Silandil

Leaflet attached to the packaging: patient information

Silandyl, 25 mg, orodispersible tablet

Silandyl, 50 mg, orodispersible tablet

Silandyl, 75 mg, orodispersible tablet

Silandyl, 100 mg, orodispersible tablet

Sildenafil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Silandyl and what is it used for

Silandyl contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Silandyl helps to achieve an erection only if there is sexual stimulation.

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, as their simultaneous use may cause a dangerous decrease in 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 pectoris ("chest pain"). In case of doubt, the doctor or pharmacist should be consulted.
• if the patient is taking medicines that release nitric oxide (e.g., amyl nitrate, so-called "poppers"), as their simultaneous use may cause a dangerous decrease in blood pressure.
• if the patient has serious heart or liver problems.
• if the patient has recently had a stroke or heart attack or has low blood pressure.
• if the patient suffers from rare hereditary eye diseases (such as retinal pigmentosis).
• if the patient has ever experienced loss of vision due to non-inflammatory 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). It has been shown that PDE5 inhibitors, such as Silandyl, 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 to take Silandyl, the patient should consult their 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 bone marrow cancer).
• if the patient has a penile deformity or Peyronie's disease.
• if the patient has heart problems. The doctor should carefully check if the patient's 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 vision loss or sudden hearing loss, they should stop taking Silandyl and immediately consult their doctor.

Silandyl should not be used simultaneously with other oral or topical treatments for erectile dysfunction.

Silandyl should not be used simultaneously with medicines used to treat pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.

Silandyl should not be used by patients who have not been diagnosed with erectile dysfunction.

Silandyl is not intended for women.

Special considerations for patients with renal or hepatic impairment

Patients with renal or hepatic impairment should inform their doctor, who may decide to administer a lower dose of the medicine.

Children and adolescents

Silandyl should not be used in persons under 18 years of age.

Silandyl and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Silandyl in the form of orodispersible tablets may interact with some medicines, especially those used to treat chest pain.

In case of an emergency requiring immediate medical attention, the patient should inform their doctor, pharmacist, or nurse that they have taken Silandyl and when they did so. Silandyl should not be taken with other medicines without the doctor's consent.

Silandyl should not be used if the patient is taking nitrate medicines, as their simultaneous use may cause a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking medicines that are usually used to treat angina pectoris ("chest pain").

Silandyl should not be used if the patient is taking medicines that release nitric oxide (e.g., amyl nitrate), as their simultaneous use may cause a dangerous decrease in blood pressure.

If the patient is taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with the lowest dose (25 mg) of Silandyl.

In some patients who are taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of orthostatic hypotension, a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking Silandyl and alpha-adrenergic blockers. The occurrence of these symptoms is most likely within 4 hours of taking Silandyl.

To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting Silandyl. The doctor may decide to use a lower initial dose (25 mg) of Silandyl.

The patient should inform their doctor or pharmacist if they are already taking riociguat.

Silandyl with food, drink, and alcohol

Silandyl can be taken with or without food. However, taking Silandyl during a heavy meal may prolong the time to the start of the medicine's action.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the potential of Silandyl, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Silandyl is not indicated for use in women.

Driving and using machines

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 exactly as prescribed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. The recommended initial dose is 50 mg.

Silandyl should not be taken more than once a day.

Silandyl should be taken about an hour before planned sexual activity. Sildenafil in the form of orodispersible tablets is intended for oral administration without water. However, the patient can also take sildenafil with water.

Instructions for use

Warning: Do not touch the orodispersible tablets with wet hands!

a) Take the sachet in hand, find the arrow sign at the top of the sachet, and hold it with the arrow pointing upwards. The sachet is not sealed at this point.

b) Gently tear the two parts of the sachet apart.

Hold each part of the sachet with one hand between the thumb and index finger.

c) Carefully pull the two parts of the sachet in opposite directions until they come apart.

At this point, the tablet is visible, lying on one of the separated parts of the sachet.

d) Hold the tablet with dry fingers, remove it from the sachet, and place it immediately in the mouth on the tongue.

The tablet dissolves quickly, making it easy to swallow.

If the patient feels that the effect of Silandyl is too strong or too weak, they should consult their doctor or pharmacist. Silandyl helps to achieve an erection only if there is sexual stimulation. The time it takes for Silandyl to work varies from person to person but is usually between half an hour and one hour. The effect of Silandyl may occur later if taken with a heavy meal.

If, after taking Silandyl, an erection does not occur or the duration of the erection is not sufficient for sexual intercourse, the patient should inform their doctor.

Taking a higher dose of Silandyl than recommended

The patient may experience more frequent side effects, and they may be more severe.

Taking a dose higher than 100 mg does not increase the efficacy of the medicine.

The patient should not take more orodispersible tablets than recommended by their doctor.

In case of taking more tablets than recommended, the patient should contact their doctor.

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Silandyl can cause side effects, although not everybody gets them.

The side effects reported in connection with the use of Silandyl are usually mild to moderate and are short-lived.

If the patient experiences any of the following serious side effects, they should stop taking Silandyl and seek immediate medical attention.

• Allergic reaction - occurs uncommonly(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 (occurs uncommonly): If it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax.
• Nitrates should not be usedto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in up to 1 in 1000 people). If an erection lasts for more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or hearing loss - occurs rarely. Severe skin reactions - occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely.

Other side effects:

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 a sudden feeling of heat in the upper part of the body), indigestion, seeing with a colored glow, blurred vision or changes in vision, stuffy nose, dizziness.

Uncommon(may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased sensitivity to light, tearing, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and feeling of tiredness.

Rare(may occur in up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, dilated pupils, discoloration of the white of the eye, bleeding from the penis, blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden loss of hearing.

Additional side effects reported after the medicine was placed on the market:

Unstable angina (heart disease), sudden cardiac death have been reported rarely. In most, but not all patients who experienced these side effects, cardiovascular disorders existed before taking the medicine. It is impossible to determine whether these side effects were directly related to the use of Silandyl.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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]

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Silandyl

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the carton and sachet after "EXP". The expiry date refers to the last day of the month stated.

Store in the original packaging to protect from moisture. There are no special precautions for storage temperature.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Silandyl contains

• The active substance is sildenafil (in the form of citrate). Each orodispersible tablet contains 25 mg of sildenafil (in the form of citrate). Each orodispersible tablet contains 50 mg of sildenafil (in the form of citrate). Each orodispersible tablet contains 75 mg of sildenafil (in the form of citrate). Each orodispersible tablet 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-lime flavor (lemon essential oil, citral, linalool, grapefruit essential oil, orange essential oil, nootkatone, butylated hydroxyanisole (E 320), ascorbic acid (E 300), maltodextrin, arabic gum (E 414)), sucralose, titanium dioxide (E 171), indigotine (E 132).

What Silandyl looks like and contents of the pack

Silandyl is an orodispersible tablet.

Sildenafil 25 mg orodispersible tablet.

The orodispersible tablet is a rectangular, elastic, light blue strip (30 mm x 15 mm)

Sildenafil 50 mg orodispersible tablet.

The orodispersible tablet is a square, elastic, light blue strip (30 mm x 30 mm)

Sildenafil 75 mg orodispersible tablet.

The orodispersible tablet is a rectangular, elastic, light blue strip (30 mm x 45 mm)

Sildenafil 100 mg orodispersible tablet.

The orodispersible tablet is a rectangular, elastic, light blue strip (40 mm x 45 mm)

Silandyl is supplied in packs containing 2, 4, 8, or 12 orodispersible tablets. Each sachet contains one orodispersible tablet.

Not all pack sizes may be marketed.

Marketing authorization holder

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi

Italy

Manufacturer

IBSA Farmaceutici Italia srlS.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

Date of last revision of the leaflet: 01.01.2019