VENTAVIS 10 MCG/ML Roztwór do nebulizacji

Treść ulotki

1. Ventavis 10 micrograms/ml solution for nebulisation
   1. What is Ventavis and what is it used for
   2. What you need to know before using Ventavis
   3. How to use Ventavis
   4. Possible side effects
   5. How to store Ventavis
   6. Contents of the pack and other information
2. Ventavis 20 micrograms/ml solution for nebulisation
   1. What is Ventavis and what is it used for
   2. What you need to know before using Ventavis
   3. How to use Ventavis
   4. Possible side effects
   5. How to store Ventavis
   6. Contents of the pack and other information

Ventavis 10 micrograms/ml solution for nebulisation

Iloprost

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Ventavis and what is it used for

What is Ventavis
The active ingredient of Ventavis is iloprost. It mimics the action of a natural substance called
prostacyclin. Ventavis inhibits the undesirable blockage or constriction of blood vessels and allows for
a greater amount of blood to flow through the vessels.

What is Ventavis used for
Ventavis is used to treat cases of moderate primary pulmonary hypertension (PPH) in
adult patients. PPH is a type of pulmonary hypertension in which the cause of the increased
blood pressure is unknown.
This is a disease in which blood pressure in the vessels that carry blood between the heart
and the lungs is too high.
Ventavis is used to improve the ability to perform physical activity and symptoms.

How does Ventavis work
By inhaling the nebulized solution, Ventavis is delivered to the lungs where it acts with maximum
effectiveness at the level of the artery located between the heart and the lungs. Improved blood
flow promotes better oxygen supply to the body and reduces the strain on the heart.

2. What you need to know before using Ventavis

Do not use Ventavis

• if you are allergicto iloprost or any of the other ingredients of this medicine (listed in section 6),
• if you have a risk of bleeding- for example if you have an active stomach ulcer or ulcer of the first part of the small intestine (duodenal ulcers), if you have had a physical injury (trauma), if you are at risk of bleeding in the brain,
• if you have had heart problems, such as
• insufficient blood flow to the heart (severe coronary artery disease or unstable angina). Symptoms may include chest pain,
• a heart attack in the last six months,
• heart failure (congestive heart failure) that is not under strict medical supervision,
• a severely unstable heart rate,
• a heart valve defect (present at birth or acquired) that causes heart failure (not related to pulmonary hypertension),
• if you have had a stroke in the last 3 monthsor any other event that has reduced blood flow to the brain (e.g. transient ischemic attack),
• if the pulmonary hypertension you suffer from is caused by a blockage or narrowing of the veins(occlusive venous disease).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ventavis:

• Inhalation of Ventavis can cause breathing difficulties (see section 4), especially in patients with bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing. Tell your doctor if you have a lung infection, severe asthma or chronic lung disease(chronic obstructive pulmonary disease). Your doctor will monitor you carefully.
• Your blood pressure will be measured before treatment and, if it is too low(less than 85 mmHg as the maximum value), treatment with Ventavis should not be started.
• In general, you should be particularly careful to avoid the effects of low blood pressuresuch as fainting and dizziness: o Tell your doctor if you are taking any other medicine as the effects associated with Ventavis may lower your blood pressure further (see below “Other medicines and Ventavis”). o Get up slowly from a chair or bed. o If you tend to faint when you get up from bed, it may be helpful to take the first dose of the day while still lying in bed. o If you tend to faint, avoid any excessive exertion, for example during exercise; it may be helpful to inhale Ventavis before exercise.
• Episodes of fainting may be due to your illness. Tell your doctor if these episodes worsen. They may consider adjusting the dose or changing the therapy.
• If you suffer from heart failure such as right heart failure and you feel that your condition is worsening,talk to your doctor. Symptoms of this worsening may include swelling of the feet and ankles, shortness of breath, palpitations, needing to urinate frequently at night, or edema. Your doctor will assess whether to change your therapy.
• If you have difficulty breathing, cough up blood and/or excessive sweating, these may be signs that you have fluid in your lungs (pulmonary edema). Stop the therapy with Ventavis and talk to your doctor immediately. The doctor will check the cause of your symptoms and take appropriate measures.
• If you have liver problems or if you have severe kidney problems that require dialysis, talk to your doctor. They may prescribe gradual doses or a lower dose of Ventavis compared to other patients (see section 3 “How to use Ventavis”)

Contact of Ventavis with the skin or ingestion of Ventavis

• DO NOT allow the Ventavis solution to come into contact with your skin or eyes. If this should happen, rinse your skin or eyes immediately with plenty of water.
• DO NOT drink or swallow the Ventavis solution. If you accidentally swallow it, drink plenty of water and tell your doctor.

Children and adolescents
The safety and efficacy of Ventavis have not been established in children under the age of 18.

Other medicines and Ventavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. Ventavis and certain other medicines can influence each other in their
action within the body.
Tell your doctor if you are taking:

• Medicines used to treat high blood pressure or heart disease,such as
• beta-blockers,
• nitrovasodilators,
• ACE inhibitors. Your blood pressure may drop too low. Your doctor may adjust the dosage.
• Medicines that thin the blood or inhibit blood clottingincluding
• acetylsalicylic acid (ASA - a substance present in many medicines that lower fever and relieve pain)
• heparin,
• coumarin anticoagulants, such as warfarin or phenprocoumone,
• non-steroidal anti-inflammatory drugs,
• non-selective phosphodiesterase inhibitors, such as pentoxifylline,
• selective phosphodiesterase 3 (PDE 3) inhibitors, such as cilostazol or anagrelide,
• ticlopidine,
• clopidogrel,
• glycoprotein IIb/IIIa antagonists, such as
• abciximab,
• eptifibatide,
• tirofiban,
• defibrotide. Your doctor will monitor you carefully.

Before taking any medicine ask your doctor or pharmacist for advice, who can give you
more information about the medicines to which you need to pay attention or which must be avoided
when using Ventavis.

Ventavis with food and drink
Food and drink should not affect Ventavis. However, you should avoid eating or drinking
during inhalation.

Pregnancy

• If you suffer from pulmonary hypertension,avoid pregnancy, because pregnancy can worsen the disease to the point of endangering your life.
• If you might become pregnant,use reliable contraception from the start of treatment and during it .
• If you are pregnant, suspect you are pregnant or are planning a pregnancyask your doctor for advice immediately before taking this medicine. Ventavis should only be used during pregnancy if the doctor decides that the potential benefit outweighs the potential risk to you and the fetus.

Breastfeeding
It is not known whether Ventavis passes into breast milk. The potential risk to infants cannot be
excluded and therefore it is preferable to avoid breastfeeding during therapy with Ventavis.
Ask your doctor or pharmacist for advice before taking any medicine.

Infants, children and pregnant women should not be in the same room while you are
inhaling Ventavis.
Driving and operating machinery
Ventavis lowers blood pressure and can cause dizziness or inattention in some people.
Do not drive and do not operate machinery if you experience these effects.

Ventavis contains ethanol
Ventavis 10 micrograms/ml contains 0.81 mg of alcohol (ethanol) in each ml which is equivalent to
0.081% (v/v). The amount of 0.81 mg of alcohol in 1 ml of this medicine is equivalent to less than
1 ml of beer or wine.
The small amount of alcohol in this medicine will not have any significant effects.

3. How to use Ventavis

Therapy with Ventavis must be initiated exclusively by a physician experienced in the
treatment of pulmonary hypertension.

How much Ventavis should be inhaled and for how long
Use this medicine following exactly the instructions of your doctor. If you have doubts consult your
doctor.
The dose of Ventavis and the duration of treatment suitable for you depend on your individual conditions.
Your doctor will advise you on this. Do not change the recommended dose without first consulting
your doctor.
Different nebulization devices can be used to administer Ventavis. Depending on the
type of device used and the prescribed dose, 1 ml or 2 ml of Ventavis 10 micrograms/ml are
appropriate.

• Breelib Nebulizer

If you start treatment with Ventavis or if you have previously used a different device, the
first inhalation must be performed with Ventavis 10 micrograms/ml (vial with white and
yellow rings). If you tolerate this dose well, the subsequent inhalation will be with Ventavis 20 micrograms/ml
(vial with yellow and red rings). You should then continue with this dose.
If you do not tolerate the inhalation of Ventavis 20 micrograms/ml, consult your doctor, who may
prescribe Ventavis 10 micrograms/ml (1 ml vial).

Most people will have 6 to 9 inhalation sessionsdistributed throughout the
day. The duration of each session with Breelib is typically about 3 minutes.
When you start using the Breelib nebulizer, the doctor will supervise the treatment to
ensure that you tolerate the dose and the inhalation rate.

• I-Neb AAD Nebulizer (1 ml vial with white and yellow rings)

Generally, at the beginning of treatment with Ventavis, the first inhaled dose should correspond to
2.5 micrograms of iloprost delivered to the mouthpiece. If you tolerate this dose well, the dose should be
increased to 5 micrograms of iloprost and maintained at that level. If you do not tolerate the 5 microgram dose,
it should be reduced to 2.5 micrograms.

Most people will have 6 to 9 inhalation sessionsdistributed throughout the
day. The duration of each session is between 4 and 10 minutes with I-Neb AAD depending on the
prescribed dose.

• Venta-Neb Nebulizer (2 ml vial with white and pink rings)

Generally, at the beginning of treatment with Ventavis, the first inhaled dose should correspond to
2.5 micrograms of iloprost delivered to the mouthpiece. If you tolerate this dose well, the dose should be
increased to 5 micrograms of iloprost and maintained at that level. If you do not tolerate the 5 microgram dose,
it should be reduced to 2.5 micrograms.

Most people will have 6 to 9 inhalation sessionsdistributed throughout the
day. The duration of each inhalation session with Venta-Neb is between 4 and 10 minutes
depending on the prescribed dose.
Depending on individual needs, Ventavis can be used for prolonged treatment.

