PACKAGE LEAFLET: INFORMATION FOR THE USER    D01902

Calcium Chloride Injection BP 10mmol in 10ml

Calcium Chloride

Read all of this leaflet carefully before you use Calcium

Chloride Injection.

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

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

•    If any of the side effects become 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 Chloride Injection is and what it is used for

2.    Before Calcium Chloride Injection is given

3.    How Calcium Chloride Injection will be given

4.    Possible side effects

5.    How to store Calcium Chloride Injection

6.    Further information

1.    What Calcium Chloride Injection is and what it is used for

Calcium Chloride is a source of calcium, a chemical essential to many of the biological processes within the body.

Calcium Chloride Injection is used:

•    To correct an imbalance in the level of calcium in the body.

2.    Before Calcium Chloride Injection is given

DO NOT use Calcium Chloride Injection if:

•    you are allergic (hypersensitive) to calcium salts or any of the ingredients of Calcium Chloride Injection (see section 6)

•    you have severe difficulty breathing

•    you suffer from long standing kidney problems or kidney stones

•    you are aware that you have an excess of calcium in your blood or urine or are being treated for magnesium deficiency

Take special care with Calcium Chloride Injection if:

•    you suffer from heart disease

•    you suffer from an inflammatory disorder known as sarcoidosis

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

Taking other medicines

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

Medicines that may interact with Calcium Chloride Injection include:

•    medicines used to treat for problems in passing urine (thiazide diuretics)

•    medicines containing magnesium

•    medicines containing potassium

•    medicines used to treat heart problems e.g. digitalis

•    medicines used to treat bacterial infections (antibiotics) e.g. tetracyclines

This product must not be mixed with any other product containing any carbonates, bicarbonates, phosphates, sulphates or tartrates.

Pregnancy and breast-feeding

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

Driving and using machines

Calcium Chloride may make you dizzy or drowsy. If you feel dizzy or drowsy you should not drive or operate machinery.

3. How Calcium Chloride Injection will be given

Your doctor will dilute Calcium Chloride Injection with sodium chloride intravenous infusion (0.9% w/v). They will then inject or infuse (drip) the product slowly into a vein. Use by any other route will cause severe irritation and tissue damage at the injection site.

Adults (including the elderly)

•    An initial injection or infusion (drip) of up to 10 millimoles (at a rate not exceeding 1 millimole per minute) may be given. This may be continued by infusion of up to 10 millimoles per day.

Children

2 to 12 years of age:

•    0.5 millimoles to 3.5 millimoles by intravenous infusion after dilution with at least 4 times its volume of sodium chloride intravenous infusion BP (0.9% w/v)

•    the dose may be repeated every one to three days

Under 2 years of age:

•    less than 0.5 millimoles by intravenous infusion after dilution with at least 4 times its volume of sodium chloride intravenous infusion BP (0.9% w/v)

•    the dose may be repeated every one to three days

The precise amount that you are given depends on how much your doctor believes you need. In the case of children a doctor qualified in the diseases of children should decide how much is given.

If you are given more Calcium Chloride Injection than you should

If you are at all concerned that you have been given too much of this medicine please tell your doctor immediately.

Continued overleaf

4.    Possible side effects

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

Possible side effects include:

•    dizziness

•    drowsiness

•    hot flushes

•    irregular heartbeat

•    low blood pressure

•    feeling sick (nausea)

•    being sick (vomiting)

•    sweating

•    tingling sensations

•    stomach problems

•    irritation in the injected vein

Rare side effects include:

•    severe constipation

•    continuous headaches

•    loss of appetite

•    a metallic taste in the mouth

•    dry mouth and thirst

•    tiredness

•    muscle weakness

•    confusion

•    high blood pressure

•    increased light sensitivity

•    muscle or bone pain

•    increase in the amount of urine passed

•    excitement

•    delirium

•    enlarged (dilated) pupils

•    rapid pulse

•    hot flushes and reddened skin

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

5.    How to store Calcium Chloride Injection

Keep out of the reach and sight of children.

The medicine will have been stored protected from light.

The product has an expiry date on the ampoule label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date. Any product that has passed this date must be returned to a pharmacist or doctor for safe disposal.

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 protect the environment.

6.    Further Information

What Calcium Chloride Injection contains.

The active ingredient is Calcium Chloride, Dihydrate BP 14.7 % w/v The other ingredient is Water for Injections. The pH may be adjusted with hydrochloric acid.

What Calcium Chloride Injection looks like and the contents of the pack.

The injection is supplied in colourless glass ampoules containing 5 or 10 ml of product. The ampoules are supplied to your doctor or pharmacist in packs of 10 ampoules.

Marketing Authorisation Holder:

Martindale Pharmaceuticals Ltd Bampton Road,

Harold Hill Romford Essex RM3 8UG United Kingdom

Manufacturer:

Martindale Pharmaceuticals Ltd Bampton Road,

Harold Hill Romford Essex RM3 8UG United Kingdom

Product licence numbers: PL 01883/6174R Calcium Chloride Injection BP 10 mmol in 10 ml Date of last revision: September 2011

MARTJNDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D01902

Paper size: 170 x 180mm

MARTjNDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK

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Grand Fromage Creative Ltd

60 Churchill Square, Kings Hill West Malling, Kent ME19 4YU t:+44 (0)1732 54 34 94 f:+44 (0)1732 54 34 04 e:studio@grand-fromage.co.uk

100mm Measurement Verification Bar