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SILDENAFIL TORRENT 100 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Contact your doctor if you take more tablets than you should.

Package leaflet: Information for the user

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

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.

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, please 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.

If you have chest pains during or after intercourse:
• Get in a semi-sitting position and try to relax.
• Do not use nitrates to treat your chest pain.
• Contact your doctor immediately.
All medicines including Sildenafil can cause allergic reactions. You should contact your doctor
immediately if you experience any of the following symptoms after taking Sildenafil: sudden wheeziness,
difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

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

Prolonged and sometimes painful erections have been reported after taking Sildenafil. If you have an
erection which lasts for more than 4 hours, you should contact a doctor immediately.
If you experience a sudden decrease or loss of vision, stop taking Sildenafil and contact your doctor
immediately.
A very common side effect (likely to occur in more than 1 in 10 patients) is:
• headache.

1. What Sildenafil is and what it is used for

Common side effects (likely to occur in 1 to 10 patients in 100) include:
• facial flushing,
• indigestion,
• effects on vision (including colour tinge to vision, light sensitivity, blurred vision or reduced
sharpness of vision),
• stuffy nose,
• dizziness.

Sildenafil 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. You should
not take Sildenafil if you do not have erectile dysfunction. You should not take Sildenafil if you are a
woman.
Sildenafil is a treatment for 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.

Uncommon side effects (likely to occur in 1 to 10 patients in 1000) include:
• vomiting,
• skin rash,
• bleeding at the back of the eye,
• eye irritation,
• bloodshot eyes /red eyes,
• eye pain,
• double vision,
• abnormal sensation in the eye,
• irregular or rapid heartbeat,
• muscle pain,
• feeling sleepy,
• reduced sense of touch,
• vertigo,
• ringing in the ears,
• nausea,
• dry mouth,
• chest pain,
• feeling tired.

2. What you need to know before you take Sildenafil
Do not take Sildenafil
If you are taking medicines called nitrates, as the combination may cause a potentially dangerous
decrease 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 drugs known as nitric oxide donors such as amyl nitrite (“poppers”), as the
combination may also lead to a potentially dangerous decrease in your blood pressure.
If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
If you have a severe heart or liver problem.
If you have recently had a stroke or a heart attack.
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 in that case 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.

Rare side effects (likely to occur in 1 to 10 patients in 10000) include:
• high blood pressure,
• low blood pressure,
• fainting,
• stroke,
• nosebleed
• sudden decrease or loss of hearing
• Hypersensitivity reactions.
Additional side effects reported from post-marketing experience include:
• sudden death,
• pounding heartbeat,
• chest pain,
• heart attack or temporary decreased blood flow to parts of the brain.
Most, but not all, of these men had heart problems before taking this medicine. It is not possible to
determine whether these events were directly related to Sildenafil.

Children and adolescents
Sildenafil should not be given to individuals under the age of 18.
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.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Cases of convulsions or seizures and serious skin reactions characterised by rash, blisters, peeling skin
and pain which require immediate medical attention have also been reported.

Sildenafil tablets may interfere with some medicines, especially those used to treat chest pain. In the
event of a medical emergency, you should tell any health care professional treating your condition that
you have taken Sildenafil and when you did. Do not take Sildenafil with other medicines unless your
doctor tells you that you can.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
5. How to store Sildenafil

You should not take Sildenafil if you are taking medicines called nitrates, as the combination of these
products may cause a potentially dangerous decrease 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”).

Keep this medicine out of the sight and reach of children

You should not take Sildenafil if you are using any of the drugs known as nitric oxide donors such as amyl
nitrite (“poppers”) as the combination may also lead to a potentially dangerous decrease in your blood
pressure.

This medicinal product does not require any special storage conditions.

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.
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.

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.

6. Contents of the pack and other information

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 occur within 4 hours after taking Sildenafil. In order
to reduce the likelihood that these symptoms occur, 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.

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).

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.

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.

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.

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.

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.

Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex RH11 7XA
United Kingdom

The recommended starting dose is 50 mg.
You should not take Sildenafil more than once a day.
You should take Sildenafil about one hour before you plan to have sex. Swallow the tablet whole with a
glass of water.
If you have the impression that the effect of Sildenafil is too strong or too weak, talk to your doctor or
pharmacist.

This medicinal product is authorised in the Member States of the EEA under the following names:

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.

Austria:
Germany:
Italy:
Lithuania:
Malta:
Netherlands:
Romania:
United Kingdom:

If Sildenafil does not help you to get an erection, or if your erection does not last long enough for you to
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.

This leaflet was last revised in 07/2013.

Colour Black

LOCATION : Indrad
SIZE

COUNTRY : UK

: 150 x 465 mm_Front/Back Side

Supersedes A / W No.:
CODE : 8042313-7803

DATE : 12-07-2013

REMARK : Folding Length 35 mm
SUBSTRATE :
Activities

Department

Name

Signature

Sildenafil Torrent 25/50/100mg Filmtabletten
Sildenafil Heumann 25/50/100 mg Filmtabletten
Sildenafil Torrent
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

Date

Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Reviewed By RA
Approved By CQA

This colour proof is not colour binding. Follow Pantone shade reference for actual colour matching.

8042313-7803

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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