Leaflet: information for the user

Mastical D 500mg/400UI chewable strawberry-flavored tablets

calcium/colecalciferol (vitamin D3)

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMastical Dand what it is used for

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

3. How to takeMastical D

4. Possible side effects

5. Storage ofMastical D

6. Contents of the pack and additional information

Mastical D are chewable tablets that contain calcium and vitamin D3, both substances are important for bone formation. Mastical D is used in the prevention and treatment 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 other 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 calcium stones in your kidney
• 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 altered renal function.
• 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

This medication is not indicated for use in children and adolescents.

Use of 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), you should 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 to treat osteoporosis) should be taken at least one hour before taking Mastical D.

Calcium can reduce the effect of levothyroxine (used to treat hypothyroidism). Therefore, levothyroxine should be taken at least four hours before or four hours after taking this medication.

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.

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

Other medications that may influence or be influenced by Mastical D are:

• thiazide diuretics (used in the treatment of high blood pressure or edema)
• cardiac glycosides (used to treat cardiac disorders)

If you are using any of the mentioned medications, your doctor will give you further instructions.

Taking Mastical D with food and drinks

This medication can be taken with food or drinks or without them.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be 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.

During pregnancy, do not take more than 2500 mg of calcium and 4000 IU of vitamin D per day, as excessive doses can affect the fetus.

This medication can be taken during 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 saccharose.

Mastical D contains saccharose (0.8 mg), which can cause tooth decay. 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; it 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 medicationis not intended for use in children.

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 915620420, 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 hypersensitivity reactions (cannot be estimated from available data) 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 (hypercalciuria) with high doses.

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 occur in fewer than 1 in 10,000 patients)

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.

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.

Do not store above 86°F (30°C). Store in the original packaging to protect it from light. Keep the container perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of 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 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 1250mg (equivalent to 500mg of calcium)
• Cholecalciferol (Vitamin D3) 400UI (10micrograms).

The other components are:Xylitol (E967), povidone, strawberry flavoring, corn maltodextrin, triacetin (E1518), esters of mono- and diacetyl tartaric acid of mono- and diglycerides of fatty acids,magnesium stearate,sucralose (E955), all-rac-alpha-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 with strawberry flavor, white, and round, 14mm in size. They may have small spots.

Size of the packaging:

PEAD bottle with PEAD screw cap: 20, 30, 50, 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:

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

Republic of Chile:Calcichew D3 Jahoda 500mg/400 IU chewable tablets

Finland:Calcichew D3 Forte strawberry-melon 500 mg/10 micrograms

Spain:Mastical D 500 mg/400 UI chewable tablets with strawberry flavor

Sweden:Calcichew-D3 Melon 500 mg/400 IE chewable tablets

Date of the last review of this leaflet:30/09/2020

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)