POTASSIUM CHLORIDE 0.2% AND GLUCOSE 5% IV INFUSION BP AS STERIFLEX NO. 29 AND FREEFLEX - patient leaflet, side effects, dosage

1. WHAT POTASSIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS ARE AND WHAT THEY ARE USED FOR

Potassium Chloride helps to maintain the body’s store of essential potassium.

Glucose is a simple sugar, which provides a source of energy.

Potassium Chloride and Glucose Infusions are used to replace potassium in the body.

The names of these medicines are:

Potassium Chloride 0.15% and Glucose 5% intravenous infusion BP as Steriflex®

No. 13 or freeflex®

Potassium Chloride 0.2% and Glucose 5% intravenous infusion BP as Steriflex®

No. 29 or freeflex®

Potassium Chloride 0.3% and Glucose 5% intravenous infusion BP as Steriflex®

No. 16 or freeflex®

In this leaflet the three solutions are collectively referred to as Potassium Chloride and Glucose Infusion Solutions.

2. BEFORE YOU ARE GIVEN POTASSIUM CHLORIDE AND GLUCOSE INFUSION SOLUTIONS

You should not receive a Potassium Chloride and Glucose Infusion Solution if you have:

• a known allergy (hypersensitivity) to any of the ingredients of Potassium Chloride and Glucose Intravenous Infusion Solutions mentioned in Section 6 (for symptoms of an allergic reaction, please refer to Section 4).
• Addison's disease
• Adrenal insufficiency (where the adrenal glands do not produce enough hormones)
• Oliguria or anuria (decreased or no urine production)
• Hyperkalaemia (high potassium levels)
• Liver disorder

Your doctor will check for these.

Care should be taken when being administered with a Potassium Chloride and Glucose Infusion Solution:

Tell your doctor if you:

• suffer from acute illness, pain, post-operative stress, infections, burns, or diseases of the central nervous system
• have any type of liver disease.
• have been treated with a medicine increasing the effect of vasopressin (a hormone regulating the body's water retention) because this may increase the risk of hospital-acquired low sodium levels in the blood (hyponatraemia).
• have heart disease
• have kidney disease
• are dehydrated or have heat cramp
• have sickle cell disease (a condition affecting the red blood cells)

Before you receive a Potassium Chloride and Glucose infusion Solution, your doctor will give you a non-potassium containing solution to prevent kidney damage.

Your doctor will make sure that the intravenous infusion is carried out slowly. Your doctor or nurse will ensure the solution is clear and free from particles before use.

In addition to the information above your doctor may monitor your blood potassium levels and you may have your heart monitored by electrocardiogram (ECG) if you are being administered Potassium Chloride 0.2% and Glucose 5% Intravenous Infusion BP as Steriflex® No. 29 or freeflex®.

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.

Inform your doctor if you take or have recently taken any of the below medicines:

• Potassium sparing diuretics (water tablets that preserve potassium)
• Potassium containing intravenous solutions
• Medicines leading to an increased vasopressin effect e.g.:
• Medicines stimulating vasopressin release (e.g. Chlorpropamide, clofibrate, carbamazepine,vin­cristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetami­ne,ifosfamide,an­tipsychotics, narcotics)
• Medicines potentiating vasopressin action (e.g. non-steroidal anti-inflammatory drugs, Chlorpropamide, cyclophosphamide)
• Medicines acting as vasopressin, so called vasopressin analogues e.g.: Desmopressin, Oxytocin, vasopressin, terlipressin
• Other medicinal products increasing the risk of hyponatraemia including diuretics in general and antieplileptics e.g. oxacarbazepine
• Amikacin (an antibiotic)
• Amphotericin (an antifungal treatment)
• Benzyl-penicillin (an antibiotic)
• Dobutamine (for heart disease)

In addition to the previous medicines Potassium Chloride 0.3% and Glucose 5% Intravenous Infusion VP as Steriflex No.16 or freeflex should not be used with following medicines:

• Digitalis (for heart disease)
• ACE-inhibitors (for high blood pressure or heart disease)
• Cyclosporine (a drug used after organ transplant)

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, if you think you are pregnant or you are planning to become pregnant or if you are breastfeeding. Your doctor will decide whether you should receive a Potassium Chloride and Glucose Infusion Solution. This medicine should be given with special caution for pregnant women during labour particularly if combined with oxytocin (a hormone which may be given to induce labour and to control bleeding) due to the risk of hyponatraemia.

