TadimColistimethate sodium sterile powder for nebuliser solution

Consumer Medicine Information

Tadim Published by MIMS December 2014 1

What is in this leaflet

This leaflet answers some commonquestions about Tadim. It does notcontain all the available information.It does not take the place of talking toyour doctor.

All medicines have risks andbenefits. Your doctor has weighedthe risks of you taking Tadim againstthe benefits they expect it will havefor you.

If you have any concerns abouttaking this medicine, ask yourdoctor.

Keep this leaflet in a safe place.You may need to read it again.

What Tadim is used for

Tadim contains colistimethatesodium, an antibiotic that fightsinfections caused by Pseudomonasaeruginosa.

This is a very common bacteriumthat infects the lungs of nearly allpatients with cystic fibrosis at sometime during their lives. If theinfection is not properly controlled itwill continue to damage the lungs,causing further problems.

Tadim is used to treat chestinfections caused by Pseudomonasaeruginosa in people with cysticfibrosis. The medicine is breathedinto the lungs (inhaled) via anebuliser so that more of theantibiotic can work against thebacteria causing the infection.

Ask your doctor if you have anyquestions about why this medicinehas been prescribed for you.Your doctor may have prescribed itfor another reason.

Before you use Tadim

When you must not use it

You should not use Tadim if youhave an allergy to:

• any medicine containingcolistimethate sodium

Some of the symptoms of an allergicreaction may include:

• shortness of breath• wheezing or difficulty breathing• swelling of the face, lips, tongue

or other parts of the body• rash, itching or hives on the skin.

You should not use this medicine ifyou suffer from myasthenia gravis(a rare disease where your musclesare extremely weak and get tiredvery quickly).

You should not use this medicineafter the expiry date printed on thepack or if the packaging is torn orshows signs of tampering.If you take this medicine after theexpiry date has passed, it may notwork as well. The expiry date refersto the last day of the stated month.

If you are not sure whether youshould use this medicine, talk toyour doctor.

Before you use it

Tell your doctor if you haveallergies to any other medicines,foods, preservatives or dyes.

Tell your doctor if you have orhave had any of the followingmedical conditions:

• kidney problems• porphyria (a rare metabolic

disease that some people areborn with)

• asthma.

Tell your doctor if you arepregnant or plan to becomepregnant. Your doctor can discusswith you the risks and benefitsinvolved.

Tell your doctor if you arebreastfeeding or planning tobreastfeed.The active ingredient in Tadimpasses into breast milk and there is apossibility that your baby may beaffected. Your doctor will discusswith you the risks and benefits ofusing Tadim if you are breastfeeding.

If you have not told your doctorabout any of the above, tell thembefore you use Tadim.

Taking other medicines

Tell your doctor if you are usingany other medicines, including anythat you get without a prescriptionfrom your pharmacy,supermarket, health food shop,naturopath or herbalist.Some medicines and Tadim mayinterfere with each other. Theseinclude:

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• antibiotics such as cephalothinsodium, gentamicin, amikacinand tobramycin. Using Tadim atthe same time as these otherantibiotics could increase yourrisk of kidney problems.

• other medicines which can affectthe kidneys, such as tacrolimus,ACE inhibitors, AngiotensinReceptor Blockers (ARBs),cyclosporin, Non-Steroidal Anti-inflammatory Drugs (NSAIDs)like aspirin.

• medicines which can affect thenerves (e.g. cocaine,methamphetamine, ketamine, ormedicines for Parkinson'sdisease).

• muscle relaxing medicines, whichmay be used as part of a generalanaesthetic if you have anoperation. Tadim can prolong theeffect of such medicines. If youneed to have a generalanaesthetic, tell the anaesthetistthat you are using Tadim.

These medicines may be affected byTadim or may affect how well itworks. You may need differentamounts of your medicines, or youmay need to use different medicines.

Your doctor and pharmacist havemore information on medicines to becareful with or avoid while takingthis medicine.

How to use Tadim

Follow all directions given to youby your doctor, pharmacist ornurse carefully.They may differ from theinformation contained in this leaflet.

If you do not understand theinstructions on the packaging, askyour doctor, pharmacist or nursefor help.

