DEMILOS 600 MG/2000 IU ORALLY DISINTEGRATING TABLETS
How to use DEMILOS 600 MG/2000 IU ORALLY DISINTEGRATING TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Demilos 600 mg/ 2,000 UI Orodispersible Tablets
Calcium / 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:
- What is Demilos 600 mg/ 2,000 UI and what is it used for
- What you need to know before you take Demilos 600 mg/ 2,000 UI
- How to take Demilos 600 mg/ 2,000 UI
- Possible side effects
- Storage of Demilos 600 mg/ 2,000 UI
- Contents of the pack and other information
1. What is Demilos 600 mg/ 2,000 UI and what is it used for
This medicine is used to treat calcium and vitamin D deficiency in adults.
This medicine 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 questions and always follow their instructions.
You should consult a doctor if it gets worse or does not improve within a few days.
2. What you need to know before you take Demilos 600 mg/ 2,000 UI
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 medicine (listed in section 6).
- If you have hypercalcemia (high blood calcium levels) or hypercalciuria (high urine calcium levels).
- If you have hypervitaminosis D (high blood vitamin D levels).
- If you have kidney stones.
- If you have kidney failure.
- If you are pregnant.
- This medicine contains partially hydrogenated soybean oil. It should not be used in case of peanut or soy allergy.
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 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.
Children and Adolescents
Demilos 600 mg/ 2,000 UI is not recommended for use in children or adolescents.
Other Medicines and Demilos 600 mg/ 2,000 UI:
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
The effect of treatment may be affected if this medicine is taken at the same time as 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 / immune system suppression (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 are taking medicines for:
- Osteoporosis (bisphosphonates). You should take them at least 3 hours before taking Demilos 600 mg/ 2,000 UI.
If you are taking medicines 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 medicines for:
- Some infections (tetracyclines). You should take them 2 hours before or 4-6 hours after taking Demilos 600 mg/ 2,000 UI.
If you are taking medicines 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 medicines for:
- Hypothyroidism (levothyroxine), you should space out the intake of Demilos 600 mg/ 2,000 UI by at least 4 hours.
Using Demilos 600 mg/ 2,000 UI with Food, Drinks, 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 during the 2 hours following the intake of foods with high oxalic or phytic acid content.
Pregnancy, Breast-feeding, and Fertility:
This medicine is not recommended during pregnancy.
Demilos 600 mg/ 2,000 UI can be taken during breast-feeding. 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 breast-feeding, 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. |
Demilos 600 mg/ 2,000 UI contains aspartame, lactose, sucrose, and partially hydrogenated soybean oil
This medicine contains 8.67 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine. It may cause tooth decay.
This medicine contains soybean oil. It should not be used in case of peanut or soy allergy.
3. How to Take Demilos 600 mg/ 2,000 UI
Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, 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 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 600 mg/ 2,000 UI is less than the daily recommended intake. Therefore, this medicine is recommended for patients who need an additional intake of vitamin D but have a daily calcium intake of 500-1,000 mg per day. Your doctor should estimate your daily calcium intake through your diet.
Use in Children and Adolescents
Demilos 600 mg/ 2,000 UI is not indicated for use in children and adolescents.
If You Take More Demilos 600 mg/ 2,000 UI Than You Should:
Call your doctor or pharmacist immediately if you take more of this medicine than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.
The symptoms of a possible overdose of Demilos 600 mg/ 2,000 UI may include loss of appetite, thirst, excessive urination, nausea, vomiting, and constipation.
If You Forget to Take Demilos 600 mg/ 2,000 UI:
Do not take a double dose to make up for forgotten 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 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 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 side effects (may affect up to 1 in 100 people):hypercalcemia (elevated blood calcium levels) and/or hypercalciuria (elevated urine calcium levels).
Rare side effects (may affect less than 1 in 1,000 people):constipation, flatulence, nausea, abdominal distension (pain), diarrhea, pruritus (itching), rash, and urticaria.
Unknown frequency side effects (cannot be estimated from the available data):serious 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 Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Demilos 600 mg/ 2,000 UI
- 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 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 30 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. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the Pack and Other Information
Composition of Demilos 600 mg/ 2,000 UI Orodispersible Tablets
The active substances are calcium carbonate 1,500 mg, corresponding to 600 mg of calcium, and colecalciferol 2,000 UI (vitamin D3) corresponding to 0.050 mg.
The other ingredients are: maltodextrin, anhydrous citric acid (E330), low-substituted hydroxypropylcellulose (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 UI and Contents of the Pack
Orodispersible tablets are white or almost white, circular, and beveled.
Bottle of 30 tablets.
Multi-pack of 60 (2 packs of 30) orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder: ITALFARMACO, S.A.
San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN
Tel.: 916572323
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 under the following names:
- Italy: Dincrel 600 mg / 2000 U.I. orodispersible tablet
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Date of Last Revision of this Leaflet: June 2020
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.es/
- Country of registration
- Average pharmacy price18.01 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to DEMILOS 600 MG/2000 IU ORALLY DISINTEGRATING TABLETSDosage form: CHEWABLE TABLET, 1000 mg/880 IUActive substance:Manufacturer: Lacer S.A.Prescription requiredDosage form: ORALLY DISINTEGRATING TABLET/LIOTAB, 1500 mg calcium carbonate; 400 IU cholecalciferolActive substance:Manufacturer: Itf Medilab Farma S.A.Prescription requiredDosage form: ORALLY DISINTEGRATING TABLET/LYOTAB, 1500 mg calcium carbonate (600 mg Calcium) + 2000 IU cholecalciferolActive substance:Manufacturer: Italfarmaco S.A.Prescription required
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