RABESTROM 25 mg Orodispersible Tablet

Зміст інструкції

1. Rabestrom 25 mg orodispersible film, 50 mg orodispersible film
2. Rabestrom 100 mg orodispersible film
   1. What is Rabestrom and what is it 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. Contents of the pack and other information

Rabestrom 25 mg orodispersible film, 50 mg orodispersible film

Rabestrom 75 mg orodispersible film

Rabestrom 100 mg orodispersible film

Sildenafil
Generic medicine

Read this leaflet carefully before you start taking this medicine because 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 they have the same symptoms as you, as it may 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 Rabestrom is and what it is used for
• 2. What you need to know before you take Rabestrom
• 3. How to take Rabestrom
• 4. Possible side effects
• 5. How to store Rabestrom
• 6. Contents of the pack and other information

1. What is Rabestrom and what is it used for

Rabestrom contains the active ingredient sildenafil which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in the
penis, allowing blood flow to the penis in the presence of sexual stimulation. Rabestrom
helps to 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
hardening sufficient to have sexual intercourse.

2. What you need to know before taking Rabestrom

Do not take Rabestrom

• If you are allergic to sildenafil or 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. Tell your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris (or “chest pain”). If you are unsure, ask your doctor or pharmacist.
• If you are taking any medicines known as nitric oxide donors such as amyl nitrite (also called “poppers”), as the combination could also lead to a dangerous drop in blood pressure.
• If you have had a severe problem with your liver or heart.
• If you have recently had a stroke or a heart attack, or if you have low blood pressure.
• If you have rare hereditary eye diseases (such as retinitis pigmentosa).
• If you have ever had a loss of vision due to non-arteritic anterior ischaemic 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). It has been shown that PDE5 inhibitors, such as Rabestrom, 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 anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• If you have a deformity of the penis or Peyronie’s disease.
• If you have heart problems. Your doctor needs to carefully assess whether your heart can cope with the additional strain of sexual activity.
• If you currently have a stomach ulcer or problems that may cause bleeding (such as haemophilia).
• 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 treatment 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 suffer from erectile dysfunction.
You must not take Rabestrom if you are a woman.

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

Children and adolescents
Rabestrom must not be given to people under the age of 18 years.

Other medicines and Rabestrom
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Rabestrom orodispersible film may interfere with some medicines, especially those used
to treat chest pain.
In the event of a medical emergency, you must inform your 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 given you permission.
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 tell your doctor, pharmacist or nurse if you are taking any of these
medicines, which are often prescribed for the relief of angina pectoris (or “chest pain”).
You must not take Rabestrom if you are taking any of the medicines, known as nitric oxide donors such as amyl nitrite (also called “poppers”), as the combination could
also lead to a dangerous drop in blood pressure.
If you are taking medicines known as protease inhibitors, such as those for the treatment
of HIV, your doctor may start you on the lowest dose (25 mg) of Rabestrom.
Some patients receiving therapy with alpha-blockers for the treatment of high blood pressure
or for an enlarged prostate may experience dizziness or lightheadedness, which may be due to low blood pressure when sitting or standing
quickly. Some patients have experienced these symptoms while taking Rabestrom with alpha-
blockers. This is more likely to occur within 4 hours of taking Rabestrom.
To reduce the risk of these symptoms, you should be on a regular daily dose of
alpha-blockers before starting Rabestrom. Your doctor may start you on the lowest dose (25 mg) of Rabestrom.
Tell 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 you take it with a heavy meal.
Drinking alcohol can temporarily impair the ability to achieve an erection. To get the
maximum benefit from this medicine, it is advisable to avoid drinking excessive amounts of alcohol
before taking Rabestrom.

