POTASSIUM CHLORIDE SERRACLINICS 2 mEq/mL CONCENTRATE FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Potassium ChlorideSerraclinics2 mEq/ml, 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 are the parent of a child who is going to be given this medicine, read this leaflet replacing "you" with "your child" throughout the leaflet.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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. See section 4.

The name of this medicine is Potassium Chloride Serraclinics 2 mEq/ml, concentrate for solution for infusion

From now on, Potassium Chloride Serraclinics 2 mEq/ml, concentrate for solution for infusion will be referred to as Potassium Chloride Serraclinics.

Contents of the pack:

1. What Potassium Chloride Serraclinics is and what it is used for
2. What you need to know before you use Potassium Chloride Serraclinics
3. How to use Potassium Chloride Serraclinics
4. Possible side effects
5. Storage of Potassium Chloride Serraclinics
6. Contents of the pack and other information

1. What Potassium Chloride Serraclinics is and what it is used for

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

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

Your body needs the right amount of potassium. Potassium helps your muscles, heart, and other organs work properly. Potassium also helps balance the water levels that affect many electrical and chemical processes in your body. Without the right amount of potassium, your heart may start beating abnormally, which could put your life in danger.

If you cannot take potassium orally, your doctor or nurse will give you this medicine as a drip (infusion).

2. What you need to know before you use Potassium Chloride Serraclinics

The doctor or nurse who is going to give you this medicine will ask you some questions. They need the following information before giving you this medicine for the first time.

Do not use Potassium Chloride Serraclinics

• If you have hyperkalemia (high levels of potassium in your blood).

Do not use Potassium Chloride Serraclinics if the above applies.

Warnings and precautions

Before starting treatment, tell 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 a large area of skin damaged (e.g. severe burns)
• You are elderly (over 65 years old)
• You have problems urinating
• You are being treated with a drip (infusion) that contains the sugar called glucose.

Using Potassium Chloride Serraclinics with other medicines

Tell your doctor about any medicines you are taking or have recently taken. Also, remember any medicines you are taking that do not need a prescription.

It is very important that you tell your doctor if you are taking any of the following medicines:

• ACE inhibitors (angiotensin-converting enzyme) such as lisinopril, captopril, enalapril (may cause the level of potassium in your blood to be too high)
• Angiotensin II receptor antagonists such as losartan, valsartan, candesartan (may cause the level of potassium in your blood to be too high)
• Blood transfusion (may cause the level of potassium in your blood to be too high)
• Cyclosporin (may cause the level of potassium in your blood to be too high)
• Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone (may cause potassium chloride to not work properly)
• Digoxin (may increase side effects)
• Potassium-sparing diuretics such as spironolactone (may cause the level of potassium in your blood to be too high)
• Quinidine (may cause your heart to beat abnormally)
• Tacrolimus (may cause the level of potassium in your blood to be too high)

Potassium Chloride Serraclinics contains potassium

Tell your doctor if you are using salt substitutes that contain potassium in your diet. You may receive too much potassium if you use this medicine at the same time.

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant or think you may be pregnant.
• Tell your doctor if you are breastfeeding a child.

Your doctor will decide whether you should use this medicine or not.

3. How to use Potassium Chloride Serraclinics

Potassium chloride must be diluted before use in at least 50 times its volume, with a suitable diluent.

Generally, this medicine will be given to you by a doctor or nurse.

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

Your doctor will decide the amount (dose) of medicine to be given and for how long you will need it.

Your doctor will also decide the concentration of the medicine to be given. The medicine is very concentrated and must always be diluted by adding more liquid before administration.

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

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

If you have very low levels of potassium in your blood, or if you have diabetic ketoacidosis (a complication of diabetes), you may be given this medicine more quickly than usual.

Adults and elderly

The usual dose is up to 80 mmol (millimoles) per day. The medicine 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 medicine 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

Generally, this medicine will be given to you by a doctor or nurse. If you think you may have received too much medicine, please tell your doctor or nurse immediately.

Too much potassium in your blood can cause serious side effects that can put your life in danger.

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 forget to use Potassium Chloride Serraclinics

Normally, this medicine will be given to you by a doctor or nurse. If you think they have forgotten to give you a dose, please tell your doctor or nurse.

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

4. Possible side effects

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

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

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

Immune system disorders:

• Fever.

Heart and circulation disorders:

• Low blood pressure (you may feel dizzy)

Infusion site disorders:

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

Nervous system disorders:

• Pins and needles or tingling in the hands or feet
• Flaccid paralysis
• Loss of reflexes
• Weakness, lack of energy
• Mental confusion
• Weakness and heaviness in the legs

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Potassium Chloride Serraclinic

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

No special storage conditions are required.

Use your medicine only if it is a clear 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Potassium Chloride Serraclinic

• The active substance is potassium chloride.
• The other ingredients are: water for injections.

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.

Appearance of the product and pack contents

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 clear and colorless liquid. Potassium chloride must be diluted before use with at least 50 times its volume of a suitable diluent. More liquid must be added to the solution (diluted) to prepare a less concentrated solution that can be administered as a drip (infusion).

Each plastic ampoule contains 5 ml (milliliters), 10 ml or 20 ml of the medicine. There are 20 ampoules in a box. Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

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 under the following names:

AT: Kaliumchlorid Noridem 15% Konzentrat zur Herstellung einer Infusionslösung

BE: CHLORURE DE POTASSIUM NORIDEM 15% (w/v) solution à diluer pour perfusion

DE: Kaliumchlorid Noridem 150mg/mL Konzentrat zur Herstellung einer Infusionslösung

DK: Kaliumchlorid “Noridem”, koncentrat til infusionsvæske, opløsning 2mmol/mL

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

ES: Cloruro de potasio SERRACLINIC 2 mEq/ml, concentrado para solución para perfusión

IE: Potassium Chloride 15% (w/v) concentrate for solution for infusion

NL: Kaliumchloride Noridem 15% (w/v) concentraat voor oplossing voor infusie

NO: Kaliumklorid 2mmol/mL konsentrat til infusjonsvæske "Noridem"

PT: Cloreto de potássio Noridem 150 mg/ml Concentrado para solução para perfusão

SE: Kaliumklorid Noridem 2mmol/mL koncentrat till infusionsvätska, lösning

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

Date of last revision of this leaflet: 10/10/2016.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/