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
Sildenafilum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Silandyl is and what it is used for
2. What you need to 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. The medicine works by helping to relax blood vessels in the penis, 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 a penile erection 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, as 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"), as 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 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). 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 penile deformity 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 worsening of vision or sudden vision loss, they should stop taking Silandyl immediately and contact their doctor without delay.

Silandyl should not be used concomitantly with other oral or topical treatments for erectile dysfunction.
Silandyl should 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 do not have erectile dysfunction.
Silandyl is not intended for use in women.

Special considerations in 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.

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 used, recently taken, or planned for use.
Silandyl orally disintegrating tablets may interact with certain medicines, particularly those used to treat chest pain (angina).
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 with other medicines without medical approval.
Do not take Silandyl if the patient is using nitrate-containing medicines, as 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), as their concomitant use may cause dangerous lowering of blood pressure.
If the patient is taking protease inhibitors used in the treatment of HIV infection, initiation of treatment with the lowest dose of Silandyl (25 mg) is recommended.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of orthostatic hypotension—low blood pressure upon standing up or sitting down quickly. Such symptoms have occurred in some patients taking Silandyl together with alpha-blockers. These effects are most likely 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, food, drink, and alcohol
Silandyl may 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 alcohol intake should be avoided 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 assess 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 your 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 orodispersible 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 orodispersible tablets with wet hands!
a) Take the sachet in your hand, locate the arrow symbol

at the top of the sachet and hold it with this side facing upwards. The sachet is not sealed at this point.
b) Gently tear apart both sides of the sachet.

Hold each side of the sachet with one hand between the thumb and index finger.
c) Carefully pull both sides 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, take the tablet, remove it from the sachet and immediately place it in the mouth on the tongue.
The tablet will dissolve quickly, making it easy to swallow.

If the effect of Silandyl seems too strong or too weak, consult your 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 a higher than recommended dose of Silandyl
Adverse effects may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more orodispersible tablets than prescribed by your doctor.
Contact your doctor if more tablets have been taken than recommended.

If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects reported with the use of Silandyl have usually been mild to moderate in intensity and short-lived.
If any of the following serious adverse effects occur in a patient,
treatment with Silandyl must be discontinued immediately and medical help must be sought at once.

• Allergic reaction – occurs not commonly (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 not commonly): If chest pain occurs during or after sexual intercourse:
  • Sit in a semi-upright position and try to relax.
  • Do not use nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (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 – occurs rarely.
  Serious skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on the genital organs and around the eyes, fever.
• Seizures or convulsions – occur rarely.

Other adverse 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 sudden feeling of warmth in the upper body), indigestion, seeing coloured halos, blurred vision or visual disturbances, stuffy nose, dizziness.
Not common (may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and blocked nose), 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, heart attack, irregular heartbeat, transient ischaemic attack (temporary reduction in blood flow to part of the brain), sensation of tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, decreased visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small specks or spots in the field of vision, seeing halos around light sources (halo effect), pupil dilation, discolouration of the white of the eye, rectal bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden weakness or loss of hearing.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Silandyl

Keep this medicine out of the 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 required. Such measures help protect the environment.

6. Contents of the pack 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 essential oil, citral, linalool, grapefruit essential oil, orange essential 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 packs 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