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CALCICHEW® 500 mg CHEWABLE TABLETS

(calcium carbonate)

PATIENT INFORMATION LEAFLET

This medicine is called Calcichew 500 mg Chewable Tablets but will be referred to as Calcichew 500 mg through the remainder of this leaflet.

In this leaflet:

1.    What Calcichew 500 mg are and what they are used for

2.    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.    Further information

1. WHAT CALCICHEW 500 MG ARE AND WHAT| THEY ARE USED

Calcichew 500 mg are orange flavoured chewable tablets. They contain the active ingredients:

• Calcium (1250 mg calcium carbonate: equivalent to 500 mg calcium)

Calcium is found in the diet.

Calcichew 500 mg may be prescribed by doctors or recommended by pharmacists to treat and prevent calcium deficiency, or when the 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 in pregnancy. It may also be given to patients receiving kidney dialysis to remove the phosphate from food that cannot be removed by dialysis.

2. BEFORE YOU TAKE CALCICHEW 500MG

Do not take Calcichew 500 mg Chewable Tablets if you:

•    are allergic (hypersensitive) to any of the ingredients (see end of Section 2 and Section 6)

•    have a condition causing high levels of calcium in your blood or urine (hypercalcaemia or hypercalciuria) e.g.

o severe kidney failure in people not on dialysis - you should not take this medicine unless advised by your doctor

o cancer which has affected your bones

•    have kidney stones.

Take special care with Calcichew 500 mg:

If any of the following applies to you, please tell your doctor:

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

•    brittle bones (osteoporosis) as a result of being immobile

•    taking medicines for your heart, or diuretics

•    a high tendency to kidney stone (calculus) formation

•    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.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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

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

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

•    corticosteroids (e.g. prednisolone, dexamethasone); your dose of Calcichew 500 mg may need to be increased

•    tetracycline antibiotics; these should be taken at least two hours before, or four to six hours afterwards.

•    Hormones (levothyroxine); these should be taken at least four hours before, or afterwards.

•    Anti-infectives (Quinolones: Ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin): please speak with your doctor.

•    fluoride, or bisphosphonates; Calcichew 500 mg should be taken at least three hours afterwards.

Taking Calcichew 500 mg with food and drink

Calcichew 500 mg should not be taken within 2 hours of eating foods rich in oxalic acid (found in spinach and rhubarb) or phytic acid (found in whole cereals).

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding before taking Calcichew 500 mg.

Driving and using machines

Calcichew 500 mg has no known effect on your ability to drive

or use machines.

Important information about some of the ingredients of

Calcichew 500 mg

The following are ingredients in this product:

•    Sorbitol and isomalt: if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

•    Aspartame contains a source of phenylalanine and 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 Calcichew 500 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For use as additional osteoporosis therapy:

Adults and the elderly: Chew or suck one tablet 2 or 3 times a day.

For calcium deficiency:

Adults, the elderly and children: Chew or suck one tablet 2 or 3 times a day.

For osteomalacia (a softening of the bones):

Adults and the elderly: Chew or suck two to six chewable tablets a day.

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

When Calcichew 500 mg Chewable Tablets are given to patients on kidney dialysis, the dose will be different for each patient. Your doctor will decide how many Calcichew 500 mg Chewable Tablets you need.

The tablets should be taken just before, during or just after each meal to make sure that the calcium binds to the phosphate in the stomach.

If you take more than you should

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

Do not take any more Calcichew 500 mg and contact your doctor or emergency department as soon as possible. Take the packet and any remaining tablets with you.

If you forget to take Calcichew 500 mg Chewable Tablets

If you forget to take a dose, leave out that dose completely. Take your next dose when it is due. Do not take a double dose to make up for a forgotten dose.

. POSSIBLE SIDE-EFFECTS

Like all medicines, Calcichew 500 mg can cause side effects, although not everybody gets them.

Side effects with Calcichew 500 mg may include:

Uncommon side effects (affecting less than 1 in 100 people):

•    too much calcium in your blood (hypercalcaemia) - the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, a need to pass more water than usual, muscle weakness, drowsiness and confusion.

•    too much calcium in your urine (hypercalciuria)

Rare side effects (affecting less than 1 in 1,000 people):

•    nausea

•    stomach ache

•    constipation

•    diarrhoea

•    wind (flatulence)

•    rash

•    hives

•    itching

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

•    Milk alkali syndrome -(usually only seen in overdose see

“if you take more than you should”)

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 the Yellow Card Scheme at: 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 out of the sight and reach of children.

Keep the container tightly closed.

Protect from moisture.

Do not store above 30°C.

Do not use Calcichew 500 mg after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

If the tablets have changed shape or colour do not use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Calcichew 500 mg Chewable Tablets contain The active ingredients in each tablet are:

•    1250 mg calcium carbonate (equivalent to 500 mg

calcium)

The other ingredients are: Sorbitol (E420), povidone, isomalt (E953), fatty acid mono- and diglycerides, magnesium stearate, orange flavour, and aspartame (E951) (see also end of Section 2 “Important information about some of the ingredients of Calcichew 500 mg”).

This product is gluten and lactose free.

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 90 tablets.

Manufacturer

This product is manufactured by Takeda Nycomed AS, Drammensveien 852, P.O. Box 205, 1372 Asker, Norway. Procured from within the EU and repackaged by Mediwin Limited. Product Licence Holder: Mediport Limited.

13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, United Kingdom.

§    PL: 18980/0805

CALCICHEW® IS A REGISTERED TRADEMARK OF SHIRE PHARMACEUTICALS LIMITED

This medicinal product is authorised in the Member State of Spain under the following name:

MASTICAL 500 mg comprimidos masticables

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.

For patients in the UK, the National Osteoporosis Society (NOS) is a national charity dedicated to improving the diagnosis, prevention and treatment of osteoporosis. The NOS offers support to people with osteoporosis and raises awareness of the importance of healthy bones.

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.

Date of leaflet preparation: 15/01/2016

PIL-0805-S0007