iMedi.co.uk

Calcium Carbonate 1250mg Chewable Tablets

S678 LEAFLET Calcichew 20140122

PACKAGE LEAFLET: INFORMATION FOR THE USER CALCICHEW 500mg TABLETS (calcium carbonate)

Your medicine is known as Calcichew 500mg Tablets but will be referred to as Calcichew throughout the following leaflet.

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 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.

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 USED FOR

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

• 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.

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.

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

•    Fluoride, or biphosphates; 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 breast-feeding 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 pheylketonuria (a deficiency in the enzyme which breaks down phenylalanine).

3. HOW TO TAKE CALCICHEW


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.

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

-    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 level in the blood or develop signs of kidney problems, the dose of Calcichew should be reduced or the treatment discontinued.

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 500mg 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 Calcichew than you should

If you accidently 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 heartbeat. 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 1000 people):

•    nausea

•    stomach ache

•    constipation

•    diarrhoea

•    wind (flatulence)

•    rash

•    hives

•    itching

Very rare side-effects (affecting less than 1 in 10000 people):

•    milk akali syndrome - (usually only seen in overdose see “if you take more Calcichew than you should”)

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

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

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.

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

•    Do not use after the expiry date printed on the carton label or bottle.

•    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.

•    If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Calcichew contains

•    Each tablet contains 1250mg of the active ingredient, calcium carbonate, equivalent to 500mg of calcium.

•    The other ingredients are: sorbitol, povidone, orange oil, magnesium stearate, isomalt, aspartame and mono- and di-fatty acid glycerides.

What Calcichew looks like and contents of the pack

Calcichew is round, white, chewable tablet with yellow specks.

Calcichew is available in bottles of 60 and 90 tablets. Calcichew may also be marketed in boxes containing 2 bottles of 60 tablets in a single box.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Takeda Nycomed AS, Drammensveien 852, P. O. Box 205, 1372 Asker, Norway.

[P] PL No: 19488/0678 Leaflet revision date: 22 January 2014

Calcichew is a registered trade mark of Shire Pharmaceuticals Ltd, UK.

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 has 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, 33 Pearse Street, Dublin 2.

Tel/Fax: 01 677 4267 email: info@irishosteoporosis.ie

S678 LEAFLET Calcichew 20140122


S678 LEAFLET Calcium Carbonate 20140122

PACKAGE LEAFLET: INFORMATION FOR THE USER CALCIUM CARBONATE 1250mg CHEWABLE TABLETS

Your medicine is known as Calcium Carbonate 1250mg Chewable Tablets but will be referred to as Calcium Tablets throughout the following leaflet.

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 Calcium 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.

In this leaflet:

1.    What Calcium Tablets are and what they are used for

2.    Before you take Calcium Tablets

3.    How to take Calcium Tablets

4.    Possible side-effects

5.    How to store Calcium Tablets

6.    Further information

1. WHAT CALCIUM TABLETS ARE AND WHAT THEY ARE USED FOR

Calcium Tablets are orange flavoured chewable tablets. It contains the active ingredients:

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

Calcium is found in the diet.

Calcium Tablets 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 CALCIUM TABLETS

Do not take Calcium 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.

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

-    cancer which has affected your bones

•    have kidney stones.

Take special care with Calcium Tablets:

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 Calcium Tablets

•    you are already taking additional doses of calcium

If you have increased calcium level in the blood or develop signs of kidney problems, the dose of Calcium Tablets 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 Calcium 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 Calcium Tablets may need to be increased

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

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

•    Fluoride, or biphosphates; Calcium Tablets should be taken at least three hours afterwards.

Taking Calcium Tablets with food and drink

Calcium Tablets 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 breast-feeding before taking Calcium Tablets.

Driving and using machines

Calcium Tablets have no known effect on your ability to drive or use machines.

Important information about some of the ingredients of Calcium Tablets

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 pheylketonuria (a deficiency in the enzyme which breaks down phenylalanine).

3. HOW TO TAKE CALCIUM TABLETS

Always take Calcium Tablets 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 Calcium Tablets are given to patients on kidney dialysis, the dose will be different for each patient. Your doctor will decide how many Calcium 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 Calcium Tablets than you should

If you accidently take more Calcium Tablets 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, lightheadedness, muscle spasms, twitches and tingling sensation.

Do not take any more Calcium Tablets 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 Calcium 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.

4. POSSIBLE SIDE EFFECTS

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

Side effects with Calcium Tablets 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 1000 people):

•    nausea

•    stomach ache

•    constipation

•    diarrhoea

•    wind (flatulence)

•    rash

•    hives

•    itching

Very rare side-effects (affecting less than 1 in 10000 people):

•    milk akali syndrome - (usually only seen in overdose see “if you take more Calcium Tablets than you should”)

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

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

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 CALCIUM TABLETS

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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

•    Do not use after the expiry date printed on the carton label or bottle.

•    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.

•    If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Calcium Tablets contain

•    Each tablet contains 1250mg of the active ingredient, calcium carbonate, equivalent to 500mg of calcium.

•    The other ingredients are: sorbitol, povidone, orange oil, magnesium stearate, isomalt, aspartame and mono- and di-fatty acid glycerides.

What Calcium Tablets look like and contents of the pack

Calcium Tablets are round, white, chewable tablet with yellow specks.

Calcium Tablets are available in bottles of 60 and 90 tablets.

Calcium Tablets may also be marketed in boxes containing 2 bottles of 60 tablets in a single box.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Takeda Nycomed AS, Drammensveien 852, P. O. Box 205, 1372 Asker, Norway.

[P] PL No: 19488/0678

Leaflet revision date: 22 January 2014 Additional information

Calcium Tablets contain 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.

Calcium Tablets 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, 33 Pearse Street, Dublin 2.

Tel/Fax: 01 677 4267 email: info@irishosteoporosis.ie

S678 LEAFLET Calcium Carbonate 20140122