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SILDENAFIL TORRENT 100 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Package leaflet: Information for the user
Sildenafil 25 mg Film-coated Tablets
Sildenafil 50 mg Film-coated Tablets
Sildenafil 100 mg Film-coated Tablets
Sildenafil
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sildenafil is and what it is used for
2. What you need to know before you take Sildenafil
3. How to take Sildenafil
4. Possible side effects
5. How to store Sildenafil
6. Contents of the pack and other information
1. What Sildenafil is and what it is used for
Sildenafil contains the active substance Sildenafil which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to relax the blood vessels in your penis,
allowing blood to flow into your penis when you get sexually excited. Sildenafil will only help you to get
an erection if you are sexually stimulated.
Sildenafil is a treatment for adult men with erectile dysfunction, sometimes known as impotence. This is
when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
2. What you need to know before you take Sildenafil
Do not take Sildenafil

If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).

If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your
blood pressure. Tell your doctor if you are taking any of these medicines which are often given for
relief of angina pectoris (or “chest pain”). If you are not certain, ask your doctor or pharmacist.

If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”),
as the combination may also lead to a dangerous fall in your blood pressure.

If you are taking riociguat. This drug 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). PDE5 inhibitors, such as Sildenafil have been shown
to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your
doctor.

If you have a severe 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 certain rare inherited eye diseases (such as retinitis pigmentosa).

If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil

If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood
cells), multiple myeloma (cancer of bone marrow).

If you have a deformity of your penis or Peyronie’s Disease.

If you have problems with your heart. Your doctor should carefully check whether your heart
can take the additional strain of having sex.

If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).

If you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your
doctor immediately.
You should not use Sildenafil with any other oral or local treatments for erectile dysfunction.
You should not use Sildenafil with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other PDE5 inhibitors.

complete sexual intercourse you should tell your doctor.
If you take more Sildenafil than you should
You may experience an increase in side effects and their severity. Doses above 100 mg do not increase
the efficacy.
You should not take more tablets than your doctor tells you to.
Contact your doctor if you take more tablets than you should.
If you have any further questions on the use of this medicine, ask 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 sildenafil are usually mild to moderate and of a short
duration.
If you experience any of the following serious side effects stop taking Sildenafil and seek medical
help immediately:

An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms
include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face,
lips or throat

Chest pains - this occurs uncommonly
If this occurs during or after intercourse
Get in a semi-sitting position and try to relax.
Do not use nitrates to treat your chest pain.

Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000
people)
If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

A sudden decrease or loss of vision - this occurs rarely

Serious skin reactions - this occurs rarely
Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and
around the eyes, fever.

Seizures or fits - this occurs 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 flush (symptoms include a sudden
feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance,
stuffy nose and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red
eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding
heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced
sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the
lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain,
gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the
arms or legs, nosebleed, feeling hot and feeling tired.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary
decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at
the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling
of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil
of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose,
swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
From post-marketing experience cases of unstable angina (a heart condition) and sudden death have
been reported rarely. Of note, most, but not all, of the men who experienced these side effects had heart
problems before taking this medicine. It is not possible to determine whether these events were directly
related to sildenafil.
Reporting of side effects
If you get any side effects, talk to you doctor or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Sildenafil

You should not take Sildenafil if you do not have erectile dysfunction.

Keep this medicine out of the sight and reach of children

You should not take Sildenafil if you are a woman.

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.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems. Your doctor may decide on a lower dose
for you.
Children and adolescents
Sildenafil should not be given to individuals under the age of 18.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the
event of a medical emergency, you should tell your doctor or pharmacist that you have taken Sildenafil
and when you did. Do not take Sildenafil with other medicines unless your doctor tells you that you can.
You should not take Sildenafil if you are taking medicines called nitrates, as the combination of these
products may lead to a dangerous fall in your blood pressure. Always tell your doctor or pharmacist if you
are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).
You should not take Sildenafil if you are using any of the medicines known as nitric oxide donors such as
amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor
may start you on the lowest dose (25 mg) of Sildenafil.
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate
enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure
upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking
Sildenafil with alpha-blockers. This is most likely to happen within 4 hours after taking Sildenafil. To
reduce the chance that these symptoms might happen, you should be on a regular daily dose of your
alpha-blocker before you start Sildenafil. Your doctor may start you on a lower dose (25 mg) of Sildenafil.
Sildenafil with food, drink and alcohol
Sildenafil can be taken with or without food. However, you may find that Sildenafil takes longer to start
working if you take it with a heavy meal.
Drinking alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from
your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil.
Pregnancy, breast-feeding and fertility
Sildenafil is not indicated for use by women.
Driving and using machines
Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to Sildenafil
before you drive or use machinery.
3. How to take Sildenafil
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The recommended starting dose is 50 mg.
You should not take Sildenafil more than once a day.
Do not take sildenafil film-coated tablets in combination with sildenafil orodispersible tablets
You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a
glass of water.
If you feel that the effect of Sildenafil is too strong or too weak, talk to your doctor or pharmacist.
Sildenafil will only help you to get an erection if you are sexually stimulated. The amount of time Sildenafil
takes to work varies from person to person, but it normally takes between half an hour and one hour. You
may find that Sildenafil takes longer to work if you take it with a heavy meal.
If Sildenafil does not help you to get an erection, or if your erection does not last long enough for you to

This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sildenafil contains
The active substance is sildenafil. Each tablet contains 25 mg, 50mg or 100mg of sildenafil (as the citrate
salt).
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, dibasic calcium phosphate anhydrous,
hypromellose, sodium stearyl fumarate.
Film coat: hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132).
What Sildenafil looks like and contents of the pack
Sildenafil 25 mg film-coated tablets are blue, round (diameter approx. 7.1 mm), biconvex, film coated
tablets debossed with ‘86’on one side and plain on the other side.
Sildenafil 50 mg film-coated tablets are blue, round (diameter approx. 9.6 mm), biconvex, film coated
tablets, debossed with ‘8’ Bisect ‘7’ on one side and plain on the other side. The tablet can be divided into
equal doses.
Sildenafil 100 mg film-coated tablets are blue, round (diameter approx. 12.3 mm), biconvex, film coated
tablets, debossed with ‘8’ Bisect ‘8’ on one side and plain on the other side. The tablet can be divided into
equal doses.
Pack size:
Sildenafil 25mg: 4, 8 or 12 tablets.
Sildenafil 50mg, 100mg: 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex RH11 7XA
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria:
Germany:
Italy:
Lithuania:
Malta:
Netherlands:
Romania:
United Kingdom:

Sildenafil Torrent 25/50/100mg Filmtabletten
Sildenafil Heumann 25/50/100 mg Filmtabletten
Sildenafil ABC
Sildenafil Torrent 25/50/100mg plėvele dengtos tabletės
Sildenafil Torrent 25/50/100mg film-coated tablets
Sildenafil Torrent 25/50/100mg filmomhulde tabletten
Sildenafil Torrent 25/50/100mg comprimate filmate
Sildenafil 25/50/100mg Film-Coated Tablets

This leaflet was last revised in 11/2016.

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