PHENOXYBENZAMINE HYDROCHLORIDE 50 MG/ML STERILE CONCENTRATE FOR SOLUTION FOR INFUSION
Active substance(s): PHENOXYBENZAMINE HYDROCHLORIDE
Dibenyline® Injection Concentrate 100 mg/2 ml
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
The name of your medicine is Dibenyline Injection Concentrate 100 mg/2ml. It will be referred
to as Dibenyline Injection for ease hereafter.
In this leaflet:
1. What Dibenyline Injection is and what it is used for
2. Before you are given Dibenyline Injection
3. How Dibenyline Injection is given to you
4. Possible side effects
5. How to store Dibenyline Injection
6. Further information
1.WHAT DIBENYLINE INJECTION IS AND WHAT IT IS USED FOR
Dibenyline Injection belongs to a group of medicines known as alpha blockers. These interfere
with messages sent through nerves to control blood pressure.
Dibenyline Injection is used to treat high blood pressure caused by a tumour of the adrenal
glands called phaeochromocytoma. There are two adrenal glands, one on top of each kidney. In
phaeochromocytoma, certain substances are released from the adrenal glands into the
bloodstream in large quantities, causing high blood pressure.
Your medicine may be used together with another product when other alternative treatments are
2. BEFORE YOU ARE GIVEN DIBENYLINE INJECTION
You should not be given Dibenyline Injection if:
• You know that you are allergic to Phenoxybenzamine hydrochloride, or any of the other
ingredients (listed in section 6 at the end of this leaflet), or to any other medicine that is used to
lower blood pressure
• you have ever had a stroke
• you have had a heart attack within the last month
• you are being treated for shock, or have an abnormally low blood pressure, or your circulation
is unable to maintain an adequate supply of blood to your tissues
Make sure your doctor knows if you suffer from any of the above before you are given this
Take special care with this medicine if:
• you suffer from severe heart disease
• you have heart failure (which causes swelling of the ankles and breathlessness)
• you have thickening of the arteries (known as atherosclerosis) including the arteries in the brain
• you have ever had kidney problems which damaged your kidneys
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Dibenyline Injection may interfere with other drugs.You must tell your doctor if you are taking
drugs which act on the heart muscle, eg betablockers or drugs to regulate your heart beat (antiarrhythmics).
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Dibenyline Injection should not be given if you are pregnant, think you are pregnant or are
planning to become pregnant, or if you are breast feeding.
Driving and using machines
You should not drive or use machinery after this injection until your doctor advises you it is safe
to do so.
3. HOW DIBENYLINE INJECTION IS GIVEN TO YOU
You will be given this medicine by an intravenous infusion via a cannula (needle) inserted in a
• The medicine will have been diluted with sterile saline solution
• The usual dose is 1mg/kg body weight, and this dose is infused into a vein over 2 hours
• Only one dose will be given in 24 hours, and not more than two doses will be given in 48 hours
• You will be lying down to be given the infusion
• Your blood pressure will be measured every few minutes during the infusion
• If your blood pressure falls too low, the infusion will be stopped, and you may be given other
• Care must be taken to ensure that the cannula does not come out of the vein as this medicine
can irritate muscle tissue.
If you think you have been given more Dibenyline than you should have
If you have any worries about the dose of your medicine, discuss them with your doctor.
If you have any further questions on the use of this product ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines Dibenyline Injection can sometimes cause side-effects, although not
everybody gets them.
• You may become drowsy
• You may feel dizzy, especially on standing up
• Your heart rate may increase
• Your mouth may feel dry
• Your nose may become stuffy
• You may not sweat as much as normal
• You may have an upset stomach
• You may feel faint
• You may notice that the pupil of your eye becomes smaller.
If any of the side effects becomes serious, or you notice any side effects not listed in this leaflet,
please tell your doctor.
5. HOW TO STORE DIBENYLINE INJECTION
These instructions are primarily for health care professionals
• Protect from light.
• The infusion should be used immediately after dilution.
• 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. The expiry date
refers to the last day of that month.
6. FURTHER INFORMATION
The active substance is Phenoxybenzamine hydrochloride 100mg.
The other ingredients are ethyl alcohol, hydrochloric acid and propylene glycol
What Dibenyline Injection looks like and contents of pack
Dibenyline Injection is a clear, colourless to mid-straw coloured liquid, presented in a clear
It is sterile and available in packs of 3, 5 or 10 ampoules. Not all pack sizes may be marketed.
Marketing authorisation holder and Company responsible for manufacture:
Mercury Pharmaceuticals Ltd, No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon CR0 0XT,
This leaflet was last revised in March 2012
Dibenyline is a registered trademark of Mercury Pharma Group Ltd.
Source: Medicines and Healthcare Products Regulatory Agency