Phentolamine mesilate 10 mg/ ml Solution for Injection

• 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.

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

• 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.

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.

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

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.

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.

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.

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’.

Your doctor will decide the duration of the treatment.

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 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.

• 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.

Clear, colourless solution, virtually free from visible particles.

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

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