CALCILAC

CALCILAC chewable tablets

Important notes (mandatory information)

Calcium-D3 Calcilac Chewable Tablets. Areas of application: for the prevention and treatment of calcium and vitamin D deficiencies in the elderly and as a supplement to support specific osteoporosis therapy for patients at risk of vitamin D and calcium deficiency.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Calcium-D3 Calcilac Chewable Tablets
Active ingredients: 500 mg calcium, 400 IU cholecalciferol

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take 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.
• If you do not feel better or even worse after one month, contact your doctor.

What this leaflet contains

1. WHAT ARE CALCILAC CHEWABLE TABLETS 500 MG/400 IU AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCILAC CHEWABLE TABLETS 500MG/400 IU?
3. HOW TO TAKE CALCILAC CHEWABLE TABLETS 500MG/400 IU?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CALCILAC CHEWABLE TABLETS 500 MG/400 IU?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE CALCILAC CHEWABLE TABLETS 500 MG/400 IU AND WHAT ARE THEY USED FOR?

Calcilac are chewable tablets that contain calcium and vitamin D3 - two important substances for bone formation. Calcilac Chewable Tablets 500 mg/400 IU are taken to prevent and treat calcium and vitamin D deficiencies in the elderly and as a supplement to support specific osteoporosis therapy for patients at risk of vitamin D and calcium deficiency. If you do not feel better or even worse after one month, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CALCILAC CHEWABLE TABLETS 500 MG/400 IU?

Calcilac Chewable Tablets 500 mg/400 IU 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 high levels of calcium in your blood or urine.
• if you have calcium-containing kidney stones.
• if your kidney function is impaired.
• if the vitamin D level in your blood is too high.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Calcilac Chewable Tablets 500mg/400 IU:

• if you are receiving long-term treatment.
• if you have impaired kidney function or a strong tendency to form kidney stones.
• if you suffer from sarcoidosis (a disease of the immune system that can lead to an increased vitamin D level in the body).
• in case of immobilisation with osteoporosis (osteoporosis caused by prolonged immobilisation).
• if you are taking other vitamin D or calcium supplements. Additional doses of calcium and vitamin D can lead to a significant increase in blood calcium levels and cause harmful side effects. Such preparations should only be taken together with Calcilac Chewable Tablets 500mg/400 IU under strict medical supervision.

It is at your doctor's discretion whether a calcium and/or vitamin D3 preparation can be used under these circumstances. If you are using Calcilac Chewable Tablets 500mg/400 IU without a doctor's prescription, you should always consult your doctor if you have been using it for more than one month. If you are using Calcilac Chewable Tablets 500mg/400 IU for osteoporosis, it is recommended that you have your blood calcium level (calcemia) checked before starting treatment. In the case of long-term treatment with Calcilac Chewable Tablets 500mg/400 IU, the calcium content of the blood must be checked regularly. Depending on the result, your doctor may decide to reduce the dose or discontinue treatment.

Children and adolescents

Calcilac Chewable Tablets 500mg/400 IU are not intended for use in children and adolescents.

Taking Calcilac Chewable Tablets 500mg/400 IU with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Calcium carbonate can interfere with the absorption of tetracycline preparations taken at the same time (medicines from the antibiotic group). For this reason, tetracycline preparations should be administered at least 2 hours before or 4 - 6 hours after taking Calcilac Chewable Tablets 500mg/400 IU. Medicines containing bisphosphonates (for the treatment of osteoporosis) or sodium fluoride (for strengthening tooth enamel) should be taken at least three hours before Calcilac Chewable Tablets 500mg/400 IU. Calcium can impair the effect of levothyroxine. For this reason, levothyroxine should be taken at least four hours before or four hours after Calcilac Chewable Tablets 500mg/400 IU. The effect of quinolone antibiotics may be impaired if taken at the same time as calcium. Therefore, take quinolone antibiotics two hours before or six hours after Calcilac Chewable Tablets 500 mg/400 IU. Rifampicin, phenytoin or barbiturates can weaken the effect of vitamin D3 as they increase its metabolic rate. Calcium salts can impair the absorption of iron, zinc or strontium. Consequently, iron, zinc or strontium preparations should be taken two hours apart from a calcium preparation.

Other medicines that may interact with Calcilac Chewable Tablets 500 mg/400 IU are: thiazide diuretics (diuretics used to treat high blood pressure or edema), cardiac glycosides (e.g. digitalis, for the treatment of heart disease), corticosteroids (for the treatment of inflammation or as immunosuppressants), ion exchange resins such as cholestyramine (for the treatment of high cholesterol in the blood), laxatives (laxatives) such as paraffin oil or orlistat (for the treatment of obesity).

Other products containing calcium or vitamin D: Additional doses of calcium and vitamin D can lead to a significant increase in blood calcium levels and cause harmful side effects. Such preparations should only be taken together with Calcilac Chewable Tablets 500 mg/400 IU under strict medical supervision.

Taking Calcilac Chewable Tablets 500mg/400 IU with food and drink

Calcilac Chewable Tablets 500mg/400 IU can be taken with or between meals. Oxalic acid (e.g. in spinach, sorrel and rhubarb) and phytic acid (in wholemeal products) can inhibit calcium absorption. Therefore, you should not take Calcilac Chewable Tablets 500mg/400 IU within two hours before or after eating foods high in oxalate or phytic acid.

