PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SILDENAFIL DOC 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What SILDENAFIL DOC is and what it is used for
What you need to know before taking SILDENAFIL DOC
How to take SILDENAFIL DOC
Possible side effects
How to store SILDENAFIL DOC
Contents of the pack and other information

1. What SILDENAFIL DOC is and what it is used for

SILDENAFIL DOC contains the active substance sildenafil, which belongs to a class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps relax the blood vessels in the penis, allowing
blood flow into the penis during sexual stimulation. SILDENAFIL DOC will help you achieve
an erection only if you are sexually stimulated.
SILDENAFIL DOC is a treatment for adult men who have erectile dysfunction, sometimes
called impotence. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking SILDENAFIL DOC

Do not take SILDENAFIL DOC

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 this combination may cause 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 you are unsure, consult your doctor or pharmacist.
if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as this combination may also cause a dangerous drop in blood pressure.
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 SILDENAFIL DOC, have been shown to increase the blood pressure-lowering effect of riociguat. If you are taking riociguat or have any doubts, inform your doctor.
if you have a serious heart or liver problem.
if you have recently had a stroke or heart attack, or if you have low blood pressure.
if you have a rare inherited eye disease (such as retinitis pigmentosa).
if you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking SILDENAFIL DOC

if you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a bone marrow tumor).
if you have penile deformity or Peyronie’s disease.
if you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical stress of sexual activity.
if you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
if you experience sudden reduction or loss of vision, stop taking SILDENAFIL DOC and contact your doctor immediately.

You must not use SILDENAFIL DOC together with other oral or topical treatments for erectile dysfunction.
You must not use SILDENAFIL DOC together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take SILDENAFIL DOC if you do not have erectile dysfunction.
You must not take SILDENAFIL DOC if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
SILDENAFIL DOC must not be given to individuals under 18 years of age.

Other medicines and SILDENAFIL DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SILDENAFIL DOC tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken SILDENAFIL DOC and when you took it. Do not take SILDENAFIL DOC with other medicines unless authorized by your doctor.
Do not take SILDENAFIL DOC if you are taking medicines called nitrates, as the combination may cause a dangerous drop in blood pressure. Inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina attacks (or “chest pain”).
Do not take SILDENAFIL DOC if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, such as medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of SILDENAFIL DOC (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or mental confusion, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when taking SILDENAFIL DOC together with alpha-blockers. This is most likely to occur within 4 hours after taking SILDENAFIL DOC.
To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with SILDENAFIL DOC.
Your doctor may start you on a lower dose of SILDENAFIL DOC (25 mg).

SILDENAFIL DOC with food, drinks, and alcohol
SILDENAFIL DOC can be taken with or without food.
However, you may notice that the onset of effect of SILDENAFIL DOC is slower if taken after 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 consuming large amounts of alcohol before taking SILDENAFIL DOC.

Pregnancy, breastfeeding, and fertility
SILDENAFIL DOC is not indicated for use in women.

Driving and using machines
SILDENAFIL DOC may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to SILDENAFIL DOC.

SILDENAFIL DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

SILDENAFIL DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take SILDENAFIL DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
SILDENAFIL DOC must not be taken more than once a day.
Do not take SILDENAFIL DOC film-coated tablets in combination with sildenafil orodispersible tablets.
Take SILDENAFIL DOC approximately one hour before anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of SILDENAFIL DOC is too strong or too weak, consult your doctor or
pharmacist.
SILDENAFIL DOC will help you achieve an erection only if you are sexually stimulated. The time required
for SILDENAFIL DOC to take effect may vary from person to person, but generally ranges from
half an hour to one hour. The effect of SILDENAFIL DOC may take longer if you have recently consumed a
heavy meal.
If SILDENAFIL DOC does not help you achieve an erection, or if the erection does not last long enough
to complete sexual intercourse, inform your doctor.
If you take more SILDENAFIL DOC than you should:
You may experience an increase in the frequency and severity of side effects. Doses higher than 100
mg do not increase efficacy.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
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 everyone experiences them.
The side effects reported in association with the use of SILDENAFIL DOC are usually mild to moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking
SILDENAFIL DOC and contact your doctor immediately:

Allergic reaction – occurs uncommonly (may affect 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 this occurs during or after sexual intercourse:

Sit semi-upright 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 this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision – occurs rarely.
Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, mouth blisters, blisters in the genital area and around the eyes, fever.
Seizures or convulsions – 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 part of the body), indigestion, increased colour perception, blurred vision, visual disturbances, nasal congestion, and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, light flashes, increased light sensitivity, photophobia, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, epistaxis, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood flow to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding from the back of the eye, double vision, reduced visual acuity, 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 the white colour of the sclera (part of the eye), penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability, sudden decrease or loss of hearing.

Rare cases of unstable angina (a heart condition) and sudden death have been reported following marketing experience. It should be noted that most men who experienced these side effects, but not all, already had pre-existing heart problems before taking this medicine.
It is not possible to determine whether these events are directly related to the use of SILDENAFIL DOC.

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 SILDENAFIL DOC

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and blister after Exp.
The expiry date refers to the last day of the month.
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 SILDENAFIL DOC contains
The active substance is sildenafil.

Each tablet of SILDENAFIL DOC 25 mg contains 25 mg of sildenafil (as sildenafil citrate).
Each tablet of SILDENAFIL DOC 50 mg contains 50 mg of sildenafil (as sildenafil citrate).
Each tablet of SILDENAFIL DOC 100 mg contains 100 mg of sildenafil (as sildenafil citrate).
The other components are:
Core: croscarmellose sodium, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin.

Description of the appearance and contents of the pack
SILDENAFIL DOC 25 mg, 50 mg and 100 mg tablets are white, film-coated, oval-shaped tablets.
The tablets are available in PVC/aluminum blisters in packs containing 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici srl – Via Turati, 40 – 20121 Milano - Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy