iMedi.co.uk

Calcichew 500mg Chewable Tablets

Document: label-leaflet MAH BRAND_PL 16189-0023 change

Each tablet contains 1250mg calcium carbonate equivalent to 500mg calcium. Also includes sorbitol (E420), isomalt (E953) and aspartame (E951).

Please read the patient information leaflet for further information.

For oral administration.

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=    to be chewed or sucked 2 or 3 times

a day or as directed by your doctor.

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Do not store above 30°C.

Keep the container tightly closed to protect from moisture.

Takeda UK Ltd. Wooburn Green, BUCKS, HP10 0DF, UK *Registered Trademark BATCH No.


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Calcichew* 500mg Chewable Tablets

calcium carbonate

equivalent to 500mg calcium


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Very rarely in addition: irritability, continuing headache, lightheadedness, muscle spasms, twitches and tingling sensation.

If you forget to take Calcichew 500 mg Chewable Tablets

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking your medicine and see a doctor immediately if you

experience any of the following side effects. These side effects may be a sign of milk-alkali syndrome (also called Burnett’s Syndrome) that is reported to occur very rarely (affects less than 1 in 10,000 people):

•    Frequent urge to urinate

•    Headache

•    Loss of appetite, nausea or vomiting

•    Unusual tiredness or weakness, along with elevated levels of calcium in the blood and kidney impairment.


Side effects may include:

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

•    excessive amounts of calcium in your blood (hypercalcaemia) or in your urine (hypercalcuria) may occur with large doses

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

•    nausea    •    diarrhoea

•    stomach    ache    •    wind (flatulence)

•    constipation    •    heartburn (dyspepsia)

Very rare side effects (may affect less than 1 in 10,000 people):

•    rash

•    hives

•    itching

If you are taking Calcichew 500 mg Chewable Tablets because you are having kidney dialysis, tell your doctor if you notice any white deposits on your skin.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:


Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CALCICHEW 500MG

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

Store in the original package to protect from moisture. Do not store above 30 °C. Do not use this medicine after the expiry date which is stated on the label after EXP The expiry date refers to the last day of that month.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Calcichew 500 mg Chewable Tablets contain

The active ingredient in each tablet is 1250 mg calcium carbonate (equivalent

to 500 mg calcium).

The other ingredients are: sorbitol (E420), povidone, isomalt (E953), fatty acid mono- and di-glycerides, magnesium stearate, orange flavour, and aspartame (E951) (see also end of Section 2 “Calcichew 500 mg contains isomalt, sorbitol and aspartame”).

What Calcichew 500 mg look like and contents of the pack

The tablets are round, white, uncoated convex and orange flavoured; they may have small specks.

The tablets are packed in white, plastic bottles of 100 tablets.

Marketing Authorisation Holder

Takeda UK Ltd., Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS, HP10 0DF, United Kingdom


Manufacturer

Takeda AS, Drammensveien 852, N-1385 Asker, Norway.

This leaflet was last revised in October 2015.

Additional Information

Calcichew 500 mg contains calcium designed to keep bones healthy. Calcium is an essential component of bones.

Requirements for calcium increase with age and, although many people obtain enough calcium from their diet, some people may require a supplement in order that their body has all the calcium it needs to maintain healthy bones.

People with diets and lifestyles that mean they will obtain less than the recommended intake of calcium are at risk of weakened bones. Prolonged lack of adequate calcium intake can lead to the development of osteoporosis, a condition where bones become weak to a level that minimal trauma (for example, a fall) can result in a fracture, most typically at the hip, spine or wrist.

Calcichew 500 mg have been designed to give people, whose intake of calcium is low, a boost to the recommended amounts.


Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many people. There are many ways that people can help themselves: regular exercise, a balanced diet with an adequate intake of calcium and, for some people, advice on how to prevent falls which may lead to fracture.

The National Osteoporosis Society (NOS) in the UK and the Irish Osteoporosis Society (IOS) in the Republic of Ireland, are national charities dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS and IOS offer support to people with osteoporosis and raise awareness of the importance of healthy bones.

For patients in the UK, if you are concerned about osteoporosis, please contact the National Osteoporosis Society, Camerton, Bath BA2 0PJ. Tel: 01761 471 771, Fax: 01761 471 104 or email: info@nos.org.uk. For patients in the Republic of Ireland, please contact the Irish Osteoporosis Society, 114 Pembroke Road, Garden Level, Ballsbridge, Dublin 4. Tel: 1890 252 751, Fax: +353 (0)1 668 0098, email: info@irishosteoporosis.ie.

^Registered Trademark


6083706-06


PATIENT INFORMATION LEAFLET

CALCICHEW* 500 mg CHEWABLE TABLETS

calcium carbonate


Read all of this leaflet carefully before you start taking this medicine

because it contains important information for you.

-    Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must talk to a doctor if you do not feel better or if you feel worse after two weeks.

