MASTICAL D 500 MG/1000 IU CHEWABLE TABLETS, STRAWBERRY FLAVOUR

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mastical D 500mg/1000IU chewable tablets, strawberry flavor

calcium/colecalciferol (vitamin D3)

Read this 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 others, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Mastical D
6. Contents of the pack and other 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, 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 excessive levels of calcium in your blood or urine
• if you have calcium 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 impaired kidney function.

• 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

This medicine is not intended for use 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), you must 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 one hour before taking Mastical D.

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

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.

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

Other medicines that may interact with or be affected by Mastical D include:

• thiazide diuretics (used to treat high blood pressure or edema)
• cardiac glycosides (used to treat heart disorders)

If you are taking any of the medicines listed above, your doctor will provide you with further instructions.

Taking Mastical D with food and drinks

This medicine may be taken with or without food or 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 cases 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 overdosing may affect the fetus. This medicine may be taken during breastfeeding. Calcium and vitamin D3 are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Driving and use of machinery

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

Mastical D contains sucrose.

Mastical D contains sucrose (1.9 mg), which may cause dental caries. If your doctor has informed you of an intolerance to certain sugars, consult him or her before taking this medicine.

Mastical D is essentially sodium-free.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Mastical D

Follow exactly the instructions for administration of this medicine as given 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

This medicine 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, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 the forgotten 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 will experience them.

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

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

You may develop excessive levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria) with high doses.

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 occur in less than 1 in 10,000 patients)

Pruritus, rash, and urticaria. Milk-alkali syndrome (also called Burnett syndrome, and generally occurring only after excessive calcium intake). Symptoms include a strong need to urinate frequently, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with high levels of calcium in the blood and kidney function abnormalities.

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 can 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.

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

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mastical D:

The active substances are:

• calcium carbonate 1250 mg (equivalent to 500 mg of calcium)
• colecalciferol (vitamin D3) 1000 IU (25 micrograms).

The other components are: xylitol (E967), povidone, strawberry flavouring, corn maltodextrin, glyceryl triacetate (E1518), mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids, magnesium stearate, sucralose (E955), all-rac-alpha-tocopherol, sucrose, modified corn starch, medium-chain triglycerides, sodium ascorbate and colloidal anhydrous silica.

Nature of the product and contents of the pack

Mastical D are white, round, strawberry-flavoured chewable tablets, 14 mm in diameter. They may have small specks.

Pack sizes:

HDPE bottle with HDPE screw cap: 30, 60, 90, 100 and 120 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:

Asker Contract Manufacturing AS

Drammensveien 852

NO-1383 Asker, Norway

Local representative:

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

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

Estonia: Calcigran Forte Red

Finland: Calcichew D3 Opti mansikka-meloni 500 mg/25 mikrog

Lithuania: Calcigran Forte 500 mg/1000 TV kramtomosios tabletes

Spain: Mastical D 500 mg/1000 IU chewable tablets, strawberry flavour

Sweden: Calcichew-D3 Melon 500 mg/1000 IU chewable tablets

Date of the latest revision of this leaflet: 30-09-2020

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)