If you have kidney or liver problems
In patients with mild or moderate kidney problems (patients with creatinine clearance >30 ml/min)
it is not necessary to change the dose.
In case of severe kidney problems requiring dialysis or liver disease, the doctor will
gradually start therapy with Ventavis and may prescribe a smaller number of inhalations per
day. Start therapy by inhaling 2.5 micrograms of iloprost using a 1 ml vial of
Ventavis 10 micrograms/ml (with white and yellow rings). Practice intervals of 3-4 hours between inhalations
(this corresponds to a maximum of 6 administrations per day). Afterwards, the doctor may cautiously reduce the administration intervals, depending on how you tolerate the treatment. If the doctor decides
to increase the dose to a maximum of 5 micrograms, the 3 - 4 hour intervals must initially be
respected again, which can be reduced depending on how you tolerate the treatment.
If you feel that the effect of Ventavis is too strong or too weak consult your doctor or
pharmacist.
Ask your doctor to help you become familiar with the use of the nebulizer. Do not switch to
another type of nebulizer without consulting the doctor who is treating you.

How to perform the inhalation
A new vial of Ventavis must be used for each inhalation session. Immediately
before starting the inhalation, break the glass vial and pour the solution into the
nebulizer chamber, following the instructions for use of the nebulizer.
Follow the instructions provided with the device carefully, especially those relating to
the hygiene and cleaning of the nebulizer.
Take Ventavis following exactly the instructions of your doctor.

• The Ventavis 10 micrograms/ml nebulizer solution must be inhaled through the nebulizers prescribed by your doctor (Breelib, Venta-Neb or the I-Neb AAD system).
• The nebulizer transforms the Ventavis solution into an aerosol that you inhale through your mouth.
• To inhale, you must use a mouthpiece to prevent Ventavis from coming into contact with the skin. Do not use a mask.
• Also follow carefully any instructions relating to the delivery device provided by the manufacturer. Consult your doctor or pharmacist if you have any doubts.
• Any remaining Ventavis solution in the nebulizer after inhalation must be disposed of (see section 5).

Room Ventilation
Make sure to ventilate or air the room in which you have taken Ventavis. Other people
may accidentally inhale Ventavis through the air in the room. In particular, infants,
children and pregnant women should not be in the same room while you are inhaling Ventavis.

• Breelib

Pour Ventavis into the nebulizer chamber immediately before use, following the
instructions for use of the nebulizer.

• I-Neb AAD
• 1. Immediately before inhaling, break the glass vial containing 1 ml of solution and marked with two colored rings (white - yellow), and pour the entire contents into the nebulizer chamber.
• 2. The preset dose delivered by the I-Neb AAD system is controlled by the nebulizer chamber, in combination with a control disc. There are two nebulizer chambers, characterized by different colors. Each nebulizer chamber corresponds to a colored control disc:
• To deliver a dose of 2.5 micrograms, use the nebulizer chamber with the red safety stop together with the red control disc.
• To deliver a dose of 5 micrograms, use the nebulizer chamber with the purple safety stop together with the purple control disc.
• 3. To be sure to receive the prescribed dose, check the color of the nebulizer chamber and the control disc. They must have the same color, red for the 2.5 microgram dose or purple for the 5 microgram dose

The following table provides a summary of the instructions for use of I-Neb:

• Venta-Neb
• 1. Immediately before starting the inhalation, break the glass vial containing 2 ml of solution and marked with two colored rings (white - pink) and pour the entire contents into the nebulizer chamber.
• 2. You can choose between two programs:

• 3. The doctor will adjust Venta-Neb to the program you need to take the prescribed dose.
• P1 Program 1: 5 micrograms of active ingredient over 25 inhalation cycles to the mouthpiece.
• P2 Program 2: 2.5 micrograms of active ingredient over 10 inhalation cycles to the mouthpiece.
• 4. Use the green deflector to obtain droplets of the optimal size for the administration of Ventavis.

For further details read the nebulizer instruction manual or consult your doctor.

If you use more Ventavis than you should
Using more Ventavis than prescribed may cause dizziness, headache, flushing of the
face, nausea (feeling unwell), jaw or back pain.
An increase or decrease in blood pressure, bradycardia
(slowing of the heartbeat), tachycardia (acceleration of the heartbeat), vomiting, diarrhea or
limb pain may also occur. If you experience any of these symptoms when you have taken more Ventavis than
you should, you should:

• stop the inhalation session
• consult your doctor The doctor will monitor you and treat the symptoms you experience. A specific antidote is not known.

If you forget to use Ventavis
Do not take a double dose to make up for a missed dose. Consult your doctor who will tell you what to do.

If you stop taking Ventavis
If you stop or want to stop treatment, consult your doctor first.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following serious side effectsmay occur. In this case, consult your doctor immediately.

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

• Bleeding events (especially nosebleeds (epistaxis) and coughing up blood (hemoptysis)) can occur very commonly, particularly if you are also taking medicines that thin the blood (anticoagulants). The risk of bleeding may be increased in patients who are receiving platelet aggregation inhibitors or anticoagulants at the same time (see also section 2). Very rarely, fatal cases have been reported, including cases of bleeding in the brain (cerebral and intracranial hemorrhage).

Common(may affect up to 1 in 10 people):

• Fainting (syncope) is a symptom of your illness but may also occur during treatment with Ventavis (see also section 2 “Warnings and precautions” for advice on what to do to avoid it).
• Low blood pressure (hypotension)

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

• Bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing (see also section 2 “Warnings and precautions”)

Below is a list of other side effects in order of frequency:

Very common:may affect more than 1 in 10 people

• widening of blood vessels (vasodilation). Symptoms may be hot flushes or redness of the face.
• discomfort or pain in the chest
• cough
• headache
• nausea
• jaw pain or spasm of the jaw muscles (trismus)
• swelling of the limbs (peripheral edema)

Common:may affect up to 1 in 10 people

• difficulty breathing (dyspnea)
• dizziness
• vomiting
• diarrhea
• pain when swallowing (pharyngolaryngeal irritation)
• sore throat
• irritation of the mouth and tongue, accompanied by pain
• skin rashes
• fast heartbeat (tachycardia)
• awareness of a fast or strong heartbeat (palpitations)

Not known:frequency cannot be estimated from the available data.

