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GUANETHIDINE MONOSULPHATE AMPOULES 10 MG/ML

Active substance(s): GUANETHIDINE SULPHATE / GUANETHIDINE SULPHATE

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075-0315-APIL

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.

®

Ismelin Ampoules 10 mg / ml
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 for you. 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.

Ismelin is not recommended for use in children

In this leaflet:
1. What Ismelin is and what it is used for
2. Before you are given Ismelin
3. How Ismelin will be given
4. Possible side effects
5. How to store Ismelin
6. Further information

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.

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 not 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

Take special care with Ismelin if you:
• have asthma;
• have any other form of kidney problems;
• 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 any of the above apply to you, or if you are not sure,
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 dizzy. 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 with 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.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines Ismelin can cause side effects, although
not everybody gets them.

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).

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;
• slow or irregular heart rate;
• swelling (oedema).

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).

Occasional side effects of Ismelin include:
• blurred vision;
• depression;
• heart failure;
• feeling sick, being sick;
• dry mouth;
• skin problems such as dermatitis.

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).

Amdipharm QC Sign off
Confirmation that this artwork has been
checked in line with technical requirements.

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,
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.
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 Plc,
Regency House,
Miles Gray Road,
Basildon,
Essex SS14 3AF
Date of leaflet April 2008

REGULATORY AUTHORITY APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by the
appropriate market authority (if applicable, e.g. MHRA, IMB,
etc and that Amdipharm have license approval to distribute
this component for sale in the relevent market.

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Signature.............................................................................
Name....................................................................................
Date......................................................................................

JOB NO:
Originator:

Date: 30.11.08
Colours Used:

BLK

FINISHED SIZE 160 x 240

PRODUCT NAME: Ismelin

ARTWORK SCALE 100%

1012
Brian McCombe

COMPONENT: PIL
PIP CODE:

075-0315-APIL

FONT SIZE 9.5pt
VERSION: 3

MEDIA TECH
one stop solution

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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