Product Information for the User

Mastical D 500 mg / 800 IU Chewable Tablets

calcium/colecalciferol (Vitamin D3)

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experienceadverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Mastical D are chewable tablets that contain calcium and vitamin D3, both substances 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 treatment of osteoporosis.

Do not take Mastical D

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mastical D:

• 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 one side to the other.
• if you are taking other products with vitamin D. Additional doses of calcium and vitamin D should be taken under strict medical supervision.

Children and adolescents

The use of Mastical D is not indicated in children and adolescents.

Taking Mastical D 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 one hour before taking Mastical D.

Calcium can reduce the effect of levothyroxine (used in the treatment of thyroid hormone deficiency). Therefore, levothyroxine should be taken at least four hours before or four hours after taking Mastical D.

The effects of some 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 can decrease 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.

Other medications that may influence or be influenced when taking Mastical D 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 medications mentioned, your doctor will give you 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, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, you can use Mastical D in case of calcium and vitamin D deficiency.Mastical D should not be taken in excess of 2500 mg of calcium and 4000 UI of vitamin D per day, as excessive doses can affect the fetus.

Mastical D can be takenduring breastfeeding. Calcium and vitamin D3 pass into breast milk. You should be aware when administering additional vitamin D to the child.

Driving and operating machinery

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

Mastical D contains isomalt and sucrose

This medication contains sucrose (1.5 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, which 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 once a day. The tablet can 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 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

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).

Less common 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 include frequent and urgent need to urinate, 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.

Medications 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.Ask your pharmacist if you are unsure 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

The active principles are:

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

The other components are:

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

Appearance of the product and contents of the packaging

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

Package sizes:

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

Blister pack: 7, 14, 28, 50 per 1 (unit dose), 56, 84, 112, 120, 140, and 168 tablets

Not all package sizes 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 packs:

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:

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

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 comprimidos masticables

Sweden: Calcichew-D3 Citron

Last review date of this leaflet: 01/2019

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