Driving and using machines

Potassium Chloride and Glucose Infusion Solutions, may result in lack of energy, confusion, weakness, hypotension and sometimes cardiac arrest. These side effects will effect your ability to drive and use machinery. Ask your doctor when it would be safe to drive or operate machines.

3. HOW YOU ARE GIVEN POTASSIUM CHLORIDE AND

Potassium Chloride and Glucose Infusion Solutions will be given to you in hospital by healthcare professionals.

You will receive your medicine by infusion (IV drip).

Dosage

The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive. Elderly

A reduced volume and rate of infusion may be necessary, particularly if you suffer from heart and/or kidney damage.

If you receive more of a Potassium Chloride and Glucose infusion Solution than you should

It is very unlikely that you will receive more infusion than you should. If you suspect an overdosage with a Potassium Chloride and Glucose Infusion Solution you should look for the symptoms/side effects described below in this leaflet. You should immediately inform your doctor describing the symptoms.

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

Posology

General advice

Fluid balance, glucose and salts along with other electrolytes found within your blood may need to be monitored before and during administration, especially if you are at risk of high blood pressure or kidney problems. Monitoring of your salt levels is important for this type of infusion solution (hypotonic fluid), as it may become very hypotonic after administration due to glucose utilisation in the body.

4. possible side effects

Like all medicines Potassium Chloride and Glucose Infusion Solutions can cause side effects, although not everybody gets them.

Potassium Chloride and Glucose Infusion Solutions may cause severe allergic reactions. If you get any of the following symptoms after receiving this medicine you should contact your doctor immediately:

• – a rash appears on your body

• – you have a swollen face, tongue and throat

• – you have diffi culty breathing

• – you start wheezing or coughing

• – your heartbeat increases

• – you experience weakness, numbness or tingling

• – you develop severe nausea and vomiting

• – you have severe diarrhoea.

The following side effects have also been reported:

• listlessness (having no energy)
• confusion
• ‘pins and needles’
• weakness
• high blood pressure
• irregular heart beats and very rarely heart attack
• thrombosis (the formation of a clot) may occur in the vein where the infusion is given
• headache, nausea, seizures, lethargy. This can be caused by a low level of sodium in the blood. When sodium levels in the blood become very low, water enters the brain cells and causes them to swell. This results in increased pressure in the skull and causes hyponatraemic encephalopathy.

The symptoms of thrombosis include:

• – pain, swelling and redness at the blood clot site

• – an itchy rash at the clot site

• – warm skin around the clot

• – a mild fever

• – major veins that stand out from your skin.

It is unlikely that you will receive more of a Potassium Chloride and Glucose Infusion Solution than you should. In the case of an overdose you may experience:

• – a heavy feeling in your arms or legs

• – confusion

• – weak or shallow breathing

• – slow heartbeat

• – seizure (convulsions)

• – the feeling like you might pass out

As a Potassium Chloride and Glucose Infusion Solution will be given to you in hospital by healthcare professionals you will be monitored closely.

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

Reporting of side effects

If you get any side effects, talk to your doctor or 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 card or search for MHRA Yellow card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store potassium chloride and glucose infusion solutions

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

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Potassium Chloride and Glucose Infusion Solutions.

Potassium Chloride and Glucose Infusion Solutions should be stored between 2°C and 25°C.

The solutions must not be used after the expiry date shown on the label.

The expiry date refers to the last day of that month.

Any solution remaining after treatment should be disposed of using the approved hospital procedures.

6. FURTHER INFORMATION

What Potassium Chloride and Glucose Infusion Solutions contain:

The infusions contain potassium chloride, sodium chloride, glucose, water for injections, and traces of hydrochloric acid and sodium hydroxide.

The three strengths are:

• Potassium Chloride 0.15% and Glucose 5% Intravenous infusion BP as Steriflex® No. 13 or freeflex®
• Potassium Chloride 0.2% and Glucose 5% Intravenous infusion BP as Steriflex® No. 29 or freeflex®
• Potassium Chloride 0.3% and Glucose 5% Intravenous infusion BP as Steriflex® No. 16 or freeflex®

What Potassium Chloride and Glucose Infusion Solutions look like and contents of the pack.

Potassium Chloride and Glucose Infusion Solutions are clear solutions of potassium chloride and glucose in water. The solutions are contained in a sealed plastic container known as a Steriflex® bag or freeflex® bag.

Solutions are available in 500 ml and 1000 ml bags.

Not all sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT. UK.

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in August 2018

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