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SILDEHEXAL SF 25 MG ORODISPERSIBLE FILM

Active substance(s): SILDENAFIL CITRATE

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Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 1 of 8

Package Leaflet: Information for the user
SildeHEXAL SF 25 mg orodispersible film
SildeHEXAL SF 50 mg orodispersible film
SildeHEXAL SF 75 mg orodispersible film

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 SildeHEXAL SF is and what it is used for
2.
What you need to know before you take SildeHEXAL SF
3.
How to take SildeHEXAL SF
4.
Possible side effects
5.
How to store SildeHEXAL SF
6.
Contents of the pack and other information

What SildeHEXAL SF is and what it is used for
SildeHEXAL SF 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. SildeHEXAL SF will only help you to get an erection if you are sexually stimulated.
SildeHEXAL SF 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 SildeHEXAL SF

Do not take SildeHEXAL SF 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 SildeHEXAL SF 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
PIL 1333-1335.004d

11/04/2016

V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film




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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).

Warnings and precautions
Talk to your doctor before taking SildeHEXAL SF. 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 SildeHEXAL SF and contact your
doctor immediately.
You should not use SildeHEXAL SF with any other oral or local treatments for erectile dysfunction.
You should not use SildeHEXAL SF with treatments for pulmonary arterial hypertension (PAH) containing
sildenafil or any other PDE5 inhibitors.
You should not take SildeHEXAL SF if you do not have erectile dysfunction.
You should not take SildeHEXAL SF 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
SildeHEXAL SF should not be given to individuals under the age of 18.
Other medicines and SildeHEXAL SF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SildeHEXAL SF 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 SildeHEXAL SF and when you
did. Do not take SildeHEXAL SF with other medicines unless your doctor tells you that you can.
You should not take SildeHEXAL SF 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 SildeHEXAL SF 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.
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 SildeHEXAL SF.
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate
PIL 1333-1335.004d

11/04/2016

V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 3 of 8

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
SildeHEXAL SF with alpha-blockers. This is most likely to happen within 4 hours after taking SildeHEXAL
SF. In order to reduce the chance that these symptomsmight happen, you should be on a regular daily dose of
your alpha-blocker before you start SildeHEXAL SF. Your doctor may start you on a lower dose (25 mg) of
SildeHEXAL SF.
SildeHEXAL SF with food, drink and alcohol
SildeHEXAL SF can be taken with or without food. However, you may find that SildeHEXAL SF 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 SildeHEXAL SF.

Pregnancy, breast-feeding and fertilitySildeHEXAL SF is not indicated for use by women.
Driving and using machines
SildeHEXAL SF can cause dizziness and can affect vision. You should be aware of how you react to
SildeHEXAL SF before you drive or use machinery.
3.

How to take SildeHEXAL SF

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 SildeHEXAL SF more than once a day.
Do not take SildeHEXAL SF orodispersible films in combination with other sildenafil containing medicines
.
You should take SildeHEXAL SF about one hour before you plan to have sex. SildeHEXAL SF
orodispersible films are for oral use and are taken without water. If desired you may also take SildeHEXAL
SF with water.
Instructions for use
Important: Do not handle the orodispersible film with wet hands!
a)

b)

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.

Gently peel both parts of the sachet apart at the arrow
mark. Now you can hold each between your thumb and
PIL 1333-1335.004d
11/04/2016
V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 4 of 8

your index finger using one hand for each part.

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.

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.

If you feel that the effect of SildeHEXAL SF is too strong or too weak, talk to your doctor or pharmacist.
SildeHEXAL SF will only help you to get an erection if you are sexually stimulated. The amount of time
SildeHEXAL SF takes to work varies from person to person, but it normally takes between half an hour
and one hour. You may find that SildeHEXAL SF takes longer to work if you take it with a heavy meal.
If SildeHEXAL SF 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 SildeHEXAL SF 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.
PIL 1333-1335.004d
11/04/2016
V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 5 of 8

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

Like all medicines, this medicine can cause side effects although not everybody gets them. The side effects
reported in association with the use of SildeHEXAL SF are usually mild to moderate and of a short duration.
If you experience any of the following serious side effects stop taking SildeHEXAL SF 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.

PIL 1333-1335.004d

11/04/2016

V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 6 of 8

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.
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
SildeHEXAL SF.

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.

How to store SildeHEXAL SF

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.
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.
6.

Contents of the pack and other information

What SildeHEXAL SF 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

What SildeHEXAL SF looks like and contents of the pack
This medicinal product is presented as orodispersible film.
PIL 1333-1335.004d

11/04/2016

V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 7 of 8

SildeHEXAL SF 25 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film strip (14 mmx25 mm).
SildeHEXAL SF 50 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film strip (28 mmx25 mm).
SildeHEXAL SF 75 mg orodispersible film
The orodispersible film is a rectangular, flexible, light blue film strip (42 mmx25 mm).
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).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom

Manufacturers
HEXAL AG
Industriestraße 25,
D-83607 Holzkirchen
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben
Germany

LEK S.A.
ul. Domaniewska 50 C,
02-672 Warszawa
Poland
S.C. Sandoz, S.R.L.
Str. Livezeni nr. 7A,
RO-540472 Targu-Mures,
Jud. Mures
Romania
PIL 1333-1335.004d

11/04/2016

V005: SPC & PIL update in line with
originator

JG

Sandoz Ltd.
PL 04416/1333-1335
SildeHEXAL SF 25 mg, 50 mg & 75 mg orodispersible film

Page 8 of 8

Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana
Slovenia
This leaflet was last revised in 04/2016

PIL 1333-1335.004d

11/04/2016

V005: SPC & PIL update in line with
originator

JG

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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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