Isoket 1 mg/ml concentrate for solution for injection or infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• In this leaflet, Isoket 1 mg/ml concentrate for solution for injection or infusion will be called Isoket.

1. What Isoket is and what it is used for
2. What you need to know before you use Isoket
3. How to use Isoket
4. Possible side effects
5. How to store Isoket
6. Contents of the pack and other information

• You are allergic to isosorbide dinitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6)
• You suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
• You have had a brain haemorrhage (bleeding)
• You have had a head injury (head trauma) or raised intracranial pressure (high pressure within your skull)
• You have a low blood volume (hypovolaemia)
• You have very low blood pressure
• Your blood has stopped circulating around your body properly (circulatory failure)
• You have cardiogenic shock (your heart is not delivering enough oxygen around your body)
• You have constrictive pericarditis (inflammation of the sack-like covering of your heart)
• You have cardiac tamponade or hypertrophic obstructive cardiomyopathy (conditions which affect the ability of your heart to function as a pump)
• You have aortic or mitral valve stenosis (narrowing of the heart valves)
• You have an eye disease called glaucoma
• You take sildenafil (“Viagra”) or any other phosphodiesterase inhibitor.
• You take products that contain riociguat, a medicine used in treating pulmonary hypertension.

Talk to your doctor or nurse before using Isoket if:

• You have hypothyroidism (an underactive thyroid gland which can cause tiredness or weight gain)
• You are malnourished (severely underfed)
• You have liver or kidney disease
• You suffer from hypothermia (a very low body temperature)
• You have other heart problems or a family history of heart problems
• You suffer from orthostatic syndrome, (where you may have a rapid heart rate and light-headedness on standing)
• You have an abnormally low level of oxygen in the blood and impaired gas exchange due to lung disease or ischaemic heart disease

• Do not take Isoket with phosphodiesterase inhibitors such as sildenafil (“Viagra”) tadalafil, vardenafil, used for impotence. Using Isoket with these medicines could cause your blood pressure to fall to a dangerously low level.
• Do not take Isoket with products that contain riociguat.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including:

• Medicines to lower your blood pressure. They could increase the effect of Isoket and lower your blood pressure too much.
• Monoamine oxidase inhibitors (used to treat depression)
• Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety). These may also increase the effect of Isoket.
• Dihydroergotamine (used to treat migraine). This could increase your blood pressure too much.
• Sapropterin used for phenylketonuria (PKU).
• Any other medicine, including medicines obtained without a prescription.

Do not drink alcohol. It could increase the effect of Isoket and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.

Isoket may give you a headache, or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.

Isoket 1 mg/ml contains 3.54 mg/ml of sodium and may not be suitable for people on a controlled sodium diet. Tell your doctor or nurse before taking Isoket if this applies to you.

• When this medicine is given intravenously (injected into a vein), the usual dose will be between 2 mg and 12 mg per hour, although sometimes as much as 20 mg per hour is necessary.
• When used during surgical procedures on the heart the usual dose is 1 mg injected directly into the heart. Further doses may be given if your doctor thinks it necessary.

As this medicine is used in hospital, your heart beat (pulse) and blood pressure will be carefully monitored whilst you are being given Isoket. This is to make sure that your medicine is working properly and that the dose you are taking is right for you.

This medicine is not suitable for children.

As this medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much or too little.

An overdose of Isoket may cause your blood pressure to be too low resulting in paleness, sweating, weak pulse, fast heartbeat, light-headedness on standing, headache, weakness, dizziness, feeling sick, being sick and diarrhoea. If you have any concerns about this tell your doctor or nurse.

• Swelling of the face or throat, causing difficulty in breathing or wheezing
• Fainting or collapse
• Swelling or blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• dizziness
• drowsiness
• have a faster heart beat (tachycardia)
• weakness
• light-headedness on standing

Uncommon (may affect up to 1 in 100 people)

• feeling sick
• vomiting
• a reduced blood flow to the brain and heart, causing you to feel faint or dizzy
• symptoms of angina (chest pain) may be increased
• skin rash or flushing

Very rare (may affect up to 1 in 10,000 people)

• heartburn

Not known (frequency cannot be estimated from the available data)

red or scaly skin (exfoliate dermatitis)

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:

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is isosorbide dinitrate. Isoket 1 mg/ml contains 1 mg of isosorbide dinitrate in each ml of solution.
• The other ingredients are sodium chloride, water for injections and hydrochloric acid and sodium hydroxide for pH adjustment.

Isoket is a concentrate for solution for infusion and injection. It is a clear solution.

In Ireland

Isoket 1 mg/ml comes in 10 ml glass ampoules.

Each ampoule contains 10 mg of isosorbide dinitrate in 10 ml of solution.

In the UK

Isoket 1 mg/ml comes in 10 ml glass ampoules.

Each ampoule contains 10 mg of isosorbide dinitrate in 10 ml of solution.

Ireland

United Kingdom