MASTICAL D UNIDIA 1000 MG/800 IU CHEWABLE TABLETS

Introduction

Leaflet: Information for the user

Mastical D Unidia 1000 mg / 800 UI chewable tablets

calcium/colecalciferol (Vitamin D3)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine 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 Unidia and what is it used for
2. What you need to know before taking Mastical D Unidia
3. How to take Mastical D Unidia
4. Possible side effects
5. Storage of Mastical D Unidia
6. Package contents and additional information

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

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

Do not take Mastical D Unidia

• if you are allergic to calcium, vitamin D, or any of the components of this medicine (listed in section 6).
• if you have severe kidney problems.
• if you have excessive calcium in the blood or urine.
• if you have kidney stones.
• if you have excessive vitamin D in the blood.

Warnings and precautions

Consult your doctor or pharmacist before taking Mastical D Unidia:

• 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

Mastical D Unidia is not indicated for use in children and adolescents.

Taking Mastical D Unidia 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), 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.

Medicines containing bisphosphonates (used to treat osteoporosis) should be taken at least 1 hour before taking Mastical D Unidia.

Calcium may reduce the effect of levothyroxine (used to treat thyroid hormone deficiency). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after taking Mastical D Unidia.

The effects of quinolone-based antibiotics may be reduced if taken at the same time as calcium. Take quinolone-based antibiotics 2 hours before or 6 hours after taking Mastical D Unidia.

Calcium salts may 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 Unidia.

Other medicines that may interact with or be affected by Mastical D Unidia 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 medicines, your doctor will provide more instructions.

Taking Mastical D Unidia with food and drinks

Mastical D Unidia 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 medicine.

If you are pregnant, you can use Mastical D Unidia 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 Unidia 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 Unidia has no known influence on the ability to drive and use machines.

Mastical D Unidia contains isomalt and sucrose

This medicine contains sucrose (1.5 mg), which may cause tooth decay. 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 medicine.

Mastical D Unidia 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 Unidia

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, 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

This medicine is not intended for use in children and adolescents.

If you take more Mastical D Unidia than you should

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

In case of overdose or accidental ingestion, consult the Toxicology 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 Unidia

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

If you have any other questions about 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 occurred with 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 experience excessive calcium in the blood (hypercalcemia) 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 usually 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 altered 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 Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mastical D Unidia

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

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

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

Blister: Do not store above 25°C. Store in the original packaging 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. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Mastical D Unidia

The active ingredients are:

• 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium).
• 800 IU of colecalciferol (vitamin D3) (20 micrograms).

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

Appearance of the product and package contents

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

Package sizes:

Plastic bottle with screw cap: 15, 30, 40, 60, and 90 tablets.

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

Blister packaging:

Delpharm Novara S.r.l.

Via Crosa 86

Cerano 28065, Italy

or

Orifarm Manufacturing Poland Sp. z o.o.

Ul. Ksiestwa Lowickiego 12, 99-420 Lyszkowice, Poland

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 under the following names:

Germany: Calcimagon-D3 uno

Austria: Cal-D-or 1000 mg/800 I.E. - Kautabletten

Belgium: Steovit Forte citroen 1000 mg/800 I.E. - kauwtabletten

Spain: Mastical D Unidia 1000 mg / 800 UI chewable tablets

Slovakia: Calcichew-D3 Citron 1000 mg/800 IU

Greece: Calcioral D3^®1000 mg + 20 μg (800 IU) μασ?μενο δισκ?ο

Hungary: Calcichew-D3 1000 mg/800 NE rágótabletta

Ireland: Calcichew-D3 Forte Double Strength 1000 mg/800IU Chewable Tablets

Lithuania: Calcigran Forte 1000 mg/800 TV kramtomosios tabletés

Luxembourg: Steovit Forte citron 1000 mg/800 U.I. comprimés à croquer

Norway: Calcigran Forte 1000mg/ 800 IE tyggetabletter

Netherlands: Calci-Chew D3 1000mg/ 800 I.E., kauwtabletten

United Kingdom: Calchichew- D3 1000mg/ 800 IU Once Daily Chewable tablets

Czech Republic: Calcichew D3 Lemon 800 IU žvýkací tablety

Sweden: Calcichew-D3 Citron 1000mg/ 800 IE tuggtablett

Date of the last revision of this 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.