ISOket 1 mg/ml_

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Isosorbide Dinitrate 50 ml bottle

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Patient Information Leaflet

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.

•    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.

•    In this leaflet, Isoket 1 mg/ml concentrate for solution for injection or infusion will be called Isoket.

In this leaflet:

1.    What Isoket is for

2.    Before you use Isoket

3.    How to use Isoket

4.    Possible side effects

5.    How to store Isoket

6.    Further information.

I.What Isoket is for

Isoket belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Isoket is used to treat heart failure (heart problems that can cause shortness of breath or ankle swelling) and angina pectoris.

Angina usually feels like a tight pain in the

chest, neck or arm area.

It is also used sometimes during surgical

procedures on the heart.

2. Before you use Isoket

Do not use Isoket if:

•    You are allergic to isosorbide dinitrate, other nitrates or any of the other ingredients of Isoket (see 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 the 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.

If any of the above applies to you talk to

your doctor or pharmacist.

Check with your doctor 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)

Taking other Medicines

•    Do not take Isoket with phosphodiesterase inhibitors such as Sildenafil (“Viagra”) used for impotence . Using Isoket with

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these medicines could cause your blood pressure to fall to a dangerously low level.

Tell your doctor if you are taking any of the following medicines:

•    Medicines to lower your blood pressure. They could increase the effect of Isoket and lower your blood pressure too much.

•    Tricyclic antidepressants (used to treat depression) and neuro-leptics (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.

•    Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you, talk to your doctor or nurse.

Using Isoket with food and drink

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.

| ISOket 1 mg/ml_

concentrate for I solution for injection i or infusion

Isosorbide Dinitrate | 50 ml bottle

I ISOket® 1 mg/ml_

I concentrate for solution for injection | or infusion

. Isosorbide Dinitrate ' 10 ml ampoule

The following information is intended for medical or healthcare professionals only.

It supplements the information provided above in section 3.

Posology and Method of Administration

Adults, including the elderly Intravenous route

A dose of between 2 mg and 12 mg per hour is usually satisfactory. However, dosages up to 20 mg per hour administered should be adjusted to the patient response.

Intra-coronary Route

The usual dose is 1 mg given as a bolus injection prior to balloon inflation. Further doses maybe given not exceeding 5 mg within a 30 minute period.

Children

The safety and efficacy of Isoket has not yet been established in children.

Administration:

Isoket is a concentrated solution and must be diluted prior use. The diluted solution should never be injected directly in the form of a bolus except via the intracoronary route prior to balloon inflation.

A dilution of 50% is advocated for intracoronary administration.

Isoket can be administered as an intravenous admixture with a suitable vehicle, see below.

Prepared Isoket admixtures should be given by intravenous infusion or with the aid of a syringe pump incorporating a glass or rigid plastic syringe. During administration the patient’s blood pressure and pulse should be closely monitored. Once diluted chemical and physical in-use stability for 24 hours at 2-8°C has been demonstrated. From a microbiological point of view, the product must be used immediately once opened/diluted. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. Open ampoules or bottles should be used immediately and any unused drug discarded.

Incompatabilities

Isoket contains isosorbide dinitrate in isotonic solution and is compatible with commonly employed infusion fluids, such as sodium chloride solution, 5-30% glucose solution, Ringer’s solution and solutions containing albumin. No incompatibilities have so far been demonstrated.

Isoket is compatible with glass infusion bottles and infusion packs made from polyethylene (PE), polypropylene (PP) or polytetrafluoroethylene (PTFE).

Isoket may be infused slowly using a syringe pump with glass or plastic syringe. Polyvinyl chloride (PVC) or polyurethane (PU) giving sets and containers should not be used since significant losses of the active ingredient by adsorption occur and it has not been verified how the dose can be adjusted to suit the patient’s needs to account for this adsorption.

Example of admixture preparation

To obtain a dose of 6 mg per hour, add 50 ml of Isoket 1 mg/ml to 450 ml of a suitable vehicle, under aseptic conditions.

The resultant admixture (500ml) contains 100 pg/ml (1mg/10ml) isosorbide dinitrate. An infusion rate of 60ml per hour (equivalent to 60 paediatric microdrops per minute or 20 standard drops per minute) will deliver the required dose of 6mg per hour.

Should it be necessary to reduce fluid intake, 100ml of Isoket 0.1% may be diluted to 500ml using a suitable vehicle. The resultant solution now contains 200 pg/ml (2mg/10ml) isosorbide dinitrate. An infusion rate of 30ml per hour (equivalent to 30 paediatric microdrops per minute or 10 standard drops per minute), will deliver the required dose of 6 mg per hour.

A dilution of 50% is advocated to produce a solution containing 0.5 mg/ml where fluid intake is strictly limited.

Rev. November 201 3

Adults

•    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.

Children

This medicine is not suitable for children.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you think you have been given too much Isoket

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 heart beat, 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.

4.    Possible side effects

Like all medicines Isoket can cause side effects, although not everybody gets them.

•    headache

•    feeling sick

•    have a faster heart beat (tachycardia)

•    A reduced blood flow to the brain and heart, causing you to feel faint or dizzy.

•    drowsiness

•    weakness

•    light-headedness on standing

•    fainting.

•    symptoms of angina (chest pain) may be increased.

•    skin rash or flushing,

•    heartburn

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Isoket

Keep out of the reach and sight of children. Do not use Isoket after the expiry date on the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions when it is unopened. Once opened the product should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6. Further information

What Isoket contains

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.

What Isoket looks like

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 and 50 ml glass bottles.

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

Each bottle contains 50 mg of isosorbide dinitrate in 50 ml of solution.

In the UK

Isoket 1 mg/ml comes in 10 ml glass ampoules and 50 ml & 100 ml glass bottles.

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

The bottles contain either 50 mg of isosorbide dinitrate in 50 ml of solution or 100 mg isosorbide dinitrate in 100 ml of solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Schwarz Pharma Ltd, 5 Hercules Way, Leavesden Park, Watford, WD25 7GS, UK

Manufacturer

Aesica Pharmaceuticals GmbH, Alfred-Nobel-StraRe 10,

40789 Monheim, Germany

This leaflet was last updated June 2014.

If this leaflet is difficult to see or read or you would like it in a different format, please contact Schwarz Pharma Ltd, 5 Hercules Way, Leavesden Park, Watford, WD25 7GS, UK

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