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SILDENAFIL 50 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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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 (PDE 5)
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 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.
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 problem
(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.
You should not take Sildenafil if you do not have erectile
dysfunction.
You should not take Sildenafil if you are a woman.
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.
Other medicines and Sildenafil Tell your doctor or pharmacist if
you are taking, have recently taken or might take any other
medicines.

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Sildenafil

Package leaflet: Information for the user

Sildenafil

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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 medicines 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.
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 alphablockers. This is most likely to occur within 4 hours after taking
Sildenafil. In order to reduce the chance that these symptoms might
happen, you should be on a regular daily dose of your alphablocker 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.
Sildenafil contains lactose
Sildenafil film-coated tablets contain lactose monohydrate. If you
have been told by your doctor that you have an intolerance to some
sugars, such as lactose, contact your doctor before taking this
medicinal product
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.
Sildenafil 50 mg film-coated tablets:
This strength is not suitable for dosages below 50 mg
Sildenafil 100 mg film-coated tablets:
This strength is not suitable for dosages below 100 mg
Other medicinal products of Sildenafil in adequate strength are
available.
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 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 medicine, ask
your doctor or pharmacist.

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 1000 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 orloss 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 your doctor, pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
The United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Sildenafil
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions
Do not use this medicine after the expiry date which is stated on
the label, carton and blister 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.
6. Contents of the pack and other information
What Sildenafil contains
The active substance is sildenafil.
Each film-coated tablet contains 50 mg Sildenafil (as sildenafil
citrate).
Each film-coated tablet contains 100 mg Sildenafil (as sildenafil
citrate).
-

The other ingredients are
Tablet core: Calcium hydrogen phosphate anhydrous, cellulose
microcrystalline, croscarmellose sodium, silica colloidal
anhydrous, magnesium stearate.
Tablet coat: Lactose monohydrate, hypromellose 15cP,
titanium dioxide (E171), triacetin.

What Sildenafil looks like and contents of the pack
Film-coated tablet
Sildenafil 50 mg film-coated tablets
White to off-white, round (9.6 mm diameter), biconvex film-coated
tablets debossed with “SL” on one side and 50 on the other side.
Sildenafil 100 mg film-coated tablets
White to off-white, round (11.2 mm diameter), biconvex film-coated
tablets debossed with “SL” on one side and 100 on the other side.
Sildenafil film-coated tablets are available in clear PVC/PVdCAluminium foil blisters and HDPE bottle packs.
Pack sizes:
Blister pack: 1, 2, 4, 8 & 12 film-coated tablets
HDPE pack:
50 mg: 30, 1000 film-coated tablets
100 mg: 30, 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder
UK - Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
MT - Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
Estonia:
Sildenafil Aurobindo 100 mg, õhukese
polümeerikattega tabletid
France:
SILDENAFIL ARROW LAB 50 mg/100 mg,
comprimé pelliculé
Germany:
Sildenafil Aurobindo 50 mg/100 mg
Filmtabletten
Italy:
Sildenafil Aurobindo 50 mg/100 mg
compresse rivestite con film
Latvia:
Sildenafil Aurobindo 100 mg apvalkotās
tabletes
Malta
Sildenafil 50 mg/100 mg film-coated tablets
Netherlands:
Sildenafil Aurobindo 50 mg/100 mg,
filmomhulde tabletten
Portugal:
Sildenafil Aurobindo
Spain:
Sildenafilo Aurobindo 50 mg/100 mg
comprimidos recubiertos con película EFG
United Kingdom:
Sildenafil 50 mg/100 mg film-coated tablets
This leaflet was last revised in 04/2015.
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4. Possible side effects

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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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