Sildenafil 50mg Tablets (UK) 4

The active substance is sildenafil. Each tablet contains 100mg of sildenafil citrate.

Package Leaflet Information for the user:

Read all of this leaflet carefully before you start taking Sildenafil.
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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
 If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Sildenafil is and what it is used for
2. Before you take Sildenafil
3. How to take Sildenafil
4. Possible side effects
5. How to store Sildenafil
6. Further information
1. What Sildenafil is and what it is used for
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.
2. Before you take Sildenafil:
Do not take Sildenafil
 If you are taking medicines containing 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, as the combination may also lead to a potentially dangerous decrease in your blood pressure.
 If you are allergic (hypersensitive) to sildenafil or any of the other
ingredients of Sildenafil.
 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).
Take special care with Sildenafil:
Tell your doctor
 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.
Special considerations for children and adolescents
Sildenafil should not be given to individuals under the age of 18.
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.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently
taken other medicines, including medicines obtained without
prescription.
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.
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").
You should not take Sildenafil if you are using any of the drugs
known as nitric oxide donors as the combination may also lead to a potentially dangerous decrease in your blood pressure.
If you are taking medicines known as protease inhibitors 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 problems may experience dizziness
or light-headedness, which may be caused by low 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.
Taking Sildenafil with food and drink:
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 the ability to get an erection.
To get the maximum benefit from your medicine, you are advised not
to drink large amounts of alcohol before taking Sildenafil.
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.
Important information about some of the ingredients of Sildenafil:
If you have been told by your doctor that you have an intolerance
to some sugars, such as lactose, contact your doctor before taking
Sildenafil.
3. How to take Sildenafil:
Always take Sildenafil exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. The
usual dose is 50 mg.
You should not use Sildenafil more than once a day.
You should take Sildenafil about one hour before sexual activity. 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.
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 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 product, ask your
doctor or pharmacist.
Sildenafil 100 mg film‑coated tablets
Sildenafil

4. Possible side effects:

Like all medicines, Sildenafil can cause side effects, although
not everybody gets them. These effects are normally mild to moderate
and of short duration.
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 this medicinal product: sudden
wheeziness, difficulty in breathing or dizziness, swelling of the eyelids,
face, lips or throat.
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 the
medicinal product and contact your doctor immediately.
The frequency of possible side effects listed below is defined using the
following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
A very common side effect is headache.
Common side effects include: facial flushing, indigestion, effects on
vision (including colour tinge to vision, light sensitivity, blurred vision
or reduced sharpness of vision) stuffy nose and dizziness.
Uncommon side effects 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, watery eyes, irregular
or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of
touch, vertigo, ringing in the ears, nausea, dry mouth, penile bleeding,
presence of blood in semen and/or urine, chest pain and feeling tired.
Rare side effects include: high blood pressure, low blood pressure,
fainting, stroke, heart attack, nosebleed and sudden decrease or loss
of hearing.
Additional side effects reported with Sildenafil from post-marketing experience
include: pounding heartbeat, chest pain, sudden death 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. 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.
If any of the side effects get serious, or of you notice any side effects
not listed in this leaflet please tell your doctor.
5. How to store Sildenafil

Keep out of the reach and sight of children
Do not use Sildenafil after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information

What Sildenafil contains
 The active substance is sildenafil. Each tablet contains 100 mg of
sildenafil (as citrate).
 The other ingredients are: lactose monohydrate, microcrystalline
cellulose, povidone K29‑32, croscarmellose sodium, magnesium
stearate, hypromellose, titanium dioxide (E171), macrogol 6000,
indigo carmine aluminium lake (E132).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76‑78
IS-220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:
Belgi«/Belgique/Belgien
ALL-in-1 bvba
Tél/Tel: +32 (0)32 86 88 88
Luxembourg/Luxemburg
ALL-in-1 bvba
Belgique/Belgien
Tél/Tel: +32 (0)32 86 88 88
България
Актавис ЕАД
Teл.: + 359 2 9321 680
Magyarország
Actavis Hungary Kft
Tel.: +36 1 501 7001
Česká republika
Actavis CZ a.s.
Tel: +420251113 002
Malta
Actavis Ltd.
Tel: + 35621693533
Danmark
Actavis A/S
Tlf: +45 72 22 30 00
Nederland
Actavis B.V.
Tel: +31 3554 299 33
Deutschland
Actavis Deutschland GmbH &
Co. KG
Telefon: +49 (0) 89 558909 0
Norge
Actavis Norway AS
Tlf: +47 815 22 099
Eesti
UAB "Actavis Baltics" Eesti Filiaal
Tel: +372 6100 565
Österreich
Actavis GmbH
Tel: + 43 (0)662 435 235 00
Ελλάδα
Pharmathen SA
Τel: +30 210 66 04 300
Polska
Actavis Export Int. Ltd., Malta.
Kontakt w Polsce:
Tel: (+48 22) 512 29 00
España
Actavis Spain, S.A.
Tfno.: +34 91 630 86 45
Portugal
Actavis A/S Sucursal
Tel: + 351 21 722 06 50
France
Actavis France
Tél: + 33 1 40 83 77 77
România
Actavis SRL
Tel: + 40 21 318 17 77
Ireland
Actavis Ireland Limited
Tel: + 353 (0)21 4619040
Slovenija
Apta Medica Internacional
d.o.o.
Tel: +386 51 615 015
Ísland
Actavis Group PTC ehf
Sími: + 354-550 3300
Slovenská republika
Actavis s.r.o.
Tel: +421 2 3255 3800
Italia
Actavis Italy S.p.A.
Tel: +39 0331 583111
Suomi/Finland
Actavis Oy
Puh/Tel: +358 (0)9 348 233
Κύπρος
A. Potamitis Medicare Ltd
Τηλ: +35722583333
Sverige
Actavis AB
Tel: + 46 8 13 63 70
Latvija
Actavis Baltics pārstāvniecība
Latvijā
Tel: +371 67067873
United Kingdom
Actavis UK Limited
Tel: + 441271311257
Lietuva
UAB "Actavis Baltics"
Tel: +370 5 260 9615
This leaflet was last approved in March 2013.
Detailed information on this medicine is available on the European
Medicines Agency web site: http://www.ema.europa.eu/.
AAAF1631