How much to use

The usual dose for adults andchildren over the age of two years is1-2 vials reconstituted and usedwith a nebuliser two or three timesa day. Your doctor will work out thebest dose for you. This will dependon the seriousness of your infection,your general health and the type ofnebuliser you will be using. Not allnebulisers are the same.

Always read the instructions forthe nebuliser that you will use toinhale Tadim, as well as this leaflet.

Your doctor will work out the bestdose for you.

Tadim may be reconstituted withWater for Injections (WFI) or a 50:50mixture of WFI and 0.9% SodiumChloride Injection. It is then inhaledusing a nebuliser.

Check with the Pulmonary or CysticFibrosis Nurse to make sure you havethe right nebuliser and compressor.

When to use it

You should use your first dose ofTadim when you are with yourdoctor or nurse.

Use Tadim after physiotherapy (ifyou have physiotherapy) and afterusing any other nebulisedmedicines or bronchodilator thatyou have been prescribed.

Tadim has to be breathed in from anebuliser. It can be inhaled using anynebuliser system that can be used todeliver antibiotics to the lungs.

If you use Tadim with a conventionalnebuliser you should make sure theroom is well ventilated.

How to prepare Tadim

Your doctor or nurse will show youhow to use Tadim with yournebuliser.

The following are generalinstructions on how to dissolveTadim.

1. Flip open the Tadim plastic cap.Locate the lip on the plastic top,shown by the arrow marked"FLIP UP". Using the thumbunder the lip, push the plastic topup by about 40°.

2. Grasp the plastic top as shownand pull open slowly, like ahinge, to almost 180°.

3. Pull the plastic top backwards sothat the metal seal starts to tearopen. During this step hold boththe plastic and metal portion ofthe cap and slightly angle/twistthe top (to either the left or theright) so that the metal collar isbroken on one side only.

4. Once the seal is broken on oneside, hold the vial tightly andpush the cap backwards (holdingboth the plastic and metal portionof the cap) whilst rotating the vialin the opposite direction.

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5. Continue opening the vial asdescribed in step 4.

6. Remove the Flip Tear seal toreveal the vial stopper.

7. Remove the rubber stoppercarefully.

8. Slowly add Water for Injections(WFI) or a 50:50 mixture of WFIand 0.9% Sodium ChlorideInjection to the Tadim vial usinga syringe. Note: a needle is notrequired. (The nebulisationinstructions provided by yourdoctor will tell you the correctvolume of liquid to add to theTadim vial.)

9. Replace the rubber bung and rollthe vial gently between bothhands to dissolve the Tadim inthe liquid. This should help pickup the powder 'settled' on the base& sides of the vial. You may needto leave the vials to stand for 5-10minutes for the powder to fullydissolve. Avoid shaking the vialtoo hard. Vials that are shakenstay foamy for longer.

10. Remove the rubber bung andwithdraw the Tadim solutionfrom the vial with a syringe (aneedle is not required). (Thenebulisation instructionsprovided by your doctor willtell you the correct volume ofliquid to withdraw from theTadim vial.)

11. Add the appropriate volume ofTadim solution into the nebuliser.

Any unused solution from the vialor the nebuliser should be disposedof immediately after use.Medicines should not be disposed ofvia wastewater or household waste.Ask your pharmacist how to disposeof medicines you no longer require.These measures will help to protectthe environment.

Once prepared, Tadim should beused immediately. Tadim containsno anti-microbial preservatives.

If it is not possible to use the solutionimmediately, store it in therefrigerator. Stored solutions mustnot be kept for more than 24 hoursafter you have prepared it.

There is a chance of serious lung sideeffects if the solution is used morethan 24 hours after it was prepared.

Do not use solution from a vial onmore than one occasion.

How long to use it for

Continue using the medicine for aslong as your doctor tells you.This medicine helps to treat yourinfection. It is important to keepusing your medicine even if you feelwell.

If you forget to use it

Inhale the dose as soon as youremember, unless it is near thetime for your next dose. Do nothave a double dose to make up forthe dose you have missed.

If you use too much(overdose)

Immediately telephone yourdoctor, or go to the EmergencyDepartment at the nearest hospital,if you think that you or anyone elsemay have used too much Tadim.Do this even if there are no signs ofdiscomfort or poisoning.You may need urgent medicalattention.

