Sterile Potassium Chloride Concentrate Bp 10%W/V
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Sterile Potassium Chloride
10%, 15% and 20% w/v Concentrate for Solution for Infusion
Potassium
Chloride
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• If you experience any side effects, talk to your doctoi this leaflet.
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What is in this leaflet
1. What Sterile Potassium Chloride Concentrate is, and what it is used for
2. What you need to know before you are given Sterile Potassium Chloride Concentrate
3. How Sterile Potassium Chloride Concentrate is given
4. Possible side effects
5. How to store Sterile Potassium Chloride Concentrate
5. Contents of the pack and other information
1. What Sterile Potassium Chloride Concentrate is, and what it is used for
Potassium Chloride belongs to a group of medicines called electrolytes. Electrolytes are needed by the body to carry out all of its normal functions.
Sterile Potassium Chloride Concentrate, when diluted, is used to put electrolytes back into your body if you have lost them through too much sweating or prolonged diarrhoea and sickness (dehydration).
2. What you need to know before you are given Sterile Potassium Chloride Concentrate
Do not have Sterile Potassium Chloride Concentrate if you:
• are allergic (hypersensitive) to potassium chloride or any of the other ingredients of this medicine (listed in section 5 of this leaflet)
• have severe kidney problems
• have too much potassium in your blood (hyperkalaemia)
• have too much chloride in your blood (hyperchloraemia)
If you are unsure about being given this medicine or you have any questions, talk to your doctor or nurse.
Warnings and precautions
Talk to your doctor or nurse before having Sterile Potassium Chloride Concentrate if you:
• have liver or kidney problems
• have a history of stomach ulcers
• have heart disease
• are severely dehydrated
• have difficulty opening your bowels, or your doctor has told you that you have narrowing of the intestines (intestinal strictures)
• are suffering from muscle pains caused by exercising or overheating (heat cramps)
• have suffered severe burns
Other medicines and Sterile Potassium Chloride Concentrate
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Medicines that may interact with Sterile Potassium Chloride Concentrate include:
• medicines containing potassium
• medicines that make you pass more urine, but stop you passing potassium in your urine (potassium sparing diuretics)
• products used for blood transfusions (these may make the amount of potassium in your blood too high)
• medicines used to treat an irregular heartbeat such as quinidine and digitalis
• medicines used to treat high blood pressure such as ACE inhibitors, thiazide diuretics, angiotensin-II receptor antagonists, beta-blockers
• ciclosporin (given to suppress the immune system following organ transplants, and in severe skin, rheumatic and bowel disorders)
• tacrolimus (used to reduce the inflammation in certain skin conditions and can be given after organ transplant to prevent rejection of the organ)
• glucose infusions (used in patients who have low levels of sugar in their blood)
• medicines used to treat redness and swelling (non-steroidal anti-inflammatory drugs or NSAIDs)
• certain steroids such as betamethasone, dexamethasone, prednisolone, hydrocortisone and aldosterone
If you have any doubts about whether this medicine should be administered to you, speak to your doctor or nurse.
Pregnancy and breast-feeding Please tell your doctor or nurse before being given this injection if you are pregnant or breast-feeding. The doctor will then decide if the injection is suitable for you.
Driving and using machines
There are no known effects of Sterile Potassium
Chloride Concentrate on driving or using
machines.
Continued overleaf
3.How Sterile Potassium Chloride Concentrate is given
Your doctor will decide the correct dosage, and how and when the injection will be given to you.
The doctor or nurse will give you Sterile Potassium Chloride Concentrate into a vein by slow infusion (drip) once it has been diluted. Adults (including the elderly)
The usual dose is a maximum of 6g daily, after dilution.
Children
The usual dose is a maximum of 3 mmol per kilogram body weight daily, after dilution If you think you have been given too much Sterile Potassium Chloride Concentrate As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much; however, tell your doctor or nurse if you have any concerns. The likely signs of an overdose are the occurrence of possible side effects as listed below.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects include:
• feeling or being sick
• a fast, slow or irregular heartbeat
• pain or blood clots at the site of injection
• stomach pains
• muscle weakness or loss of movement
• hyperkalaemia (too much potassium in the blood, which would be identified by a blood test)
• hypotension (low blood pressure causing dizziness on standing)
If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
5. How to store Sterile Potassium Chloride Concentrate
• Your doctor or pharmacist is responsible for storing Sterile Potassium Chloride Concentrate in a safe place where children cannot see or reach it. They are also responsible for disposing of any unused solutions correctly
• You should not be given Sterile Potassium Chloride Concentrate after the expiry date (EXP) which is stated on the ampoule label and carton. The expiry date refers to the last day of that month. Your doctor or nurse will check that the date has not passed before giving the injection to you
• This medicine will be stored below 25oC in the original container. Only clear solutions free of particles should be used
• For single use only. Discard any unused solution
6. Contents of the pack and other information
What Sterile Potassium Chloride Concentrate contains
• The active substance is potassium chloride.
- Sterile Potassium Chloride Concentrate 10%: each 1ml (millilitre) of solution contains 0.1g of potassium chloride in a sterile solution for injection
- Sterile Potassium Chloride Concentrate 15%: each 1ml (millilitre) of solution contains 0.15g of potassium chloride in a sterile solution for injection
- Sterile Potassium Chloride Concentrate 20%: each 1ml (millilitre) of solution contains 0.2g of potassium chloride in a sterile solution for injection
• The other ingredients are dilute hydrochloric acid, potassium hydroxide and water for injections.
What Sterile Potassium Chloride Concentrate looks like and contents of the pack
Sterile Potassium Chloride Concentrate is a clear, colourless solution supplied in clear glass ampoules. Each carton contains 10 ampoules.
- Sterile Potassium Chloride Concentrate 10% is available in ampoules containing 5ml, 10ml or 50ml of solution
- Sterile Potassium Chloride Concentrate 15% is available in ampoules containing 10ml or 20ml of solution
- Sterile Potassium Chloride Concentrate 20% is available in ampoules containing 5ml or 10ml of solution
Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.
Product licence numbers:
PL 01883/5154R PL 01883/5185R PL 01883/5185R
This leaflet was last revised in August 2013
Martindale AJa Pharmaceuticals fV®
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom
D02457 DC
D02457-G
100mm Measurement Verification Bar