The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/1044.
Iloprost Zentiva 100 micrograms/ml concentrate for solution for infusion
Iloprost 100 micrograms/ml concentrate for solution for infusion
(as iloprost trometatmol)
1. What Iloprost is and what it is used for
2. What you need to know before you use Iloprost
3. How to use Iloprost
4. Possible side effects
5. How to store Iloprost
6. Contents of the pack and other information
The name of this medicine is Iloprost 100 micrograms / ml concentrate for solution for infusion called Iloprost throughout this leaflet. It contains the active ingredient iloprost which imitates a natural substance in the body called prostacyclin. Iloprost and prostacyclin prevent unwanted blockages or narrowing of blood vessels and allow improved blood flow in the arteries.
Iloprost promotes the healing of wounds caused by insufficient blood flow (ischemia) by providing better oxygenation, and relieving pain in severe, chronic disorders of the blood circulation.
Iloprost is used in adults in the treatment of:
If you think that any of the above applies to you, talk to your doctor.
Talk to your doctor before Iloprost is given to you if you:
After administration, when moving from a lying to upright position, your blood pressure may fall. This can make you feel dizzy for a while until your blood pressure returns to normal values (this is called ‘orthostatic hypotension’). Stand up slowly when you get out of bed. This will help your body get used to this change in position and blood pressure.
If undiluted Iloprost is infused in the veins, this may lead to local changes at the injection site due to extravasation.
If Iloprost comes into contact with your skin or eyes:
This medicine should not come into contact with your skin or eyes. On contact with the skin, iloprost may cause long-lasting but painless redness of the skin (erythema). In the event of such contact, wash immediately the skin or the eyes with water or saline.
The safety and efficacy of iloprost in children aged up to 18 years have not been established.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Iloprost and some other medicines may affect each other in the way they work in your body. Tell your doctor if you are taking:
Iloprost is not indicated for pregnant or breastfeeding women.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you.
This medicine must not be used during pregnancy or while breast-feeding.
Women of childbearing potential have to use effective contraception during treatment.
Iloprost lowers blood pressure and may cause dizziness or light-headedness in some people.
Do not drive or operate any tools or machines if you feel these effects.
Important information about some of the ingredients of Iloprost Ethanol This medicine contains 8.10 mg of alcohol (ethanol) in each ml of the concentrate. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains 7.08 mg sodium in 1 ml of the concentrate, that is to say essentially “sodium-free”.
Iloprost should only be used under strict monitoring in hospitals or in out-patient clinics with adequate facilities.
Iloprost concentrate for solution for infusion is NOT ready to use and requires dilution before administration.
Iloprost is a solution contained in a glass ampoule. The content of the ampoule is diluted with physiological saline solution or a 5% glucose solution. The infusion should be prepared just before it is administered to ensure sterility.
The content of the ampoule and the diluent must be mixed thoroughly.
Iloprost must be used only after dilution. For further information for physicians or healthcare professionals on the preparation of the dilution see section “The following information is intended for medical and healthcare professionals only” at the end of this leaflet.
The solution is infused intravenously with a venous catheter directly into one of the veins in your arm or into a central intravenous catheter inserted into a vein near your neck.
Iloprost is administered as infusion over 6 hours daily.
The dose is adjusted according to individual tolerability within the range of 0.5 to 2.0 nanograms iloprost/kg body weight/min. iloprost/kg/min.
Your blood pressure and heart rate will be measured at the start of the infusion and after every dose increase.
During the first 2 to 3 days, the individually tolerated dose is established. For this purpose, your doctor will start the treatment at a low dose. Treatment should be started at an infusion rate of 0.5 nanograms/kg/min for 30 minutes. The dose should then be increased at intervals of 30 minutes in steps of 0.5 nanograms/kg/min up to a maximum of 2.0 nanograms/kg/min. The exact infusion speed should be calculated on the basis of body weight to reach an infusion within the range of 0.5 to 2.0 nanograms/kg/min.
If adverse effects occur, such as headache and nausea or an undesirable drop in blood pressure, tell your doctor immediately. The infusion rate should be reduced until the tolerable dose is found. If the adverse effects are severe, the infusion should be interrupted. For the remaining duration, the treatment should be continued with the dose found to be tolerated in the first 2 to 3 days.
The doctor will determine whether Iloprost will be infused intravenously by an infusion pump or with an injector. If Iloprost is administered with an infusion pump, it will be diluted before infusion to a final concentration of 0.2 micrograms/ml.
If Iloprost is administered with an injector, it will be diluted before infusion to a final concentration of 2 micrograms/ml.
If you have kidney problems requiring dialysis or liver cirrhosis, iloprost elimination is reduced and a dose reduction (e.g. half the recommended dose) is necessary. Tell your doctor if you have problems with your liver or kidneys.
The duration of the treatment is up to 4 weeks.
The safety and efficacy of Iloprost has not been studied for treatment for longer than 4 weeks or after repetitive cycles.
Continuous infusion over several days is not recommended, because it can lead to reduced effect on platelets and increased platelet aggregation (platelet hyperaggregability) at the end of treatment. No clinical complications associated with these phenomena have been reported.
If you feel that the effect of Iloprost is too strong or too weak, tell your doctor.
Drop in blood pressure (hypotensive reaction) can be expected, as well as headache, redness of the face (flushing), nausea, vomiting and diarrhoea. An increase in blood pressure, reduced or increased heart rate and limb or back pain may also occur.
No specific antidote is known.
In case of overdose, your doctor is advised to discontinue infusion of iloprost, to monitor you and treat your symptoms.
If the infusion therapy with Iloprost is discontinued, your doctor will take care to restore the changes that might have been made to other medicines you take, due to Iloprost administration (e.g. dose reductions).
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most severe side effects which have been reported as having a fatal or life-threatening effect in patients taking iloprost are:
The most common side effects observed in patients taking Iloprost include headache, flushing (redness of the face), hyperhidrosis (sweating) and gastrointestinal symptoms, such as nausea and vomiting. These side effects are likely to occur during the dose titration at the start of treatment to identify the best tolerable dose for the individual patient. However, all these side effects usually disappear quickly with dose reduction.
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Iloprost may cause chest pain or discomfort due to angina pectoris, especially in patients with coronary disease.
The risk of bleeding is increased in patients when inhibitors of platelet aggregation, heparin or anticoagulants of the coumarin type are given concomitantly.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not freeze.
After opening and dilution; chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless the dilution has taken place in controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the carton and ampoule label, after EXP.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
Clear and colourless solution free of visible particles.
Clear Type I glass 1 ml ampoule, in a PVC blister and paper folding carton.
Pack sizes: 1 ampoule and 5 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in May 2022