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PACKAGE LEAFLET: INFORMATION FOR THE USER

Kolneb 1 MIU., Powder for Nebuliser Solution

Colistimethate sodium

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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Kolneb 1 MIU. is and what it is used for

2.    What you need to know before you use Kolneb 1 MIU.

3.    How to use Kolneb 1 MIU.

4.    Possible side effects

5.    How to store Kolneb 1 MIU.

6.    Contents of the pack and other information

1. What Kolneb 1 MIU. is and what it is used for

Kolneb 1 MIU is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis. Kolneb 1 MIU is used when these infections are cause by specific bacteria called Pseudomonas aeruginosa.

2. What you need to know before you use Kolneb 1 MIU.

Do not use Kolneb 1 MIU.

-    If you are allergic (hypersensitive) to colistimethate sodium, colistin sulphate or to other polymyxins. Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Kolneb 1 MIU

-    If you have or have had kidney problems.

-    If you suffer from myasthenia gravis

-    If you suffer from porphyria

-    If you suffer from asthma.

In premature and new-born babies, special care should be taken when using Kolneb 1 MIU as the kidney are not yet fully developed.

Other medicines and Kolneb 1 MIU.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines you bought without a prescription. These medicines may interfere with the effect of Kolneb 1 MIU.

-    medicines which can affect how your kidneys function. Taking such medicines at the same time as Kolneb 1 MIU can increase the risk of damage to the kidneys.

-    medicines which can affect your nervous system. Taking such medicines at the same time as Kolneb 1 MIU can increase the risk of side effects in your nervous system

- medicines called muscle relaxants, often used during general anaesthesia. Kolneb 1 MIU can increase the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having Kolneb 1 MIU

If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking Kolneb 1 MIU further increases the risk of muscle weakness and breathing difficulties.

Having Kolneb 1 MIU as an infusion at the same time as receiving Kolneb 1 MIU as an inhalation can increase your risk of side effects.

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 or pharmacist for advice before taking this medicine. Kolneb 1 MIU. should only be given during pregnancy or breast-feeding when clearly needed.

Driving and using machines

Kolneb 1 MIU. may make you feel dizzy, confused or have problems with your sight, such as blurred vision. If this happens to you, do not drive or operate any tools or machines and talk to your doctor or pharmacist.

3. How to use Kolneb 1 MIU.

Kolneb 1 MIU. is for inhalation use.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor may decide to adjust the dose depending on your circumstances. If you also take other inhaled medicines, your doctor will tell you which order to taken them in.

The recommended dose is:

	Recommended Dose	Maximum dose per day
Adults	1 to 2 Million International Units (MIU) two to three times a day	6 MIU per day
Children (age 2 years to 11 years) and Adolescents (age 12 years to 17 years)	1 to 2 Million International Units (MIU) two to three times a day	6 MIU per day
Children younger than 2 years	0.5 to 1 Million International Units (MIU) two times a day	2 MIU per day

Please note Kolneb 1 MIU. is also available as 2 MIU vial.

You should take your first dose of Kolneb 1 MIU. when you are with your doctor or nurse. Take your Kolneb 1 MIU. after physiotherapy (if you have physiotherapy).

Duration of treatment

Your doctor will tell you how long your treatment with Kolneb 1 MIU. will last. Do not stop treatment early because when treating bacterial infections it is important to complete the full course of treatment to reduce the risk of resistance formation of the infectious bacteria.

Preparation for inhalation treatment

If you are treating yourself at home, your doctor or nurse will show you how to use Kolneb 1 MIU. in your nebuliser when you first start this treatment.

Before Kolneb 1 MIU. can be used it must be dissolved in isotonic saline solution (salt water).

It is important that your nebuliser system functions properly before starting your treatment with Kolneb 1 MIU. Read carefully the instructions for use of the nebuliser for further information on handling the nebuliser system.

Place the components of your nebuliser on a clean flat surface and follow the manufacturer’s instructions for use.

Preparing your Kolneb 1 MIU. for inhalation

Kolneb 1 MIU. must be used immediately after dissolution. Do not dissolve Kolneb 1 MIU. until ready to administer a dose (see also section 5).

Step 1: Take one vial of Kolneb 1 MIU. and gently tap the glass vial so that the powder settles to the bottom. This helps ensure you get the proper dose of medication. Open the drug vial by lifting up the plastic overcap on the top (Figure 1).

Step 2: Pull down to carefully remove the entire plastic overcap together with metal ring from the vial (Figure 2). Safely dispose of the ring and overcap.