• decreased number of platelets in the blood (thrombocytopenia)
• hypersensitivity (e.g. allergy)
• taste disturbances (dysgeusia)

Other possible side effects

• Swelling, especially in the ankles and legs, due to fluid retention (peripheral edema) is a very common symptom of the disease itself but can also occur during treatment with Ventavis.

Reporting of side effects
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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ventavis

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 package and on the vial.
There are no special storage instructions.
Any remaining Ventavis solution in the nebulizer after inhalation must
be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ventavis contains:

• The active substanceis iloprost

1 ml of solution contains 10 micrograms of iloprost (as iloprost trometamol).
Each 1 ml vial contains 10 micrograms of iloprost. Each 2 ml vial contains
20 micrograms of iloprost.

• The other ingredients aretrometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment and water for injections.

Description of Ventavis and contents of the pack:
Ventavis is a clear and colourless solution for nebuliser, for inhalation with the nebuliser
Breelib, I-Neb or Venta-Neb.
Ventavis 10 micrograms/ml is supplied in colourless vials, each containing 1 ml or 2 ml of solution
for nebuliser.

Ventavis 10 micrograms/ml is available in the following packs:

• 1 ml vials for use with the Breelib or I-Neb nebuliser: o Pack containing 30 or 42 vials for use with the Breelib and I-Neb nebulisers. o Multipack containing 168 (4 x 42) vials for use with the Breelib and I-Neb nebulisers. o Multipack containing 168 (4 x 42) vials with Breelib consumables (including 1 mouthpiece and 1 nebuliser chamber). The vials containing 1 ml are marked with two coloured rings (white - yellow).
• 2 ml vials for use with Venta-Neb: o Pack containing 30, 90, 100 or 300 vials. o Multipack containing 90 (3 x 30) or 300 (10 x 30) vials. The vials containing 2 ml are marked with two coloured rings (white - pink).

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Bayer AG
51368 Leverkusen
Germany

Manufacturer:
Berlimed S.A.
Francisco Alonso 7
Poligono Industrial Santa Rosa
28806 Alcala de Henares
Madrid
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België / Belgique / Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +37 05 23 36 868

България
Байер България ЕООД
Тел. +359 (0)2-424 72 80

Luxembourg / Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária KFT
Tel.: +36 14 87-41 00

Danmark
Bayer A/S
Tlf: +45-45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-(0)23 799 1000

Eesti
Bayer OÜ
Tel: +372 655 8565

Norge
Bayer AS
Tlf. +47 23 13 05 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500

Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel.: +48 22 572 35 00

France
Bayer HealthCare
Tél(N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00

Hrvatska
Bayer d.o.o.
Tel: + 385-(0)1-6599 900

România
SC Bayer SRL
Tel: +40 21 529 59 00

Ireland
Bayer Limited
Tel: +353 1 216 3300

Slovenija
Bayer d. o. o.
Tel.: +386 (0)1 58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39 02 397 81

Suomi/Finland
Bayer Oy
Puh/Tel: +358 20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu . Also, links to other websites on rare diseases and related
therapeutic treatments are provided.
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The following information is intended exclusively for healthcare professionals:
Instructions for use and handling
Patients stabilised on one type of nebuliser should not switch to another nebuliser without the
close supervision of the treating physician, as different nebulisers produce an aerosol with
slightly different physical characteristics and may deliver the solution more quickly (see
section 5.2 of the summary of product characteristics).
To minimise accidental exposure, it is recommended to keep the environment well ventilated.

• Breelib

For use of the Breelib nebuliser, follow the instructions for use provided with the device.
Pour Ventavis into the nebuliser chamber immediately before use.

• I-Neb AAD

The I-Neb AAD system is a portable, manual nebuliser based on vibrating mesh technology.
To generate the droplets, the system uses ultrasound, which pushes the
solution through a mesh. The I-Neb AAD nebuliser is suitable for administering
Ventavis 10 micrograms/ml (vial with white and yellow rings).
The Mass Median Aerodynamic Diameter (MMAD) of the
aerosol droplets was 2.1 micrometres.
This nebuliser monitors the breathing pattern to determine the aerosol release intervals
required to deliver a pre-set dose of 2.5 or 5 micrograms of iloprost.
The dose delivered by the I-Neb AAD system is controlled by the nebuliser chamber, in
combination with a control disc. Each nebuliser chamber is characterised by a
colour, which corresponds to a coloured control disc.

• To deliver a dose of 2.5 micrograms, use the nebuliser chamber with the red safety stop together with the red control disc.
• To deliver a dose of 5 micrograms, use the nebuliser chamber with the purple safety stop together with the purple control disc.

For each inhalation session with I-Neb AAD, transfer the contents of one 1 ml vial of Ventavis,
marked with two coloured rings (white – yellow), into the nebuliser chamber
immediately before use.

