Mastical 500 mg chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mastical 500 mg chewable tablets
Calcium
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Mastical is and what it is used for
- What you need to know before taking Mastical
- How to take Mastical
- Possible side effects
- How to store Mastical
- Contents of the pack and other information
1. What Mastical is and what it is used for
Mastical is a chewable tablet containing calcium, a substance important 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 high levels of phosphate in the blood.
2. What you need to know before starting to take Mastical
Do not take Mastical:
- if you are allergic to calcium or to any of the other ingredients of this medicine (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 are taking diuretics (used in the treatment of high blood pressure or edema) or cardiac glycosides (used to treat heart disorders).
- if you have excessive calcium levels in the blood or signs of renal insufficiency, or if you have ever had kidney stones.
- if you are taking high doses of calcium and additionally using products containing vitamin D.
- if you are taking high doses of calcium and additionally using antacids.
Use of Mastical with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Calcium carbonate may interfere with the absorption of tetracyclines if taken at the same time. Therefore, tetracyclines should be taken at least 2 hours before or 4–6 hours after taking Mastical.
Medicines containing bisphosphonates should be taken at least one hour before taking Mastical.
Calcium may reduce the effects of levothyroxine. Therefore, levothyroxine should be taken at least four hours before or four hours after Mastical.
The effects of certain antibiotics (quinolones) may be reduced if taken simultaneously with calcium. Therefore, quinolones should be taken two hours before or six hours after taking Mastical.
Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, preparations containing iron, zinc, or strontium ranelate should be taken at least two hours before or after Mastical.
Other medicines that may interact with Mastical are thiazide diuretics and cardiac glycosides.
If you are using any of the medicines mentioned above, your doctor will provide you with further instructions.
Taking Mastical with food and drinks
Mastical may be taken with or without food and drinks.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
During pregnancy, the daily intake of calcium should not exceed 2500 mg (including food and supplements). Mastical may be used during pregnancy in cases of calcium deficiency.
Mastical may be used during breastfeeding. Calcium passes into breast milk.
Driving and using machines
Mastical has no known influence on the ability to drive or operate machinery.
Mastical contains isomalt
Mastical contains isomalt (E953). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Mastical
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Dyspepsia has been reported with frequency not known (cannot be estimated from available data).
Uncommon adverse effects (may affect up to 1 in 100 people)
Elevated levels of calcium in 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. The milk-alkali syndrome usually occurs only after ingestion of high amounts of calcium; symptoms include frequent urge to urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness and weakness, elevated calcium levels in blood, and renal disturbances.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mastical
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Plastic bottle: Do not store above 30°C. Keep the container tightly closed to protect it from moisture.
Period of validity after opening: 6 months
Blister: Do not store above 25°C. Keep in the original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mastical 500 mg
The active substance is 1250 mg of calcium carbonate (equivalent to 500 mg of calcium).
The other components are:
Xylitol (E967), povidone, isomalt (E953), flavour enhancer (orange), magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids.
Appearance of the medicine and contents of the pack
Mastical is white, round tablets.
Pack sizes:
Plastic bottle: 20, 30, 50, 60, 90, 100, 120 and 180 tablets of 500 mg.
30, 60, 90, 100 tablets of 1000 mg
Blister pack: 50 x 1 tablet (unit dose)
Not all pack 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 medicinal product 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 leaflet was last approved in February 2023