20 micrograms / mL concentrate for infusion solution
iloprost

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Ilomedin is and what it is used for
2. What you need to know before you receive Ilomedin
3. How to get Ilomedin
4. Possible side effects
5. How to store Ilomedin
6. Contents of the packaging and other information

1. What Ilomedin is and what it is used for

Ilomedin mimics a naturally occurring substance in the body called prostacyclin. It inhibits unwanted blockage or narrowing of blood vessels and thus improves microcirculation in tissues with poor blood circulation.

Ilomedin is used to treat severe chronic peripheral circulatory insufficiency (insufficient blood circulation), where there is a risk of amputation and where vascular surgery or radiological treatment is not possible or can not be used for other medical reasons.

2. What you need to know before you receive Ilomedin

Do not use Ilomedin

Do not use Ilomedin if you have any of the conditions listed below.

  • If you are allergic to iloprost or any of the other ingredients of Ilomedin.
  • If you have an increased risk of bleeding – e.g. an active stomach ulcer , bodily injury or other bleeding.
  • If you have an accumulation of fluid in your lungs, that makes it difficult to breathe.
  • If you are pregnant or breastfeeding.
  • If you have or have had a heart problem, for example:
    • a heart attack in the last six months
    • severe heart rate disorders
    • poor blood flow to the heart muscle (severe coronary heart disease or unstable angina ). Symptoms of this can be chest pain
    • if you have acute or chronic heart failure .

If you think any of these apply to you, tell your doctor.

Warnings and cautions

Take special care with Ilomedin

  • if you have low blood pressure
  • if you have liver problems or have very severe kidney problems, your doctor may prescribe a lower dose of Ilomedin than other patients
  • When you get up after an infusion , you may experience a drop in blood pressure, which makes you feel dizzy for a short while until your blood pressure returns to normal . Therefore, get up slowly. In this way, you help the body get used to the change in posture and blood pressure
  • if you have had a stroke in the last 3 months, or any other disruption in blood flow to the brain.

Other medicines and Ilomedin

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Be especially careful to tell if you are taking any of the following:

  • drugs used to treat high blood pressure or heart disease.
  • drugs that inhibit blood coagulation e.g. warfarin , heparin , acetylsalicylic acid (a substance found in many medicines that have antipyretics and painkillers), NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic drugs).
  • drugs containing phosphodiesterase inhibitors e.g. sildenafil, tadalafil, vardenafil.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Ilomedin is not intended for use by pregnant women

  • If you are pregnant or think you may be, talk to your doctor straight away. Pregnant women are not allowed to take Ilomedin.
    • Women of childbearing potential should use a reliable method of contraception from the start of treatment and at all times (consult your doctor).

Ilomedin is not for breastfeeding women
Stop breastfeeding when you start treatment with Ilomedin. Breast-feeding women should not take Ilomedin because it is not known whether the active substance is transmitted through milk.

Driving and using machines

Ilomedin lowers blood pressure and may cause dizziness in some people. Do not drive or use any tools or machines if you feel such effects of low blood pressure.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ilomedin contains excipients

Ilomedin contains ethanol and sodium

This medicine contains 1.62 mg alcohol ( 96% ethanol ) per ml. The amount in 1 ml of this medicine corresponds to less than 0.04 ml of beer or 0.02 ml of wine.

The low amount of alcohol in this medicine does not produce any noticeable effects.

This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free.

3. How to get Ilomedin

Ilomedin should only be given under close supervision, in a hospital with adequate equipment.
Use and dosage are determined by your doctor

The treatment time is 6 hours/day for a maximum of 4 weeks.

If you take more Ilomedin than you should

If you may have an overdose, your doctor will stop the treatment and treat the symptoms.

4. Possible side effects

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

The most common side effect is (can occur in 1 or more of 10 patients) in patients receiving iloprost are headache, flushing (flushing), hyperhydrosis (sweating), and gastrointestinal symptoms such as nausea and vomiting. These side effects usually occur at the beginning of treatment when the dose is adjusted to find the most appropriate dose for the individual patient. However, all of these side effects usually go away quickly if you reduce the dose.

The most serious adverse reactions, for which a life-threatening or fatal outcome has been observed in patients treated with iloprost, are :

Common (may affect 1 to 10 users in 100)

  • hypotension (abnormally low blood pressure )
  • tachycardia (increased heart rate)
  • angina (chest pain or pressure over the chest caused by insufficient blood flow to the heart)
  • dyspnoea (difficulty breathing)

Uncommon (may affect 1 to 10 users in 1,000)

  • cerebrovascular injury ( stroke )
  • heart attack (heart attack)
  • Pulmonary embolism (breathing difficulties or chest pain when inhaled caused by a blood clot in the lungs)
  • heart failure
  • seizures
  • asthma
  • pulmonary edema (difficulty breathing or blood clots caused by fluid accumulation in the lungs).

If any of the above serious side effects occur, treatment with Ilomedin should be stopped.

Other possible side effects are listed below according to how often they occur:

Common (may affect 1 to 10 users in 100)

  • decreased appetite
  • indifference
  • state of confusion
  • dizziness / vertigo (feeling of spinning)
  • paresthesia (numbness and tingling / throbbing sensation / hyperesthesia (increased sensitivity to pain or pressure) / burning sensation
  • restlessness / anxiety
  • silence
  • somnolence
  • bradycardia (decreased heart rate)
  • increased blood pressure
  • diarrhea
  • abdominal discomfort / abdominal pain
  • jaw pain / trismus (difficult to open mouth)
  • myalgia (muscle pain) / arthralgia (joint pain)
  • pain
  • fever / increased body temperature
  • feeling of warmth
  • asthenia (weakness) / general malaise
  • overindulge
  • fatigue / drowsiness
  • thirst
  • reactions at the infusion site such as redness, pain or phlebitis ( inflammation of a vein at the infusion site

Uncommon (may affect 1 to 10 users in 1,000)

  • thrombocytopenia (blood disease that causes bruising or bleeding easily)
  • hypersensitivity ( allergy )
  • anxiety, depression, hallucinations
  • syncope (short-term loss of consciousness)
  • tremor (shaking or trembling)
  • migraine
  • dimsyn
  • eye irritation
  • eye pain
  • arrhythmia / extrasystoles (irregular heartbeat)
  • deep vein thrombosis (pain in the legs caused by a blood clot in the blood vessels in the legs)
  • diarrhea with blood in the stool
  • rectal bleeding
  • dyspepsia (heartburn and abdominal pain)
  • rectal tenesmus (pain caused by constipation)
  • constipation
  • eruktation (belching)
  • dysphagia (difficulty swallowing)
  • dysgeusi (taste disturbances)
  • dry mouth
  • jaundice
  • itching
  • tetani (muscle cramps)
  • increased tension in muscles
  • kidney pain
  • vesical tenesmus (feeling of need to urinate)
  • abnormal urine
  • dysuria (painful urination or difficulty urinating)
  • urinary tract diseases

Rare (may affect 1 to 10 users in 10,000)

  • vestibular diseases (dizziness caused by disease of the inner ear)
  • cough
  • proctitis ( inflammation of the rectum)

Iloprost can cause angina, which causes pain or pressure over the chest, especially in patients with coronary heart disease.

The risk of bleeding is increased in patients receiving Ilomedin at the same time as medicines that inhibit blood coagulation, heparin, or coumarin-type medicines.

One group of side effects is related to infusion site reactions. For example. can redness and pain occur at the infusion site or so-called cutaneous vasodilation that may cause striped erythema above the infusion vein?

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Ilomedin

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 and vial.

No special storage instructions.

For information for healthcare professionals, see section 6, under “The following information is intended for healthcare professionals only”.

6. Contents of the packaging and other information

Content declaration

  • The active substance is iloprost
  • The other ingredients are trometamol, ethanol (96%), sodium chloride, hydrochloric acid 1N, water for injections

What the medicine looks like and contents of the pack

Ilomedin is a clear, particle-free solution.

Ilomedin is supplied in packs of:
5 x 1 ml
5 x 2.5 ml

Marketing Authorisation Holder

Bayer AB

Box 606

SE-169 26 Solna

Muhammad Nadeem

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