PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SILDENAFIL DOC Generics 25 mg chewable tablets, 50 mg chewable tablets, 100 mg chewable tablets

Generic 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, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

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

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

SILDENAFIL DOC Generics 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 increased blood flow into the penis during sexual stimulation. SILDENAFIL DOC Generics will help you achieve an erection only if you are sexually stimulated.
SILDENAFIL DOC Generics 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 Generics

Do not take SILDENAFIL DOC Generics
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, because this combination may cause a dangerous
decrease in blood pressure. Inform your doctor if you are taking any of these medicines,
which are often used to relieve attacks of angina pectoris (or “chest pain”). If you have
any doubts, consult your doctor or pharmacist.
if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination may also cause a dangerous decrease 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 Generics, have been shown to increase the hypotensive effect of this medicine. 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 a 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 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 Generics
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 a 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 strain of sexual activity.
if you currently have a stomach ulcer or coagulation disorders (such as hemophilia).
if you experience a sudden decrease or loss of vision, stop taking SILDENAFIL DOC Generics and contact your doctor immediately.
You must not use SILDENAFIL DOC Generics together with other oral or local treatments for erectile dysfunction.
You must not use SILDENAFIL DOC Generics together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or with any other phosphodiesterase type 5 (PDE5) inhibitors.
You must not take SILDENAFIL DOC Generics if you do not have erectile dysfunction.
You must not take SILDENAFIL DOC Generics 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 Generics must not be administered to individuals under 18 years of age.

Other medicines and SILDENAFIL DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
SILDENAFIL DOC Generics chewable 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 Generics and when you took it. Do not take SILDENAFIL DOC Generics with other medicines unless authorized by your doctor.
Do not take SILDENAFIL DOC Generics if you are taking medicines called nitrates, because 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 pectoris (or “chest pain”).
Do not take SILDENAFIL DOC Generics if you are using medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because 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, for example medicines used to treat HIV, your doctor may initially prescribe you the lowest dose of SILDENAFIL DOC Generics (25 mg).
Some patients receiving 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 down or standing up quickly. Some patients have reported these symptoms when taking SILDENAFIL DOC Generics together with alpha-blockers. This is more likely to occur within 4 hours after taking SILDENAFIL DOC Generics. To reduce the likelihood of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with SILDENAFIL DOC Generics. Your doctor may start you on a lower dose of SILDENAFIL DOC Generics (25 mg).

SILDENAFIL DOC Generics with food, drinks, and alcohol
SILDENAFIL DOC Generics can be taken with or without food. However, you may notice that the onset of effect of SILDENAFIL DOC Generics may be slower if taken after a heavy meal.
Consuming alcoholic beverages may temporarily impair your ability to achieve an erection. To obtain the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using SILDENAFIL DOC Generics.

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

Driving and using machines
SILDENAFIL DOC Generics may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to SILDENAFIL DOC Generics.

SILDENAFIL DOC Generics chewable tablets contain aspartame, a source of phenylalanine. If you suffer from phenylketonuria (a rare inherited metabolic disorder), you should take this into account.

SILDENAFIL DOC Generics chewable tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.

3. How to take SILDENAFIL DOC Generics

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 Generics must not be taken more than once a day.
Do not take sildenafil chewable tablets in combination with orodispersible tablets or sildenafil film-coated tablets.
You should take SILDENAFIL DOC Generics approximately one hour before anticipated sexual activity. The tablet must be chewed completely.
If you feel that the effect of SILDENAFIL DOC Generics is too strong or too weak, consult your doctor or pharmacist.
SILDENAFIL DOC Generics will help you achieve an erection only if you are sexually stimulated. The time required for SILDENAFIL DOC Generics to take effect varies from person to person, but generally ranges from half an hour to one hour. The effect of SILDENAFIL DOC Generics may take longer if you have recently eaten a heavy meal.
If SILDENAFIL DOC Generics 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 Generics than you should
You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than those prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions 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 Generics are usually mild to
moderate in intensity and short-lived.
If you experience any of the following serious side effects, stop taking
SILDENAFIL DOC Generics 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:
Adopt a semi-sitting position 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 lasts 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, blisters in the mouth, genital area, or 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 body),
indigestion, increased colour brightness in vision, blurred vision, visual disturbances, nasal congestion, and
dizziness.
Uncommon (may affect up to 1 in 100 people):
vomiting, rash, eye irritation, eye redness, eye pain, flashes of light, increased light perception, light
sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain,
drowsiness, reduced sensitivity to touch, vertigo, tinnitus, dry mouth, blocked or stuffy nose, inflammation of
the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), upper abdominal pain,
gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds,
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
particles in the visual field, seeing halos around lights, pupil dilation, changes in the white colour of the sclera
(part of the eye), penile bleeding, presence of blood in semen, dry nose, swelling of the nasal mucosa,
irritability, and sudden decrease or loss of hearing.
From post-marketing experience, rare cases of unstable angina (a heart condition) and sudden death have
been reported. It should be noted that most of the men who experienced these side effects, but not all, had
pre-existing heart conditions before using this medicine. It is not possible to determine whether these events
are directly related to the use of SILDENAFIL DOC Generics.

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
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SILDENAFIL DOC Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SILDENAFIL DOC Generics contains
The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil.
The other components are: potassium polacrilin, anhydrous colloidal silica, lactose monohydrate, povidone K-30,
aspartame (E951), sodium croscarmellose, mint flavour, magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).
Description of the appearance of SILDENAFIL DOC Generics and pack contents
25 mg: white, triangular, biconvex tablets, embossed with '25' on one side.
50 mg: white, triangular, biconvex tablets, embossed with '50' on one side.
100 mg: white, triangular, biconvex tablets, embossed with '100' on one side.
Blister packs containing 1, 2, 4 or 8 chewable tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Manufacturer:
Genepharm S.A. - 18 km Marathon Avenue - 15351 Pallini – Greece.
Pharmadox Healthcare Ltd - KW20A Kordin Industrial Park - Paola PLA 3000 – Malta.
This medicinal product is authorised in other EEA Member States under the following names:
Italy: SILDENAFIL DOC Generics chewable tablets
Netherlands: Sildenafil DOC Generici chewable tablets
This patient information leaflet was approved on