MASTICAL D 500 MG/400 IU CHEWABLE TABLETS STRAWBERRY FLAVOR

Introduction

Package Leaflet: Information for the User

Mastical D 500mg/400UI Chewable Tablets Strawberry Flavor

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 chewable tablets that contain calcium and vitamin D3, both of which are important for bone formation. Mastical D is used in the prevention and treatment 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 other 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 calcium kidney stones
• if you have excessive vitamin D in your blood

Warnings and Precautions

Consult your doctor or pharmacist before taking Mastical D.

• 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 impaired renal function.
• 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 calcium and vitamin D doses should be taken under strict medical supervision.

Children and Adolescents

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

Using Mastical D with Other Medications

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

If you are also taking tetracyclines (a type of antibiotic), you should 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 deficiency). For this reason, 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. For this reason, 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. Consequently, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after Mastical D.

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

Other medications that may interact with Mastical D are:

• thiazide diuretics (used to treat high blood pressure or edema)
• cardiac glycosides (used to treat heart conditions)

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

Taking Mastical D with Food and Drinks

This medication can be taken with or without food and drinks.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, 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, you should not take more than 2500 mg of calcium and 4000 IU of vitamin D per day, as overdoses can 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

Mastical D has no known influence on the ability to drive and use machines.

Mastical D Contains Sucrose

Mastical D contains sucrose (0.8 mg), which may cause cavities. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Mastical D is Essentially Sodium-Free

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

3. How to Take Mastical D

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, 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

This medication is not intended for use in children.

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 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 about 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 will experience them.

Hypersensitivity reactions have occurred with an unknown frequency (cannot be estimated from available data). If you experience the following symptoms, you should 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 (hypercalciuria) with high doses.

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 occur in less than 1 in 10,000 patients)

Pruritus, exanthema, and urticaria. Milk-alkali syndrome (also called Burnett syndrome and 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 kidney function alterations.

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 Agency's 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, after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C. Keep 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 you have any questions, 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

Composition of Mastical D

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: xylitol (E967), povidone, strawberry flavor, corn maltodextrin, glycerol triacetate (E1518), mono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids, magnesium stearate, sucralose (E955), all-rac-alpha-tocopherol, sucrose, modified corn starch, medium-chain triglycerides, sodium ascorbate, and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Mastical D are chewable tablets with a strawberry flavor, white, and round, 14 mm in size. They may have small spots.

Package sizes:

PEAD bottle with PEAD screw cap: 20, 30, 50, 60, 90, 100, 120, 168, and 180 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturers:

Asker Contract Manufacturing AS

Drammensveien 852

NO-1383 Asker, Norway

Local Representative:

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names

Czech Republic: Calcichew D3 Jahoda 500mg/400 IU chewable tablets

Finland: Calcichew D3 Forte mansikka-meloni 500 mg/10 micrograms

Spain: Mastical D 500 mg/400 UI chewable tablets strawberry flavor

Sweden: Calcichew-D3 Melon 500 mg/400 IU chewable tablets

Date of the Last Revision of this Package Leaflet:30/09/2020

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