Leaflet: information for the user

Mastical D Unidia 1000 mg / 800 IU chewable 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 D Unidiaand what it is used for

2. What you need to know before you start takingMastical D Unidia

3. How to takeMastical D Unidia

4. Possible side effects

5. Storage ofMastical D Unidia

6. Contents of the pack and additional information

Mastical D Unidia are chewable tablets that contain calcium and vitamin D3, both substances are important for bone formation. Mastical D Unidia is used for 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 Unidia

• 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 Unidia:

• 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 abnormalities).
• 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 and adolescents

Mastical D Unidia is not indicated for use in children and adolescents.

Taking Mastical D Unidia 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 Unidia.

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 Unidia.

The effects of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Mastical D Unidia.

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 Unidia.

Other medications that may influence or be influenced when taking Mastical D Unidia are:

• Thiazide diuretics (used in the treatment of hypertension or edema)
• Cardiac glycosides (used for the treatment of cardiac abnormalities)

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 Unidia with food and drinks

Mastical D Unidia 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 Unidia 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.

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

Mastical D Unidia 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 Unidia 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

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

If you take more Mastical D Unidia than you should

If you have taken more Mastical D Unidia than you should, consult your doctor or pharmacist immediately.

For cases 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 Unidia

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 everyone will experience them.

Unknown frequency reactions of hypersensitivity have been reported. If you have the following symptoms, contact your doctor immediately. Swelling of the face, tongue, lips (angioedema) or swelling of the throat (laryngeal edema).

Adverse effects infrequently occurring (may affect up to 1 in 100 people)

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

Adverse effects rarely occurring (may affect up to 1 in 1,000 people)

Constipation, indigestion, flatulence, nausea, abdominal pain, and diarrhea.

Adverse effects very rarely occurring (may affect up to 1 in 10,000 people)

Pruritus, exanthema, and urticaria. Milk-alkali syndrome (also known as Burnett syndrome and generally only appears when excessive amounts of calcium have been ingested). Symptoms include a 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 Medicinal Products 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 how to dispose of the containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Mastical D Unidia

The active principles are:

-2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium).

-800 UI of colecalciferol (vitamin D3) (20 micrograms).

The other components are xylitol (E967), povidone, isomalt (E953), lemon flavoring, magnesium stearate, sucralose (E955), mono- and diglycerides of fatty acids, 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 Unidia are chewable tablets, round and white. They may have small spots.

Package sizes:

Plastic bottle with PEAD screw cap: 15, 30, 40, 60, and 90 tablets.

Blister pack: 7, 14, 28, 50 per 1 (unit dose), 56, 84, 112, 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

Blister packaging:

Tjoapack Netherlands B.V.

Nieuwe Donk 9,

4879 AC Etten-Leur, Netherlands

or

Delpharm Novara S.r.l.

Via Crosa 86

Cerano 28065, Italy

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:

Germany:Calcimagon-D3 uno

AustriaCal-D-or 1000 mg/800 I.E. - Kautabletten

Belgium:SteovitForte citron1000 mg/800 I.E. - kauwtabletten

Spain:Mastical D Unidia 1000 mg / 800 UI chewable tablets

Slovakia:Calcichew-D3Citron 1000 mg/800 IU

Greece:CalcioralD3®1000 mg + 20μg (800 IU) μασ?μενο δισκ?ο

Hungary:Calcichew-D3 1000 mg/800 NE rágótabletta

Ireland:Calcichew-D3 Forte Double Strength 1000 mg/800IU Chewable Tablets

Lithuania:Calcigran Forte 1000 mg/800 TV kramtomosios tabletés

Luxembourg:Steovit Forte citron 1000mg/800 U.I. comprimés à croquer

Norway:Calcigran Forte 1000mg/ 800 IE tyggetabletter

Netherlands:Calci-Chew D31000mg/ 800 I.E.,kauwtabletten

United Kingdom:Calchichew- D31000mg/ 800 IU Once Daily Chewable tablets

Czech Republic:Calcichew D3 Lemon 800 IU žvýkací tablety

Sweden:Calcichew-D3Citron1000mg/ 800 IE tuggtablett

Last review date of this leaflet:01/2019

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.