SILDENAFIL SANDOZ 50 MG TABLETS

Active substance: SILDENAFIL CITRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000TL000

Sildenafil 25 mg Tablets
Sildenafil 50 mg Tablets
Sildenafil 100 mg Tablets

Sildenafil

Read all of this leaflet carefully before you start taking this medicine.
• 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 get serious, or 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 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 (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
because of 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 Peyronieʼs 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 disorder (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 treatment 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.

Using other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any 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 such as amyl nitrite
(“poppers”) as the combination may
also lead to a potentially dangerous
decrease in your blood pressure.
If you are taking 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 problems may
experience dizziness or lightheadedness, 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 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
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 and breast-feeding
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 Sildenafil exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure. The usual 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 unchewed with a
glass of water.

Sildenafil 25 mg:
The scoreline is only to facilitate
breaking for ease of swallowing.

Dividing the tablets
Place the tablet on a hard, flat surface
with the scoreline facing upwards.
Press with your thumb on the middle of
the tablet and the tablet breaks into
equal halves.

Sildenafil 50 mg:
The tablet can be divided into equal
quarters. You have to take at least two
quarters (corresponding to 25 mg) to
reach the minimum effective dose.

Dividing the tablets
Place the tablet on a hard, flat surface
with the scoreline facing upwards.
Press with your thumb on the middle of
the tablet and the tablet breaks into
equal quarters.

Continued on the next page >>

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: Day 90: national phase closure
Proof no.
001.0

Date prepared:
18/08/2011

Prepared by:
TB

RA Approved?
Yes

Date approved:
18/08/2011

Approved by:
PR
Fonts:
Helvetica

Colours:
Black
Dimensions: 130 x 540 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 8.5pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

Sildenafil 100 mg:
The tablet can be divided into equal
quarters.

Dividing the tablets
Place the tablet on a hard, flat surface
with the deeper scoreline facing
upwards. Press with your thumb on the
middle of the tablet and the tablet
breaks into equal quarters.

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 medicine, ask your doctor or
pharmacist.

4

Possible side effects

Like all medicines, Sildenafil 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 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.

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.

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 and
dizziness.

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
and feeling tired.

Rare side effects (likely to occur in 1 to
10 patients in 10000) include: high
blood pressure, low blood pressure,
fainting, stroke, nosebleed and sudden
decrease or loss of hearing.

Additional side effects reported from
post-marketing experience include:
pounding heartbeat, chest pain, sudden
death, 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. 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.

5

How to store Sildenafil

Keep out of the reach and sight of
children.

This medicinal product does not require
any special storage conditions.
Do not use Sildenafil after the expiry
date which is stated on the carton and
label. The expiry date refers to the last
day of that month.

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 25 mg/50 mg/
100 mg of Sildenafil (as the citrate salt).
The other ingredients are: calcium
hydrogen phosphate anhydrous,
microcrystalline cellulose, copovidone,
croscarmellose sodium, magnesium
stearate, saccharin sodium, indigo
carmine aluminium lake (E 132).

What Sildenafil looks like and
contents of the pack
Sildenafil 25 mg tablets
Sildenafil 25 mg tablets are light blue
round slightly dotted tablets, with
breaking notch on one side and
embossment “25” on the other side.

Sildenafil 50 mg tablets
Sildenafil 50 mg tablets are light blue
round slightly dotted tablets, with cross
breaking notch on one side and
embossment “50”on the other side.

Sildenafil 100 mg tablets
Sildenafil 100 mg tablets are light blue
round slightly dotted tablets, with cross
breaking notch on both sides and
embossment “100” on one side.

Sildenafil is available in blister packs
with 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 or
28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
UK
Sandoz Limited,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
United Kingdom
Malta
Sandoz d.d.,
Verovškova 57,
1000 Ljubljana,
Slovenia

Manufacturerʼs

Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia
LEK S.A.,
ul. Domaniewska 50 C,
02-672 Warszawa,
Poland

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany

Salutas Pharma GmbH,
Dieselstrasse 5,
70839 Gerlingen,
Germany

S.C. Sandoz S.R.L.,
Str. Livezeni nr. 7A,
RO-540472 Targu-Mures,
Romania

This leaflet was last approved in
08/2011 (to be amended upon
approval)

If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet please tell your doctor.

SZ00000LT000

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: Day 90: national phase closure
Proof no.
001.0

Date prepared:
18/08/2011

Prepared by:
TB

RA Approved?
Yes

Date approved:
18/08/2011

Approved by:
PR
Fonts:
Helvetica

Colours:
Black
Dimensions: 130 x 540 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 8.5pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

Expand view ⇕

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.

Hide
(web3)