Siler

Patient Information Leaflet

Siler 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Siler is and what it is used for

Siler contains the active substance 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 into the penis during sexual stimulation. Siler helps achieve an erection only in the presence of sexual stimulation.
Siler 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 Siler

Do not take Siler

• 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 in doubt, consult 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 severe liver or heart problems.
• 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 Siler 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 Siler

• 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 assess 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 Siler and contact your doctor immediately.

You must not use Siler with any other oral or topical treatments for erectile dysfunction.
You must not use Siler with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other PDE5 inhibitor.
You must not take Siler if you do not have erectile dysfunction.
You must not take Siler 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
Siler must not be administered to individuals under 18 years of age.
Other medicines and Siler
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Siler 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 Siler and when you took it. Do not take Siler with other medicines unless your
doctor has authorized it.
Do not take Siler 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").
Do not take Siler 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 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 Siler.
Some patients receiving treatment with alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness, which may be due to
low blood pressure when sitting down or standing up quickly.
Some patients have experienced such symptoms while taking Siler with alpha-blockers.
This is more likely to occur within 4 hours after taking Siler.
To reduce the risk of such symptoms, you should be on a stable daily dose of alpha-blockers
before starting Siler. Your doctor may start you on the lowest dose (25 mg) of Siler.
Inform your doctor or pharmacist if you are already taking riociguat.
Siler with food, drinks, and alcohol
Siler can be taken with or without food. However, you may notice that Siler 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 Siler.
Pregnancy, breastfeeding, and fertility
Siler is not indicated for use in women.
Driving and using machines
Siler may cause dizziness and visual disturbances. You should be aware of how your body
reacts to Siler before driving or operating machinery.

3. How to take Siler

Take this medicine exactly as instructed 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 Siler more than once a day.
Take Siler approximately one hour before sexual intercourse. Siler orodispersible film is for oral use and should be taken without water. If desired, you may also take Siler 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 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 separate. The orodispersible
film is now visible and located
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,
making it easy to swallow.
If you feel that the effect of Siler is too strong or too weak, discuss this with your doctor or pharmacist.
Siler will help you achieve an erection only in the presence of sexual stimulation. The time it takes for
Siler to start working varies from person to person, but normally ranges between half an hour and one hour.
You may notice that Siler takes longer to work when taken with a heavy meal.
If Siler 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 Siler than you should:
You may experience an increase in the frequency and severity of adverse 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 doubts about how to use 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 side effects reported with Siler are generally mild to moderate and short-lived.
If you notice any of the following serious side effects, stop taking Siler and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (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 uncommonly): If it 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, skin rash, eye irritation, red or inflamed eyes, eye pain, seeing flashes of light, increased light perception, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), blood in 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, temporary reduction in blood flow to certain parts of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced sharpness of vision, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters 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 inside 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 Siler.

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 https://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 Siler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box and sachet after
Exp.
Keep the medicine in the original packaging to protect it from moisture.
This medicine does not require any special storage temperature.
Do not dispose of any medicine 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 Siler 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 in 30% dispersion, 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 Siler and package contents
Siler is an orodispersible film.
Siler 25 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film (30 mm x 15 mm).
Siler 50 mg orodispersible film
The orodispersible film is a square, flexible, light blue film (30 mm x 30 mm).
Siler 75 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film (30 mm x 45 mm).
Siler 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
IBSA Farmaceutici Italia S.r.l., 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.