The following table provides a summary of the instructions for use of I-Neb with Ventavis:

• Venta-Neb

Venta-Neb, a portable battery-powered ultrasonic nebuliser, has also been found to be suitable
for administering Ventavis 10 micrograms/ml. The measured MMAD value of the aerosol droplets is 2.6 micrometres. For each inhalation session, the contents of a vial
containing 2 ml of Ventavis 10 micrograms/ml nebuliser solution marked with
two coloured rings (white – pink) will be transferred into the nebuliser chamber immediately
before use.
Two programmes can be used:

• PI Programme 1: 5 micrograms of active substance over 25 inhalation cycles to the mouthpiece.
• P2 Programme 2: 2.5 micrograms of active substance over 10 inhalation cycles to the mouthpiece. The pre-set programme is selected by the doctor.

Venta-Neb signals the patient’s inhalation with an optical and acoustic signal. It stops at the
end of delivery of the pre-set dose. To obtain optimal droplet size for
administration of Ventavis, it is recommended to use the green deflector. For more
details, please refer to the Venta-Neb nebuliser instruction manual.

The efficacy and tolerability of inhaled iloprost administered using other nebulisation systems,
which impart different nebulisation characteristics to the iloprost solution, have not been
established.

Ventavis 20 micrograms/ml solution for nebulisation

Iloprost

Read this leaflet carefully before you use this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Ventavis and what is it used for

What is Ventavis
The active substance of Ventavis is iloprost. It mimics the action of a natural substance called
prostacyclin. Ventavis inhibits the undesirable blockage or constriction of blood vessels and allows for
a greater amount of blood to flow through the vessels.

What is Ventavis used for
Ventavis is used to treat cases of moderate primary pulmonary hypertension (PPH) in
adult patients. PPH is a type of pulmonary hypertension in which the cause of the increased
blood pressure is unknown.
This is a disease in which blood pressure in the vessels that carry blood between the heart
and the lungs is too high.
Ventavis is used to improve the ability to perform physical activity and symptoms.

How Ventavis works
By inhaling the nebulized solution, Ventavis is delivered to the lungs where it acts with maximum
effectiveness at the level of the artery located between the heart and the lungs. Improved blood
flow promotes better oxygen supply throughout the body and reduces strain on the heart.

2. What you need to know before using Ventavis

Do not use Ventavis

• if you are allergicto iloprost or any of the other ingredients of this medicine (listed in section 6),
• if you have a risk of bleeding- for example if you have an active stomach ulcer or the first part of the small intestine (duodenal ulcers), if you have had a physical injury (trauma), if you are at risk of intracranial bleeding,
• if you have had heart problems, such as
• insufficient blood flow to the heart (severe coronary artery disease or unstable angina ) Symptoms may include chest pain,
• a heart attack in the last six months,
• heart failure (decompensated heart failure) that is not under strict medical supervision,
• severely unstable heart rate,
• a defect in the heart valves (present at birth or acquired) that causes heart failure (not related to pulmonary hypertension),
• if you have had a stroke in the last 3 monthsor any other event that has reduced blood flow to the brain (e.g. transient ischemic attack),
• if the pulmonary hypertension you suffer from is caused by a blockage or narrowing of the veins(occlusive venous disease).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ventavis:

• Inhalation of Ventavis can cause difficulty breathing (see section 4), especially in patients with bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing. Tell your doctor if you have a lung infection, severe asthma or chronic lung disease(chronic obstructive pulmonary disease). Your doctor will monitor you carefully.
• Your blood pressure will be measured before treatment and, if it is too low(less than 85 mmHg as the maximum value), treatment with Ventavis should not be started.
• In general, you should be particularly careful to avoid the effects of low blood pressuresuch as fainting and dizziness: o Tell your doctor if you are taking any other medicine as the effects associated with Ventavis can further lower your blood pressure (see below “Other medicines and Ventavis”). o Get up slowly from the chair or bed. o If you tend to faint when you get out of bed, it may be helpful to take the first dose of the day while still lying in bed. o If you tend to faint, avoid any excessive exertion, for example during exercise; it may be helpful to inhale Ventavis before exercise.
• Episodes of fainting may be due to your illness. Tell your doctor if these episodes worsen. They may consider adjusting the dose or changing therapy.
• If you suffer from heart failure such as right heart failure and you feel that your condition is worsening,talk to your doctor. The symptoms of this worsening may include swelling of the feet and ankles, shortness of breath, palpitations, needing to urinate frequently at night or edema. Your doctor will assess whether to change your therapy.
• If you have difficulty breathing, coughing up blood and/or excessive sweating, these may be signs that you have fluid in your lungs(pulmonary edema). Stop the therapy with Ventavis and talk to your doctor immediately. The doctor will check the cause of your symptoms and take appropriate measures.
• If you have liver problems or if you have severe kidney problems that require dialysis, talk to your doctor. They may prescribe gradual doses or a lower dose of Ventavis compared to other patients (see section 3 “How to use Ventavis”).

Contact of Ventavis with the skin or ingestion of Ventavis

• DO NOT allow the Ventavis solution to come into contact with your skin or eyes. If this should happen, rinse your skin or eyes immediately with plenty of water.
• DO NOT drink or swallow the Ventavis solution. If you accidentally swallow, drink plenty of water and tell your doctor.