Symptoms of an overdose mayinclude:

• irregular breathing, breathlessness• muscle weakness

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• changes in sight• spinning sensation• sensation of burning or prickling

of the skin of the face• seeing things that are not there• slurred speech• confusion• flushing (reddening of the face).

In Australia, contact the Poisonsinformation centre on 13 11 26 forfurther advice on overdosemanagement.

While you are usingTadim

Things you must do

If you are about to be started onany new medicine, remind yourdoctor and pharmacist that youare using Tadim.

Tell any other doctors, dentists,and pharmacists who treat youthat you are using this medicine.

If you are going to have surgery,tell the surgeon or anaesthetist thatyou are using this medicine.It may affect other medicines usedduring surgery.

If you become pregnant whileusing this medicine, tell yourdoctor immediately.

Things to be careful of

Tadim may make you feel dizzy,confused or have problems withyour sight, such as blurred vision.If this happens to you, do not drive acar, use any tools or machines, or doanything else that could bedangerous.

Side effects

Tell your doctor as soon as possibleif you do not feel well while you areusing Tadim.

This medicine helps most peoplewith a chest infection caused byPseudomonas aeruginosa but it mayhave unwanted side effects in a fewpeople. All medicines can have sideeffects. Sometimes they are serious,most of the time they are not. Youmay need medical attention if you getsome of the side effects.

Do not be alarmed by the followinglist of side effects. You may notexperience any of them.

Ask your doctor to answer anyquestions you may have.

Tell your doctor or pharmacist ifyou notice any of the following andthey worry you:

• sore throat• sore mouth.

Tell your doctor as soon as possibleif you notice any of the following:

• cough• tightness in the chest• difficulty with breathing.The above list includes the morecommon side effects of yourmedicine.

If any of the following happen, tellyour doctor immediately or go tothe Emergency Department atyour nearest hospital:

• allergic reactionsSome of the symptoms of anallergic reaction may include:- shortness of breath- wheezing or difficulty breathing- swelling of the face, lips, tongueor other parts of the body- rash, itching or hives on theskin.

These are serious side effects thatmay require medical attention.

Tell your doctor, nurse orpharmacist if you notice anythingthat is making you feel unwell.

Other side effects not listed abovemay also occur in some people.Some of these side effects (forexample, changes in kidney function)can only be found when your doctordoes tests from time to time to checkyour progress.

Ask your doctor or nurse if you donot understand anything in thislist.

After using Tadim

Storage

Tadim vials should be stored below25°C.

Tadim contains no preservatives.Once the solution is prepared, itshould be used immediately andany remainder discarded.If it is not possible to use the solutionimmediately, store it in a refrigerator.Stored solutions must not be kept formore than 24 hours after you haveprepared it.

There is a chance of serious lung sideeffects if the solution is used morethan 24 hours after it was prepared.

Do not use solution from a vial onmore than one occasion.

Keep it where children cannotreach it.A locked cupboard at least one-and-a-half metres above the ground is agood place to store medicines.

Disposal

Medicines should not be disposed ofvia wastewater or household waste.Ask your pharmacist how to disposeof medicines you no longer require.These measures will help to protectthe environment.

Product description

What it looks like

Tadim is a sterile powder fornebuliser solution. It is supplied as asterile white to off-white powder in aglass vial.

It is supplied in packs containing 30vials.

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Ingredients

Each vial of Tadim contains 1million International Units (IU) ofcolistimethate sodium, which weighsabout 80 milligrams. There are noother ingredients.

Tadim contains no preservatives.

This medicine does not containlactose, sucrose, gluten, tartrazine orany other azo dyes, or alcohol.

Supplier

Tadim is supplied by:Phebra Pty Ltd19 Orion Road,Lane Cove West, NSW 2066,Australia

AUST R 165709

Phebra product code - SOL040.

This leaflet was amended in June2014.

Tadim is a registered trademark ofProfile Pharma Ltd, UK.

Phebra and the Phi symbol aretrademarks of Phebra Pty Ltd, 19Orion Road, Lane Cove West, NSW2066, Australia.