Document: leaflet MAH GENERIC_PL 01502-0054 change

• leaflet MAH GENERIC_PL 01502-0054
• leaflet WOCKHARDT UK_PL 01502-0054

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Patient Information Leaflet _w hameln

Dobutamine Concentrate

What is in this leaflet

1.    What Dobutamine Concentrate is and what it is used for

2.    What you need to know before you use Dobutamine Concentrate

3.    How to use Dobutamine Concentrate

4.    Possible side effects

5.    How to store Dobutamine Concentrate

6.    Contents of the pack and other information

1.    What Dobutamine Concentrate is and what it is used for

Dobutamine Concentrate belongs to a group of medicines known as inotropes, which make your heart beat more strongly.

In adults it is used:

•    in open heart surgery

•    to treat heart disease

•    to treat heart failure

•    in shock

•    as an alternative to exercise for stress testing the heart.

Paediatric population

Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.

2.    What you need to know before you use Dobutamine Concentrate

Do not use Dobutamine Concentrate if you:

•    Are sensitive or allergic to Dobutamine Concentrate, sodium metabisulfite or any

of the other ingredients in this injection.

• suffer    from    high    blood pressure

due to a tumour    near the kidney

(Phaeocromocytoma).

•    have certain heart or blood vessel disorders. Dobutamine 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 nurse if you have any of the following conditions:

•    have recently had a heart attack

•    have had a heart transplant

•    are asthmatic

•    have unstable angina

•    have heart disease

•    have high blood pressure

•    have any condition that would make exercise dangerous for you.

Children

Increments in heart rate and blood pressure appear to be more frequent and intense in children than in adults. The new-born baby cardiovascular system has been reported to be less sensitive to dobutamine and hypotensive effect (low blood pressure) seems to be more often observed in adult patients than in small children. Accordingly, the use of dobutamine in children should be monitored closely.

Other medicines and Dobutamine Concentrate:

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

•    beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine).

•    anaesthetics.

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

Pregnancy and breast feeding:

Please tell your doctor or nurse before being ! given this injection if you are pregnant or breast feeding. The doctor will then decide if ; the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Dobutamine Concentrate.

3. How to use Dobutamine Concentrate Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, feel sick, are sick, feel anxious, feel palpitations, have a headache, feel short of breath or have chest pain you must tell the person giving you the injection.

Use in Children

Your child will be given the injection by a nurse or doctor who will decide the correct dosage for your child and how and when the injection will be given.

If you have any further questions or concerns on the use of this medicine for your child ask the doctor or nurse giving the injection.

4. Possible side effects

Like all medicines, Dobutamine Concentrate can

cause side effects, although not everybody gets

them.

Your doctor will examine your heart before giving you Dobutamine Concentrate to decide if you are suitable to receive the drug.

The following side-effects have been reported: Very common (more than 1 in 10 patients)

-    increased heart rate

-    chest pain

-    heartbeat disturbances

Common (in less than 1 in 10, but more than 1 in 100 patients)

-    blood pressure increase or decrease

-    narrowing of the blood vessels (vasoconstriction)

-    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 in 1000 patients)

-    fast contractions of the ventricles of the heart (ventricular tachycardia)

-    uncontrolled contractions of the ventricles of the heart (ventricular fibrillation)

-    heart attack (myocardial infarction)

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

-    slow heartbeat (bradycardia)

-    not enough blood supplied to the heart (myocardial ischaemia)

-    low potassium (hypokalaemia)

-    spots on the skin (petechial bleeding)

-    heart block

-    narrowing of the blood vessels supplying the heart (coronary vasospasm)

Not known (cannot be estimated from the available data)

-    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 metabisulfite (see Section 2)

-    muscle cramp (myoclonus) in patients with severe renal failure receiving dobutamine

-    abnormal heart function test (electrocardiogram ST segment elevation)

-    inflammation of heart muscle (eosinophilic myocarditis) in heart transplant patients

-    heart block (left ventricular outflow tract obstruction)

-    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)

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.    How to store Dobutamine Concentrate Your doctor and pharmacist are responsible for the correct storage, use and disposal of this medicine.

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

•    Do not use this medicine after the expiry date (Exp. date) which is stated on the label. The expiry date refers to the last day of the month.

•    Do not use this medicine if you notice the solution is not clear and free of particles or if the container is damaged.

•    Your pharmacist will dispose of any medicine that remains unused.

6.    Contents of the pack and other information

What Dobutamine Concentrate contains:

This injection contains the active ingredient dobutamine hydrochloride. Each 1 ml contains dobutamine hydrochloride equivalent to 12.5 mg dobutamine in a sterile solution for injection.

This injection contains the following inactive ingredients: sodium metabisulfite, sodium hydroxide, hydrochloric acid, sterile water for injections and carbon dioxide.

What Dobutamine Concentrate looks like and contents of the pack:

Dobutamine Concentrate is supplied in 20 ml clear glass ampoules, in cartons containing one, five or ten ampoules. Not all sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502/0054.

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

hameln rds a.s. Horna 36 900 01 Modra Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved November 2014

43821/03/15