Demilos 600 mg/2000 IU orodispersible tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Demilos 600 mg/2,000 IU orodispersible tablets

calcium / colecalciferol

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet (see section 4).

Package leaflet:

1. What Demilos 600 mg/2,000 IU is and what it is used for
2. What you need to know before taking Demilos 600 mg/2,000 IU
3. How to take Demilos 600 mg/2,000 IU
4. Possible side effects
5. How to store Demilos 600 mg/2,000 IU
6. Contents of the pack and other information

1. What Demilos 600 mg/2,000 IU is and what it is used for

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

This medicine contains calcium and vitamin D3, both of which are important components in bone formation. Vitamin D3 regulates the absorption and metabolism of calcium, as well as the incorporation of calcium into bones.

If you have any questions, consult your doctor or pharmacist and always follow their instructions.

Consult a doctor if your condition worsens or does not improve within a few days.

2. What you need to know before taking Demilos 600 mg / 2,000 IU

Do not take Demilos 600 mg / 2,000 IU:

• If you are allergic (hypersensitive) 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 (renal calculi).
• If you have renal failure.
• If you are pregnant.
• This medicine contains partially hydrogenated soybean oil. It should not be used if you are allergic to peanuts or soybeans.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Demilos 600 mg/ 2,000 IU

• If you have sarcoidosis (a specific type of connective tissue disease affecting the lungs, skin, and joints).
• If you are taking other medicines containing vitamin D or calcium.
• If your kidneys are not functioning properly or if you have a tendency to develop kidney stones.
• If you are immobilized due to osteoporosis.

Children and adolescents

Demilos 600 mg/ 2,000 IU is not recommended for use in children or adolescents.

Other medicines and Demilos 600 mg/2,000 IU:

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

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

If you are taking medicines simultaneously for:

• Osteoporosis (bisphosphonates), you should take them at least 3 hours before taking Demilos 600 mg/2,000 IU.

If you are taking medicines simultaneously for:

• Certain infections (quinolones), you should take them 2 hours before or 6 hours after taking Demilos 600 mg/2,000 IU.

If you are taking medicines simultaneously for:

• Certain infections (tetracyclines), you should take them 2 hours before or between 4 and 6 hours after taking Demilos 600 mg/2,000 IU.

If you are taking medicines simultaneously for:

• Dental caries (sodium fluoride).
• Anemia (iron), you should take them at least 3 hours before taking Demilos 600 mg/2,000 IU.

If you are taking medicines simultaneously for:

• Hypothyroidism (levotiroxine), you should separate the administration from Demilos 600 mg/2,000 IU by at least 4 hours.

Use of Demilos 600 mg/2,000 IU with food, beverages, and alcohol:

Calcium absorption may be inhibited by foods containing oxalic acid (found in spinach and rhubarb) or phytic acid (found in most cereals). It is recommended not to take this medicine within two hours after consuming foods high in oxalic acid or phytic acid.

Pregnancy, lactation, and fertility:

This medicine is not recommended during pregnancy.

Demilos 600 mg/2,000 IU can be taken during lactation. Calcium and vitamin D3 are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant. Supplementation with Demilos 600 mg/2,000 IU does not replace the administration of vitamin D in newborns.

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

Driving and use of machinery:

Demilos 600 mg/ 2,000 IU contains aspartame, lactose, sucrose, and partially hydrogenated soybean oil

This medicine contains 8.67 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine. It may cause dental caries.

This medicine contains soybean oil. It must not be used if you are allergic to peanuts or soybeans.

3. How to take Demilos 600 mg/2,000 IU

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose will be individually determined by your doctor for you.

The usual dose is: 1 tablet per day.

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

The tablets should preferably be taken after meals.

The amount of calcium in Demilos 600 mg/2,000 IU is lower than the daily intake usually recommended. Therefore, this medicine is recommended for patients who require an additional supply of vitamin D but who already have a daily dietary intake of 500–1,000 mg of calcium. Your doctor should assess your daily calcium intake from diet.

Use in children and adolescents

Demilos 600 mg/2,000 IU is not indicated for use in 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 medicine than prescribed by your doctor. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

Symptoms of a possible overdose of Demilos 600 mg/2,000 IU may include loss of appetite, thirst, abnormally large volume of urine, nausea, vomiting, and constipation.

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

Do not take a double dose to make up for the missed dose.

Take it as soon as you remember. Afterwards, take the next dose as usual. However, if it is already time for your next dose, skip the missed dose and take only a single dose as usual.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You should stop taking this medicine and inform your doctor immediately if you experience symptoms of serious allergic reactions such as:

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

Uncommon adverse effects (may affect up to 1 in 100 patients): hypercalcemia (high levels of calcium in the blood) and/or hypercalciuria (high levels of calcium in the urine).

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

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

Other special populations

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

Reporting of 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 leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Demilos 600 mg/2,000 IU

• 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 stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
• Store in the original packaging to protect from light. Keep the container tightly closed to protect from moisture.
• The shelf life is 30 days after first opening.
• Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Demilos 600 mg/2,000 IU orodispersible tablets

The active substances are calcium carbonate 1,500 mg, equivalent to 600 mg of calcium, and colecalciferol 2,000 IU (vitamin D3), equivalent to 0.050 mg.

The other components are: maltodextrin, anhydrous citric acid (E330), low-substituted hydroxypropyl cellulose (E463), lactose monohydrate, stearic acid, aspartame (E951), sucrose, gelatin, orange flavor (natural flavorings, maltodextrin, dextrin), corn starch, partially hydrogenated soybean oil, ALL-rac-α-tocopherol (E307), silicon dioxide.

Appearance of Demilos 600 mg / 2,000 IU and contents of the pack

White or almost white, round, bevelled orodispersible tablets.

Bottle containing 30 tablets.

Multi-pack containing 60 tablets (2 packs of 30) orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party:

Marketing Authorization Holder:

ITALFARMACO, S.A.

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

Tel.: 916572323

Manufacturing Responsible Party:

ITALFARMACO, S.p.A.

Viale Fulvio Testi 330

Milan (ITALY)

Tel.: 39 02 6443.1

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

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

Date of the last review of this leaflet: June 2020

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/