Iloprost Waymade 20 micrograms/ml – patient leaflet, side effects, dosage

1. What Iloprost Waymade is and what it is used for

Iloprost Waymade contains the active ingredient iloprost which imitates a natural substance in the body called prostacyclin. Iloprost Waymade and prostacyclin prevent unwanted blockages or narrowing of blood vessels and allow improved blood flow in the arteries.

Iloprost Waymade 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 Waymade is used in adults in the treatment of:

• Severe chronic ischaemia of lower limbs (decreased blood supply) in patients at risk of amputation, in whom surgical revascularisation or angioplasty (repair of blood vessel) has failed or is not indicated, following the meeting of physicians, surgeons and radiologists. • Severe Raynaud's phenomena (reduced blood flow to fingers and toes) in patients with progressive trophic disorders

2. What you need to know before you use Iloprost Waymade

Do not use Iloprost Waymade if you:

• have hypersensitivity (allergy) to iloprost or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”)
• are at increased risk of bleeding – for example, if you have an active gastric (stomach) or duodenal ulcer, bleeding from wounds or had bleeding inside the skull • have suspected fluid build-up in the lungs (pulmonary oedema) accompanied by difficulty in breathing
• had a heart attack within the last six months • have an irregular heart rate
• have poor blood flow to the heart muscle (severe coronary artery disease or unstable angina)
• are suffering with angina or chest pain • had an acute or chronic congestive heart failure
• have congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
• had a stroke in the past 3 months • are pregnant or breast feeding

Warnings and precautions

Talk to your doctor before using Iloprost Waymade if you:

• require urgent amputation. Surgery should not be delayed if you need urgent amputation (e.g. in case of infected gangrene). • are a smoker. You should stop smoking. • have liver problems or severe kidney problems, tell your doctor. You may be prescribed a lower dose of Iloprost Waymade and your doctor will monitor you closely. • have low blood pressure, care should be taken so as not to further reduce blood pressure (hypotension).
• have severe heart disease, you will be monitored closely.

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 Waymade is infused in the veins this can lead to local changes at the injection site due to extravasation.

If Iloprost Waymade comes into contact with your skin:

Iloprost Waymade solution 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.

This medicine contains 1.62 mg of alcohol (ethanol) in each ampoule which is equivalent to 1.62 mg/ml. The amount in 1 ml of this medicine is equivalent to less than 0.0405 ml beer or 0.0162 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

Other medicines and Iloprost Waymade Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Iloprost Waymade and some other medicines may affect each other in the way they work in your body. Take special care to mention any of the following:

• Medicines used to treat high blood pressure or heart disease (e.g.

  beta-blockers, calcium channel blockers, ACE inhibitors and vasodilators). Your blood pressure may drop much further. Tell your doctor if you are taking any of these. He/she may change the dose of Iloprost Waymade you should take.

• Medicines that thin the blood or inhibit blood clotting (e.g Aspirin® or acetylsalicylic acid, ticlopidine, clopidogrel, NSAIDs, phosphodiesterase inhibitors, heparin). The risk of bleeding may be increased. If you suffer from bleeding, treatment with Iloprost Waymade should be discontinued.

  Pregnancy, breast-feeding and fertility

  Iloprost Waymade is not indicated for pregnant or breast-feeding 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 using this medicine. Women of childbearing potential have to use effective contraception during treatment.

  Driving and using machines

  Iloprost Waymade 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.

3. How to use Iloprost Waymade

Iloprost Waymade should be used only under strict monitoring in hospitals or outpatient clinics with adequate facilities. Your doctor will be able to tell you what dose you are receiving and how often you should take it. If you are in doubt, ask your doctor or healthcare professional. Only the doctor can change the dose.

How Iloprost Waymade is prepared for administration

Iloprost Waymade is a solution contained in a glass ampoule. The content of the ampoule is diluted with 0.9% physiological sodium chloride solution or a 5% glucose solution. The infusion solution should be prepared just before the infusion daily, to ensure sterility. The content of the ampoule and the diluent must be mixed thoroughly. Iloprost Waymade 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.

How Iloprost Waymade is given

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 Waymade 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 ng iloprost/kg body weight/min. Your blood pressure and heart rate will be measured at the start of the infusion and after every dose increase.

