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Phentolamine mesilate 10 mg/ ml Solution for Injection

Active Ingredient:

Phentolamine mesilate

Company:

Roma Pharmaceuticals Limited See contact details

ATC code:

C04AB01

About Medicine

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL)

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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.

Last updated on emc: 15 Oct 2025

View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 49578/0038.

Print patient leaflet as text only

Phentolamine Inj PIL

Package leaflet: Information for the user

Phentolamine mesilate 10 mg/ml solution for injection

Phentolamine mesilate

Read all of this leaflet carefully before you start taking 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.
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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Phentolamine solution for injection is and what it is used for
2. What you need to know before you use Phentolamine solution for injection
3. How to use Phentolamine solution for injection
4. Possible side effects
5. How to store Phentolamine solution for injection
6. Contents of the pack and other information

1. What Phentolamine solution for injection is and what it is used for

The active substance in Phentolamine mesilate 10 mg/ml solution for injection (called Phentolamine solution for injection in this leaflet) is phentolamine. It belongs to a group of medicines called alpha blockers. These medicines lower high blood pressure by relaxing blood vessels.

Phentolamine solution for injection can be used in the following cases:

For the treatment of high blood pressure caused by a tumour of certain cells in the adrenal medulla (pheochromocytoma) before and during the surgery.
As a test to diagnose pheochromocytoma, if other tests are not available.

Ask your doctor if you are not sure why Phentolamine solution for injection is going to be used for you.

2. What you need to know before you use Phentolamine solution for injection

Do not take Phentolamine solution for injection:

if you are allergic to phentolamine mesilate or any of the other ingredients of this medicine (listed in section 6).
if you are hypersensitive to sulphite.
if you have low blood pressure.
if you are having a heart attack or if you have had a heart attack in the past.
if your heart does not function properly and if you have chest tightness or any other signs of disease of the blood vessels around the heart.

Warnings and precautions

Talk to your doctor or pharmacist before using this medicine:

if you have fast or irregular heartbeats.
if you have heartburn, abdominal pain, nausea or vomiting.
if you have darker coloured stools or blood in your stools.
if you have kidney impairment.

Children and adolescents

This medicine can be used in children and adolescents up to 18 years of age.

Other medicines and Phentolamine solution for injection

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This applies especially to other blood pressure−lowering medicines and medicines for the treatment of certain mental and emotional disorders.

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 for advice before taking this medicine. Your doctor will inform you about the benefits and risks and decide whether Phentolamine solution for injection can be used for you.

Also talk to your doctor if want to breast−feed. Phentolamine solution for injection is not advised for use in breast−feeding women.

Driving and using machines

Phentolamine solution for injection may cause dizziness or other side effects. Do not drive or use machines if this happens to you. If so, contact your doctor.

Phentolamine solution for injection contains sodium metabisulphite.

In rare cases, sodium metabisulphite can cause severe hypersensitivity reactions and shortness of breath due to spasm of the muscles of the airways (bronchospasm).

This medicine contains less than 1 mmol sodium (23 mg) per each 1 ml ampoule, that is to say essentially ‘sodium−free’.

3. How to take Phentolamine solution for injection

This medicine is for use in hospitals and will be given by a doctor or nurse as an injection.

Your doctor will determine the dose.

Duration of the treatment

Your doctor will decide the duration of the treatment.

If you are given more Phentolamine solution for injection than you should

This medicine is given to you by your doctor or nurse. It is unlikely that you will be given too much. Your doctor will carefully work out how much you should be given.

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

4. Possible side effects

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

Very common: (may affect more than 1 in 10 people)

fast heart rate (tachycardia)
low blood pressure when sitting or standing up (orthostatic hypotension)

Common: (may affect up to 1 in 10 people)

dizziness
sudden or prolonged periods of low blood pressure (may lead to a heart attack or stroke)
flushing
blocked nose
nausea
vomiting
diarrhoea
general body weakness/feeling weak (asthenia)

Uncommon: (may affect up to 1 in 100 people)

tight, painful feeling in the chest (angina)
abnormal heart rhythm (arrhythmia)

Reporting of side effects

If you get any side effects, talk to your doctor 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Phentolamine solution for injection

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

Store in the original package in order to protect from light.

Store in a refrigerator (2˚C − 8˚C).

Do not freeze.

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

6. Contents of the pack and other information

What Phentolamine solution for injection contains

The active substance is phentolamine mesilate. Each ampoule of 1 ml contains 10 mg phentolamine mesilate. This is equivalent to a total of 7.45 mg/ml phentolamine.
The other ingredients are: sodium metabisulphite (E223), glucose monohydrate and water for injections.

What Phentolamine solution for injection looks like and contents of the pack

Clear, colourless solution, virtually free from visible particles.

Each pack of Phentolamine solution for injection contains 5 single use ampoules of 1 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ROMA Pharmaceuticals Limited
Gibraltar House
Centrum 100
Burton−upon−Trent
DE14 2WE

Email: [email protected]

Manufacturer

Anfarm Hellas S.A.
61st Km National Road Athens Lamia
Schimatari
Viotias
320 09
Greece

This leaflet was last revised in August 2025.

For information in other formats contact medinfo@ romapharma.co.uk