Prospecto: Information for the User

Potassium ChlorideSerraclinics2 mEq/ml, Concentrate for Infusion Solution

Potassium Chloride

Read this prospectus carefully before starting to use this medication, as it contains important information for you

·Keep this prospectus, as you may need to read it again.

·If you are the parent of a child who will be administered this medication, read the prospectus replacing “you” with “your child” throughout the prospectus.

·If you have any doubts, consult your doctor or pharmacist.

·This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.

·If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this prospectus. See section 4.

The name of this medication is Potassium ChlorideSerraclinics2 mEq/ml, Concentrate for Infusion Solution

From now on, Potassium Chloride Serraclinics 2 mEq/ml, Concentrate for Infusion Solution will be referred to as Potassium ChlorideSerraclinics.

1.What is Potassium ChlorideSerraclinicsand for what it is used

2.What you need to know before starting to use Potassium ChlorideSerraclinics

3.How to use Potassium ChlorideSerraclinics

4.Possible adverse effects

5.Storage of Potassium ChlorideSerraclinics

6.Contents of the package and additional information

Potassium chloride is a type of medication called an electrolyte. Electrolytes help maintain the correct balance of water levels in the different parts of your body.

Potassium chloride acts by replacing a substance called potassium that your body has lost.

Your body needs the correct amount of potassium. Potassium contributes to the proper functioning of your muscles, heart, and other organs. Potassium also helps to balance the levels of water that affect many electrical and chemical processes in your body. Without the appropriate amount of potassium, your heart may start to beat abnormally, which could put your life at risk.

If you cannot take potassium orally, your doctor or nurse will administer this medication as an infusion (perfusion).

The doctor or nurse who will administer this medication to you will ask you some questions. They need the following information before giving you this medication for the first time.

Do not use Potassium ChlorideSerraclinics

·If you have hyperkalemia (elevated potassium levels in your blood).

Do not use Potassium ChlorideSerraclinicsif the above condition applies.

Warnings and precautions

Before starting treatment, inform your doctor or nurse if:

·You have kidney or adrenal gland problems.

·You have heart problems.

·You have been told you are severely dehydrated (do not have enough water in your body)

·You have heat cramps

·You have extensive skin damage (for example, severe burns)

·You are elderly (over 65 years old)

·You have difficulty urinating

·You are being treated with an infusion (perfusion) that contains the sugar called glucose.

Use of Potassium ChlorideSerraclinicswith other medications

Inform your doctor about any medicationyou are takingorhave taken recently.Also, remember any medicationyou are taking that does not require a prescription.

It is very important to inform your doctor if you are taking any of the following medications:

·ACE inhibitors such as lisinopril, captopril, enalapril (may cause potassium levels in your blood to be too high)

·Angiotensin II receptor antagonists such as losartan, valsartan, candesartan (may cause potassium levels in your blood to be too high)

·Blood transfusion (may cause potassium levels in your blood to be too high)

·Ciclosporin (may cause potassium levels in your blood to be too high)

·Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone (may cause potassium chloride not to work correctly)

·Digoxin (may increase adverse effects)

·Potassium-sparing diuretics such as spironolactone (may cause potassium levels in your blood to be too high)

·Quinidine (may cause your heart to beat abnormally)

·Tacrolimus (may cause potassium levels in your blood to be too high)

Potassium ChlorideSerraclinicscontains potassium

Inform your doctor if you are using in your diet potassium-containing salt substitutes. You may receive too much potassium if you use this medication at the same time

Pregnancy and breastfeeding

·Inform your doctor if you are pregnant or think you may be pregnant.

·Inform your doctor if you are breastfeeding a child.

Your doctor will tell you if you should use or not this medication.

Potassium Chloride must be diluted before use at least 50 times its volume, with an appropriate diluent.

This medication will generally be administered to you by a doctor or a nurse.

Your doctor or nurse will give you the correct dose as an infusion into a vein (your doctor or nurse may call it IV perfusion or intravenous).

Your doctor will decide the amount (dose) of medication to administer to you and for how long you will need it.

Your doctor will also decide the concentration of the medication to give you. The medication is very concentrated, and it must be diluted by adding more liquid before administering it.

Your doctor will monitor your heart while you are receiving this medication.

Your doctor will also ask you to have some blood tests and check the amount of urine you produce. This is to check the amount of potassium in your blood while you are receiving this medication.

If you have very low levels of potassium in your blood, or if you have diabetic ketoacidosis (a complication of diabetes), it is possible that you will be given this medication at a faster rate than usual.