Pregnancy and

breastfeeding

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

During pregnancy, the daily intake should not exceed 1,500 mg of calcium and 600 IU of vitamin D, as an overdose could have harmful effects on the unborn child. If you are pregnant, you can use Calcilac Chewable Tablets 500mg/400 IU for calcium and vitamin D deficiency. However, the daily dose of Calcilac Chewable Tablets 500mg/400 IU should not exceed one tablet per day.

Breastfeeding

If you are breastfeeding, you can also use Calcilac Chewable Tablets 500mg/400 IU. However, if your child is receiving additional doses of vitamin D, it should be taken into account that the active ingredients contained in Calcilac Chewable Tablets 500mg/400 IU pass into breast milk.

Driving and using machines

No studies have been conducted on the effects on driving and using machines. However, an adverse effect is unlikely.

Calcilac Chewable Tablets 500mg/400 IU contain sorbitol and sucrose

This medicine contains sorbitol and sucrose (sugar). Please only take Calcilac Chewable Tablets 500 mg/400 IU after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Calcilac Chewable Tablets 500 mg/400 IU can be harmful to the teeth (caries).

Calcilac Chewable Tablets 500mg/400 IU contain aspartame

Calcilac Chewable Tablets 500mg/400 IU contain aspartame as a source of phenylalanine and may be harmful if you have phenylketonuria.

3. HOW TO TAKE CALCILAC CHEWABLE TABLETS 500MG/400 IU?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is one chewable tablet twice a day. The chewable tablets can be chewed or sucked. It is preferable to take them with a meal. Treatment without medical advice should not exceed a period of one month. If you wish to take Calcilac Chewable Tablets 500mg/400 IU for longer than one month, please contact your doctor.

If you have taken more Calcilac Chewable Tablets 500mg/400 IU than you should

If you have taken more Calcilac Chewable Tablets 500mg/400 IU than you should, contact your doctor or pharmacist immediately. Symptoms of hypercalcemia (elevated blood calcium levels) include loss of appetite, nausea, vomiting, constipation, abdominal pain, muscle weakness, drowsiness and confusion, extreme thirst, excessive or unusually strong urine output and/or frequent urination and bone pain.

If you forget to take Calcilac Chewable Tablets 500mg/400 IU

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.

Not known (frequency cannot be estimated from the available data)

Hypersensitivity reactions. Contact your doctor immediately if you experience any of the following signs of a severe allergic reaction: Swollen face, swelling of the lips, tongue (angioedema) or throat (laryngeal edema).

Occasionally (may affect up to 1 in 100 people)

High doses may lead to elevated blood calcium levels (hypercalcemia) or urine calcium levels (hypercalciuria). Symptoms of hypercalcemia include loss of appetite, nausea, vomiting, constipation, abdominal pain, muscle weakness, drowsiness and confusion, extreme thirst, excessive or unusually strong urine output and/or frequent urination and bone pain.

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

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

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

Itching, rash and hives.

Milk-alkali syndrome (also known as Burnett syndrome, usually only occurs after excessive calcium intake); symptoms include hypercalcemia, metabolic alkalosis, impaired kidney function and soft tissue calcification.

Patients with impaired kidney function

If you have impaired kidney function, you may be at risk of 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 on the safety of this medicine.

5. HOW TO STORE CALCILAC CHEWABLE TABLETS 500MG/400 IU?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "use by:". The expiry date refers to the last day of the month indicated. Keep the container tightly closed to protect the contents from moisture. Do not store above 30°C. After opening the container, Calcilac Chewable Tablets 500mg/400 IU can be stored for six months. Do not dispose of medicines in wastewater. 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 Calcilac Chewable Tablets 500 mg/400 IU contain

The active ingredients are: Calcium and cholecalciferol (vitamin D3). One chewable tablet contains 1250mg calcium carbonate (equivalent to 500 mg calcium) and 4mg cholecalciferol dry concentrate (equivalent to 10 micrograms cholecalciferol = 400 IU vitamin D3). The other ingredients are: Sorbitol, povidone, croscarmellose sodium, dextrose-maltose-saccharide mixture (92:3.5:4.5), lemon flavor (corn maltodextrin, flavorings, all-rac-alpha-tocopherol), magnesium stearate (Ph.Eur.) [vegetable], starch[hydrogen-2-(oct-1-en-1-yl)butanedioate]-sodium salt, aspartame, sucrose (sugar), sodium ascorbate, medium-chain triglycerides, highly dispersed silicon dioxide and all-rac-a-tocopherol.

What Calcilac Chewable Tablets 500 mg/400 IU look like and contents of the pack

Calcilac Chewable Tablets 500mg/400 IU are white, round chewable tablets. The chewable tablets may have small spots. Pack sizes: 20, 50, 100, 120 or 180 chewable tablets in tablet containers. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Tel.: 034954/247-0
Fax: 034954/247-100

This leaflet was last revised in May 2016.

Source: Information from the package leaflet
Status: 04/2018
Areas of application: for the prevention and treatment of calcium and vitamin D deficiencies in the elderly and as a supplement to support specific osteoporosis therapy for patients at risk of vitamin D and calcium deficiency.