Rabestrom

Patient Information Leaflet: Information for the patient

Rabestrom 25 mg orodispersible film, 50 mg orodispersible film, 75 mg orodispersible film, 100 mg orodispersible film

Sildenafil
Generic medicine
Please read this leaflet carefully before taking 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Rabestrom is and what it is used for
2. What you need to know before taking Rabestrom
3. How to take Rabestrom
4. Possible side effects
5. How to store Rabestrom
6. Package contents and other information

1. What Rabestrom is and what it is used for

Rabestrom contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by helping the blood vessels in the penis to relax, thereby allowing blood flow into the penis during sexual stimulation. Rabestrom helps achieve an erection only in the presence of sexual stimulation.
Rabestrom is a treatment for adult men with erectile dysfunction, sometimes called impotence. This condition is defined as the inability to achieve or maintain an erection and penile rigidity sufficient for sexual intercourse.

2. What you need to know before taking Rabestrom

Do not take Rabestrom

• If you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination could lead to a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina attacks (or "chest pain"). If you have any doubts, consult your doctor or pharmacist.
• If you are taking medicines known as nitric oxide donors such as amyl nitrite (also called "poppers"), as the combination may also lead to a dangerous drop in blood pressure.
• If you have had a serious liver or heart problem.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have rare inherited eye diseases (such as retinitis pigmentosa).
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs due to blood clots). PDE5 inhibitors such as Rabestrom have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Rabestrom

• If you suffer from sickle cell anemia (an abnormality of red blood cells in the blood), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. Your doctor must carefully evaluate whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or conditions that may cause bleeding (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Rabestrom and contact your doctor immediately.

You must not use Rabestrom with any other oral or topical treatments for erectile dysfunction.
You must not use Rabestrom with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other PDE5 inhibitor.
You must not take Rabestrom if you do not have erectile dysfunction.
You must not take Rabestrom if you are a woman.

Special considerations for patients with kidney or liver problems
You must inform your doctor if you have liver or kidney problems. Your doctor may decide to
prescribe a lower dose.

Children and adolescents
Rabestrom must not be administered to individuals under 18 years of age.

Other medicines and Rabestrom
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Rabestrom orodispersible film may interact with certain medicines, especially those used
to treat chest pain.
In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that
you have taken Rabestrom and when you took it. Do not take Rabestrom with other medicines unless
your doctor has specifically authorized it.
You must not take Rabestrom if you are taking medicines called nitrates, as the combination
of these medicines could lead to a dangerous drop in blood pressure.
Always inform your doctor, pharmacist, or nurse if you are taking any of these
medicines, which are often prescribed for relief of angina pectoris (or "chest pain").
You must not take Rabestrom if you are taking any medicines known as nitric oxide donors such as amyl nitrite (also called "poppers"), as the combination may also lead to a dangerous drop in blood pressure.
If you are taking medicines known as protease inhibitors, such as those used for the treatment
of HIV, your doctor may start you on the lowest dose (25 mg) of Rabestrom.
Some patients receiving alpha-blocker therapy for high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which could be due to low blood pressure when sitting down or standing up quickly. Some patients have experienced these symptoms while taking Rabestrom with alpha-blockers. This is more likely to occur within 4 hours after taking Rabestrom.
To reduce the risk of such symptoms, you should be on a stable daily dose of alpha-blockers before starting Rabestrom. Your doctor may start you on the lowest dose (25 mg) of Rabestrom.
Inform your doctor or pharmacist if you are already taking riociguat.

Rabestrom with food, drinks, and alcohol
Rabestrom can be taken with or without food. However, you may notice that Rabestrom takes
longer to start working if taken with a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To get the
maximum benefit from this medicine, it is advisable to avoid excessive alcohol consumption
before taking Rabestrom.

Pregnancy, breastfeeding, and fertility
Rabestrom is not indicated for use in women.

Driving and using machines
Rabestrom may cause dizziness and visual disturbances. You should be aware of how your body reacts to Rabestrom before driving or operating machinery.

3. How to take Rabestrom

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Do not take Rabestrom more than once a day.
You should take Rabestrom approximately one hour before engaging in sexual activity. Rabestrom orodispersible film is for oral use and should be taken without water. If you wish, you may also take Rabestrom with water.
Instructions for use
Important: do not handle the orodispersible film with wet hands!
a) Take the sachet, locate the arrow symbol

on the top of the pouch and hold it with this
side facing upwards. The sachet is not sealed at
this point.
b) Gently open both sides of the sachet.

