PACKAGE LEAFLET: INFORMATION FORTHE USER

_ _ _ _ _ _n nogen Pharma\

¹ Sterile Dobutamine Hydrochloride Solution 250mg in 20ml

| (Dobutamine hydrochloride)

iRead all ofthis leaflet carefully before you start .using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it I again.

•    If you have any further questions ask your ' doctor or 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.

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What is in this leaflet:

|1. What Dobutamine Hydrochloride Solution is and what it is used for |2. What you need to know before you are given Dobutamine Hydrochloride Solution

3.    How to use Dobutamine Hydrochloride Solution

4.    Possible Side Effects

,5. How to store Dobutamine Hydrochloride I Solution

i6. Contents of the pack and other information

1. WHAT DOBUTAMINE HYDROCHLORIDE SOLUTION IS AND WHAT IT IS USED FOR

Dobutamine Hydrochloride Solution belongs to a proup of medicines known as inotropes. Dobutamine Hydrochloride Solution is a heart ^timulant and is used to increase the strength of the heart beat.

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Dobutamine Hydrochloride Solution is used to increase the output of the heart in some conditions of heart failure caused by disease of the heart Imuscle or shock, after a heart attack or after heart surgery. It may also be used to improve the performance of the heart during artificial ventilation. Sometimes dobutamine hydrochloride may be used to stimulate the heart instead of exercise during special stress testing of the heart.

You will be closely monitored during your treatmentwith Dobutamine Hydrochloride Solution.

Other medicines and Dobutamine Hydrochloride Solution:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without prescription. This is especially important with the following medicines as they may interact with Dobutamine Hydrochloride Solution:

•    Beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine e.g carvedilol)

•    Anaesthetics in particular cyclopropane, halothane

•    Entacapone (a medicine used to treat Parkinson's Disease).

Pregnancy and breast-feeding:

Please tell your doctor or nurse before being given this medicine ifyou are pregnant or breast-feeding. The doctor will then decide if this medicine is suitable for you.

Driving and using machines:

You should not drive or use any machinery if you think you are affected after receiving this medicine.

Dobutamine Hydrochloride Solution contains sodium metabisulpite (E223):

This may rarely cause severe hypersensitivity reactions and bronchospasm.

3. HOW TO USE DOBUTAMINE HYDROCHLORIDE SOLUTION

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOBUTAMINE HYDROCHLORIDE SOLUTION

iDo not use Dobutamine Hydrochloride Solution ifyou:

|* Are hypersensitive (allergic) to dobutamine, sodium metabisulphate (E223) or any other ingredients contained in the injection (listed in section 6)

|* Suffer from high blood pressure due to a tumour near the kidney (phaeocromocytoma)

|* Have certain heart or blood vessel disorders. Dobutamine Hydrochloride Solution should not be used to detect poor blood supply to your heart (a cardiac stress test known as Dobutamine Stress Echocardiography).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using this medicine ifyou:

•    Have recently had a heart attack L Have had a heart transplant

» Are asthmatic

•    Have unstable angina b Have heart disease

•    Have high blood pressure

|* Have any condition that would make exercise dangerous for you.

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Dobutamine Hydrochloride Solution is diluted prior, to being administered by intravenous infusion. I Your nurse or doctor will administer the infusion. , Your doctor will decide the correct dosage for you ' and how and when the infusion will be given. They i can give you more information if you need it. ¹

Adults and the elderly:

The solution must be diluted to at least 50ml beforei being administered but it must not be added to any¹ solution which is alkaline. Because it has a very short duration ofaction, dobutamine is given by continuous infusion into a vein. Ifyour blood volume is low for any reason, you may be given an infusion of blood or plasma before treatment with dobutamine starts.

Dobutamine Hydrochloride Solution must be diluted to at least 50ml with one of the following intravenous solutions before use:

•    Sodium chloride intravenous infusion BP 0.9% I

w/v    .

•    Dextrose intravenous infusion BP 5% w/v I

•    5% dextrose and 0.9% sodium chloride    ,

intravenous infusion BP    '

•    5% dextrose and 0.45% sodium chloride i

intravenous infusion BP    ¹

•    Sodium lactate intravenous infusion BP.    i

Heart Failure    i

When dobutamine is used for the treatment of heart failure, the rate of administration will be adjusted according to the effect but the usual dose is between 2.5 and 10 micrograms per kilogram body weight per minute. The dose can be as low as 0.5 micrograms/kg/minute or as high as 40 micrograms/kg/minute. It is better to reduce the dose gradually than stop it suddenly.