How much Iloprost Waymade is given

During the first 2-3 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 ng/kg/min for 30 minutes. The dose should then be increased at intervals of 30 minutes in steps of 0.5 ng/kg/min up to 2.0 ng/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 ng/kg/min (see tables below for use with infusion pump or syringe driver).

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 Waymade will be infused intravenously by an infusion pump or with syringe driver. If Iloprost Waymade is administered with an infusion pump, it will be diluted before infusion to a final concentration of 0.2 micrograms/ml. If Iloprost Waymade is administered with a syringe driver, it will be diluted before infusion to a final concentration of 2 micrograms/ml.

If you have renal failure 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.

How long Iloprost Waymade is given:

The duration of treatment is up to 4 weeks.

The safety and efficacy of Iloprost Waymade have not been studied for treatment longer than 4 weeks or after repetitive treatment 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 Waymade is too strong or too weak, tell your doctor or pharmacist.

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

If you use more Iloprost Waymade than you should:

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 you stop using Iloprost Waymade:

If the infusion therapy with Iloprost Waymade is discontinued, your doctor will take care to restore the changes that might have been made to other medicines you take, due to Iloprost Waymade administration (e.g. dose reductions).

4. Possible side effects

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:

• Cerebrovascular event (stroke)
• Myocardial infarction (heart attack) Approved for submission

UK 676-2546-02

• Pulmonary embolism (difficulties breathing or chest pain when breathing due to blood clot in the lung)
• Heart failure
• Convulsions
• Hypotension (abnormally low blood pressure)
• Tachycardia (fast heart rate)
• Asthma
• Angina pectoris (chest pain or discomfort due to insufficient blood flow to the heart)
• Dyspnoea (difficulty breathing)
• Pulmonary oedema (difficulty breathing or coughing blood due to fluid buildup in the lung)

The most common side effects observed in patients taking Iloprost Waymade 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.

Possible side effects are listed below according to their frequency:

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Apathy
• Confusional state
• Dizziness/vertigo (feeling of ‘spinning’)

• Paraesthesia (numbness and

  tingling)/palpitations/hyperesthesia (increased sensitivity to pain or touch)/ Burning sensation

• Restlessness/Agitation
• Sedation
• Drowsiness
• Tachycardia (fast heart rate)
• Bradycardia (slow heart rate)
• Angina pectoris (chest pain or discomfort due to insufficient blood flow to the heart)
• Hypotension (abnormally low blood pressure)
• Blood pressure increased
• Dyspnoea (difficulty breathing)
• Diarrhoea
• Abdominal discomfort/abdominal pain
• Pain in jaw/trismus (jaw spasm, locking jaw)
• Myalgia (muscle pain)/arthralgia (joint pain)
• Pain
• Fever/body temperature increased
• Asthenia (weakness)/malaise (feeling of major weakness)
• Chills
• Fatigue
• Thirst
• Infusion site reactions such as infusion site erythema, infusion site pain or infusion site phlebitis (vein irritation)

Uncommon (may affect up to 1 in 100 people)

• Thrombocytopenia (blood disorder characterized by easy bruising or bleeding)
• Hypersensitivity (allergy)
• Anxiety, depression, hallucination
• Syncope (short loss of consciousness)
• Tremor (trembling or shaking)
• Migraine
• Blurred vision
• Eye irritation
• Eye pain
• Arrhythmia/extrasystoles (abnormal heart rate)
• Deep vein thrombosis (pain in the legs due to a blood clot in the blood vessels of the legs)
• Haemorrhagic diarrhoea (diarrhoea with blood in stools)
• Rectal haemorrhage
• Dyspepsia (heartburn or stomach pain)
• Rectal tenesmus (pain due to constipation)
• Constipation
• Dysphagia (difficulty swallowing)
• Dry mouth
• Dyspepsia (sense of taste disorder)
• Liver disorder (hepatic impairment)
• Jaundice (yellowing of the skin and white of the eye and/or itching due to hepatic disorder)
• Pruritus (itching)
• Tetany (prolonged painful muscle spasm), muscle spasms
• Hypertonia (increased muscle tension)
• Kidney pain
• Vesical tenesmus (failed urinary urgency)
• Abnormal urine
• Dysuria (painful urination or difficulty urinating)
• Urinary tract disorder

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

• Vestibule disorders
• Cough
• Proctitis (rectal irritation)

Iloprost may cause chest pain or discomfort due to angina pectoris, especially in patients with coronary artery disease.

