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Calcium 500

PACKAGE LEAFLET: INFORMATION FOR THE USER    D00187


Calcium 500

500mg film coated tablet


Calcium Carbonate


Read all of this leaflet carefully before you start taking this

medicine.

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

   If you have any further questions, ask your doctor or pharmacist.

   This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

   If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Calcium 500 is and what it is used for

2.    Before you take Calcium 500

3.    How to take Calcium 500

4.    Possible side effects

5.    How to store Calcium 500

6.    Further information

1.    What Calcium 500 is and what it is used for

The name of your medicine is Calcium 500. It contains prepared

chalk, a naturally occurring form of Calcium Carbonate.

Calcium 500 is used:

   As an additional source of calcium when people do not receive enough from their normal diet

•    To control levels of phosphates in the blood of patients undergoing dialysis

2.    Before you take Calcium 500

DO NOT take Calcium 500 if:

•    You are allergic (hypersensitive) to prepared chalk (Calcium Carbonate) or any of the ingredients of Calcium 500 (see section 6)

•    You have been told that your blood calcium level is raised (hypercalcaemia)

   You have been told that you have high levels of calcium in your urine (hypercalciuria)

   You have been told that you have hyperparathyroidism (a disorder of the parathyroid gland)

   You are taking digitalis based drugs, such as digoxin (used to treat certain heart conditions)

   You suffer from, or have a family history of kidney stones, or if you have any other kidney problems

   You suffer from Zollinger-Ellison Syndrome (a disease of the pancreas)

Calcium 500 is not recommended in children under 12 years of

age.


Take special care with Calcium 500 if:

   You have severe kidney failure

If any of the above applies to you or your child, please consult your doctor.

Taking other medicines

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

   Vitamin D

   Medicines to help you pass water such as thiazide diuretics

   Bisphosphonates (drugs used to treat an excess of calcium in the body tissues)*

   Fluoroquinolones and tetracyclines (types of antibiotics e.g. ciprofloxacin)*

   Fluoride*

* Calcium 500 may reduce the absorption of bisphosphonates, fluoroquinolones, tetracyclines and fluoride. A gap of 3 hours should occur between taking any of these drugs and Calcium 500.

Taking Calcium 500 with food and drink

You may eat and drink as normal whilst taking this medicine. However, if you are taking a high amount of bran in your diet this medicine may not be effective.

Pregnancy and breast-feeding

If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before taking this medicine.

Driving and using machines

This medicine does not affect your ability to drive a car or operate machinery.

Important information about some of the ingredients of Calcium 500

This medicine contains sucrose. If you have been advised by your doctor that you have intolerance to some sugars, contact your doctor before taking Calcium 500.

3. How to take Calcium 500

Always take Calcium 500 as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The label on the carton will tell you how many tablets you should take and when.

As a supplemental source of calcium

Adults, the elderly and children over 12 years of age

   1 tablet, 2 to 3 times a day

   Swallow the tablet whole with lots of water

   Take your tablets at the same time each day


Continued overleaf


As a phosphate binding agent

Adults, the elderly and children over 12 years of age

   Initially 1 tablet, 3 times a day

   Swallow the tablet whole with lots of water

   Take your tablets at the same time each day

   Your doctor will gradually adjust your dose until the level of phosphate in your blood is controlled. This will involve regular monitoring by your doctor

If you are on long term treatment your doctor may occasionally wish to check the level of calcium in your blood and take urine samples to monitor your kidney function.

If you take more Calcium 500 than you should

If you (or someone else) take more Calcium 500 than you should, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Always take the container with you, if possible, even if empty.

If you forget to take Calcium 500

Do not worry. Simply leave out the forgotten tablet completely and then take your next tablet at the right time. Do not take a double dose to make up for the missing dose.

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

4.    Possible side effects

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

Calcium 500 may cause constipation and if taken in large amounts may produce stomach ache, belching and "wind”.

In certain patients high doses taken for long periods or with calcium rich foods, such as dairy products, may produce an excess of calcium in the blood. This may cause:

   Headaches

   Feeling sick (nausea)

   Passing an abnormal amount of urine during the night (nocturia)

   Irritability

   Weakness

   Increase in the amount of acid your stomach produces (acid rebound)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.

5.    How to Store Calcium 500

Keep out of the reach and sight of children.

Store below 25°C.

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

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


6. Further Information

What Calcium 500 contains

Each tablet contains:

1.25g of the active ingredient prepared chalk BP (Calcium Carbonate) equivalent to 500mg of Calcium.

Other ingredients are:

Tablet core: Polyvinylpyrrolidone, Microcrystalline Cellulose, Magnesium Stearate, Sodium Starch Glycollate. Film coating: Erythrosine (E127), Titanium Dioxide (E171), Sugar, Sodium Benzoate (E211), Indigo Carmine (E132), Polyoxyethene (8) Stearate (E430), Hydroxy propyl methyl cellulose (E464), Purified Water.

What Calcium 500 Tablets look like and the contents of the pack

Calcium 500 is a pink film coated 'capsule' shaped tablet for oral administration. The tablets are supplied in packs of 100.

Marketing Authorisation Holder:

Martindale Pharmaceuticals Ltd Bampton Road,

Romford,

RM38UG United Kingdom

Manufacturer:

Dales Pharmaceuticals Ltd Skipton,

North Yorkshire,

BD23 2RW United Kingdom

Product licence numbers: PL 0156/0086 Calcium 500

Leaflet approved: 15/09/2008


MARTIN DALE

Pharmaceuticals


Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom