PATIENT INFORMATION LEAFLET

CALCICHEW® 500mg CHEWABLE TABLETS

(calcium carbonate) equivalent to 500mg Calcium

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Calcichew 500mg Chewable Tablets carefully to get the best results from it.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve after two weeks.

•    If any of the side effects become serious or if you notice any side effect(s) not listed in this leaflet, please talk to your doctor or pharmacist.

The name of your medicine is CALCICHEW® 500mg CHEWABLE TABLETS, but it will be referred to as Calcichew throughout this leaflet.

In this leaflet:

1.    What Calcichew is and what it is used for

2.    Before you take Calcichew

3.    How to take Calcichew

4.    Possible side effects

5.    How to store Calcichew

6.    Further information

1.    WHAT CALCICHEW IS AND WHAT IT IS UESD FOR

Calcichew is orange flavoured chewable tablet. It contains the active ingredient:

•    Calcium (1250mg calcium carbonate: equivalent to 500mg calcium) Calcium is found in the diet.

Calcichew 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 Do not take Calcichew 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:

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 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:

•    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 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 should be taken at least three hours afterwards.

Taking Calcichew with food and drink

Calcichew 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 breast-feeding

Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding before taking Calcichew.

Driving and using machines

Calcichew has no known effect on your ability to drive or use machines.

Important information about some of the ingredients of Calcichew

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

Always take Calcichew 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 is given to patients on kidney dialysis, the dose will be different for each patient. Your doctor will decide how many Calcichew 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 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 heart beat.

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

Do not take any more Calcichew 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

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.

4.    POSSIBLE SIDE EFFECTS

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

Side effects with Calcichew 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

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’)

The National Osteoporosis Society (NOS) in the UK is national charity 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.

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.

If you are taking Calcichew 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, pharmacist or nurse. 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

Keep 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 take Calcichew after the expiry date which is stated on the label after ‘Exp'. The expiry date refers to the last day of the month.

If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

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. FUTHER INFORMATION What Calcichew contain

The active ingredients in each tablet are:

•    1250mg calcium carbonate (equivalent to 500mg 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 ‘Important information about some of the ingredients of Calcichew’).

This product is gluten and lactose free.

What Calcichew look like and contents of the pack

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

The tablets are packed in white, plastic bottles of 60 and 90 tablets. Manufactured by:

For Pack Size 60: NYCOMED PHARMA AS, Norway.

For Pack Size 90: Takeda Nycomed AS, Norway.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

CALCICHEW® 500mg CHEWABLE TABLETS; PL 18799/1967

Leaflet date: 08.10.2015    POM

Calcichew® is a registered trademark of Nycomed Pharma

Additional Information

Calcichew 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 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.