CALCIO D ISDIN 600 MG/400 IU CHEWABLE TABLETS

Introduction

Patient Information Leaflet

Calcio D ISDIN 600 mg/400 UI Chewable Tablets

Calcium / Colecalciferol (Vitamin D3)

Read this leaflet carefully before starting to use this medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Calcio D Isdin and what is it used for
2. What you need to know before taking Calcio D Isdin
3. How to take Calcio D Isdin
4. Possible side effects
5. Storage of Calcio D Isdin
6. Package contents and additional information

1. What is Calcio D Isdin and what is it 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 manifest calcium and vitamin D deficiency or at high risk of developing it.

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 components of this medicine (listed in section 6).
• If you have kidney stones.
• If you have severe kidney failure.
• If you have high levels of calcium in the blood or urine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Calcio D Isdin.

• If you suffer from any of the following diseases, always inform your doctor before taking this medicine:
• If you are taking other products that contain vitamin D, inform your doctor, as you should stop taking them.
• If you have sarcoidosis (a granulomatous disease that affects various organs, including the skin, and can be associated with high blood calcium levels).
• If you have kidney failure or a tendency to form kidney stones.
• If you have any heart disease.

Consult your doctor, even if any of the above circumstances have occurred in the past.

Children

The safety and efficacy of Calcio D Isdin have not been established in children, and 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 may need to take any other medicine.

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.
• Colestyramine.
• Corticosteroids.
• Mineral oils.
• Phenytoin.
• Barbiturates.
• Bisphosphonate.
• Sodium fluoride.

Taking Calcio D Isdin with food, drinks, and alcohol

If you take Calcio D Isdin chewable tablets with foods that contain oxalates (beet, spinach, chocolate), phosphates (red meat), or phytic acid (whole wheat bread, cereals), interactions may occur, so it is recommended not to take Calcio D Isdin with meals.

During treatment with Calcio D Isdin, do not take foods that may be "fortified" with vitamin D.

Pregnancy, breastfeeding, and fertility

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

Consult your doctor or pharmacist before taking any medicine.

Your doctor will assess the suitability of the treatment 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 and use machines have been observed.

Important information about some of the components of Calcio D Isdin

This medicine contains 5 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine, which may be harmful in cases 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 certain sugars, consult with them before taking this medicine.

This medicine contains 600 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) 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, consult with your doctor before taking this medicine.

3. How to take Calcio D Isdin

Follow the administration instructions for this medicine exactly 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 indicate the duration of your treatment with Calcio D Isdin. Do not stop treatment before, as the desired effect will not be achieved.

Method of administration:

Calcio D Isdin chewable tablets are for oral use. Chew the tablets, then drink a little water if desired.

They can also be dispersed in half a glass of water and taken afterwards.

If you think the action 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 a feeling of thirst, nausea, vomiting, dehydration, increased urination frequency, and constipation.

In case of overdose or accidental ingestion, consult 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 taking Calcio D Isdin

If you have any further questions about 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.

The following side effects have been observed:

Rare (may affect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, and diarrhea.

In case of prolonged administration at high doses, high levels of calcium in the blood and urine may appear, with symptoms such as loss of appetite, vomiting, nausea, headache, weakness, apathy, and somnolence. Other more serious symptoms are thirst, dehydration, increased urination frequency, abdominal pain, and irregular heartbeat.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website, www.notificaram.es. By reporting side 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. Store in the original package.

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

Do not use this medicine after the expiration date stated on the package, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the package and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Calcio D Isdin

• The active ingredients are calcium (carbonate) and colecalciferol (vitamin D3). Each chewable tablet contains 600 mg of calcium and 400 UI 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 package contents

Calcio D Isdin are white, anise-menthol flavored chewable tablets.

They are available in polyethylene bottles containing 60 chewable tablets.

Marketing authorization holder and manufacturer

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

28709 Madrid

Spain

Date of the last revision of this leaflet:July 2018

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es