Stress testing

When dobutamine is being used instead of exercise during stress testing, the starting dose is 6 micrograms/kg/minute and increased at 8 minute intervals by 5 micrograms/kg/minute to a maximum pf20 micrograms/kg/min.

During this time, continuous electrocardiogram |(ECG) monitoring should be done and the infusion stopped if the heart rate or blood pressure rises too |high, or there are abnormalities on the ECG trace.

|Use in children:

This medicine is not for use in children.

Ifyou are given too much Dobutamine iHydrochloride solution

Your dose will be carefully calculated by the doctors so overdose is unlikely.

.However, if too much is given, you may feel sick, or be sick, lose your appetite, feel shaky, anxious, have palpitations, have a headache, feel short of breath and have chest pain. You should tell the doctor or nurse straight away.

Muscle cramp (myoclonus) in patients, with severe renal failure receiving    I

dobutamine    .

Abnormal heart function test    '

(electrocardiogram ST segment    i

elevation)

Inflammation ofheart muscle (eosinophilic myocarditis) in heart transplant patients    |

Heart block (left ventricular outflow tract obstruction)    ^L

Fatal heart rupture Restlessness Feeling sick (nausea)

Headache

Pins and needles (paraesthesia)

Tremor

Increased desire to urinate (at high doses) Feelings of heat and anxiety Muscle cramp (myoclonic spasm).

4. POSSIBLE SIDE EFFECTS

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

^our doctor will examine your heart before giving ^ou this medicine to decide if you are suitable to receive the drug.

Reporting of side effects

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

5. HOWTOSTORE DOBUTAMINE HYDROCHLORIDE SOLUTION

The following side effects have been reported:

^ery common (more than 1in10 patients)

• Increased heart rate L Chest pain I* Heartbeat disturbances.

Common (in less than 1in10 but more than 1 in hOO patients)

C Blood pressure increase or decrease Narrowing ofthe blood vessels I (vasoconstriction)

L Irregular heartbeat (palpitations)

• Asthma-like symptoms (bronchospasm)

• Shortness of breath

|* Increase in white blood cells (eosinophilia)

• Inhibition of blood clot formation |* Rash (exanthema)

• Fever

|* Inflammation of the vein at the injection site (phlebitis).

Uncommon (in less than 1 in 100, but more than 1 |n 1000 patients)

• Fast contractions of the ventricles of the heart (ventricular tachycardia)

• Uncontrolled contractions of the ventricles of the heart (ventricular fibrillation) p Heart attack (myocardial infarction).

Very rare (in less than 1 in 10,000, including isolated cases)

• Slow heartbeat (bradycardia)

L Not enough blood supplied to the heart i (myocardial ischaemia)

Low potassium (hypokalaemia)

|« Spots on the skin (petechail bleeding)

• Heart block

|* Narrowing ofthe blood vessels supplying the heart (coronary vasospasm).

Not known (cannot be estimated from the available ^ata)

• Chest pain caused by stress (stress | cardiomyopathy)

• Allergic reactions (hypersensitivity reactions) including symptoms of rash, fever, increase in white blood cells (eosinophilia) and asthma-like symptoms (bronchospasm)

• Severe allergic reactions (anaphylactic

reactions) and severe life-threatening asthmatic ■ episodes possibly due to sensitivity to sodium I metabisulphite (see Section 2)

The solution will be stored below 21⁰C and protected from light. The nurse or doctor will check that the solution is not past its expiry date before administering the infusion. After dilution the solution should be administered immediately or it may be stored at 2-8 C for a maximum of 24 hours.

Keep out of the sight and reach of children.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dobutamine Hydrochloride Solution contains:

The solution contains the active ingredient dobutamine hydrochloride. Each 20 ml ofsolution contains dobutamine hydrochloride equivalent to 250 mg dobutamine in a sterile solution for infusion.

The solution contains the following inactive ingredients:

Sodium metabisulphate (E223)

Sodium hydroxide Hydrochloric acid Water for injection.

What Dobutamine Hydrochloride Solution looks like and the contents ofthe pack:

Dobutamine Hydrochloride Solution is supplied in 20ml clear glass ampoules.

Dobutamine Hydrochloride Solution is available in cartons containing 1, 5or10 ampoules.

Marketing Authorisation Holderand Manufacturer:

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

EGIS Pharmaceutical Works RTLACTAT Apszergy Ara, 9900 Kormend MaTyAs Kiral Y Uta Hungary

This leafletwas revised in December2014.

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