Children and adolescents
The safety and efficacy of Ventavis have not been established in children under the age of 18.

Other medicines and Ventavis
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine. Ventavis and certain other medicines can influence each other in their
action within the body.
Tell your doctor if you are taking:

• Medicines used to treat high blood pressure or heart disease,such as
• beta-blockers,
• nitrovasodilators,
• ACE inhibitors. Your blood pressure may drop too low. Your doctor may adjust the dosage.
• Medicines that thin the blood or inhibit blood clottingincluding
• acetylsalicylic acid (ASA - a substance present in many medicines that lower fever and relieve pain),
• heparin,
• coumarin anticoagulants, such as warfarin or phenprocoumone,
• non-steroidal anti-inflammatory drugs,
• non-selective phosphodiesterase inhibitors, such as pentoxifylline,
• selective phosphodiesterase 3 (PDE 3) inhibitors, such as cilostazol or anagrelide
• ticlopidine,
• clopidogrel,
• glycoprotein IIb/IIIa antagonists, such as
• abciximab,
• eptifibatide,
• tirofiban,
• defibrotide Your doctor will monitor you carefully.

Before taking any medicine ask your doctor or pharmacist for advice, who can give you
more information about the medicines to which you need to pay attention or which must be avoided
when using Ventavis.

Ventavis with food and drink
Food and drink should not affect Ventavis. However, you should avoid eating or drinking
during inhalation.

Pregnancy

• If you suffer from pulmonary hypertension,avoid pregnancy, because pregnancy can worsen the disease to the point of endangering your life.
• If you might become pregnant,use reliable contraception from the start of treatment and during it .
• If you are pregnant, if you suspect or are planning a pregnancyask your doctor for advice immediately before taking this medicine. Ventavis should only be used during pregnancy if the doctor decides that the potential benefit outweighs the potential risk to you and the fetus.

Breastfeeding
It is not known whether Ventavis passes into breast milk. The potential risk to infants cannot be
excluded and therefore it is preferable to avoid breastfeeding during therapy with Ventavis.
Ask your doctor or pharmacist for advice before taking any medicine.

Infants, children and pregnant women should not be in the same room while you are
inhaling Ventavis.
Driving and using machines
Ventavis lowers blood pressure and can cause dizziness or inattention in some people.
Do not drive and do not operate machinery if you experience these effects.

Ventavis contains ethanol
Ventavis 20 micrograms/ml contains 1.62 mg of alcohol (ethanol) in each ml which is equivalent to
0.162% (v/v). The amount of 1.62 mg of alcohol in 1 ml of this medicine is equivalent to less than
1 ml of beer or wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Ventavis

Therapy with Ventavis must be initiated exclusively by a physician experienced in the
treatment of pulmonary hypertension.

How much Ventavis to inhale and for how long
Use this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor.
The dose of Ventavis and the duration of treatment suitable for you depend on your individual conditions.
Your doctor will advise you on this. Do not change the recommended dose without first consulting
your doctor.
Different nebulization devices can be used to administer Ventavis 20µg/ml.

• Breelib Nebulizer

If you start treatment with Ventavis or if you have previously used a different device, the first
inhalation must be performed with Ventavis 10 micrograms/ml (1 ml vial with white and yellow rings). If
you tolerate this dose well, the next inhalation will be with Ventavis 20 micrograms/ml (vial with
yellow and red rings). You should then continue with this dose.
If you do not tolerate the inhalation of Ventavis 20 micrograms/ml, consult your doctor, who may prescribe
Ventavis 10 micrograms/ml (1 ml vial).

Most people will have 6 to 9 inhalation sessionsdistributed throughout the day.
The duration of each inhalation session with Breelib is typically about 3 minutes.
When you start using the Breelib nebulizer, your doctor will supervise the treatment to ensure that
you tolerate the dose and the inhalation rate.

• I-Neb Nebulizer

Since your inhalation times with Ventavis 10 micrograms/ml (1 ml vial with white and
yellow rings) have been repeatedly prolonged, your doctor has decided to switch to
Ventavis 20 micrograms/ml.
Ventavis 20 micrograms/ml has a double concentration compared to Ventavis 10 micrograms/ml. The
active ingredient can be delivered more quickly to the lungs.
The switch from Ventavis 10 micrograms/ml to Ventavis 20 micrograms/ml will be carried out under the
supervision of your doctor, who will monitor how you tolerate the higher concentration.
The dose should be administered 6 to 9 times a day, based on individual needs and tolerability.
Depending on individual needs, Ventavis can be used for prolonged treatment.

If you have kidney or liver problems
In patients with mild or moderate kidney problems (patients with creatinine clearance >30 ml/min)
it is not necessary to modify the dose.
In case of severe kidney problems requiring dialysis or liver disease, your doctor
will gradually start therapy with Ventavis and may prescribe you a smaller number of inhalations per
day. Start therapy by inhaling 2.5 micrograms of iloprost using Ventavis 10 micrograms/ml
(1 ml vial with white and yellow rings). Allow an interval of 3 - 4 hours between administrations (this
corresponds to a maximum of 6 administrations per day). Afterwards, your doctor may cautiously reduce the
administration intervals, depending on how you tolerate the treatment. If your doctor decides
to increase the dose to a maximum of 5 micrograms, the 3 - 4 hour intervals must initially be
respected again, which may be reduced depending on how you tolerate the treatment.
If you feel that the effect of Ventavis is too strong or too weak consult your doctor or
pharmacist.
Ask your doctor to help you become familiar with using the nebulizer. Do not switch to
another type of nebulizer without consulting your treating physician.

