Patient leaflet - GUANETHIDINE MONOSULPHATE AMPOULES 10 MG / ML, ISMELIN AMPOULES 10 MG / ML
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– 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.
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– 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.
What is in this leaflet
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1. What Ismelin is and what it is used for
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2. What you need to know before you are given Ismelin
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3. How Ismelin will be given
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4. Possible side effects
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5. How to store Ismelin
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6. Contents of the pack and other information
1. what ismelin is and what it is used for
The name of your medicine is Ismelin.
Ismelin contains the active ingredient guanethidine monosulphate.
Guanethidine belongs to a group of medicines called antihypertensives.
Ismelin is used to treat high blood pressure in people with hypertensive crises (very high blood pressure with symptoms including headache, vomiting, dizziness and blurred vision).
2. what you need to know before you are given ismelin are allergic to guanethidine or any of the other ingredients of this medicine (listed in section 6). allergic reactions include mild symptoms such as itching and/or rash. more severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing
- are taking, or have recently taken monoamine oxidase inhibitors (MAOIs) for depression (e.g. moclobemide, phenelzine, isocarboxazid, tranylcypromine)
- suffer from heart failure
- have a tumour of the adrenal gland
(phaeochromocytoma)
- have severe kidney problems.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ismelin:
- if you have asthma
- if you have moderate kidney problems
- if you have Parkinson’s disease
- if you have any disease of the blood vessels, heart or brain (arteriosclerosis)
- if you have ever had an ulcer in your stomach or intestines.
Avoid heat or physical exertion whilst being treated with Ismelin as this may increase the effect of the medicine.
If you are going to have a general anaesthetic , you should tell the doctor or dentist in charge that you are taking Ismelin, as your treatment should be stopped a few days before the surgery.
Children and adolescents
Ismelin is not recommended for use in children.
Other medicines and Ismelin
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
This is especially important if you are taking:
- monoamine oxidase inhibitors (MAOIs) for depression, (e.g. moclobemide, phenelzine, isocarboxazid, tranylcypromine) – these medicines should be stopped for at least 14 days before initiating treatment with Ismelin
- oral contraceptives
- adrenaline (for acute allergic reactions), and other sympathomimetic agents (e.g. salbutamol, pseudoephedrine, phenylpropanolamine)
- amphetamines (for narcolepsy)
or if you are taking medicines for:
- an irregular heartbeat (e.g. digoxin, digitoxin)
- high blood pressure including reserpine, methyldopa, vasodilators (especially minoxidil), calcium antagonists (e.g. nifedipine, diltiazem), beta-blockers (e.g. atenolol, propranolol, metoprolol, bisoprolol) and ACE inhibitors (e.g. enalapril, lisinopril)
- problems such as depression or psychosis (e.g. chlorpromazine, promazine, thioridazine, amitriptyline, clomipramine)
- diabetes (e.g. insulin).
Ismelin with food, drink and alcohol
It is advisable not to drink alcohol whilst taking Ismelin as it may increase the effect of your medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You can drive while being treated with Ismelin, but do not drive until you know how it affects you. It may make you feel drowsy, dizzy or have blurred vision. If it affects you in this way, do not drive or operate any machinery.
Ismelin contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially ‘sodium-free’.
3. how to use ismelin
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Ismelin is given by injection into the muscle. The doctor will decide the dose of Ismelin which is best for you.
The recommended dose is:
The usual dose is 10 mg to 20 mg.
This dose may be reduced if you suffer with kidney problems. A second dose can be given after at least 3 hours if needed.
If you receive more Ismelin than you should
As this medicine is given to you by a doctor, it is very unlikely that an overdose will happen. Should an overdose occur, the doctor will treat any symptoms that follow.
4. possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you develop symptoms of heart failure on prolonged treatment with Ismelin.
Isolated cases of the following have also been reported, tell your doctor immediately if you notice any of the these:
- A reduction in:
- red blood cells (anaemia, which can make you feel tired or breathless)
- white blood cells (leucopenia, which can cause fever or frequent infections)
- blood platelets (thrombocytopenia, which can cause unexplained bruising or bruising more easily).
- If you feel very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.
If you may suffer from some kidney problems which may cause an increase in the amount of urea or nitrogen in your blood. This may cause the following:
- feeling or being sick
- weakness
- headaches
- convulsions
- dimmed vision.
Common: may affect up to 1 in 10 people:
- tiredness, fatigue
- dizziness, headaches
- low blood pressure (hypotension) which can cause dizziness or faintness on standing
- numbness and tingling in your fingers or toes
- severe pain in your legs when you walk
- diarrhoea, trapped wind
- ejaculation disorders
- erectile dysfunction (including prolonged and sometimes painful erection)
- slow or irregular heart rate
- swelling (oedema)
- vomiting, nausea, dry mouth
Rare: may affect up to 1 in 1,000 people:
- muscle pain or shaking
- pain in your chest (angina)
- asthma
- swollen glands
- hair loss.
Not known: frequency cannot be estimated from the available data:
- blurred vision
- depression
- skin problems such as dermatitis
- blocked nose
- a raised level in the blood of urea and other nitrogenous waste compounds that are normally eliminated by the kidneys (Uraemia).
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: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 ismelin
Keep this medicine out of the sight and reach of children.
Ismelin will be stored in a safe place by your doctor. The doctor or nurse will check that the expiry date on the label has not passed before you are given the injection.
Do not use this medicine after the expiry date which is stated on the label, carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information- the active substance is 10 mg of guanethidine monosulphate in 1 ml of solution.
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– The other ingredients are sodium chloride, sulphuric acid and water for injections.
What Ismelin looks like and contents of the pack
Ismelin is a colourless solution which comes in a clear glass 1 ml ampoule and comes in packs of 5.
Marketing Authorisation Holder and Manufacturer
Amdipharm UK Limited,
Capital House, 85 King William Street,
London EC4N 7BL, UK
This leaflet was last revised in May 2020.