Mastical D 500 mg/800 IU chewable tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mastical D 500 mg / 800 IU chewable tablets

calcium/colecalciferol (Vitamin D3)

Read the entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Mastical D are chewable tablets containing calcium and vitamin D3, both of which are important for bone formation. Mastical D is used for the prevention and treatment of calcium and vitamin D deficiency in adults at risk of calcium and vitamin D deficiency, and as a supplement to specific osteoporosis treatment.

2. What you need to know before starting to take Mastical D

Do not take Mastical D

• 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 levels of calcium in your blood or urine.
• if you have kidney stones.
• if you have excessive levels of vitamin D in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 disorders).
• if you have signs of impaired kidney function or a tendency to develop kidney stones.
• if you have sarcoidosis (an immune system disorder that may increase vitamin D levels in the body).
• if you have osteoporosis and are simultaneously unable to move around.
• if you are taking other products containing vitamin D. Additional doses of calcium and vitamin D should be taken only 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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). Therefore, levothyroxine should be taken at least four hours before or four hours after taking Mastical D.

The effects of certain 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 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 D.

Other medicines that may interact or be affected when taking Mastical D include:

• thiazide diuretics (used to treat hypertension or edema)
• cardiac glycosides (used to treat heart disorders)

Orlistat (used to treat obesity) may alter the absorption of fat-soluble vitamins, for example, vitamin D3.

If you are taking any of the medicines mentioned above, your doctor will provide you with further 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 become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, you may use Mastical D in case of calcium and vitamin D deficiency. During pregnancy, you should not take more than 2500 mg of calcium and 4000 IU of vitamin D per day, as overdoses may affect the fetus.

Mastical D may 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 infant.

Driving and using machines

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

Mastical D contains isomalt and sucrose

This medicine contains sucrose (1.5 mg), which may cause dental caries. The tablets also contain isomalt (E953). If your doctor has informed you of an intolerance to certain sugars, consult him 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 considered essentially "sodium-free".

3. How to take Mastical D

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

Dosage:

The recommended dose is 1 tablet once daily. The tablet may 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, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20, stating the product and the amount ingested. Take this leaflet with you.

If you forget to take Mastical D

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

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 experiences them.

Hypersensitivity reactions have occurred with unknown frequency (cannot be estimated from available data). If you experience the following symptoms, contact your doctor immediately: swelling of the face, tongue, lips (angioedema), or swelling of the throat (laryngeal edema).

Uncommon adverse effects (may affect up to 1 in 100 people)

You may experience high levels of calcium in the blood (hypercalcemia) or in the urine at high doses (hypercalciuria).

Rare adverse effects (may affect up to 1 in 1,000 people)

Constipation, dyspepsia, flatulence, nausea, abdominal pain, and diarrhea.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Pruritus, exanthema, and urticaria. Milk-alkali syndrome (also known as Burnett's syndrome, and generally occurring only after ingestion of excessive amounts of calcium). Symptoms include urgent need to urinate frequently, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, together with high levels of calcium in the blood and changes in kidney function.

If you have renal insufficiency, you may be at risk of experiencing increased levels of phosphate in the blood, kidney stone formation, and increased calcium deposits in the kidneys.

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 via 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 D

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 pack: 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Mastical D

The active substances are:

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

The other components are:

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

Appearance of the medicinal product and contents of the container

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

Container sizes:

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

Blister pack: 7, 14, 28, 50 single-dose units, 56, 84, 112, 120, 140 and 168 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturers:

Tablets packed in plastic bottles:

Asker Contract Manufacturing AS

Drammensveien 852

NO-1383 Asker, Norway

or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23 – 24

17489 Greifswald

Germany

Tablets packed in blisters:

Tjoapack Netherlands B.V.

Nieuwe Donk 9,

4879 AC Etten-Leur, The 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 medicinal product is authorized in the European Economic Area (EEA) Member States 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

The 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 the most recent review of this leaflet: 01/2019

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