Calcio D Isdin 600 mg/400 IU chewable tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Calcio D ISDIN 600 mg/400 IU chewable tablets
Calcium / colecalciferol (vitamin D3)
Read the entire leaflet carefully before you start using 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 or pharmacist.
- 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, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Calcio D Isdin is and what it is used for
- What you need to know before taking Calcio D Isdin
- How to take Calcio D Isdin
- Possible side effects
- How to store Calcio D Isdin
- Contents of the pack and other information
1. What Calcio D Isdin is and what it is used for
Calcio D Isdin is a calcium and vitamin D supplement.
Calcio D Isdin is indicated for the treatment of calcium and vitamin D deficiency states. It can also be used as a supplement in the treatment of osteoporosis in patients with evident calcium and vitamin D deficiency or at high risk of developing such deficiency.
2. What you need to know before taking Calcio D Isdin
Do not take Calcio D Isdin:
- If you are allergic to calcium carbonate, vitamin D3, or any of the other ingredients of this medicine (listed in section 6).
- If you have kidney stones (calculi).
- If you have severe renal insufficiency.
- If you have high levels of calcium in your blood or urine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Calcio D Isdin.
- If you suffer from any of the following conditions, remember to always inform your doctor before taking this medicine:
- If you are taking other products containing vitamin D, you must inform your doctor, as you should stop taking them.
- If you have sarcoidosis (a granulomatous disease affecting various organs, including the skin, which may be associated with elevated blood calcium levels).
- If you have renal insufficiency or a tendency to form kidney stones (calculi).
- If you have any heart disease.
Consult your doctor, even if any of the above circumstances occurred in the past.
Children
The safety and efficacy of Calcio D Isdin have not been established in children, therefore its use is not recommended in this age group.
Other medicines and Calcio D Isdin
Taking Calcio D Isdin with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Calcio D Isdin may interact with the following medicines:
- Cardiac glycosides, such as digoxin.
- The following antibiotics: tetracyclines, penicillin, neomycin, chloramphenicol.
- Certain diuretics: loop diuretics (furosemide, ethacrynic acid) and thiazide diuretics (hydrochlorothiazide).
- Antacids containing aluminum salts.
- Thyroid hormones.
- Cholestyramine.
- Corticosteroids.
- Mineral oils.
- Phenytoin.
- Barbiturates.
- Bisphosphonates.
- Sodium fluoride.
Taking Calcio D Isdin with food, drinks, and alcohol
If you take Calcio D Isdin chewable tablets together with foods containing oxalates (cabbage, spinach, chocolate), phosphates (red meat), or phytic acid (wholemeal bread, cereals), interactions may occur; therefore, it is advisable not to take Calcio D Isdin with meals.
During treatment with Calcio D Isdin, you should not consume foods that may be "fortified" with vitamin D.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Talk to your doctor or pharmacist before taking any medicine.
Your doctor will assess whether treatment is appropriate for you.
The use of Calcio D Isdin is not recommended during pregnancy or breastfeeding.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Important information about some of the ingredients of Calcio D Isdin
This medicine contains 5 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 him before taking this medicine.
This medicine contains 600 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, you (or your child) should consult your doctor before taking this medicine.
3. How to take Calcio D Isdin
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Adults and elderly patients
The recommended dose is 1 to 2 tablets per day.
Your doctor will determine the duration of your treatment with Calcio D Isdin. Do not stop the treatment prematurely, as the desired effect will not be achieved.
Method of administration:
The Calcio D Isdin chewable tablets are for oral use. Chew the Calcio D Isdin tablets and, if desired, drink a little water afterwards.
Alternatively, 1 or 2 tablets can be dispersed in half a glass of water and then ingested.
If you feel that the effect of Calcio D Isdin is too strong or too weak, inform your doctor or pharmacist.
If you take more Calcio D Isdin than you should
If you have taken more Calcio D Isdin than you should, consult your doctor or pharmacist immediately.
In case of overdose, you may experience thirst, nausea, vomiting, dehydration, increased frequency of urination, and constipation.
In case of overdose or accidental ingestion, contact the Toxicology Information Service: Telephone 91 562 04 20.
If you forget to take Calcio D Isdin
Do not take a double dose to make up for forgotten doses.
If you forget to take a dose, take the next one as soon as possible and continue as before.
If you stop treatment with Calcio D Isdin
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 will experience them.
The following adverse effects have been observed:
Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, and diarrhoea.
With prolonged administration at high doses, elevated levels of calcium in blood and urine may occur, with symptoms such as loss of appetite, vomiting, nausea, headache, weakness, apathy, and drowsiness. Other more severe symptoms include thirst, dehydration, increased frequency of urination, abdominal pain, and irregular heartbeat.
If you notice any reaction not described in this leaflet, consult your doctor or pharmacist.
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 Pharmacovigilance System for Human Medicines at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Calcio D Isdin
Do not store above 30°C. Keep in the original container.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 Calcio D Isdin
- The active substances are calcium (carbonate) and colecalciferol (vitamin D3). Each chewable tablet contains 600 mg of calcium and 400 IU of colecalciferol.
- The other components are: sodium saccharin, sorbitol (E-420), pregelatinized corn starch, magnesium stearate (E-572), sodium croscarmellose, aspartame (E-951), anhydrous lactose, anise flavor, mint flavor, and milk flavor.
Appearance of the product and contents of the container
Calcio D Isdin is white chewable tablets with an anise-mint flavor.
It is available in polyethylene bottles containing 60 chewable tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Isdin S.A.
Provençals 33
08019 Barcelona
Spain
Manufacturer:
Farmasierra Manufacturing S.L.
Ctra de Irún km 26,200 San Sebastián de los Reyes
28706 Madrid
Spain
Date of the most recent revision of this leaflet: July 2018
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es