Leaflet: information for the user

Mastical D 500 mg/ 400 IU chewable tablets orange flavor

calcium / colecalciferol (Vitamin D3)

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMastical Dand what it is used for

2. What you need to know before starting to takeMastical D

3. How to takeMastical D

4. Possible side effects

5. Storage ofMastical D

6. Contents of the pack and additional information

Mastical D are chewable tablets in white color and orange flavor, containing calcium and vitamin D3, both substances are important for bone formation. Mastical D is used in the prevention and treatment of calcium and vitamin D deficiency in adults at risk of calcium and vitamin D deficiency and as a supplement to specific treatment of osteoporosis.

Do not take Mastical D:

• if you are allergic to calcium, vitamin D, or any of the components of this medication (listed in section 6).
• if you have severe kidney problems.
• if you have excessive calcium in your blood or urine.
• if you have kidney stones.
• if you have excessive vitamin D in your blood.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you are undergoing long-term treatment, especially if you take diuretics (used in the treatment of high blood pressure or edema) or cardiac glycosides (used for the treatment of cardiac arrhythmias).
• if you have signs of altered renal function or a tendency to form kidney stones.
• if you have sarcoidosis (a disorder of the immune system that can increase vitamin D levels in the body).
• if you have osteoporosis and are unable to move from side to side.
• if you are taking other products with vitamin D. Additional doses of calcium and vitamin D should be taken under strict medical supervision.

Children and adolescents

This medication is not indicated for use in children and adolescents.

Taking Mastical D with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to takeany other medication.

If you are also taking tetracyclines (a type of antibiotic), take them at least 2 hours before or 4-6 hours after taking Mastical D. Calcium carbonate can interfere with the absorption of tetracycline preparations if taken at the same time.

Medications containing bisphosphonates (used in the treatment of osteoporosis) should be taken at least one hour before taking Mastical D.

Calcium can reduce the effect of levothyroxine (used in the treatment of thyroid hormone deficiency). Therefore, levothyroxine should be taken at least four hours before or four hours after taking this medication.

The effects of some antibiotics (quinolones) may be reduced if taken at the same time as calcium. For this reason, quinolones should be taken two hours before or six hours after taking Mastical D.

Calcium salts can decrease the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least two hours before or after Mastical D.

Other medications that may influence or be influenced when taking Mastical D are:

• thiazide diuretics (used in the treatment of hypertension or edema)
• cardiac glycosides (used for the treatment of cardiac arrhythmias)

Orlistat (used for the treatment of obesity) may alter the absorption of fat-soluble vitamins, such as vitamin D3.

If you are using any of the medications mentioned, your doctor will give you further instructions.

Taking Mastical D with food and drinks

Mastical D orange flavor can be taken with or without food and drinks.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, you can use Mastical D in case of calcium and vitamin D deficiency.During pregnancy, do not take more than 2500 mg of calcium and 4000 IU of vitamin D per day, as excessive doses can affect the fetus.

This medication can be taken during breastfeeding. Calcium and vitamin D3pass into breast milk. You should be aware of this when administering additional vitamin D to the child.

Driving and operating machinery

This medicationhas no known influence on the ability to drive and operate machinery.

Mastical D contains sorbitol

This medication contains 324.45 mg of sorbitol (E-420) in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you have a condition that makes you intolerant to certain sugars or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

Mastical D is essentially sodium-free

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

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

Dose:

The recommended dose is 1 tablet twice a day. The tablet can be chewed or sucked.

Use in children and adolescents

This medication is not intended for use in children and adolescents.

If you take more Mastical D than you should

If you have taken more Mastical D than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested. Bring this leaflet with you.

If you forgot to take Mastical D

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Unknown frequency (cannot be estimated from available data) hypersensitivity reactions have occurred. If you have the following symptoms, contact your doctor immediately. Swelling of the face, tongue, lips (angioedema) or throat (laryngeal edema).

Infrequent Adverse Effects (may affect up to 1 in 100 people)

You may experience excessive amounts of calcium in the blood (hypercalcemia) or urine with high doses (hypercalciuria).

Rare Adverse Effects (may affect up to 1 in 1,000 people)

Constipation, indigestion, flatulence, nausea, abdominal pain, and diarrhea.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

Pruritus, exanthema, and urticaria. Milk-Alkali Syndrome (also known as Burnett Syndrome and generally only occurs when excessive amounts of calcium have been ingested). Symptoms include frequent and urgent need to urinate, headache, loss of appetite, nausea or vomiting, excessive fatigue or weakness, along with high levels of calcium in the blood and kidney function alterations.

If you have kidney insufficiency, you may be at risk of experiencing an increase in blood phosphate levels, kidney stone formation, and increased calcium levels in the kidneys.

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 for Pharmacovigilance of Medicinal Products for Human Use: 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.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from light. Keep the container perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mastical D:

The active principles are:

• calcium carbonate 1250 mg (equivalent to 500 mg of calcium)
• colecalciferol (vitamin D3) 400 UI (10 micrograms).

The other components are:sorbitol (E-420), sodium saccharin anhydrous, orange flavor, hydroxypropylcellulose, magnesium stearate.

Appearance of the product and contents of the packaging

Mastical D contains 60 chewable tablets, white in color.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

INDUSTRIA QUIMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Industrial Park Urtinsa II.

28923; Alcorcón. Madrid

Spain

Local representative

Laboratorios Rubió, S.A.

Industry, 29 - Industrial Park Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet:July 2019

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es