SILDENAFIL 25 mg Film-Coated Tablets

Зміст інструкції

1. Sildenafil ABC 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
2. Sildenafil
   1. What is Sildenafil ABC and what is it used for
   2. What you need to know before taking Sildenafil ABC
   3. How to take Sildenafil ABC
   4. Possible side effects
   5. How to store Sildenafil ABC
   6. Package contents and other information

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

Generic medicine

Sildenafil

Read this leaflet carefully before you start to 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sildenafil ABCis and what it is used for
• 2. What you need to know before you take Sildenafil ABC
• 3. How to take Sildenafil ABC
• 4. Possible side effects
• 5. How to store Sildenafil ABC
• 6. Contents of the pack and other information

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

Sildenafil ABCbelongs to a class of medicines called phosphodiesterase type 5 inhibitors
(PDE5). It helps to relax the blood vessels in the penis, allowing blood to flow into the penis when it is
sexually stimulated. Sildenafil ABCwill only help you achieve an erection if you are sexually stimulated.

Sildenafil ABCis a treatment for adult men who experience erectile dysfunction, sometimes called
impotence. This condition occurs when a man cannot achieve or maintain
an erection sufficient for satisfactory sexual intercourse.

2. What you need to 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 can cause a dangerous drop in blood pressure. Tell 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, ask your doctor or pharmacist.
• If you are taking any of the medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), because this combination can 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 secondary to blood clots). It has been shown that PDE5 inhibitors, such as Sildenafil ABC, increase the hypotensive effect, if you are taking riociguat or have any doubts contact your doctor.
• if you have a serious problem with your heart or liver.
• if you have recently had a stroke or heart attack, or if you have low blood pressure.
• if you have a rare hereditary eye disease (such as retinitis pigmentosa).
• if you have previously experienced loss of vision caused by anterior ischaemic 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 (cancer of the blood cells), multiple myeloma (cancer of the bone marrow).
• if you have a deformity of the penis or Peyronie's disease.
• if you have heart problems. Your doctor needs to carefully check that your heart condition allows you to cope with the exertion of sexual activity.
• if you currently have a stomach ulcer, or problems with blood clotting (such as haemophilia).
• if you experience a sudden decrease or loss of vision, stop taking Sildenafil ABCand contact your doctor immediately. You should not use Sildenafil ABCtogether with other oral or local treatments for erectile dysfunction.

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

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

Children and adolescents
Sildenafil ABCmust not be given to anyone under the age of 18.

Other medicines and Sildenafil ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The tablets of Sildenafil ABCcan interfere with some medicines, particularly those used for
treating chest pain. If you should experience a medical emergency, you must tell your doctor or
pharmacist that you have taken Sildenafil ABCand when you took it. Do not take Sildenafil ABCtogether
with other medicines, unless your doctor has authorised it.
You must not take Sildenafil ABCif you are taking medicines called nitrates because the combination
of these medicines can cause a dangerous drop in blood pressure. Tell your doctor or
pharmacist if you are taking any of these medicines which are often used to relieve angina attacks
(or “chest pain”).
You must not take Sildenafil ABCif you are using any of the medicines known as nitric oxide
donors, such as amyl nitrite (“poppers”) because this combination can also cause a dangerous
drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example medicines for the treatment
of HIV, your doctor may initially prescribe Sildenafil ABCat the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness which may be caused by low blood pressure when sitting or standing up quickly. Some patients have reported these symptoms when
they have taken Sildenafil ABCtogether with alpha-blockers. This is more likely to occur within 4 hours
of taking Sildenafil ABC. To reduce the possibility of these symptoms occurring, you should
be on a stable dose of your alpha-blocker before starting treatment with Sildenafil
ABC. Your doctor may start you on a lower dose of Sildenafil ABC(25 mg).

Sildenafil ABCwith food, drinks and alcohol
Sildenafil ABCcan be taken with or without food. However, you may notice that the onset of the effect of

Sildenafil ABCmay be slower if you take it after consuming a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To
get the most benefit from this medicine, it is advisable to avoid consuming large amounts of
alcohol before using Sildenafil ABC.

Pregnancy, breastfeeding and fertility
Sildenafil ABCis not indicated for use in women.

Driving and using machines
Sildenafil ABCcan cause dizziness and can alter your vision. Before driving and using machines you should
be aware of how you react to Sildenafil ABC.

3. How to take Sildenafil ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.

Sildenafil ABCshould not be taken more than once a day.
Do not take the film-coated tablets of Sildenafil ABC in combination with the orodispersible
tablets of sildenafil.
You should take Sildenafil ABCapproximately one hour before the anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of Sildenafil ABCis too strong or too weak, consult your doctor or
pharmacist.

Sildenafil ABCwill only help you to achieve an erection if you are sexually stimulated. The time it takes for

Sildenafil ABCto take effect varies from person to person, but generally ranges from half an
hour to one hour. The effect of Sildenafil ABCmay be delayed if you have recently
consumed a heavy meal.
If Sildenafil ABCdoes not help you to 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 notice an increase in the undesirable effects and the severity of these effects. Higher doses than 100
mg do not increase efficacy.

Do not take a number of tablets greater than those prescribed by your doctor.
If you take a number of tablets greater than prescribed, contact your doctor.
If you have any doubts 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 everybody gets them.
The side effects reported in association with the use of Sildenafilare usually mild to moderate and of
short duration.

If you experience any of the following serious side effects, stop taking
Sildenafil ABC and contact your doctor immediately:

• Allergic reaction - occurs with a frequency of uncommon(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 with a frequency of uncommon: If it occurs during or after sexual activity:
• Assume a semi-sitting position and try to relax.
• Do not use nitratesto 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 uninterrupted for more than 4 hours, contact your doctor immediately.
• Sudden reduction 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, on the genitals and around the eyes, fever.
• Convulsions or seizures - 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, flushing, hot flushes (the
symptoms include a sudden feeling of warmth in the upper body), indigestion,
increased intensity of colors to vision, blurred vision, visual disturbances, stuffy nose and
dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, red eyes, eye pain, flashes of light, increased perception of light, sensitivity
to light, tearing, heart palpitations, fast heartbeat, high blood pressure,
low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing
in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain,
gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain
in the arms or legs, nosebleeds, feeling of heat and fatigue.

Rare (may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular
heartbeat, temporary reduction in blood flow to certain areas of the brain, feeling
of constriction in the throat, numb mouth, bleeding in the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids,
appearance of spots or corpuscles in the visual field, seeing halos around lights, dilation of
the pupils, alteration of the white color of the sclera (part of the eye), bleeding of the penis,
presence of blood in the seminal fluid, dry nose, swelling of the nasal mucosa, irritability and
sudden or loss of hearing.
Cases of unstable angina (a heart disease) and sudden death have been reported from post-marketing experience. It should be noted that most men
who experienced these side effects, but not all, had heart problems before
using 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 get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the package after SCAD. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in 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 ingredient is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate salt).
The active ingredient is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate salt).
The active ingredient is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate salt).
The other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose, anhydrous dibasic calcium phosphate,
hypromellose, sodium stearyl fumarate.
Coating: hypromellose, titanium dioxide (E171), triacetin, aluminum lake containing indigo carmine
(E132).

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

Marketing authorization holder and manufacturer
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Turin
Italy

This medicinal product is authorized in the Member States of the European Economic Area with 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