental caries (sodium fluoride).
• Anemia (iron), you should take them at least 3 hours before taking Demilos 600 mg/ 2.000 UI.

If you are taking simultaneously medications for:

• Hypothyroidism (levotiroxine), you should space the intake of Demilos 600 mg/ 2.000 UI, at least, 4 hours.

Use of Demilos 600 mg/ 2.000 UI with foods, beverages, 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). It is recommended not to take this medication during the 2 hours following the intake of foods with high content of oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility:

This medication is not recommended during pregnancy.

Demilos 600 mg/ 2.000 UI can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when administering additional vitamin D to the baby. Supplementation with Demilos 600 mg/ 2.000 UI does not replace the administration of vitamin D in newborns.

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 machines:

Demilos 600 mg/ 2.000 UI contains aspartame, lactose, sucrose, and partially hydrogenated soybean oil

This medication contains 8.67 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication. It may cause tooth decay.

This medication contains soybean oil. Do not use in case of allergy to peanuts or soy.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is established by your doctor for you individually.

The usual dose is: 1 tablet per day.

The tablets must dissolve in the mouth. They must not be swallowed whole.

The tablets should be taken preferably after meals.

The amount of calcium in Demilos 600 mg/ 2,000 IU is less than the usual daily recommended intake. Therefore, this medication is recommended for patients who need an additional intake of vitamin D but have a daily intake of 500-1,000 mg of calcium. Your doctor should estimate the amount of your daily calcium intake through your diet.

Use in children and adolescents

Demilos 600 mg/ 2,000 IU is not indicated for children and adolescents.

If you take more Demilos 600 mg/ 2,000 IU than you should:

Call your doctor or pharmacist immediately if you take more of this medication than prescribed by your doctor. You can also consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The symptoms of a possible overdose of Demilos 600 mg/ 2,000 IU may include loss of appetite, thirst, abnormal emission of large amounts of urine, nausea, vomiting, and constipation.

If you forgot to take Demilos 600 mg/ 2,000 IU:

Do not take a double dose to compensate for the missed doses.

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 take only one dose as usual.

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

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

You should stop taking this medication 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 patients):hypercalcemia (elevated calcium levels in the blood) and/or hypercalciuria (elevated calcium levels in the urine).

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

Unknown adverse effects (cannot be estimated with 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 of Pharmacovigilance of Medicines 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 use this 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 date is 30 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 in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Demilos 600 mg/ 2.000 UI buccal dispersible tablets

The active principles are calcium carbonate 1.500 mg, corresponding to 600 mg of calcium, and colecalciferol 2.000 UI (vitamin D 3 ) corresponding to 0.050 mg.

The other components are: maltodextrin, anhydrous citric acid (E330), low-substitution hydroxypropylcellulose (E463), lactose monohydrate, stearic acid, aspartame (E 951), sucrose, gelatin, orange flavor (natural flavorings, maltodextrin, dextrin), cornstarch, partially hydrogenated soybean oil, ALL-rac-α-tocopherol (E 307), silicon dioxide.

Appearance of Demilos 600 mg/ 2.000 UI and contents of the packaging

White or almost white, circular, bisected buccal dispersible tablets.

Blister pack of 30 tablets.

Multi-pack of 60 (2 packs of 30) buccal dispersible tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

ITALFARMACO, S.A.

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

Phone: 916572323

Responsible manufacturer:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Phone: 39 02 6443.1

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

• Italy: Dincrel 600 mg / 2000 U.I. orodispersible Tablet

Last review date of this leaflet: June 2020

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