How to perform the inhalation
A new vial of Ventavis must be used for each inhalation session. Immediately
before starting the inhalation, break the glass vial and
pour the solution into the nebulizer chamber, following the instructions for use of the
nebulizer.
Follow the instructions provided with the device carefully, especially those relating to
nebulizer hygiene and cleaning.
Take Ventavis following exactly the instructions of your doctor.

• The Ventavis 20 micrograms/ml nebulizer solution must be inhaled through the nebulizers prescribed by your doctor (the Breelib or I-Neb AAD nebulizers).
• The nebulizer transforms the Ventavis solution into an aerosol that you inhale through your mouth.
• For inhalation, you must use a mouthpiece to prevent Ventavis from coming into contact with the skin. Do not use a mask.
• Also follow carefully any instructions relating to the delivery device provided by the manufacturer. Consult your doctor or pharmacist if you have any doubts.
• Any residual Ventavis solution remaining in the nebulizer after inhalation must be discarded (see section 5).

Room ventilation
Make sure to ventilate or air the room in which you have taken Ventavis. Other people
may accidentally inhale Ventavis through the air in the room. In particular, infants,
children and pregnant women should not be in the same room while you are inhaling Ventavis.

• Breelib

Pour Ventavis into the nebulizer chamber immediately before use, following the
instructions for use of the nebulizer.

• I-Neb AAD
• 1. Immediately before inhaling, take the Ventavis 20 micrograms/ml vial marked with the yellow – red colors ,break the glass vial and pour the entire contents of 1 ml into the gold-colored chamber of the nebulizer.
• 2. The preset dose delivered by the I-Neb AAD nebulizer is controlled by the nebulizer chamber, in combination with a control disc. For Ventavis 20 micrograms/ml (dose of 5 micrograms), use the nebulizer chamber with the gold safety stop together with the gold control disc.
• 3. To be sure to receive the prescribed dose, check the color of the nebulizer chamber and the control disc. They must have the same color.

Since the I-Neb AAD nebulizer can be used for both Ventavis 10 micrograms/ml and
Ventavis 20 micrograms/ml, the following table summarizes the instructions for
I-Neb users for the two Ventavis concentrations:

For further details, read the nebulizer instruction manual or consult your doctor.

If you use more Ventavis than you should
Using more Ventavis than prescribed may cause dizziness, headache, flushing of the
face, nausea (feeling unwell), jaw or back pain.
An increase or decrease in blood pressure, bradycardia
(slowing of the heartbeat), tachycardia (acceleration of the heartbeat), vomiting, diarrhea or
limb pain may also occur. If you experience any of these symptoms when you have taken more Ventavis than
you should, you should:

• stop the inhalation session
• seek medical attention Your doctor will monitor you and treat the symptoms you experience. A specific antidote is not known. If you forget to use VentavisDo not take a double dose to make up for a missed dose. Consult your doctor, who will tell you what to do.

If you stop taking Ventavis
If you stop or want to stop treatment, consult your doctor first.
If you have any doubts about using this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following serious side effectsmay occur. In this case, consult your doctor immediately.

Very common(may affect more than 1 in 10 people):
Bleeding events (especially nosebleeds (epistaxis) and coughing up blood (hemoptysis) can occur very
commonly, particularly if you are also taking medicines that thin the blood (anticoagulants). The risk of bleeding may increase in patients who are receiving
platelet aggregation inhibitors or anticoagulants at the same time (see also
section 2). Very rarely, fatal cases have been reported, including cases of bleeding in the
brain (cerebral and intracranial hemorrhage).

Common(may affect up to 1 in 10 people):

• Fainting (syncope) is a symptom of your condition but may also occur during treatment with Ventavis (see also section 2 “Warnings and precautions” for advice on what to do to avoid it).
• Low blood pressure (hypotension)

Not known(frequency cannot be estimated based on available data):

• Bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing (see also section 2 “Warnings and precautions”)

Below is a list of other side effects in order of frequency:

Very common:may affect more than 1 in 10 people

• widening of blood vessels (vasodilation). Symptoms may include hot flushes or facial redness.
• discomfort or pain in the chest
• cough
• headache
• nausea
• jaw pain or spasm of the jaw muscles (trismus)
• swelling of the limbs (peripheral edema)

Common:may affect up to 1 in 10 people

• difficulty breathing (dyspnea)
• dizziness
• vomiting
• diarrhea
• pain when swallowing (pharyngolaryngeal irritation)
• sore throat
• irritation of the mouth and tongue, accompanied by pain
• skin rashes
• fast heartbeat (tachycardia)
• awareness of a fast or strong heartbeat (palpitations)

Not known:frequency cannot be estimated based on available data.

• decreased number of platelets in the blood (thrombocytopenia)
• hypersensitivity (e.g. allergy)
• taste disturbances (dysgeusia)

Other possible side effects

• Swelling, especially in the ankles and legs, due to fluid retention (peripheral edema) is a very common symptom of the disease itself but can also occur during treatment with Ventavis.

