PATIENT INFORMATION LEAFLET Eudemine Injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Eudemine Injection is and what it is used for
2. Before you are given Eudemine Injection
3. How Eudemine Injection is given
4. Possible side effects
5. How to store Eudemine Injection
6. Further information
1. WHAT EUDEMINE INJECTION IS AND WHAT IT IS USED FOR
Eudemine Injection is known as a Benzothiadiazine analogue, which is a drug that lowers blood pressure. Eudemine Injection is given for the treatment or control of severely high blood pressure.
2. BEFORE YOU ARE GIVEN EUDEMINE INJECTION DO NOT USE Eudemine Injection if:
• you know that you are allergic to Diazoxide or to any other ingredients (see section 6 of this leaflet) or to any other medicines for lowering blood pressure. Speak to your doctor before you are given this injection if this applies to you.
Take special care and tell your doctor if you have already been told that:
• the blood supply to your brain is reduced.
• your general blood circulation is reduced, e.g. when you have severe blood loss or are dehydrated.
• you are having sodium and water retention problems (causing swelling of ankles).
• you have decreased potassium levels.
• your plasma proteins may be at a lower level than normal.
• you have kidney or heart disorders.
• you have high blood sugar levels.
Many of these are technical problems and your doctor should already know if any apply to you. However, tell your doctor before you are given this injection if you recognize that any of them apply to you. Remember that if you are in doubt about anything, your doctor will be able to advise you.
Tell your doctor before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
A number of drugs can interact with Eudemine Injection which can significantly alter their effects. These drugs include:
• Any other medicines to lower your blood pressure, including water tablets.
• Any anticoagulant drugs (drugs to prevent your blood clotting) such as warfarin.
• Phenytoin, for the prevention of fits.
• Steroid hormones (e.g corticosteroids)
• Combined oestrogen/progestogen drugs (e.g oral contraceptive pills)
If you are already taking any of these medicines, speak to your doctor before you receive Eudemine Injection.
Tell your doctor before you are given this medicine if you are or think you may be pregnant or are planning to become pregnant, or are breast-feeding. As with all drugs, this medicine should only be given in pregnancy and when breast feeding if absolutely necessary.
Driving and using machines
Eudemine may cause some patients to feel light-headed which could interfere with the ability to drive or to operate machines. If you notice any effect, do not drive or operate machinery and ask your doctor for advice.
Important information about some of the ingredients of Eudemine Injection
This medicinal product contains less than 1mmol sodium (23mg) per 20ml, i.e. is essentially
You will have to lie down to be given Eudemine Injection and your blood pressure will be measured every few minutes. You will also have to lie still so that the injection goes into a vein. If it goes outside a vein, it could cause irritation to the tissues.
• This injection will be given into a vein by means of a needle and syringe or a small tube (cannula) which can be used for other intravenous injections. The injection will last for about half a minute.
• The usual adult dose is one ampoule (300mg Diazoxide in 20ml of solution), but half this dose may be enough to lower your blood pressure adequately. This blood pressure lowering effect occurs within five minutes and usually lasts for at least four hours. You may need a further injection or more injections, but not more than four injections of 300mg Diazoxide will be given to you in 24 hours. Rarely the first dose may be two ampoules (600mg Diazoxide).
•On rare occasions when Eudemine Injection is used to treat children, the dose level is 5mg Diazoxide for every kilogram of body weight.
• Your blood pressure will be measured every few minutes and your blood will be tested for sugar periodically.
• During long term treatment your blood will be tested for changes in the blood cells.
• In a child, growth and bone development, and psychological tests will be assessed.
• You may be given other medicines to lower your blood pressure so that the effect of this injection is maintained.
If your blood pressure falls too low after receiving this injection, you may be given other medicines to balance this effect.
As the injection will be administered under the supervision of a doctor, it is unlikely that you will be given more than is necessary. However, if you have any concerns about the dose of your medicine discuss them with your doctor.
If you have any further questions on the use of this product ask your doctor or pharmacist.
Like all medicines Eudemine Injection can sometimes cause side-effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
Other side effects may include:
• Increased heart rate.
• Light-headedness, due to lowering of your blood pressure.
• Excessive growth of body hair, particularly in females.
• Sodium and water retention (may cause ankle swelling). This may require drug treatment.
• Raised blood sugar (shown by blood tests). This is almost inevitable with this medicine and may require treatment.
• Loss of consciousness (coma).
• Enlargement of your heart (shown on X-ray).
• Changes in your blood cells (causing you to bruise easily and develop infections).
If you are female and in labour, the delivery of your baby may become delayed, which may require drug treatment.
Your doctor will be looking to see if you develop any of these side effects. However, if you become aware of any of these side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor at once.
Keep out of reach and sight of children.
The medicine must not be used after the expiry date printed on the pack.
Do not store above 25°C.
Keep the ampoules in the outer carton in order to protect from light.
If you have any questions about this medicine ask your doctor or nurse.
The active substance is Diazoxide. There is 300mg of Diazoxide in each 20ml ampoule (small glass bottle).
The other ingredients are sodium hydroxide and water for injections.
Eudemine Injection is a colourless solution presented in 20ml glass ampoules.
Each 1ml sterile solution for injection contains Diazoxide 15mg.
There are 5 ampoules packed in to a cardboard box
Capital House, 85 King William Street, London EC4N 7BL, UK Trading as Mercury Pharmaceuticals.
Recipharm Limited, Vale of Bardsley, Ashton-under- Lyne, OL7 9RR, Lancashire, UK. This leaflet was last revised in: December 2013.