Leaflet: information for the user

Mastical D lemon flavor 500 mg / 400 IU chewable tablets

calcium/colecalciferol (Vitamin D3)

Read this 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experienceside effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMastical D lemon flavorand for what it is used

2. What you need to know before starting to takeMastical D lemon flavor

3. How to takeMastical D lemon flavor

4. Possible side effects

5. Storage ofMastical D lemon flavor

6. Contents of the pack and additional information

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

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 starting to take Mastical D lemon flavor:

• if you are undergoing long-term treatment, especially if you take diuretics (used in the treatment of high blood pressure or edema) or cardiac glycosides (used for the treatment of cardiac disorders).
• if you have signs of altered renal function or a tendency to form kidney stones.
• if you have sarcoidosis (a disorder of the immune system that can increase vitamin D levels in the body).
• if you have osteoporosis and are unable to move from side to side.
• if you are taking other products with vitamin D. Additional doses of calcium and vitamin D should be taken under strict medical supervision.

Children

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

Taking Mastical D lemon flavor with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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 can interfere with the absorption of tetracycline preparations if taken at the same time.

Medications containing bisphosphonates (used in the treatment of osteoporosis) should be taken at least 1 hour before taking Mastical D lemon flavor.

Calcium can reduce the effect of levothyroxine (used in the treatment of thyroid hormone deficiency). Therefore, 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. Therefore, 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 influence or be influenced when taking Mastical D lemon flavor are:

• thiazide diuretics (used in the treatment of hypertension or edema)
• cardiac glycosides (used for the treatment of cardiac disorders)

Orlistat (used for the treatment of 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 give you further 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 or breastfeeding, or if you 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 excessive doses may affect the fetus

Mastical D lemon flavor can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. You should be aware of this when administering additional vitamin D to the child.

Driving and operating machinery

Mastical D lemon flavor has no known influence on the ability to drive and operate machinery.

Mastical D lemon flavor contains isomalt and sucrose

This medication contains sucrose (0.8 mg) which may cause tooth decay. The tablets also contain isomalt (E953). If your doctor has indicated 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".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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, contact the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested. Bring this leaflet with you.

If you forgot to take Mastical D lemon flavor

Do not take a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Unknown frequency (cannot be estimated from available data) hypersensitivity reactions have occurred. If you have the following symptoms, contact your doctor immediately. Swelling of the face, tongue, lips (angioedema) or throat (laryngeal edema).

Infrequent Adverse Effects (may affect up to 1 in 100 people)

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

Rare Adverse Effects (may affect up to 1 in 1,000 people)

Constipation, indigestion, 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 syndrome and generally only occurs when excessive amounts of calcium have been ingested). Symptoms are urgent need to urinate frequently, headache, loss of appetite, nausea or vomiting, excessive fatigue or weakness, along with high levels of calcium in the blood and kidney function alterations.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Blister pack: Do not store at a temperature above 25 °C. Store in the original packaging to protect it from moisture. Store the blister pack in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mastical D lemon flavor:

The active principles are:

• Calcium carbonate 1250 mg (equivalent to 500 mg of calcium)
• Vitamin D3 (colecalciferol) 400 IU (10 micrograms).

The other components are:

Xylitol (E967), povidone, isomalt (E953), lemon flavoring, magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, tocopherol, saccharose, modified cornstarch, medium-chain triglycerides, sodium ascorbate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

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

Size of the packaging:

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

Blister: 20, 30, 50, 50 per 1 (unit dose), 60, 90, 100, 120, 168, and 180 tablets

Not all packaging may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

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 blister:

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

AustriaCal-D-Or

Belgium:Steovit D3citron 500 mg/400 I.E.

Denmark:Calcichew-D3 Forte

Slovakia:Calcichew-D3

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

Finland:Calcichew D3Forte sitruuna 500 mg/400 IU – purutabletti

Greece:Calcioral D3

Netherlands:Calci-Chew D3500 mg/400 I.E., kauwtabletten

Hungary:Calcichew-D3 500 mg/400 NE rágótabletta

Luxembourg:Steovit D3citron 500 mg/400 I.E.

Norway:Calcigran Forte

Poland:Orocal D3 Lemon

Czech Republic:CALCICHEW D3 400 IU žvýkací tablety

Sweden:Calcichew-D3 Citron

Last review date of this leaflet: 01/2019

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http:www.aemps.gob.es.