Reporting of side effects
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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ventavis

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 package and on the vial.
There are no special storage instructions.
Any remaining Ventavis solution in the nebulizer after inhalation must
be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ventavis contains:

• The active substanceis iloprost. 1 ml of solution contains 20 micrograms of iloprost (as iloprost trometamol). Each vial of 1 ml contains 20 micrograms of iloprost.
• The other ingredientsare trometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment and water for injections.

Description of the appearance of Ventavis and contents of the pack:
Ventavis is a clear, colourless to slightly yellowish solution for nebuliser, for inhalation with the Breelib or I-Neb nebuliser.
Ventavis 20 micrograms/ml is supplied in colourless vials containing 1 ml of solution for
nebulisation .

Ventavis 20 micrograms/ml is available in the following pack sizes:

• Pack containing 30 vials or 42 vials for use with the Breelib and I-Neb nebulisers.
• Multipack containing 168 (4 x 42) vials for use with the Breelib and I-Neb nebulisers.
• Multipack containing 168 (4 x 42) vials with Breelib consumables (including 1 mouthpiece and 1 nebuliser chamber).

The vials containing 1 ml are marked with two coloured rings (yellow - red).
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Bayer AG
51368 Leverkusen
Germany

Manufacturer:
Berlimed S.A.
Francisco Alonso 7
Poligono Industrial Santa Rosa
28806 Alcala de Henares
Madrid
Spain
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder.

België / Belgique / Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Lietuva
UAB Bayer
Tel. +37 05 23 36 868

България
Байер България ЕООД
Тел. +359 (0)2-424 72 80

Luxembourg / Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11

Česká republika
Bayer s.r.o.
Tel: +420 266 101 111

Magyarország
Bayer Hungária KFT
Tel.: +36 14 87-41 00

Danmark
Bayer A/S
Tlf: +45-45 23 50 00

Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05

Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48

Nederland
Bayer B.V.
Tel: +31-(0)23 799 1000

Eesti
Bayer OÜ
Tel: +372 655 8565

Norge
Bayer AS
Tlf. +47 23 13 05 00

Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210 61 87 500

Österreich
Bayer Austria Ges. m. b. H.
Tel: +43-(0)1-711 46-0

España
Bayer Hispania S.L.
Tel: +34-93-495 65 00

Polska
Bayer Sp. z o.o.
Tel.: +48 22 572 35 00

France
Bayer HealthCare
Tél(N° vert): +33-(0)800 87 54 54

Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00

Hrvatska
Bayer d.o.o.
Tel: + 385-(0)1-6599 900

România
SC Bayer SRL
Tel: +40 21 529 59 00

Ireland
Bayer Limited
Tel: +353 1 216 3300

Slovenija
Bayer d. o. o.
Tel.: +386 (0)1 58 14 400

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Bayer, spol. s r.o.
Tel: +421 2 59 21 31 11

Italia
Bayer S.p.A.
Tel: +39 02 397 81

Suomi/Finland
Bayer Oy
Puh/Tel: +358 20 785 21

Κύπρος
NOVAGEM Limited
Τηλ: +357 22 48 38 58

Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

United Kingdom (Northern Ireland)
Bayer AG
Tel: +44-(0)118 206 3000
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .
Also, links to other websites on rare diseases and related therapeutic treatments are provided.
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The following information is intended exclusively for healthcare professionals:
Instructions for use and handling
Patients stabilised on one type of nebuliser should not switch to another nebuliser without
strict medical supervision, as different nebulisers produce an aerosol with
slightly different physical characteristics and may release the solution more quickly (see
section 5.2 of the Summary of Product Characteristics).
To minimise accidental exposure, it is recommended to keep the environment well ventilated.

• Breelib

For use of the Breelib nebuliser, follow the instructions for use provided with the device.
Pour Ventavis into the nebuliser chamber immediately before use.

• I-Neb AAD

The I-Neb AAD system is a portable, manual nebuliser based on vibrating mesh technology.
To generate the droplets, the system uses ultrasound, which pushes the
solution through a mesh. This nebuliser monitors the breathing pattern to determine
the aerosol release intervals needed to deliver the pre-set dose of 5 micrograms of
iloprost from the Ventavis 20 micrograms/ml nebulisation solution (1 ml vial with
yellow and red rings).
The nebuliser releases 5 mg of iloprost to the mouthpiece. The Mass Median Aerodynamic Diameter
(Mass Median Aerodynamic Diameter, MMAD) of the aerosol is between 1 and 5 micrometres.
For use of the I-Neb AAD system, follow the following instructions.
The dose delivered by the I-Neb AAD system is under the control of the nebuliser chamber, in
combination with a control disc. Each nebuliser chamber is characterised by a
colour, which corresponds to a coloured control disc.
For each inhalation session with I-Neb AAD, immediately before use, transfer the contents
of one 1 ml vial of Ventavis 20 micrograms/ml, marked with two coloured rings (yellow –
red), into the appropriate nebuliser chamber, with the gold safety stop with a gold control disc.
Because the I-Neb AAD system can be used for both Ventavis 10 micrograms/ml and
Ventavis 20 micrograms/ml, the following table summarises the instructions for
user of I-Neb for the two Ventavis concentrations.