CALCIMAGON

CALCIMAGON D3 Uno chewable tablets

Important notes (mandatory information)

Calcimagon-D3 UNO, 1,000 mg/800 IU, chewable tablets Active ingredient: Calcium/Vitamin D3. Areas of application: used for the prevention and treatment of calcium and vitamin D deficiencies in the elderly and as an additional treatment 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 UNO, 1,000 mg/800 IU, chewable tablets
Active ingredient: Calcium/Vitamin D3

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

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

Calcimagon-D3 UNO are white, round chewable tablets that contain calcium and vitamin D3, which are important for bone formation. Calcimagon-D3 UNO is used for the prevention and treatment of calcium and vitamin D deficiencies in the elderly and as an additional treatment to support specific osteoporosis therapy.

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

Calcimagon-D3 UNO 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 have high levels of calcium in your blood or urine.
• If you suffer from kidney stones.
• If you have high levels of vitamin D in your blood.

Warnings and precautions

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

• If you are receiving long-term treatment, especially if you are also taking diuretics (to treat high blood pressure or edema) or cardiac glycosides (to treat heart disease).
• If you have impaired kidney function or a tendency to form 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 immobilization osteoporosis.
• If you are using other vitamin D-containing preparations. Taking additional calcium and vitamin D should only be done under close medical supervision.

Children and adolescents

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

Taking Calcimagon-D3 UNO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. The absorption of tetracycline preparations (antibiotics) can be affected by the simultaneous intake of calcium carbonate. For this reason, tetracycline-containing medicines should be taken at least 2 hours before or 4 to 6 hours after taking Calcimagon-D3 UNO. Bisphosphonate preparations (for the treatment of osteoporosis) should be taken at least 1 hour before Calcimagon-D3 UNO. Calcium can reduce the effect of levothyroxines (given to treat thyroid hormone deficiency). Therefore, please take levothyroxine at least 4 hours before or 4 hours after Calcimagon-D3 UNO. The effect of quinolone antibiotics can be reduced if taken at the same time as calcium. Please take quinolone antibiotics 2 hours before or 6 hours after Calcimagon-D3 UNO. 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 UNO.
Other medicines whose effect is influenced by Calcimagon-D3 UNO or which could affect the effect of Calcimagon-D3 UNO:

• 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) can interfere with 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 Calcimagon-D3 UNO with food and drink

Calcimagon-D3 UNO 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 become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant, you can take Calcimagon-D3 UNO in case of a 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 UNO can be taken during breastfeeding. Calcium and vitamin D3 pass into breast milk. This should be taken into account if the child is given additional vitamin D.

Driving and using machines

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

Calcimagon-D3 UNO contains isomalt and sucrose

This medicine contains isomalt (E 953) and sucrose (sugar). Therefore, please only take Calcimagon-D3 UNO after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Calcimagon-D3 UNO can be harmful to teeth.

3. HOW TO TAKE CALCIMAGON-D3 UNO?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Please ask your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is: 1 chewable tablet daily. You can suck or chew the tablet.

Use in children and adolescents

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

If you have taken more Calcimagon-D3 UNO than you should

If you have taken more Calcimagon-D3 UNO than you should, please talk to your doctor or pharmacist immediately.

If you forget to take Calcimagon-D3 UNO
Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of 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 have occurred with unknown frequency (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 syndrome) 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 calcium levels in the blood and impaired kidney function. If you have impaired kidney function, you may be at risk for elevated phosphate levels in the blood, kidney stone formation, and elevated 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 53175 Bonn Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CALCIMAGON-D3 UNO?

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.

Storage conditions

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

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcimagon-D3 UNO contains

The active ingredients in one tablet are: Calcium carbonate 2,500 mg (equivalent to 1,000 mg calcium), colecalciferol (vitamin D3) 800 IU (equivalent to 20 micrograms colecalciferol). The other ingredients are: Xylitol (E 967), povidone, isomalt (E 953), lemon flavor, magnesium stearate, sucralose (E 955), mono- and diglycerides of fatty acids, all-rac-alpha-tocopherol, sucrose (sugar), modified corn starch, medium chain triglycerides, sodium ascorbate and anhydrous colloidal silicon dioxide.

What Calcimagon-D3 UNO looks like and contents of the pack

Calcimagon-D3 UNO are white, round chewable tablets. These may have small spots. Pack sizes: 30, 40, 60 and 90 chewable tablets.

Pharmaceutical entrepreneur

Takeda GmbH
Byk-Gulden-Straße 2
78467 Konstanz
Tel.: 0800 8253325
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 October 2015.

Source: Information from the package leaflet
Status: 02/2016
Active ingredient: Calcium/Vitamin D3. Areas of application: used for the prevention and treatment of calcium and vitamin D deficiencies in the elderly and as an additional treatment to support specific osteoporosis therapy.