Leaflet: information for the user

Mastical 500 mg chewable tablets

Calcium

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.Keep this leaflet, as you may need to read it again.
• For advice on any matter relating to this medicine or for information about any aspect of its use, consult your pharmacist.
• 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 isMasticaland what it is used for

2. What you need to know before you start takingMastical

3. How to takeMastical

4. Possible side effects

5. Storage ofMastical

6. Contents of the pack and additional information

Masticalare chewable tablets that contain calcium, an important substance in 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 elevated phosphate levels in the blood.

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 your blood or urine.

- if you have kidney stones.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Mastical:

• if you take diuretics (used in the treatment of high blood pressure or edema) or cardiac glycosides (used for the treatment of heart rhythm disorders).

• if you have excessive calcium in your blood or signs of kidney insufficiency or have had kidney stones at any time.
• if you take high doses of calcium and additionally use products containing vitamin D.
• if you take high doses of calcium and additionally use antacids.

Use of Mastical with other medications

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

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

If you are using any of the mentioned medications, your doctor will give you further 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 intend 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 through breast milk.

Driving and operating machinery

Mastical has no known influence on the ability to drive and operate machinery.

Mastical contains isomalt

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

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

Dose:

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 forgot to take Mastical:

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

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 all people may experience them.

Indigestion has occurred at an unknown frequency (cannot be estimated from available data).

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

High levels of calcium in the blood or urine.

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

Constipation, gas, nausea, abdominal pain, diarrhea

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

Itching and urticaria. Milk-alkali syndrome usually appears only when high amounts of calcium have been ingested, symptoms are frequent sensation of urgency to urinate, headache, loss of appetite, nausea or vomiting, unusual fatigue and weakness, high levels of calcium in the blood, and renal alterations.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 out of 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.

Plastic bottle: Do not store at a temperature above 30°C. Keep the container perfectly closed to protect it from moisture.

Validity period after opening: 6 months

Blister pack: Do not store at a temperature above 25°C. Storein the original packaging to protect it from moisture.

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

Composition of Mastical 500 mg

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

The other components are:

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

Appearance of the product and content of the packaging

Mastical are round white tablets,

Packaging sizes:

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

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

Blister: 50 x 1 tablets (single dose)

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the Marketing Authorization:

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 medicine is authorized in the Member States of the European Economic Area with the following names:

500 mg:

Belgium: Calci - Chew

Finland: Calcichew appelsiini 500 mg tablet

Greece: Calcioral

Luxembourg: Calcichew

Netherlands: Caci - Chew 500 mg

Spain: Mastical

Sweden: Calcitugg 500 mg

This leaflet was approved in February 2023