Patient Information Leaflet: Information for the User

Sildenafil ABC 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Sildenafil
Please read all of this leaflet carefully before you take 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See Section 4.

Contents of this leaflet:

What Sildenafil ABC is and what it is used for
What you need to know before taking Sildenafil ABC
How to take Sildenafil ABC
Possible side effects
How to store Sildenafil ABC
Package contents and other information

1. What Sildenafil ABC is and what it is used for

Sildenafil ABC 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 to the penis when sexually stimulated.
Sildenafil ABC will help you achieve an erection only if you are sexually stimulated.
Sildenafil ABC 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 should know before taking Sildenafil ABC

Do not take Sildenafil ABC

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 drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
if you are taking nitric oxide donors such as amyl nitrite ("poppers"), because 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 ABC have been shown to increase the hypotensive effect when taken with riociguat. If you are taking riociguat or have any doubts, contact your doctor.
if you have a severe 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 vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil ABC

if you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (blood cell cancer), or multiple myeloma (a cancer of the bone marrow).
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 intercourse.
if you currently have a stomach ulcer or bleeding disorders (such as haemophilia).
if you experience a sudden decrease or loss of vision, stop taking Sildenafil ABC and contact your doctor immediately. You must not use Sildenafil ABC together with other oral or topical treatments for erectile dysfunction.

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

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

Children and adolescents
Sildenafil ABC must not be administered to individuals under 18 years of age.

Other medicines and Sildenafil ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil ABC tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor or pharmacist that you have taken Sildenafil ABC and when it was taken. Do not take Sildenafil ABC with other medicines unless authorized by your doctor.

Do not take Sildenafil ABC if you are taking medicines called nitrates, because the combination may cause a dangerous drop in blood pressure. Inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain").

Do not take Sildenafil ABC 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 the lowest dose of Sildenafil ABC (25 mg).

Some patients taking alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or mental confusion, which may be due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking Sildenafil ABC together with alpha-blockers. This is most likely to occur within 4 hours after taking Sildenafil ABC. To reduce the risk of these symptoms, you should already be on a stable dose of an alpha-blocker before starting treatment with Sildenafil ABC. Your doctor may start you on a lower dose of Sildenafil ABC (25 mg).

Sildenafil ABC with food, drinks and alcohol
Sildenafil ABC can be taken with or without food. However, you may notice that the onset of Sildenafil ABC's effect 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 using Sildenafil ABC.

Pregnancy, breast-feeding and fertility
Sildenafil ABC is not indicated for use in women.

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

3. How to take Sildenafil ABC

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 ABC must not be taken more than once a day.
Do not take Sildenafil ABC film-coated tablets in combination with sildenafil orodispersible tablets.
You should take Sildenafil ABC approximately one hour before anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of Sildenafil ABC is too strong or too weak, consult your doctor or pharmacist.
Sildenafil ABC will help you achieve an erection only if you are sexually stimulated. The time needed for
Sildenafil ABC to take effect varies from person to person, but generally ranges from half an hour to
one hour. The effect of Sildenafil ABC may take longer if you have recently eaten a heavy meal.
If Sildenafil ABC 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 ABC 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 the use of this medicine, consult your doctor or pharmacist.

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 Sildenafil use are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking
Sildenafil ABC 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 it occurs during or after sexual intercourse:
- Sit in a semi-upright 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 skin peeling and swelling, 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 intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, redness of the eyes, eye pain, light flashes, 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 congested sinuses, nasal mucosal inflammation (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, 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, 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.

Rare cases of unstable angina (a heart condition) and sudden death have been reported during post-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.

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 through the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 ABC contains
The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt).
The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate salt).
The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).

The other components are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, anhydrous dibasic calcium phosphate,
hypromellose, sodium stearyl fumarate.
Coating: hypromellose, titanium dioxide (E171), triacetin, aluminium lake containing indigo carmine (E132).

Description of the appearance of Sildenafil ABC and contents of the package
Sildenafil ABC 25 mg film-coated tablets are blue, round (diameter approximately 7.1 mm), biconvex,
film-coated tablets marked with "86" on one side and smooth on the other.
Sildenafil ABC 50 mg film-coated tablets are blue, round (diameter approximately 9.6 mm), biconvex,
film-coated tablets marked with "8" bar "7" on one side and smooth on the other. The tablet can be divided
into two equal doses.
Sildenafil ABC 100 mg film-coated tablets are blue, round (diameter approximately 12.3 mm), biconvex,
film-coated tablets marked with "8" bar "8" on one side and smooth on the other. The tablet can be divided
into two equal doses.
Pack sizes: 4, 8, 12 and 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Torino
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Sildenafil Torrent 100 mg Filmtabletten
Germany: Sildenafil Heumann 100 mg Filmtabletten
Italy: Sildenafil ABC
Lithuania: Sildenafil Torrent 100 mg plėvele dengtos tabletės
Malta: Sildenafil Torrent 100 mg film-coated tablets
Netherlands: Sildenafil Torrent 100 mg filmomhulde tabletten
Romania: Sildenafil Torrent 100 mg comprimate filmate
United Kingdom: Sildenafil 100 mg Film-Coated Tablets