Adults and elderly

The usual dose is up to 80 mmol (millimoles) per day. The medication will be prepared with a concentration of 20-40 mmol/liter.

Use in children and adolescents

The usual dose is up to 3 mmol (millimoles) per kilogram of body weight and per day. The medication will be prepared with a concentration of 20 mmol/liter. For children weighing 25 kg or more, consult the adult dose.

If you use more Potassium Chloride Serraclinics than you should

This medication will generally be administered to you by a doctor or a nurse. If you think you may have received too much medication, please inform your doctor or nurse immediately.

Too much potassium in your blood can cause severe adverse effects that may put your life at risk.

Please read carefully the important warning at the beginning of the next section, Section 4, about the signs that would allow you to detect that you have too much potassium in your blood.

If you forgot to use Potassium Chloride Serraclinics

This medication will generally be administered to you by a doctor or a nurse. If you think they may have forgotten to administer a dose, please inform your doctor or nurse.

If you have any other questions about the use of this medication, ask your doctor or pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The expected benefit of the medicine will generally be greater than the risk of you experiencing a harmful side effect.

Important: Side effects or symptoms to be aware of, and what to do if you are affected. The first signs of high potassium levels in your blood are: irregular heartbeats, chest pain, possible heart attack, muscle weakness, paralysis, or difficulty breathing. If you experience any of these symptoms, seek urgent medical attention.

In some people, the following other side effects may occur:

Immune system problems:

·Fever.

Heart and circulation problems:

·Low blood pressure (you may feel dizzy)

Problems at the injection site:

·Pain, redness, irritation, and swelling at the injection site

Nervous system problems:

·Needles or pins and needles in the hands or feet

·Flaccid paralysis of the muscles

·Loss of reflexes

·Weakness, lack of energy

·Mental confusion

·Weakness and heaviness in the legs

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Use your medication only if it is a transparent and colorless liquid. Open and use it immediately. The product must be diluted and used immediately after opening. Any unused portion must be discarded.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacisthow to dispose ofthepackaging and of themedicines that you no longerneed.. This will help protect the environment.

Potassium Chloride Serraclinic Composition

-The active ingredient is potassium chloride.

-The other components are: water for injection preparations.

The medicine contains 15% w/v (150 mg per ml) of potassium chloride. Each ml (milliliter) of this medicine contains 2 mmol of potassium and 2 mmol of chloride.

Product Appearance and Packaging Content

Potassium Chloride Serraclinic is a concentrate for solution for infusion. This means it is a concentrated (strong) solution in a plastic container. It is a transparent and colorless liquid. The potassium chloride must be diluted before use at least with 50 times its volume of an appropriate diluent. More liquid must be added to the solution (diluted) to prepare a less concentrated solution that can be administered by infusion (infusion).

Each plastic ampoule contains 5 ml (milliliters), 10 ml, or 20 ml of the medicine. In a box, there are 20 ampoules. Some sizes of packaging may only be commercially available.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for Manufacturing

Demo S.A.

21st Km National Road Athens-Lamia

14568 Athens

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

AT: Kaliumchlorid Noridem 15% Concentrate for the Preparation of an Infusion Solution

BE: POTASSIUM CHLORIDE NORIDEM 15% (w/v) Solution to be Diluted for Infusion

DE: Kaliumchlorid Noridem 150mg/mL Concentrate for the Preparation of an Infusion Solution

DK: Kaliumchlorid “Noridem”, Concentrate for Infusion Fluid, Solution 2mmol/mL

EL: POTASSIUM CHLORIDE 15%/NORIDEM,?????d????µa??apa?as?e??d?a??µat??p???????s?150mg/mL

ES:Potassium Chloride SERRACLINIC 2 mEq/ml, Concentrate for Solution for Infusion

IE: Potassium Chloride 15% (w/v) Concentrate for Solution for Infusion

NL: Kaliumchloride Noridem 15% (w/v) Concentrate for Solution for Infusion

NO: Kaliumklorid 2mmol/mL Concentrate for Infusion Fluid "Noridem"

PT: Potassium Chloride Noridem 150 mg/ml Concentrate for Solution for Infusion

SE: Kaliumklorid Noridem 2mmol/mL Concentrate for Infusion Fluid, Solution

UK: Potassium Chloride 15% (w/v) Concentrate for Solution for Infusion

Last Review Date of this Leaflet: 10/10/2016.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/