Silandil

Leaflet attached to the packaging: patient information

Silandyl, 25 mg, orally disintegrating tablet

Silandyl, 50 mg, orally disintegrating tablet

Silandyl, 75 mg, orally disintegrating tablet

Silandyl, 100 mg, orally disintegrating tablet

Sildenafil

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

• This leaflet should be kept, so that it can be re-read if necessary.
• 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 their 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 (PDE5) inhibitors. 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.

Silandyl is used to treat men with erectile dysfunction, sometimes called impotence. This is defined as the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual performance.

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 drop in blood pressure. If the patient is taking any of these medicines, they should inform their doctor; these medicines are often used to relieve angina pectoris (chest pain).
• 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 drop 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 retinitis pigmentosa).
• if the patient has ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).
• if the patient is taking riociguat. This is a medicine 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 cancer of the bone marrow).
• if the patient has a physical deformity of the penis 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 in combination with other oral or topical treatments for erectile dysfunction.

Silandyl should not be used in combination 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 kidney or liver function disorders

Patients with kidney or liver function disorders 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 orally disintegrating tablets may interact with some medicines, especially those used to treat chest pain.

In the event of a medical emergency, 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 drop 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 drop 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 to take Silandyl. The doctor may decide to use a lower dose (25 mg) of Silandyl initially.

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 doubts, the doctor or pharmacist should be consulted. The recommended starting 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 orally disintegrating 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 orally disintegrating 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.

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

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

The tablet will dissolve 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 it is 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 orally disintegrating tablets than recommended by their doctor.

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

If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

Side effects reported in connection with the use of Silandyl are usually mild to moderate and are short-term.

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

• 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 seek medical help immediately.
• 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 body), indigestion, seeing a blue tint on objects or having difficulty telling the difference between the colors blue and green, 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, eye swelling, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy nose, nasal congestion (symptoms include a runny nose, sneezing, and a stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling hot, and feeling tired.

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, reduced 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 lights, dilation of the pupil, discoloration of the white of the eye, bleeding from the penis, presence of blood in the semen, dryness of the 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 were present before taking this 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Email: ndl@urpl.gov.pl

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 packaging and sachet after "EXP". The expiry date refers to the last day of the month stated.

The medicine should be stored in its original packaging to protect it from moisture. There are no special precautions for storing the medicine at a certain 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 orally disintegrating tablet contains 25 mg of sildenafil (in the form of citrate). Each orally disintegrating tablet contains 50 mg of sildenafil (in the form of citrate). Each orally disintegrating tablet contains 75 mg of sildenafil (in the form of citrate). Each orally disintegrating 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%, citrus-grapefruit flavor (citrus oil, citral, linalool, grapefruit oil, orange 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 what the packaging contains

Silandyl is an orally disintegrating tablet.

Sildenafil 25 mg orally disintegrating tablet.

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

Sildenafil 50 mg orally disintegrating tablet.

The orally disintegrating tablet is a square, elastic, light blue strip (30 mm x 30 mm).

Sildenafil 75 mg orally disintegrating tablet.

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

Sildenafil 100 mg orally disintegrating tablet.

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

The medicine is supplied in packaging containing 2, 4, 8, or 12 orally disintegrating tablets. Each sachet contains one orally disintegrating 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 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

Date of last revision of the leaflet: 01.01.2019