Now grasp each side between your thumb and
forefinger, using one hand for each side.
c) Carefully pull both sides of the sachet in opposite
directions until they separate. The orodispersible film is now visible, placed on one of the separated sides of the sachet.
d) Remove the orodispersible film with dry fingers

from the sachet and place it in your mouth directly on the tongue. It will dissolve rapidly and can be easily swallowed.
If you feel that the effect of Rabestrom is too strong or too weak, discuss this with your doctor or pharmacist. Rabestrom will help you achieve an erection only when accompanied by sexual stimulation. The time needed for Rabestrom to start working varies from person to person, but normally ranges between half an hour and one hour. You may notice that Rabestrom takes longer to work when taken with a heavy meal.
If Rabestrom does not help you achieve an erection, or if your erection does not last long enough to allow you to complete sexual intercourse, inform your doctor.
If you take more Rabestrom than you should:
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase the effectiveness of the medicine.
Do not take more orodispersible films than prescribed by your doctor.
Contact your doctor if you have taken more orodispersible films than prescribed.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The side effects reported in association with the use of Rabestrom are generally mild to moderate and short-lived.
If you notice any of the following serious side effects, stop taking Rabestrom and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden breathlessness, difficulty breathing or dizziness, swelling of the eyelids, face, tongue or throat.
• Chest pain (occurs uncommonly): If this occurs during or after sexual intercourse
• Sit in a semi-upright position and try to relax.
• Do not use nitrates to treat chest pain.
• Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If you have an erection lasting more than 4 hours, you must seek immediate medical attention.
• Sudden decrease or loss of vision – occurs rarely
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, appearance of blisters in the mouth, on the genitals and around the eyes, fever.
• Seizures or epileptic fits – occur rarely

Other side effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, increased intensity of colours in vision, blurred vision or visual disturbance, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, inflamed eyes/red eyes, eye pain, perception of flashes of light, increased light sensitivity, photophobia, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or stuffy nose, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and sensation of fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain parts of the brain, sensation of throat tightness, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual sharpness, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or particles in the visual field, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling of the inner part of the nose, feeling irritable and sudden decrease or loss of hearing.

Additional side effects reported during post-marketing experience:
Unstable angina (a heart condition) and sudden death have been reported rarely. Most, but not all, of the men who experienced these side effects had pre-existing heart problems before starting this medicine. It is not possible to determine whether these events were directly related to Rabestrom.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rabestrom

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after
Exp.
Keep the medicine in its original packaging to protect it from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Rabestrom Contains

• The active substance is sildenafil (as citrate). Each orodispersible film contains 25 mg of sildenafil (as citrate). Each orodispersible film contains 50 mg of sildenafil (as citrate). Each orodispersible film contains 75 mg of sildenafil (as citrate). Each orodispersible film contains 100 mg of sildenafil (as citrate).
• The other ingredients are: maltodextrin, glycerol, polysorbate 20, propylene glycol monocaprylate, polyvinyl acetate dispersion 30%, lemon and grapefruit flavours (lemon essential oil, citral, linalool, grapefruit essential oil, orange essential oil, nootkatone, butylated hydroxyanisole E320, ascorbic acid E300, maltodextrin, gum arabic E414), sucralose, titanium dioxide, indigotine.

Description of the Appearance of Rabestrom and Package Contents
Rabestrom is an orodispersible film.
Rabestrom 25 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film (30 mm x 15 mm).
Rabestrom 50 mg orodispersible film
The orodispersible film is a square, flexible, light blue film (30 mm x 30 mm).
Rabestrom 75 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film (30 mm x 45 mm).
Rabestrom 100 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film (40 mm x 45 mm).
The orodispersible films are supplied in packages containing 2, 4, 8 or 12 orodispersible films. Each sachet contains one orodispersible film.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi, Italy
Manufacturer
IBSA Farmaceutici Italia srl, S.S. n. 11 Padana Superiore Km 160 – 20051 Cassina de’ Pecchi (Mi), Italy
Altergon Italia S.r.l., Zona Industriale, 83040 – Morra de Sanctis (AV), Italy

For any information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder.