Silandyl

Package leaflet: Information for the patient

Silandyl, 25 mg, orodispersible tablet
Silandyl, 50 mg, orodispersible tablet
Silandyl, 75 mg, orodispersible tablet
Silandyl, 100 mg, orodispersible tablet
Sildenafil
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Silandyl is and what it is used for

Silandyl contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Silandyl works by helping the blood vessels in the penis (penis) to relax, thereby increasing blood flow into the penis during sexual stimulation. Silandyl helps achieve an erection only if sexual stimulation is present.
Silandyl is used to treat men with erectile dysfunction, sometimes known as impotence. This is defined as the inability to achieve or maintain an erection of the penis sufficient for sexual intercourse.

2. Important information before taking Silandyl

When not to take Silandyl:

• if the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking nitrates, because their concomitant use may cause dangerous lowering of blood pressure. If the patient is taking any of these medicines, they should inform their doctor; these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist.
• if the patient is taking medicines that release nitric oxide (e.g. amyl nitrate, so-called poppers), because their concomitant use may cause dangerous lowering of blood pressure.
• if the patient has serious heart or liver problems.
• if the patient has recently had a stroke or heart attack, or if they have low blood pressure.
• if the patient suffers from rare inherited eye diseases (such as retinitis pigmentosa).
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
• if the patient is taking riociguat. This medicine is used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as Silandyl have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Silandyl, consult a doctor, pharmacist, or nurse:

• if the patient has sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• if the patient has been diagnosed with anatomical deformity of the penis or Peyronie's disease.
• if the patient has heart problems. The doctor should carefully assess whether the heart condition allows for the additional strain associated with sexual activity.
• if the patient has a stomach ulcer or bleeding disorders (such as hemophilia).
• if the patient experiences sudden decrease or loss of vision, treatment with Silandyl should be stopped immediately and the patient should contact their doctor without delay.

Silandyl must not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Silandyl must not be used concomitantly with medicines used to treat pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
Silandyl should not be used in patients who have not been diagnosed with erectile dysfunction.
Silandyl is not intended for use in women.
Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor, who may decide to prescribe a lower dose of the medicine.
Children and adolescents
Silandyl must not be used in individuals under 18 years of age.
Silandyl and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Silandyl in the form of orally disintegrating tablets may interact with certain medicines, particularly those used to treat chest pain.
In case of a medical emergency, inform the doctor, pharmacist, or nurse that the patient has taken Silandyl and when it was taken. Do not take Silandyl concomitantly with other medicines without medical approval.
Do not take Silandyl if the patient is using nitrate-containing medicines, because their concomitant use may cause dangerous lowering of blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking medicines commonly used to treat angina (chest pain).
Do not take Silandyl if the patient is using medicines that release nitric oxide (e.g. amyl nitrate), because their concomitant use may cause dangerous lowering of blood pressure.
If the patient is taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with the lowest dose (25 mg) of Silandyl.
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of orthostatic hypotension (a drop in blood pressure upon standing up or sitting down quickly). Such symptoms have been reported in some patients taking Silandyl concomitantly with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Silandyl.
To reduce the risk of such symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting Silandyl. The doctor may decide to initiate treatment with a low dose (25 mg) of Silandyl.
Inform the doctor or pharmacist if the patient is already taking riociguat.
Silandyl with food, drink, and alcohol
Silandyl can be taken with or without food. However, taking Silandyl with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the effectiveness of Silandyl, significant amounts of alcohol should not be consumed before taking the medicine.
Pregnancy, breastfeeding, and fertility
Silandyl is not indicated for use in women.
Driving and operating machinery
Silandyl may cause dizziness and visual disturbances. Patients should be aware of how they react to Silandyl before driving or operating machinery.

3. How to take Silandyl

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist. The recommended starting dose is 50 mg.
Silandyl must not be taken more than once a day.
Silandyl should be taken approximately one hour before planned sexual activity. Sildenafil in the form of orally disintegrating tablets is intended for oral administration without water. However, the patient may also take sildenafil with water.

Instructions for use
Warning: Do not handle the orally disintegrating tablets with wet hands!
a) Take the sachet and locate the arrow mark

at the top of the sachet, holding it with this side facing upwards. The sachet is not sealed at this point.
b) Gently tear apart both sections of the sachet.

Hold each part of the sachet with one hand, between the thumb and index finger.
c) Carefully pull both parts of the sachet in opposite directions until they separate.
At this point, the tablet will be visible, lying on one of the separated parts of the sachet.

d) With dry fingers, pick up the tablet, remove it from the sachet and place it immediately on the tongue in the mouth.
The tablet will dissolve quickly, making it easy to swallow.

If the effect of Silandyl seems too strong or too weak, consult a doctor or pharmacist. Silandyl helps achieve an erection only in the presence of sexual stimulation. The time it takes for Silandyl to take effect varies between individuals, but usually ranges from half an hour to one hour. The effect of Silandyl may be delayed if taken together with a heavy meal.

If an erection does not occur after taking Silandyl, or if the duration of erection is insufficient for sexual intercourse, inform your doctor.

Taking more Silandyl than recommended
The risk of adverse effects may increase in frequency and intensity.
Taking a dose higher than 100 mg does not increase the medicine’s effectiveness.
Do not take more orally disintegrating tablets than prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported with Silandyl have usually been mild to moderate in intensity and transient.
If any of the following serious adverse reactions occur in a patient,
treatment with Silandyl must be discontinued immediately and medical help must be sought without delay.

• Allergic reaction – uncommon (may occur in up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain (uncommon): If chest pain occurs during or after sexual intercourse:
  • adopt a semi-sitting position and try to relax.
  • Do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – rare (may occur in up to 1 in 1000 people). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – rare. Serious skin reactions – rare. Symptoms may include severe skin peeling and swelling, formation of blisters in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – rare.

Other adverse reactions:
Very common (may occur in more than 1 in 10 people): headache.
Common (may occur in up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include sudden feeling of warmth in the upper body), indigestion, seeing coloured halos, blurred vision or visual disturbances, stuffy nose, dizziness.
Uncommon (may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, eye hyperaemia, eye pain, seeing flashes of light, bright vision, photophobia, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, somnolence, reduced sense of touch, dizziness, tinnitus, dry mouth, blocked or stuffy sinuses, rhinitis (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth and feeling of fatigue.
Rare (may occur in up to 1 in 1000 people): fainting, stroke, myocardial infarction, irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of throat tightness, lip numbness, bleeding into the back of the eye, double vision, decreased visual acuity, abnormal sensations inside the eye, eye or eyelid swelling, small particles or spots in the visual field, seeing halos around light sources (halo effect), pupil dilation, discolouration of the white part of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, irritability, and sudden hearing loss.

Additional adverse reactions reported after marketing of the medicine:
Unstable angina (heart disease) and sudden cardiac death have been reported rarely. In most, but not all patients who experienced these adverse reactions, cardiovascular disorders were present prior to taking this medicine. It is not possible to determine whether these adverse reactions were directly related to the use of Silandyl.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Silandyl

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". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture. No special precautions regarding the storage temperature of the medicine are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Silandyl contains

• The active substance is sildenafil (as citrate). Each orodispersible tablet contains 25 mg of sildenafil (as citrate). Each orodispersible tablet contains 50 mg of sildenafil (as citrate). Each orodispersible tablet contains 75 mg of sildenafil (as citrate). Each orodispersible tablet contains 100 mg of sildenafil (as citrate).
• The other ingredients are: maltodextrin, glycerol, polysorbate 20, propylene glycol monocaprylate, polyvinyl acetate dispersion 30%, lemon-grapefruit flavouring additive (lemon flavouring oil, citral, linalool, grapefruit flavouring oil, orange flavouring oil, nootkatone, butylated hydroxyanisole (E 320), ascorbic acid (E 300), maltodextrin, gum arabic (E 414)), sucralose, titanium dioxide (E 171), indigo carmine (E 132).

What Silandyl looks like and contents of the pack
Silandyl is an orodispersible tablet.
Sildenafil 25 mg orodispersible tablet.
Orodispersible tablet in the form of a rectangular, flexible, light blue strip (30 mm x 15 mm).
Sildenafil 50 mg orodispersible tablet.
Orodispersible tablet in the form of a square, flexible, light blue strip (30 mm x 30 mm).
Sildenafil 75 mg orodispersible tablet.
Orodispersible tablet in the form of a rectangular, flexible, light blue strip (30 mm x 45 mm).
Sildenafil 100 mg orodispersible tablet.
Orodispersible tablet in the form of a rectangular, flexible, light blue strip (40 mm x 45 mm).
The medicine is supplied in packages containing 2, 4, 8 or 12 orodispersible tablets. Each sachet contains one orodispersible tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi
Italy

Manufacturer
IBSA Farmaceutici Italia srl
S.S. n. 11 Padana Superiore Km 160
20060 Cassina de’ Pecchi (Mi), Italy
Altergon Italia S.r.l.,
Zona Industriale,
83040 – Morra de Sanctis (AV), Italy