MASTICAL 500 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Mastical 500 mg Chewable Tablets

Calcium

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

• Follow the administration instructions for this medication exactly as indicated in this package leaflet or as directed by your doctor or pharmacist. Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Mastical and what is it used for

Mastical is a chewable tablet that contains calcium, an essential substance for bone formation.

Mastical is used to prevent and treat calcium deficiency and as a supplement in the treatment of osteoporosis. Mastical is also used under medical prescription as a phosphate binder in patients with high phosphate levels in the blood.

2. What you need to know before taking Mastical

Do not take Mastical:

-if you are allergic to calcium or any of the other components of this medication (listed in section 6).

• -if you have high levels of calcium in the blood or urine.
• -if you have kidney stones.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Mastical:

• -if you are taking diuretics (used to treat high blood pressure or edema) or cardiac glycosides (used to treat heart conditions).

• -if you have excessive calcium levels in the blood or signs of kidney failure or have had kidney stones in the past.
• -if you are taking high doses of calcium and also using products containing vitamin D.
• -if you are taking high doses of calcium and also using antacids.

Using Mastical with Other Medications

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

Calcium carbonate may interfere with the absorption of tetracyclines if taken at the same time. For this reason, tetracyclines should be taken at least 2 hours before or 4-6 hours after taking Mastical.

Medications containing bisphosphonates should be taken at least 1 hour before taking Mastical.

Calcium may reduce the effects of levothyroxine. For this reason, levothyroxine should be taken at least 4 hours before or 4 hours after Mastical.

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.

Calcium salts may reduce 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.

Other medications that may interact with Mastical include thiazide diuretics and cardiac glycosides.

If you are using any of the mentioned medications, your doctor will provide you with more instructions.

Taking Mastical with Food and Drinks

Mastical 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.

During pregnancy, the daily intake of calcium should not exceed 2500 mg (including food and supplements). Mastical can be used during pregnancy in case of calcium deficiency.

Mastical can be used during breastfeeding. Calcium passes into breast milk.

Driving and Using Machines

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

Mastical Contains Isomalt

Mastical contains isomalt (E953). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Mastical

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

Dosage:

The recommended dose in adults is 500-1500 mg of calcium per day.

Use in Children

The recommended dose in children is 500-1000 mg of calcium per day.

The tablets can be chewed or sucked.

If You Take More Mastical Than You Should:

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

If You Forget to Take Mastical:

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

If you have any other 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.

Dyspepsia has occurred with an unknown frequency (cannot be estimated from available data).

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

High levels of calcium in the blood or urine.

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

Constipation, gas, nausea, abdominal pain, diarrhea.

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

Itching and urticaria. The milk-alkali syndrome usually occurs only when high amounts of calcium have been ingested; symptoms include frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual fatigue and weakness, high levels of calcium in the blood, and kidney damage.

Reporting Side Effects

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

5. Storage of Mastical

Keep out of sight and reach of children.

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

Plastic bottle: Do not store above 30°C. Keep the container tightly closed to protect from moisture.

Shelf life after opening: 6 months.

Blister: Do not store above 25°C. Store in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Dispose of packaging and unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Mastical 500 mg Composition

The active ingredient is 1250 mg of calcium carbonate (equivalent to 500 mg of calcium).

The other ingredients are:

Xylitol (E967), povidone, isomalt (E953), flavor enhancer (orange), magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids.

Product Appearance and Package Contents

Mastical is a round, white tablet.

Package sizes:

Plastic bottle: 20, 30, 50, 60, 90, 100, 120, and 180 tablets of 500mg.

30, 60, 90, 100 tablets of 1000mg.

Blister: 50 x 1 tablet (single dose).

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.

or

Tjoapack Netherlands B.V.

Nieuwe Donk 9.

4879 AC Etten-Leur, Netherlands.

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:

500 mg:

Belgium: Calci - Chew.

Finland: Calcichew appelsiini 500 mg purutabletti.

Greece: Calcioral.

Luxembourg: Calcichew.

Netherlands: Caci - Chew 500 mg.

Spain: Mastical.

Sweden: Calcitugg 500 mg.

This package leaflet was approved in February 2023.