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SILDENAFIL-HAMELN 25 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
Sildenafil citrate

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, 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 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

You should not use Sildenafil with any other oral or local
treatments for erectile dysfunction.

1. What Sildenafil is and what it is used for

You should not take Sildenafil if you are a woman.

Sildenafil belongs to a group of medicines called

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

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 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 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 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.
• 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).

Warnings and precautions
Tell 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)
• 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 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.

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 other medicines or might take 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 healthcare
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
medicines 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 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 alpha-blockers.
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.
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 recommended 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 whole with a glass of water.
The 50mg and 100mg tablets can be divided into equal
doses.
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, 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 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 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.

5. How to store Sildenafil
Keep this medicine out of the sight and reach of children.
Store in the outer carton in order to protect from light.
Do not use Sildenafil after the expiry date which is stated on
the carton. The expiry date refers to the last day of the 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
• Sildenafil 25 mg: Each tablet contains 35.12 mg of
sildenafil citrate quantitatively equivalent to 25 mg sildenafil.
• Sildenafil 50 mg: Each tablet contains 70.24 mg of sildenafil
citrate quantitatively equivalent to 50 mg of sildenafil.
• Sildenafil 100 mg: Each tablet contains 140.48 mg of
sildenafil citrate quantitatively equivalent to 100 mg of
sildenafil.
The other ingredients are:
• Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate
(anhydrous), povidone 25, croscarmellose sodium,
magnesium stearate.
• Film-coat:
Hypromellose, microcrystalline cellulose, titanium
dioxide (E171), brilliant blue FCF aluminium lake
(E133), macrogol stearate, macrogol 6000.
What Sildenafil looks like and contents of the pack
• Sildenafil 25 mg film-coated tablets are blue, oval and
biconvex.
• Sildenafil 50 mg film-coated tablets are blue, oval and
biconvex with break-marks on both sides to facilitate
ease of dosing. The tablet can be divided into equal doses.
• Sildenafil 100 mg film-coated tablets are blue, oval and
biconvex with break-marks on both sides to facilitate ease
of dosing. The tablet can be divided into equal doses.
The tablets are provided in blister packs containing 4, 10,
12 or 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, United Kingdom
Manufacturer
hameln rds a.s.
Horná 36, 900 01 Modra, Slovak Republic
This leaflet was last revised in February 2016.
XXXXX/06/16

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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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