SILDENAFIL ZENTIVA 50MG FILM-COATED TABLETS

Active substance: SILDENAFIL CITRATE

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7

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.

Package leaflet: Information for the user

SILDENAFIL 25MG
FILM-COATED TABLETS
SILDENAFIL 50MG
FILM-COATED TABLETS
SILDENAFIL 100MG
FILM-COATED TABLETS

Children and adolescents
Sildenafil should not be given to individuals
under the age of 18.

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 pharmacist or nurse.
• 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, pharmacist or nurse. 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

Other medicines and sildenafil
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Sildenafil film-coated 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”).

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 (25mg) of sildenafil.

Sildenafil will only help you to get an erection
You should not use sildenafil with any other
if you are sexually stimulated. The amount of
oral or local treatments for erectile dysfunction.
time sildenafil takes to work varies from
person to person, but it normally takes
You should not take sildenafil if you do not
between half an hour and one hour. You may
have erectile dysfunction.
find that sildenafil takes longer to work if you
You should not take sildenafil if you are a
take it with a heavy meal.
woman.

148

SIGNATURE:
DATE:

FONT:

1 mm, de la muchia de taiere

RO

QC STATEMENT:

NR
17.10.2013
OPERATOR: L. Florea
DATE:

CHANGE CONTROL:

TERRITORY:

PM TYPE:

lfl

GB

AW VERSION:

12.

Helvetica Neue min.9pt

If you feel that the effect of sildenafil is too
strong or too weak, talk to your doctor or
pharmacist.

DESIGN:

You should take sildenafil about one hour
before you plan to have sex. Swallow the
tablet whole with a glass of water.

TEXT:

Do not take sildenafil film-coated tablets in
combination with sildenafil containing
orodispersible tablets.

BRAILLE:
TRANSCRIPT:

You should not take sildenafil more than
once a day.

P Bl ack C

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure. The
recommended starting dose is 50mg.

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3.How to take sildenafil

INFO:

Sildenafil contains lactose
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.

COLORS:

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.

GB

Pregnancy, breast feeding and fertility
Sildenafil is not indicated for use by women.

ZV/51784

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.

EMBOSS.:

Warnings and precautions
Talk to your doctor, pharmacist or nurse
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 problem (such as haemophilia).
- If you experience sudden decrease or loss
of vision, stop taking sildenafil and contact
your doctor immediately.

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.

SAP ID:
100MG 2X4 ,100MG 1X4,
TEXT:
DOSAGE: 50 MG 2X4,50 MG
PHARM. FORM: COMPRIMATE FILMATE
1X4,25 MG 2X4, 25 MG 1X4
SIZE:
EAN CODE:
OPTICAL CODE:
SIZE: external:148x420 mm
THIN
THICK
7 mm LINE: 1.5 mmLINE: 0.4 mmGAP: 1.5mm± 0,1 mm
MATERIAL: STMAS 7_2011 - Prospect gramaj 40 - 45 g_m2
Format prepliat
LOOK CODE:
VARNISH:
PARCIAL:

420

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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 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 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, 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)

100MG ;50 MG;25MG GB PM CODE:

pliere

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.

PRODUCT NAME:LFL.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. In order 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 (25mg) of sildenafil.

13000568,13000569,
13000570,13000571,
13000572,13000574

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.

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The name of your medicine is Sildenafil
25mg, 50mg or 100mg film-coated tablets
(referred to as sildenafil throughout this
leaflet).

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1.What sildenafil is and what it is used for

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.

3100

1

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.

5.How to store sildenafil
Keep this medicine out of the sight and
reach of children.

The tablet can be divided into equal halves.

This medicinal product does not require any
special storage conditions.

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.

Do not use this medicine after the expiry
date which is stated on the carton, label and
blister after “EXP”. The expiry date refers to
the last day of that month.

You should not take more tablets than
your doctor tells you to.
Contact your doctor if you take more tablets
than you should.

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 have any further questions on the use 6. Contents of the pack and other inforof this medicine, ask your doctor or pharmacist. mation
4.Possible side effects

What sildenafil contains

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.

The active substance is sildenafil.

If you experience any of the following
serious side effects stop taking sildenafil
and seek medical help immediately:
• An allergic reaction (this occurs rarely)
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 (frequency unknown). 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
(frequency unknown)
• Serious skin reactions (frequency
unknown). Symptoms may include severe
peeling and swelling of the skin, blistering
of the mouth, genitals and around the
eyes, fever.
• Seizures or fits (frequency unknown)
Other side effects:
Very common (may affect more than 1 in 10
people): headache.
Common (may affect up to 1 in 10 people):
facial flushing, indigestion, effects on vision
(including colour tinge to vision, light
sensitivity, blurred vision or reduced
sharpness of vision), stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100
people): 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,
pounding heartbeat, 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 (may affect up to 1 in 1,000 people):
high blood pressure, low blood pressure,
fainting, stroke, heart attack, irregular
heartbeat, nosebleed and sudden decrease
or loss of hearing.
Not known (frequency cannot be estimated
from the available data): Additional side
effects reported from post-marketing
experience: Unstable angina (a heart
condition), sudden death, temporary
decreased blood flow to parts of the brain.
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 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.

Each 25mg film-coated tablet contains 25mg
of sildenafil (as 35.12mg sildenafil citrate).
Each 50mg film-coated tablet contains 50mg
of sildenafil (as 70.24mg sildenafil citrate).
Each 100mg film-coated tablet contains
100mg of sildenafil (as 140.48mg sildenafil
citrate).
The other ingredients are:
• Tablet core : microcrystalline cellulose,
calcium hydrogen phosphate (anhydrous),
croscarmellose sodium, magnesium
stearate
• Tablet coating: lactose monohydrate,
hypromellose, titanium dioxide (E171),
triacetin, indigo carmine aluminium lake
(E132)
What sildenafil looks like and contents of
the pack
Sildenafil 25mg film-coated tablet
Blue coloured round, biconvex, film-coated
tablets debossed with 124 on one side and J
on the other side.
Sildenafil 50mg film-coated tablet
Blue coloured round, scored biconvex,
film-coated tablets debossed with 125 on
one side and J on the other side with the
score line. The tablet can be divided into
equal doses.
Sildenafil 100mg film-coated tablet
Blue coloured round, biconvex, scored
film-coated tablets debossed with 126 on
one side and J on the other side with the
score line. The tablet can be divided into
equal doses.
Sildenafil is supplied in the following pack
sizes:
PVC/Aluminium foil blisters in cartons of 1,
2, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK.
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA
3000, Malta
Or
S.C. Zentiva S.A.
50, Theodor Pallady Blvd., 032266, Bucharest, Romania.
This leaflet was last revised in
October 2013.
‘Zentiva’ is a registered trademark. © 2013
Zentiva.

51784

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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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