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SILDENAFIL BRISTOL LAB 50 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
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. 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.
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.

3. How to take Sildenafil
Always take this medicine exactly as your doctor or pharmacist 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.

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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 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 potentially dangerous
fall 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 due to non-arteritic anterior ischaemic optic
neuropathy (NAION).
Warnings and precautions
Talk to your doctor or pharmacist 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 problems (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 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.
You should not take Sildenafil if you do not have erectile dysfunction.
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.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Sildenafil 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, pharmacist or nurse 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 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 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.
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 happen within 4 hours after taking Sildenafil.
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.
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.
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.

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

5. How to store Sildenafil
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton and
on the blister after EXP. The expiry date refers to the last day of that 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 tablet contains
• The active substance is sildenafil (as citrate) 25 mg, 50 mg or 100 mg.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen
phosphate anhydrous, croscarmellose sodium, hydroxypropylmethyl-cellulose,
colloidal anhydrous silica and magnesium stearate. In addition, the coating of
the tablets contain hydroxypropylmethylcellulose/hypromellose, polydextrose,
titanium dioxide (E171), indigo carmine (E132), talc, maltodextrin, medium
chain triglycerides, iron oxide yellow (E172) and triacetin.
What Sildenafil tablets look like and contents of the pack
• 25 mg: Blue, triangular, biconvex, embossed with “25” on one side and “BL”
on other side.
• 50 mg: Blue, triangular, biconvex, embossed with “50” on one side and “BL”
on other side.
• 100 mg: Blue, triangular, biconvex, embossed with “100” on one side and “BL”
on other side.
The tablets are provided in blister packs containing: 2, 4, 8 and 12 film-coated
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, UK
Tel:
0044 (0) 1442200922
Fax:
0044 (0) 1442873717
Email:
info@bristol-labs.co.uk
Sildenafil 25 mg film-coated tablets; PL 17907/0424
Sildenafil 50 mg film-coated tablets; PL 17907/0425
Sildenafil 100 mg film-coated tablets; PL 17907/0426
This leaflet was last revised in 10/2015.
To request a copy of this leaflet in Braille, large print or audio format, please
contact the licence holder at the address (or telephone, fax, email) above.

V11 21-10-15 D0

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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 or 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.

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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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