POTASSIUM CHLORIDE 15% W/V CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

MercuryPharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Potassium Chloride 15% w/v Concentrate for Solution for

Infusion

Potassium Chloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

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

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Sterile Potassium Chloride 15% w/v Concentrate for Solution for Infusion but will be referred to as ‘Potassium Chloride Concentrate’ throughout the remainder of this leaflet.

What is in this leaflet:

• 1. What Potassium Chloride Concentrate is and what it is used for

• 2. What you need to know before you are given Potassium Chloride concentrate

• 3. How you are given Potassium Chloride concentrate

• 4. Possible side effects

• 5. How to store Potassium Chloride concentrate

• 6. Contents of the pack and other information

1. WHAT POTASSIUM CHLORIDE CONCENTRATE IS AND WHAT IT IS USED FOR

Potassium Chloride Concentrate belongs to a group of medicines called electrolyte replacement solutions. Electrolytes are a group of chemicals and salts that are in the body fluids.

Potassium Chloride Concentrate is used in patients needing additional amounts of potassium.

Warnings and precautions

Talk to your doctor or nurse before you are given Potassium Chloride Concentrate if you:

• have heart disease.
• have had a recent severe injury involving a large area of skin such as a burn.

Make sure your doctor is aware of these situations if it is not already obvious.

Other medicines and Potassium Chloride Concentrate Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. This includes medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

• Diuretics (“water tablets”) like amiloride, spironolactone and triamterene.
• Other medicines containing potassium.
• ACE inhibitors, and angiotensin II antagonists, aliskerin (used to treat high blood pressure).
• Ciclosporin,Ta­crolimus (used to supress the immune system following transplants).
• Glucose Infusion (used in patients who have low levels of sugar in their blood or are dehydrated).

Pregnancy and breast feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not have Potassium Chloride Concentrate if you are pregnant (or think you may be), or breast feeding unless your doctor has decided that it is in your best interests.

2. what you need to know before you are given potassium chloride concentrate

You should not be given Potassium Chloride Concentrate if:

• if you are allergic to Potassium chloride or any of the other ingredients of this medicine (listed in section 6).
• you have hyperkalaemia (high levels of potassium in your blood – your doctor will advise you).
• you suffer from impaired kidney function (you may produce little or no urine).
• you suffer from Addison’s disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin).
• you are very dehydrated.
• you suffer from heat cramps.

• you suffer from Hyperchloraemia (electrolyte disturbance in which there is an abnormally elevated level of the chloride ion in the blood).

Make sure your doctor knows if you suffer from the above.

Driving and using machines

Potassium chloride Concentrate should not interfere with your ability to drive or use machines but consult your doctor first.

• 3. HOW YOU ARE GIVEN POTASSIUM CHLORIDE CONCENTRATE

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Potassium Chloride Concentrate is diluted and then slowly dripped through a needle into a vein. The process may take an hour or more depending on your dose. Your doctor will decide the best dose for you. While this medicine is being injected, your ECG (electrocardiogram, measuring the heart) should be monitored continuously.

If you are given more Potassium Chloride Concentrate than you should

As Potassium Chloride Concentrate is administered by a healthcare professional it is unlikely that you will be given too much. If you think you have been given too much medicine, tell your doctor. The likely signs of an overdose are the occurrence of side-effects as listed below.

In this event, you will be treated in the hospital and you will be given the necessary treatment.

If you miss a dose of Potassium Chloride Concentrate This is unlikely as the injection is given by a healthcare professional but if you are concerned about missing a dose speak to your doctor.

• Hypotension (low blood pressure causing dizziness on standing).
• Pain at the site of injection.
• Inflammation of the vein into which the solution is injected.

5. how to store potassium chloride concentrate

These instructions apply mainly to the healthcare professional administering the injection.

Keep this medicine out of the sight and reach of children.

This medicine should be stored out of the light at a maximum temperature of 25°C. Do not use after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month. Do not use if the ampoule is damaged or if the solution is cloudy or has solids in it. If only part of the ampoule is used, throw away the rest of the solution

6. contents of the pack and other information

The active substance is potassium chloride.

The other ingredient is Water for Injections.

Potassium Chloride must be diluted before use to not less than fifty times its volume of sodium chloride injection or other suitable liquids for dilution.

What Potassium Chloride Concentrate looks like and contents of pack

Potassium Chloride Concentrate is a clear, colourless, sterile aqueous solution for injection. Each 10ml glass ampoule contains 15%w/v (1.5g) of active ingredient, potassium chloride. Potassium Chloride Concentrate is supplied in pack of 10 ampoules.

Marketing Authorisation Holder

Mercury Pharmaceuticals Limited

Capital House, 85 King William Street,

London EC4N 7BL, UK

Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

This leaflet was last revised in April 2020.

LF-120043–01

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