Mastical D Lemon Flavor 500 mg/400 IU chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mastical D Lemon Flavor 500 mg / 400 IU 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, consult your doctor or pharmacist.
• This medicine has been prescribed only for you; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Mastical D lemon flavour is and what it is used for
2. What you need to know before taking Mastical D lemon flavour
3. How to take Mastical D lemon flavour
4. Possible adverse effects
5. Storage of Mastical D lemon flavour
6. Contents of the pack and other information

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

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

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

Do not take Mastical D lemon flavour

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Mastical D lemon flavour:

• 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 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 also 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

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

Taking Mastical D lemon flavour 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 lemon flavour.

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 Mastical D lemon flavour.

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 lemon flavour.

Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least two hours before or after Mastical D lemon flavour.

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

• 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 taking any of the medicines mentioned above, your doctor will provide further instructions.

Taking Mastical D lemon flavour with food and drinks

Mastical D lemon flavour can be taken with or without food and drinks.

Pregnancy, breast-feeding, and fertility

If you are pregnant, breast-feeding, 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 lemon flavour 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 lemon flavour may be taken during breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account when giving additional vitamin D to the infant.

Driving and using machines

Mastical D lemon flavour has no known influence on the ability to drive or use machines.

Mastical D lemon flavour contains isomalt and sucrose

This medicine contains sucrose (0.8 mg), which may cause dental caries. The tablets also contain isomalt (E953). If your doctor has informed you that you have 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; this is considered essentially “sodium-free”.

3. How to take Mastical D lemon-flavoured

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage:

The recommended dose is 1 tablet twice daily. The tablet may be chewed or sucked.

Use in children

This medicine is not intended for use in children.

If you take more Mastical D lemon-flavoured than you should

If you have taken more Mastical D lemon-flavoured than you should, contact your doctor or pharmacist immediately.

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

If you forget to take Mastical D lemon-flavoured

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 may cause adverse effects, although not everyone experiences them.

Hypersensitivity reactions have occurred with unknown frequency (cannot be estimated from the available data). If you experience any of 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 excessive 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 diarrhoea.

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

Pruritus, rash, and urticaria. Milk-alkali syndrome (also known as Burnett's syndrome, and generally occurring only after ingestion of excessive amounts of calcium). Symptoms include a strong 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 phosphate levels in the blood, kidney stone formation, and increased calcium deposits in the kidneys.

Reporting of adverse effects

If you experience any 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 lemon-flavoured

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 drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mastical D lemon-flavoured:

The active substances are:

• calcium carbonate 1250 mg (equivalent to 500 mg of calcium)
• colecalciferol (vitamin D3) 400 IU (10 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 anhydrous colloidal silica.

Nature of the product and pack sizes

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

Pack sizes:

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

Blister packs: 20, 30, 50, 50 by 1 (unit dose), 60, 90, 100, 120, 168 and 180 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 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 authorised in the European Economic Area (EEA) Member States under 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 sabor limón 500 mg/ 400 UI comprimidos masticables
Finland: Calcichew D3 Forte sitruuna 500 mg/400 IU – purutabletti
Greece: Calcioral D3
The Netherlands: Calci-Chew D3 500 mg/400 I.E., kauwtabletten
Hungary: Calcichew-D3 500 mg/400 NE rágótabletta
Luxembourg: Steovit D3 citron 500 mg/400 I.E.
Norway: Calcigran Forte
Poland: Orocal D3 Lemon
Czech Republic: CALCICHEW D3 400 IU žvýkací tablety
Sweden: Calcichew-D3 Citron

Date of the most recent review of this summary: 01/2019

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