The risk of bleeding is increased in patients when inhibitors of platelet aggregation, heparin or anticoagulants of the coumarin-type are given concomitantly.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:

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.

5. How to store Iloprost Waymade

Once opened and diluted, the product should be used immediately.

From a microbiological point of view, the diluted solution for infusion should be used immediately. 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°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice visible particles or unclear solution.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Iloprost Waymade contains

The active substance is iloprost.

Each ampoule of 1 ml of solution contains 20 micrograms of active substance. The other ingredients are trometamol, ethanol (96% v/v), sodium chloride, hydrochloric acid (for pH adjustment), water for injection.

What Iloprost Waymade looks like and contents of the pack

Iloprost Waymade is a colourless, clear solution free of visible particles.

Iloprost Waymade is available in glass type I, colourless, ampoules containing 1 ml of concentrate for solution for infusion. Iloprost Waymade is available in the following presentations:

• 1 pack of 1 ampoule containing 1 ml of concentrate for solution for infusion;
• 1 pack of 5 ampoules, each containing 1 ml of concentrate for solution for infusion;
• 1 pack of 20 ampoules (4 x 5), each containing 1 ml of concentrate for solution for infusion.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Waymade Plc

Sovereign House

Miles Gray Road, Basildon,

Essex, SS14 3FR,

United Kingdom

Manufacturer

Vianex S.A.

MetamorfosiTo Athina - Lamia N.r. (lamia) 12 Km,

Metamorfossi,

144 51, Greece

This leaflet was last revised in March 2025

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The following information is intended for medical and healthcare professionals only: Iloprost Waymade should be used only after dilution. The following sections provide more information to your doctor when using an infusion pump or a syringe driver for the administration of Iloprost Waymade.

Infusion rates (ml/hour) for different doses using an infusion pump

In general, the ready-to-use infusion solution is infused intravenously by means of an infusion pump (e.g. Infusomat^®).

In case of an Iloprost Waymade concentration of 0.2 micrograms /ml, the required infusion rate should be determined according to the below described scheme to reach a dose within the range of 0.5 to 2.0 ng/kg/min.

The following table can be used to calculate the infusion rate corresponding to the individual weight of the patient and the dose to be infused. Match the patient's actual body weight on the table, then set the infusion rate based on the desired dose in ng/kg/min.

Infusion rates (ml/hour) for different doses using a syringe driver

A syringe driver with a 50 ml injection syringe (e.g. Perfusor®) may also be used to infuse Iloprost Waymade.

In case of an Iloprost Waymade concentration of 2 micrograms/ml, the required infusion rate must be determined according to the below described scheme, to reach a dose within the range of 0.5 to 2.0 ng/kg/min.

The following table can be used to calculate the infusion rate corresponding to the individual weight of the patient and the dose to be infused. Match the patient's actual body weight on the table, then set the infusion rate based on the desired dose in ng/kg/min.

Due to possible interactions, no other medicinal product should be added to the ready-to-use solution for infusion.

In order to ensure sterility, the ready-to-use solution for infusion should be prepared every day.

Instructions for handling:

The ampoule contents and diluent must be thoroughly mixed.

Dilution of Iloprost Waymade with an infusion pump.

The contents of 1 ml Iloprost Waymade (i.e. 20 micrograms) is diluted with 100 ml sterile physiological sodium chloride solution or a 5% glucose solution.

Each 1 ml of the diluted solution for use in an infusion pump contains 0.2 micrograms of iloprost.

Dilution of Iloprost Waymade with an infusion syringe pump.

The contents of 1 ml Iloprost Waymade (i.e. 20 micrograms) must be diluted with 10 ml sterile physiological sodium chloride solution or 5% glucose solution.

Each 1 ml of the diluted solution for use in an injector contains 2.0 micrograms of iloprost.