MASTICAL D 500 mg / 400 IU CHEWABLE TABLETS ORANGE FLAVOR

Introduction

Package Leaflet: Information for the User

Mastical D 500 mg/ 400 UI Orange-Flavored Chewable Tablets

Calcium / Colecalciferol (Vitamin D3)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Mastical D and what is it used for
2. What you need to know before taking Mastical D
3. How to take Mastical D
4. Possible side effects
5. Storage of Mastical D
6. Package Contents and Additional Information

1. What is Mastical D and what is it used for

Mastical D are white, orange-flavored chewable tablets that contain calcium and vitamin D3, both of which are essential for bone formation. Mastical D is used in the prevention and treatment of calcium and vitamin D deficiency in adults with associated risk of calcium and vitamin D deficiency, and as a supplement to specific osteoporosis treatment.

2. What you need to know before taking Mastical D

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 taking this medication:

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

Children and Adolescents

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

Taking Mastical D with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medications.

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 may interfere with the absorption of tetracycline preparations if taken at the same time.

Medications containing bisphosphonates (used to treat osteoporosis) should be taken at least 1 hour before taking Mastical D.

Calcium may reduce the effect of levothyroxine (used to treat thyroid hormone deficiency). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after taking this medication.

The effects of some antibiotics (quinolones) may be reduced if taken at the same time as calcium. Therefore, quinolones should be taken 2 hours before or 6 hours after taking Mastical D.

Calcium salts may decrease the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after Mastical D.

Other medications that may interact with or be affected by Mastical D are:

• thiazide diuretics (used to treat hypertension or edema)
• cardiac glycosides (used to treat heart conditions)

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

If you are using any of the aforementioned medications, your doctor will provide further instructions.

Taking Mastical D with Food and Drinks

Mastical D orange-flavored tablets can be taken with or without food and drinks.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 overdoses may affect the fetus.

This medication can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when administering additional vitamin D to the child.

Driving and Using Machines

This medication has no known influence on the ability to drive and use machines.

Mastical D Contains Sorbitol

This medication contains 324.45 mg of sorbitol (E-420) per tablet. Sorbitol is a source of fructose. If your doctor has told you 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, 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".

3. How to Take Mastical D

Follow the administration instructions for this medication exactly as indicated by your doctor. If in 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 Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested. Bring this package leaflet with you.

If You Forget to Take Mastical D

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

Uncommon Side Effects (may affect up to 1 in 100 people)

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

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

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

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

Pruritus, exanthema, and urticaria. Milk-alkali syndrome (also called Burnett syndrome, which usually only occurs when excessive amounts of calcium have been ingested). The symptoms are urgent need to urinate frequently, headache, loss of appetite, nausea or vomiting, fatigue or weakness, along with high calcium levels in the blood and altered kidney function.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Mastical D

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

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

Do not store above 30°C. Store in the original packaging to protect from light. Keep the container tightly closed to protect from moisture.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Mastical D Composition:

The active ingredients are:

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

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

Product Appearance and Package Contents

Mastical D contains 60 white, orange-flavored chewable tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

INDUSTRIA QUIMICA Y FARMACÉUTICA VIR, S.A.

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

28923; Alcorcón. Madrid

Spain

Local Representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet:July 2019

Detailed information on this medication is available on the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.aemps.gob.es