Skip to Content

UK Edition. Click here for US version.

SILDENAFIL SANDOZ 50MG ORODISPERSIBLE FILM

Active substance(s): SILDENAFIL CITRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil 25 mg Orodispersible Film
Sildenafil 50 mg Orodispersible Film
Sildenafil 75 mg Orodispersible Film

SZ00000LT000

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

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”).

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 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.

Tell your doctor or pharmacist if you are already taking
riociguat.

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

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.

What you need to know before
you take 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 (25 mg) of Sildenafil.

Do not take Sildenafil if you
• are allergic to sildenafil or any of the other
ingredients of this medicine (listed in section 6).
• 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.
• 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.
• are taking riociguat. This drug is used to treat
pulmonary arterial hypertension (i.e., high blood
pressure in the lungs) and chronic thromboembolic
pulmonary hypertension (i.e., high blood pressure in
the lungs secondary to blood clots). PDE5 inhibitors,
such as Sildenafil have been shown to increase the
hypotensive effects of this medicine. If you are taking
riociguat or are unsure tell your doctor.
• have a severe heart or liver problem
• have recently had a stroke or a heart attack, or if you
have low blood pressure
• have certain rare inherited eye diseases (such as
retinitis pigmentosa)
• have ever had loss of vision due to non-arteritic
anterior ischaemic optic neuropathy (NAION).

Sildenafil with food and 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.

3

Warnings and precautions
Talk to your doctor 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).
• have a deformity of your penis or Peyronie’s Disease.
• have problems with your heart. Your doctor should
carefully check whether your heart can take the
additional strain of having sex
• currently have a stomach ulcer, or a bleeding
problems (such as haemophilia)
• experience sudden decrease or loss of vision, stop
taking Sildenafil and contact your doctor immediately.

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 50 mg.

You should not take Sildenafil more than once a day.

Do not take Sildenafil orodispersible films in combination
with other sildenafil containing medicines.

You should take Sildenafil about one hour before you
plan to have sex. Sildenafil orodispersible films are for
oral use and are taken without water. If desired you may
also take Sildenafil with water.

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.

Instructions for use
Important: Do not handle the orodispersible film with wet
hands!

You should not take Sildenafil if you do not have erectile
dysfunction.

a) Take the sachet, locate
the arrow mark at one of
the shorter sides and
hold the sachet with this
side facing up.
The sachet is not sealed
here.

You should not take Sildenafil if you are a woman.

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

b) Gently peel both parts of
the sachet apart at the
arrow mark. Now you can
hold each between your
thumb and your index
finger using one hand for
each part.

Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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

draft: 00000000, 00000000,
00000000
mat.no.: 00000000

How to take Sildenafil

Continued on the next page >>

Artwork Proof Box
Ref: V006: Update to SPC&PIL to align with reference product
Proof no.
004.0

Date prepared:
12/04/2016

Colours:
Black
Black 20%
Dimensions: 130 x 350 mm

Font size:
7pt
Fonts:
Helvetica

before taking this medicine. It is not possible to
determine whether these events were directly related to
Sildenafil.

c) Carefully tear both parts
of the sachet into
opposite directions until
they are separated. The
orodispersible film is
now visible and placed
on one of the separated
sachet parts.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the yellow card scheme (Website:
www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of
this medicine.

5

d) Take the orodispersible
film with dry fingers out
of the sachet and put it
in your mouth directly on
your tongue. It will
dissolve rapidly, so that
it can be easily
swallowed.

Keep this medicine out of the sight and reach of
children.

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

If you feel 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.

Store in the original package. This medicine does not
require any special temperature storage conditions.

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 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 orodispersible films than
your doctor tells you to.

Contact your doctor if you take more orodispersible films
than you should.

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

4

Possible side effects








Contents of the pack and other
information

What Sildenafil contains
• The active substance is sildenafil (as citrate).
Each orodispersible film contains 25 mg Sildenafil
(as citrate).
Each orodispersible film contains 50mg Sildenafil (as
citrate).
Each orodispersible film contains 75 mg Sildenafil
(as citrate).
• The other ingredient(s) are: Hydroxypropylcellulose,
glycerol 85%, sucralose, peppermint flavour (SYM
353592), levomenthol, sodium chloride,
contramarum forte (SYM 225023), indigocarmin
E132

This medicinal product is presented as orodispersible
film.

Sildenafil 25 mg orodispersible film
The orodispersible film is a rectangular, flexible, light
blue film strip (14 mm x 25 mm).

If you experience any of the following serious side
effects stop taking Sildenafil and seek medical help
immediately:



6

What Sildenafil looks like and contents of the pack

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.



How to store Sildenafil

Sildenafil 50 mg orodispersible film
The orodispersible film is a rectangular, flexible, light
blue film strip (28 mm x 25 mm).

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.

Sildenafil 75 mg orodispersible film
The orodispersible film is a rectangular, flexible, light
blue film strip (42 mm x 25 mm).

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.

Each orodispersible film is packed in a PET/Alu/PE –
Sachet.
Pack sizes of 1, 2, 4, 8, 10, 12, 16, 20, 24 or 28
orodispersible film(s).

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.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

A sudden decrease or loss of vision - this occurs
rarely

Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

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.

Manufacturers

HEXAL AG,
Industriestraße 25,
D-83607 Holzkirchen,
Germany

Seizures or fits - this occurs rarely

Other side effects:

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

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.

LEK S.A.,
ul. Domaniewska 50 C,
02-672 Warszawa,
Poland

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.

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

Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia.

This leaflet was last revised in 04/2016.

Rare (may affect up to 1 in 1,000 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 or loss of hearing.

draft: 00000000, 00000000,
00000000
mat.no.: 00000000

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

00000000
SZ00000LT000

Artwork Proof Box
Ref: V006: Update to SPC&PIL to align with reference product
Proof no.
004.0

Date prepared:
12/04/2016

Colours:
Black
Black 20%
Dimensions: 130 x 350 mm

Font size:
7pt
Fonts:
Helvetica

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