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Ismelin® Ampoules 10 mg/ml amdipharm

Guanethidine monosulphate

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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.

In this leaflet:

1.    What Ismelin is and what it is used for

2.    Before you are given Ismelin

3.    Mow Ismelin will be given

4.    Possible side effects

5.    Mow to store Ismelin

6.    Further information

1.    WHAT ISMELIN IS AND WHAT IS IT 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.    BEFORE YOU ARE GIVEN ISMELIN Do nut take Ismelin if you:

•    are allergic to guanethidine or any of the other ingredients of Ismelin (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.

Ismelin is not recommended for use in children.

Take special care with Ismelin    if you:

•    have    asthma;

•    have    moderate kidney problems;

•    have    Parkinson's disease;

•    have any disease of the blood vessels, heart or brain (arteriosclerosis);

•    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.

If any of the above apply to you, or if you are not sure, tell your doctor before being treated with Ismelin.

Taking other medicines

Tell your doctor if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription.

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).

Taking Ismelin with food and drink

It is advisable not to drink alcohol whilst taking Ismelin as it may increase the effect of your medicine.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, please tell your doctor before being treated with Ismelin.

Driving and operating machinery

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.

3.    HOW ISMELIN WILL BE GIVEN

Ismelin is given by injection into the muscle.

The doctor will decide the dose of Ismelin which is best for you.

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 have

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 Ismelin can cause side effects, although not everybody gets them.

Common side effects of Ismelin include:

•    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;

•    blocked nose;

•    ejaculation disorders;

•    erectile dysfunction (including priaprism);

•    slow or irregular heart rate;

•    swelling (oedema).

Occasional side effects of Ismelin include:

•    blurred vision;

•    depression;

•    heart failure;

•    feeling sick, being sick;

•    dry mouth;

•    skin problems such as dermatitis.

AMDIPHARM

Rare side effects of Ismelin include:

•    muscle pain or shaking;

•    pain in your chest (angina);

•    asthma;

•    swollen glands;

•    hair loss.

Isolated cases of the following have also been reported:

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.

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.

Problems with penis erection (including prolonged and sometimes painful erection) have been reported.

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.

5.    HOW TO STORE ISMELIN

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.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

6.    FURTHER INFORMATION What Ismelin contains

Each ampoule contains 10 mg of the active substance guanethidine monosulphate in 1 ml of solution.

It also contains 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 responsible for release:

Amdipharm UK Limited,

Capital House,

85 King William Street,

London EC4N 7BL,

UK

This leaflet was last revised in June 2014