Step 3: Carefully remove the rubber stopper (Figure 3). Add the solvent (3 ml of isotonic saline solution) to the corresponding vial to dissolve the powder:

In order to avoid foaming, shake the vial gently until all powder is dissolved. Pour the solution into the nebuliser. Do not use Kolneb 1 MIU. if you notice visible particles in the solution after dissolution.

Once prepared Kolneb 1 MIU. should be used immediately. Any unused solution should be disposed of.

Using your Kolneb 1 MIU.

Kolneb 1 MIU. is for inhalation use with an appropriate nebuliser (e.g. PARI LC PLUS, PARI LC SPRINT or eFlow rapid).

For more detailed information on correct use of the selected nebuliser follow the instruction manual of the nebuliser.

Inhalation should take place in a well ventilated room.

After inhalation of Kolneb 1 MIU.

Please refer to the manufacturer’s instructions for use of the nebuliser for cleaning and disinfecting instructions.

If you use more Kolneb 1 MIU. than you should

If you realise that you have used more Kolneb 1 MIU. than your doctor has recommended (or if someone else has used some of your Kolneb 1 MIU.), contact your doctor or pharmacist straight away.

The symptoms of taking too much Kolneb 1 MIU. can include:

•    tingling or numbness around the lips and face

•    dizziness and spinning sensation (vertigo)

•    slurred speech

•    visual disturbance

•    confusion

•    mental disturbance

•    flushing (reddening of the face)

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

If you forget to use Kolneb 1 MIU.

Take the dose as soon as you remember, unless it is near the time for your next dose. You do not need to make up for the dose you have missed.

If you stop using Kolneb 1 MIU.

Do not stop your treatment early unless your doctor says that you can. Your doctor will tell you how long your treatment will last.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Kolneb 1 MIU. can sometimes cause allergic reactions like skin rash. If this happens you should stop taking Kolneb 1 MIU. and tell your doctor immediately.

Breathing in Kolneb 1 MIU. through a nebuliser can make some people notice tightness in their chest, feel wheezy, cough or become breathless. For this reason the first dose should be taken when you are with your doctor or nurse. Your doctor may also advise you to take a medicine to help prevent any breathlessness. Your doctor may check your breathing at your clinic visits.

Kolneb 1 MIU. might also affect your kidneys, usually if the dose is high or you are taking other medicines that may affect your kidneys.

Kolneb 1 MIU. may sometimes cause you to have a sore mouth or sore throat.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kolneb 1 MIU.

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

Do not use this medicine after the expiry date which is stated on the carton and on the vial label after EXP. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Keep the vials in the outer carton.

Kolneb 1 MIU Powder for nebuliser solution should be used immediately after preparation.

Any remaining solution should be discarded.

For single use only.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Kolneb 1 MIU. contains

-    The active substance is colistimethate sodium (also known as colistin).

Each vial contains 1 million International Units (IU) of colistimethate sodium, which weighs about 80 milligrams (mg).

-    There are no other ingredients.

What Kolneb 1 MIU. looks like and contents of the pack

Kolneb 1 MIU. is a powder for nebuliser solution after reconstitution with an adequate volume of solvent.

1    MIU/vial: White to off-white powder in a 10 ml colourless glass vial with a red cap.

Also available:

2    MIU/vial: White to off-white powder in a 10 ml colourless glass vial with a lilac cap.

The product is available in the following pack sizes:

•    1 vial

•    2 vials

•    10 vials

•    14 vials

•    28 vials

•    56 vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder Forest Pharma B.V.

Newtonlaan 115

3584 BH, Utrecht Netherlands

Manufacturer

Forest Tosara Ltd.

Unit 146 Baldoyle Industrial Estate

Baldoyle, Dublin 13

Ireland

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Kolneb 1 Mio. I.E. Pulver zur Herstellung einer Losung fur einen Vernebler
Belgium	Kolneb 1 million UI/1 miljoen Internationale Eenheden (IE)/1 Million IE, poudre pour solution pour inhalation par nebuliseur/ poeder voor oplossing voor verneveling/ Pulver zur Herstellung einer Losung fur einen Vernebler
Germany	Colistineb 1 Million I.E. Pulver zur Herstellung einer Losung fur einen Vernebler
Finland	Colineb 1 MIU Jauhe sumutinliuosta varten
The Netherlands	Kolneb, 1 miljoen Internationale Eenheden (IE) poeder voor oplossing voor verneveling
Norway	Colineb 1 MIU Pulver til inhalasjonsv^ske til nebulisator, opplosning
Sweden	Colineb 1 MIU Pulver till losning for nebulisator
Spain	Colistimetato de sodio YES 1 millon de UI Polvo para solution para inhalation por nebulizador

This leaflet was last revised in {MM/YYYY}

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