Mastical D 500 mg/400 IU orange-flavored chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mastical D 500 mg/400 IU chewable tablets, orange flavor

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 for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Mastical D is and what it is used for

Mastical D are white, orange-flavoured chewable tablets containing 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 osteoporosis treatment.

2. What you need to know before taking Mastical D

Do not take Mastical D:

• 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 this medicine:

• 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 independently.
• 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 and adolescents

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

Taking Mastical D 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 in the treatment of osteoporosis) should be taken at least one hour before taking Mastical D.

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 taking this medicine.

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.

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.

Other medicines that may interact or be affected when taking Mastical D 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 listed above, your doctor will give you further instructions.

Taking Mastical D with food and drinks

Mastical D orange-flavored tablets can be taken with or without food and drinks.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 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 overdosing may affect the fetus.

This medicine may be taken during breastfeeding. 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

This medicine has no known effect on the ability to drive or operate machinery.

Mastical D contains sorbitol

This medicine contains 324.45 mg of sorbitol (E-420) per tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Mastical D is essentially sodium-free

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Mastical D

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 and adolescents

This medicine 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, contact your doctor or pharmacist immediately.

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

If you forget to take Mastical D

Do not take a double dose to make up for the 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 can cause adverse effects, although not everyone will experience them.

Hypersensitivity reactions have occurred with unknown frequency (cannot be estimated from available data). If you experience the following symptoms, contact your doctor immediately: swelling of the face, tongue, or lips (angioedema) or swelling of the throat (laryngeal edema).

Uncommon adverse effects (may affect up to 1 in 100 people)

You may develop high levels of 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 diarrhea.

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, which generally only occurs after excessive calcium intake). 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 kidney function abnormalities.

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 type of 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mastical D

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from light. Keep the container tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Mastical D:

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: sorbitol (E-420), anhydrous sodium saccharin, orange flavor, hydroxypropylcellulose, magnesium stearate.

Appearance of the product and contents of the pack

Mastical D contains 60 white chewable tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

INDUSTRIA QUIMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Pol. Industrial Urtinsa II.

28923; Alcorcón. Madrid

Spain

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the most recent review of this leaflet: July 2019

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es