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

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

3. How to take Rabestrom

Take this medicine following exactly the instructions of 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 having sexual intercourse. Rabestrom film
orodispersible is for oral use and is taken without water. If you wish, you can also take Rabestrom
with water.
Instructions for use
Important: do not handle the orodispersible film with wet hands!
a) Take the sachet, identify the arrow symbol
on the top of the bag and hold it with this
side facing upwards. The sachet is not sealed in
this point.
b) Gently open both sides of the sachet.
Now you can grasp each side between your thumb and
index finger using one hand for each side.

c) Carefully pull both sides of the sachet in
opposite directions until they are separated. The orodispersible
film is now visible and placed on one
of the separated sides of the sachet.
d) Carefully remove the orodispersible film with dry
fingers from the sachet and place it in your mouth, directly on
the tongue. It will dissolve rapidly, so as to be
easily swallowed.
If you feel that the effect of Rabestrom is too strong or too weak, talk to your doctor or
pharmacist. Rabestrom will only help you achieve an erection in the presence of sexual
stimulation. The time it takes for Rabestrom to start working varies from person to person, but
normally ranges from half an hour to an 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 have complete sexual intercourse, inform your doctor.

If you take more Rabestrom than you should:
You may experience an increase in side effects and their severity. Doses higher than
100 mg do not increase the effectiveness of the medicine.

Do not take more orodispersible films than those prescribed by your doctor
Contact your doctor if you have taken more orodispersible films than you were prescribed.
If you have any doubts 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 will experience them. The side effects reported in association with the use of Rabestrom are generally mild to moderate and of short duration.

If you notice any of the following serious side effects, stop taking Rabestrom and contact your doctor immediately:

• Allergic reaction - occurs with a frequency of uncommon(may affect up to 1 in 100 people). Symptoms include sudden shortness of breath, difficulty breathing or dizziness, swelling of the eyelids, face, tongue or throat.
• Chest pain (occurs with a frequency of uncommon): If it occurs during or after sexual intercourse
• Lie down in a semi-sitting position and try to relax.
• Do not use nitratesto treat chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1,000 people). If you have an erection that lasts for more than 4 hours, you should see a doctor immediately.
• Sudden reduction or loss of vision - occurs rarely
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genitals and around the eyes, fever.
• Convulsions or seizures - 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 color intensity of vision, blurred vision or visual disturbance, stuffy nose and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, rash, eye irritation, inflamed/red eyes, eye pain, seeing flashes of light, increased perception of light, sensitivity to light, tearing, palpitations, fast heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, obstructed or stuffy nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), presence of blood in the urine, pain in arms or legs, nosebleeds, feeling of warmth and feeling of fatigue.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporarily reduced blood flow in some parts of the brain, feeling of constriction in the throat, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or corpuscles in the visual field, seeing halos around lights, pupil dilation, change in color of the white of the eye, bleeding from the penis, presence of blood in the seminal fluid, nasal dryness, swelling of the inside of the nose, feeling of irritability 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, men who experienced these side effects had heart problems before starting to take this medicine. It is not possible to determine whether such events were directly related to Rabestrom.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the sachet after
Exp.
Keep the medicine in the original package to protect it from moisture. This medicine
does not require any particular storage temperature.
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 Rabestrom contains

• The active ingredient is sildenafil (in the form of citrate). Each orodispersible film contains 25 mg of sildenafil (in the form of citrate). Each orodispersible film contains 50 mg of sildenafil (in the form of citrate). Each orodispersible film contains 75 mg of sildenafil (in the form of citrate). Each orodispersible film contains 100 mg of sildenafil (in the form of citrate).
• The other ingredients are: maltodextrin, glycerol, polysorbate 20, propylene glycol monocaprylate, polyvinyl acetate dispersion 30%, lemon and grapefruit flavors (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 contents of the pack
Rabestrom is an orodispersible film.
Rabestrom 25 mg orodispersible film
The orodispersible film is a rectangular, flexible film, light blue in color (30 mm x 15 mm).
Rabestrom 50 mg orodispersible film
The orodispersible film is a square, flexible film, light blue in color (30 mm x 30 mm).
Rabestrom 75 mg orodispersible film
The orodispersible film is a rectangular, flexible film, light blue in color (30 mm x 45 mm).
Rabestrom 100 mg orodispersible film
The orodispersible film is a rectangular, flexible film, light blue in color (40 mm x 45 mm).
The orodispersible films are supplied in packs containing 2, 4, 8 or 12 orodispersible films. Each
sachet contains one orodispersible film.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi

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 Authorisation Holder.