MASTICAL D 500 MG/800 IU CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Mastical D 500 mg / 800 UI Chewable Tablets

Calcium/colecalciferol (Vitamin D3)

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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. Contents of the pack and further information

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

Mastical D are chewable tablets containing calcium and vitamin D3, both substances are important 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 treatment of osteoporosis.

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 ingredients of this medicine (listed in section 6).
• if you have severe kidney problems.
• if you have high levels of calcium in your blood or urine
• if you have kidney stones
• if you have high levels of vitamin D in your blood

Warnings and precautions

Talk to 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 signs of altered renal function or 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

The use of Mastical D is not indicated in children and adolescents.

Taking Mastical D with other medicines

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

If you are also taking tetracyclines (a type of antibiotic), they should be taken 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.

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

Calcium may reduce the effect of levothyroxine (used to treat thyroid hormone deficiency). For this reason, levothyroxine should be taken at least four hours before or four hours after taking Mastical D.

The effects of some antibiotics (quinolones) may be reduced if taken at the same time as calcium. For this reason, quinolones should be taken two hours before or six 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 two hours before or after Mastical D.

Other medicines that may interact with 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 above-mentioned medicines, your doctor will give you more instructions.

Taking Mastical D with food and drinks

Mastical D 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 UI of vitamin D per day, as overdoses can affect the fetus.

Mastical D 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 isomalt and sucrose

This medicine contains sucrose (1.5 mg) that may cause caries. The tablets also contain isomalt (E953). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Mastical D is essentially sodium-free

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially 'sodium-free'.

3. How to take Mastical D

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Dose:

The recommended dose is 1 tablet once a day. The tablet can be chewed or sucked.

Use in children and adolescents

Mastical D 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, talk to 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypersensitivity reactions have been reported with an unknown frequency (cannot be estimated from the available data). If you have 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 have high levels of calcium in your blood (hypercalcaemia) 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 and generally 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 levels of calcium in the blood and alterations in 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mastical D

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Mastical D

The active substances are:

• calcium carbonate 1250 mg (equivalent to 500 mg of calcium)
• colecalciferol (vitamin D3) 800 UI (20 micrograms).

The other ingredients are:

xylitol (E967), povidone, isomalt (E953), lemon flavor, magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, tocopherol, sucrose, modified corn starch, medium-chain triglycerides, sodium ascorbate, and anhydrous colloidal silica.

Appearance and packaging of the product

Mastical D are chewable tablets, round and white. They may have small spots.

Pack sizes:

Plastic bottle: 20, 30, 50, 60, 90, 100, 120, 168, and 180 tablets

Blister: 7, 14, 28, 50 x 1 (single dose), 56, 84, 112, 120, 140, and 168 tablets

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturers:

Tablets packaged in plastic bottles:

Asker Contract Manufacturing AS

Drammensveien 852

NO-1383 Asker, Norway

or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23 – 24

17489 Greifswald

Germany

Tablets packaged in blisters:

Tjoapack Netherlands B.V.

Nieuwe Donk 9,

4879 AC Etten-Leur, Netherlands

or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23 – 24

17489 Greifswald

Germany

Local representative:

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Cal-D-or Lemon 500mg/800 I.E. – Kautabletten

Estonia: Calcigran Forte D Lemon

Finland: Calcichew D3 Extra sitruuna

Germany: Calcimagon® Extra D3

Lithuania: Calcigran Forte Lemon 500 mg/800 TV kramtomosios tabletes

Netherlands: Calci-Chew D3 500 mg / 800 I.E.

Norway: Calcigran Forte 500 mg/800 IE tyggetabletter med sitronsmak

Spain: MASTICAL D 500 mg/ 800 UI chewable tablets

Sweden: Calcichew-D3 Citron

Date of last revision of this package leaflet: 01/2019

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