MASTICAL D LEMON FLAVORED 500 mg/400 IU CHEWABLE TABLETS

Introduction

Leaflet: Information for the user

Mastical D lemon flavor 500 mg / 400 UI chewable tablets

calcium/colecalciferol (Vitamin D3)

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 leaflet. See section 4.

Contents of the leaflet

1. What is Mastical D lemon flavor and what is it used for
2. What you need to know before taking Mastical D lemon flavor
3. How to take Mastical D lemon flavor
4. Possible side effects
5. Storage of Mastical D lemon flavor
6. Package contents and additional information

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

Mastical D lemon flavor are chewable tablets that contain calcium and vitamin D3, both of which are important for bone formation. Mastical D lemon flavor 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 osteoporosis treatment.

2. What you need to know before taking Mastical D lemon flavor

Do not take Mastical D lemon flavor

• if you are allergic to calcium, vitamin D, or any of the 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 kidney stones
• if you have excessive vitamin D in your blood

Warnings and precautions

Consult your doctor or pharmacist before taking Mastical D lemon flavor:

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

Children

Mastical D lemon flavor is not intended for use in children.

Taking Mastical D lemon flavor 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), 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 lemon flavor.

Calcium can reduce the effect of levothyroxine (used to treat thyroid hormone deficiency). For this reason, levothyroxine should be taken at least 4 hours before or 4 hours after taking Mastical D lemon flavor.

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 lemon flavor.

Calcium salts can decrease the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after Mastical D lemon flavor.

Other medications that may interact with Mastical D lemon flavor 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 mentioned medications, your doctor will provide more instructions.

Taking Mastical D lemon flavor with food and drinks

Mastical D lemon flavor 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 lemon flavor in case of calcium and vitamin D deficiency. During pregnancy, do not take more than 2500 mg of calcium and 4000 IU of vitamin D per day, as overdoses can affect the fetus.

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

Mastical D lemon flavor contains isomalt and sucrose

This medication contains sucrose (0.8 mg), which may cause cavities. The tablets also contain isomalt (E953). 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; this is essentially "sodium-free".

3. How to take Mastical D lemon flavor

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, 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 lemon flavor than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested. Bring this leaflet with you.

If you forget to take Mastical D lemon flavor

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

If you have any other doubts 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 unknown frequency (cannot be estimated from 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 experience excessive calcium in the blood (hypercalcemia) or in the 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 calcium levels 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 medication.

5. Storage of Mastical D lemon flavor

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

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

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, 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 lemon flavor:

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

Appearance of the product and package contents

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

Package sizes:

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

Blister: 20, 30, 50, 50 x 1 (unit dose), 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:

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 medication is authorized in the Member States of the European Economic Area, with the following names

Austria Cal-D-Or

Belgium: Steovit D3 citroen 500 mg/400 I.E.

Denmark: Calcichew-D3 Forte

Slovakia: Calcichew-D3

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

Finland: Calcichew D3 Forte sitruuna 500 mg/400 IU – chewable tablets

Greece: Calcioral D3

Netherlands: Calci-Chew D3 500 mg/400 I.E., chewable tablets

Hungary: Calcichew-D3 500 mg/400 NE chewable tablets

Luxembourg: Steovit D3 citron 500 mg/400 I.E.

Norway: Calcigran Forte

Poland: Orocal D3 Lemon

Czech Republic: CALCICHEW D3 400 IU chewable tablets

Sweden: Calcichew-D3 Citron

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

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.