CALCIMAGON

CALCIMAGON D3 chewable tablets

Important notes (mandatory information)

Calcimagon-D3 500 mg/400 IU, chewable tablets. Areas of application: for the prevention and treatment of vitamin D and calcium deficiencies in the elderly, for the prevention and treatment of osteoporosis and as a vitamin D and calcium supplement to support specific osteoporosis therapy.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcimagon-D3 500 mg/400 IU, chewable tablets
Active ingredients: Calcium/Vitamin D3
Vitamin and mineral supplement

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information.

• Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.
• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.

What this leaflet contains

1. WHAT IS CALCIMAGON-D3 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIMAGON-D3?
3. HOW TO TAKE CALCIMAGON-D3?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CALCIMAGON-D3?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CALCIMAGON-D3 AND WHAT IS IT USED FOR?

Calcimagon-D3 is a vitamin and mineral supplement. It is used for the prevention and treatment of vitamin D and calcium deficiencies in the elderly, for the prevention and treatment of osteoporosis and as a vitamin D and calcium supplement to support specific osteoporosis therapy.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCIMAGON-D3?

Calcimagon-D3 must not be taken:

• If you are allergic to calcium, vitamin D or any of the other ingredients of this medicine listed in section 6.
• If you have severe impairment of kidney function.
• If you suffer from kidney stones.
• If you have high levels of calcium in your blood or urine. Ask your doctor about this.
• If you have high levels of vitamin D in your blood. Ask your doctor about this.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Calcimagon-D3:

• If you are receiving long-term treatment with Calcimagon-D3, while taking diuretics (to treat high blood pressure or edema) or cardiac glycosides, medicines to treat heart disease.
• If you have impaired kidney function or a tendency to form kidney stones.
• If you suffer from sarcoidosis (a disease of the immune system that can lead to increased vitamin D levels in the body).
• If you have osteoporosis as a result of severe movement restrictions (immobilization osteoporosis).
• If you are using other vitamin D-containing supplements. Additional intake of calcium and vitamin D should only be taken under close medical supervision.

Children and adolescents

Calcimagon-D3 is not intended for use in children and adolescents.

Taking Calcimagon-D3 with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines.

Notes on the time of taking:

• The absorption of certain antibiotics from the tetracycline group may be reduced if taken at the same time as calcium. For this reason, tetracycline-containing medicines should be taken at least 2 hours before or 4 to 6 hours after taking Calcimagon-D3.
• The effect of quinolone antibiotics may be reduced if taken at the same time as calcium.
• Please take quinolone antibiotics 2 hours before or 6 hours after Calcimagon-D3.
• Bisphosphonate preparations (for the treatment of osteoporosis) should be taken at least 1 hour before Calcimagon-D3.
• The effectiveness of the active ingredient levothyroxine (given to treat thyroid hormone deficiency) may be reduced by calcium. Therefore, please take medicines containing the active ingredient levothyroxine at least 4 hours before or 4 hours after Calcimagon-D3.
• Calcium can reduce the absorption of iron, zinc and strontium ranelate. Therefore, please take medicines containing iron, zinc and strontium ranelate 2 hours before or 2 hours after Calcimagon-D3.

Other notes

Medicines whose effect is influenced by Calcimagon-D3 or which could affect the effect of Calcimagon-D3:

• Thiazide diuretics (for the treatment of high blood pressure and edema).
• Cardiac glycosides (for the treatment of heart disease).
• Orlistat for the treatment of obesity.

Taking Calcimagon-D3 with food and drink

Calcimagon-D3 can be taken with or without food or liquid.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant, you can take Calcimagon-D3 in case of calcium or vitamin D deficiency. During pregnancy, you should not take more than 2,500 mg of calcium and 4,000 IU of vitamin D per day, as overdoses can harm the unborn child.

Breastfeeding

Calcimagon-D3 can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. Please take this into account if the child is given additional vitamin D.

Driving and using machines

Calcimagon-D3 has no known influence on the ability to drive and use machines.

Calcimagon-D3 contains isomalt and sucrose

This medicine contains isomalt (E 953) and sucrose (sugar). Please only take Calcimagon-D3 after consulting your doctor if you are known to have an intolerance to certain sugars.

3. HOW TO TAKE CALCIMAGON-D3?

Dosage

The recommended dose is: 1 chewable tablet twice a day. You can suck or chew the tablet.

Use in children and adolescents

Calcimagon-D3 chewable tablets are not intended for use in children and adolescents.

If you have taken more Calcimagon-D3 than you should

If you have taken more Calcimagon-D3 than you should, please speak to a doctor or pharmacist immediately.

If you forget to take Calcimagon-D3

Do not take a double dose to make up for a forgotten dose. Continue taking as directed in the dosage instructions.

If you are not sure how to take this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Hypersensitivity reactions of unknown frequency have occurred (frequency not estimable from the available data). If you experience the following symptoms such as swelling of the face, tongue, lips (angioedema) or swelling in the throat (laryngeal edema), you should see your doctor immediately.

Possible side effects

Uncommon (may affect up to 1 in 100 people)

Under high doses, calcium levels in the blood (hypercalcemia) or urine (hypercalcuria) may rise excessively.

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

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

Very rare (may affect up to 1 in 10,000 people)

Itching, rash, hives. Milk-alkali syndrome, also known as Burnett's syndrome (a calcium metabolism disorder that usually only occurs after excessive calcium intake). Symptoms include frequent urination, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with elevated blood calcium levels and impaired kidney function.

If you have impaired kidney function, you may be at risk for increased phosphate levels in the blood, kidney stone formation, and increased calcium levels in the kidneys.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE CALCIMAGON-D3?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and container after "Use by:". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This will help to protect the environment. Storage conditions: Do not store above 30°C. Store in the original package to protect the contents from light. Keep the original container tightly closed to protect the contents from moisture. Disposal: Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. Or find out at www.arzneimittelentsorgung.de. You will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcimagon-D3 contains

The active ingredients are: Calcium carbonate and vitamin D3. 1 chewable tablet contains: 1,250 mg calcium carbonate (equivalent to 500 mg calcium) and 4 mg colecalciferol (vitamin D3) 400 IU (equivalent to 10 micrograms colecalciferol). The other ingredients are: Sorbitol (E 420), povidone, isomalt (E 953), lemon flavor, magnesium stearate, aspartame (E 951), mono- and diglycerides of fatty acids, all-rac-alpha-tocopherol, sucrose (sugar), modified corn starch, medium chain triglycerides, sodium ascorbate, anhydrous colloidal silicon dioxide. Note: Calcimagon-D3 is gluten-free and lactose-free.

What Calcimagon-D3 looks like and contents of the pack

Calcimagon-D3 are white, round chewable tablets that may have small specks, which do not affect the quality. Calcimagon-D3 is available in plastic jars containing 20, 30, 50, 60, 90, 100, 112, 120 and 180 chewable tablets.

Pharmaceutical entrepreneur

Takeda GmbH
Byk-Gulden-Straße 2
78467 Konstanz
Telephone: 0800 8253324
Fax: 0800 8253329
E-mail: medinfo@takeda.de

Manufacturer

Takeda AS
Drammensveien 852
NO-1383 Asker
Norway

or

Takeda Pharma AS
55B Jaama Street
63308 Polva
Estonia

This leaflet was last revised in August 2016.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for the prevention and treatment of vitamin D and calcium deficiencies in the elderly, for the prevention and treatment of osteoporosis and as a vitamin D and calcium supplement to support specific osteoporosis therapy.