-    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Calcichew 500 mg is and what it is used for

2.    What you need to know before you take Calcichew 500 mg

3.    How to take Calcichew 500 mg


4.    Possible side-effects

5.    How to store Calcichew 500 mg

6.    Contents of the pack and other information

1.    WHAT CALCICHEW 500 MG IS AND WHAT IT IS USED FOR

Calcichew 500 mg Chewable Tablets are orange flavoured chewable tablets containing the active ingredient calcium. Calcium is found in the diet and is an important substance in bone formation.

Calcichew 500 mg is used to treat and prevent calcium deficiency which may occur if your diet or lifestyle does not provide enough, or when body requirements are increased. This medicine may also be prescribed or recommended for certain bone conditions, for example osteoporosis, or during pregnancy. It may also be given to patients receiving kidney dialysis to remove the phosphate from the blood that cannot be removed by dialysis.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW 500 MG Do not take Calcichew 500 mg Chewable Tablets if you:

•    are allergic (hypersensitive) to calcium or any of the other ingredients of this medicine (listed in section 6)

•    have a condition that causes excessive amounts of calcium in your blood or


urine (hypercalcaemia or hypercalciuria)

•    have kidney stones.

Warnings and precautions

Talk to your doctor or pharmacist before taking Calcichew 500 mg:

•    if you have phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine) as these tablets contain aspartame, a source of phenylalanine

•    if you have osteoporosis (brittle bones) and are also unable to move around

•    if you are on long term treatment, especially if you are taking medicines for a heart disorder (cardiac glycosides), or diuretics (used in the treatment of high blood pressure or oedema)

•    if you have signs of impaired kidney function or a high tendency to kidney stone (calculus) formation

•    if you have cancer or any other conditions that may have affected your bones.

Your serum calcium or phosphate levels, or urinary calcium excretion must

be monitored if you have any of the following conditions:

   kidney problems

•    you are on long-term treatment with Calcichew

•    you are already taking additional doses of calcium


If you have increased calcium levels in the blood or develop signs of kidney problems, the dose of Calcichew 500 mg should be reduced or the treatment discontinued.

Other medicines and Calcichew 500 mg

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

In particular, the following medicines may interact with Calcichew 500 mg tablets:

   thiazide diuretics (water tablets); your serum calcium levels should be monitored regularly.

   cardiac glycosides (heart medicines); you should be monitored by electrocardiogram (ECG) and your serum calcium levels measured.

   tetracycline antibiotics; these should be taken at least two hours before, or four to six hours afterwards. Calcium carbonate may interfere with the absorption of tetracycline preparations if taken at the same time.

   levothyroxine (hormone used to treat thyroid deficiency); these should be taken at least four hours before, or after taking Calcichew 500 mg.

   Quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin); the effect of these medicines may be reduced if taken at the same time as calcium. Take quinolone antibiotics two hours before or six hours after taking Calcichew 500 mg.


   Bisphosphonates should be taken at least one hour before Calcichew 500 mg.

•    Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Calcichew 500 mg.

If you are taking any of the above-mentioned medicines, your doctor will give you further instructions.

Taking Calcichew 500 mg with food and drink

For treatment of calcium deficiency or use as an additional osteoporosis therapy, Calcichew 500 mg can be taken with or without food and drink.

For use as a phosphate binder, Calcichew 500 mg should be taken just before, during or just after each meal.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Calcichew 500 mg.

During pregnancy the daily intake should not exceed 2500 mg calcium (including food and supplementation). If you are pregnant, you may use Calcichew 500 mg in case of a calcium deficiency.


Calcichew 500 mg can be used during breastfeeding. Calcium passes into breast milk.

Driving and using machines

Calcichew 500 mg has no known influence on the ability to drive or use machines.

Calcichew 500 mg contains isomalt, sorbitol and aspartame

Calcichew 500 mg contains sorbitol (E420) and isomalt (E953): if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine. May be harmful to teeth.

Calcichew 500 mg contains aspartame (E951), a source of phenylalanine which may be harmful for people with phenylketonuria (a deficiency in the enzyme which breaks down phenylalanine).

3. HOW TO TAKE CALCICHEW 500 MG

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is:


For use as an additional osteoporosis therapy: One tablet 2 or 3 times a day. For calcium deficiency:

One tablet 2 or 3 times a day.

As a phosphate binder (for kidney failure patients on dialysis):

Your doctor will decide how many Calcichew 500 mg Chewable Tablets you need. The label the pharmacist puts on your medicine will tell you exactly how many tablets to take.

Use in children

The recommended dose for children is one tablet 2 or 3 times a day.

The tablets can be chewed or sucked.

If you take more than you should

If you have taken more Calcichew 500 mg than you should, talk to your doctor or pharmacist immediately.

If you accidentally take more Calcichew 500 mg than you should, you may have an increase in your blood calcium levels. Symptoms of this are: excessive thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, tiredness, mental disturbances, lack of appetite, bone pain, having to pass more water than usual, kidney problems and, in severe cases, irregular heartbeat.