Potassium Chloride 15 % Solution

Potassium naturally occurs in the body fluids. Potassium chloride is used as an electrolyte replacement.

POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS is a prescription medicine for the treatment of potassium deficiency in patients for whom dietary measures or oral medicines are inadequate.

POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS should not be administered to you, if:

• you are hypersensitive (allergic) to potassium chloride of any of the other ingredients (listed in section 6) of this medicine;
• you have hyperkalaemia (too much potassium in your blood).

Warnings and precautions

Tell your doctor or healthcare provider before being given the infusion:

• you have kidney problems (you produce little or no urine);
• if you have heart disease, if you are under treatment with digitalis (medicines used for the treatment of diseases of the heart), and if you have severe or complete heart block;
• if you have low urinary output after surgery (post-operative oliguria) or renal insufficiency (you may form less urine than usual), as the potassium in your blood may become too high (hyperkalaemia) with normal doses of POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS;
• if you have conditions which may cause an excess of potassium in the blood (hyperkalaemia): Gamstorp episodic adynamy (muscle hyperexcitability or weakness), sickle cell anaemia, impaired function of the adrenal glands (adrenal insufficiency), shock with disintegration of red blood cells and/or deficiency of body fluid (shock with haemolytic (rupturing of red blood cells) reactions and/or dehydration (water loss)), metabolic acidosis (form of acidic blood), excess of chloride in the blood (hyperchloraemia);
• if you take potassium-sparing diuretics (medicines used to increase urine excretion that retain potassium in the blood) or use a salt substitute that increases the amount of potassium in your blood (see Other medicines and POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS);
• if you have had a recent severe injury damaging a large area of your skin, such as a burn.

POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS will be given by or under the direct supervision of your doctor, who will take care of the following:

• Direct injection of potassium chloride concentrates without appropriate dilution may cause instant death.
• The administration should be slow and under control of cardiac activity.
• Since adequate urine flow must be ensured, your urine flow should be monitored.
• Your serum electrolyte levels, and acid-base status should be monitored, and the dose should be adjusted to your individual needs.
• Your doctor should closely monitor you if you have diseases of the heart, acute fluid loss (acute dehydration), heat cramps, and if you are elderly since your kidneys may not work as well or you may have other conditions that may lead to excess of potassium in the blood (hyperkalaemia).
• If signs of renal failure occur, intravenous administration of potassium-containing solutions should be stopped.
• Tell your doctor if you notice leakage of infusion fluid into the tissues (extravasation) at the administration site, as it can cause tissue death (necrotic tissue damages).

Children

The safety and efficacy of potassium chloride for paediatric patients has not been fully established.

Other medicines and POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)

The following medicines increases the amount of potassium in the blood if taken together with POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS:

• Certain diuretics (“water tablets”) like amiloride, spironolactone and triamterene, (potassium saving medicines). See If you receive more POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS than you should.
• Certain medicines for high blood pressure: ACE’s (angiotensin-converting-enzyme) inhibitors (such as captopril) and ARB’s (angiotensin receptor blockers, such as valsartan). If taken together with POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS, these medicines may cause fatal excess of potassium in the blood, particularly if you have renal impairment (weak kidneys).
• Potassium penicillin (an antibiotic).
• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen, for arthritis and pain.
• Ciclosporin, tacrolimus (used to suppress the immune system following transplants).
• Suxamethonium (used to cause short-term paralysis as part of general anaesthesia during an operation).

POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS effects the following medicines:

• Quinidine (used for abnormal heart rhythm): POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS can increase the antidysrhythmic effects of quinidine.
• Thiazides, adrenocorticoids, glucocorticoids, mineralocorticoids. Effects of POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS may be decreased.

You will not be expected to give yourself POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS. It will be given to you by a person who is qualified to do so.

Your doctor will calculate what dose you should receive; this will depend on your serum electrolyte levels, acid-base state and your body weight. The POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS solution will be first diluted and then slowly dripped into a vein. The process may take one or more hours or more, depending on the dose your doctor chose for you.

If you have renal impairment your doctor will prescribe a lower dose.

Your doctor will tell you how long your treatment with POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS will last.

If you have the impression that the effect of POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS is too strong or too weak, tell your doctor of pharmacist.

If you receive more POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS than you should

Since a healthcare provider will administer POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Some of the signs of overdosage are irregular heartbeats or heart attack, confusion, muscle paralysis (loss of movement), diarrhoea, difficulties swallowing, tingling sensation in hands and feet, faintness or death. Please tell your doctor or healthcare provider if you have any concerns.

If a dose of POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS is missed

Since a healthcare provider will administer POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS, it is unlikely that the dose will be missed.

POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS can have side effects.

Not all side effects reported for POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS are included in this leaflet. Should your general health worsen of if you experience any untoward effects while receiving POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS, please consult your healthcare provider for advice.

Tell your doctor immediately if notice any of the following side effects:

• Faintness, irregular or slowed heartbeat, palpitations (feeling your heart), confusion, weak muscles or loss of movement, an odd sensation, typically tingling or pricking (‘pins and needles’). These signs may be caused by hyperkalaemia (too much potassium in your blood).
• Pain and redness due to inflammation of the vein or death of tissue at the site of injection. Your doctor may stop giving you POTASSIUM CHLORIDE 15 % FLEXIVIAL FRESENIUS and you will be given urgent medical attention.

Tell your doctor if you notice any of the following:

Frequency unknown:

• Acidosis (when acid builds up or when bicarbonate (a base) is lost). Some signs are quick heartbeat, confusion, dizziness, headache.
• Hyperchloraemia (an excess of chloride in the blood). Some signs are fatigue, sluggish body, weak muscles, thirst, high blood pressure.
• Venous thrombosis (when a blood clot forms in a vein). Some signs are swelling of the leg, pain or tenderness in the leg, unexplained shortness of breath.
• Nausea (feeling sick).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children.

Store at or below 25 °C.

The product should be used immediately after opening the ampoule.

Do not use after the expiry date indicated on the label.

Do not dispose of unused medicine in drains or sewerage systems (such as toilets). Return all unused medicine to your pharmacist.