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SILDENAFIL RANBAXY 25MG FILM-COATED TABLETS

Active substance: SILDENAFIL CITRATE

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Package leaflet: Information for the patient
Sildenafil 25 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, pharmacist or nurse. 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 contains the active substance sildenafil which 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.
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 dangerous fall in your blood pressure.
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, pharmacist or nurse 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 medicines may lead to a dangerous fall in your blood pressure. Always tell your doctor,
pharmacist or nurse 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.

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.
If you are taking medicines such as ketoconazole, itraconazole (used to treat fungal infections),
erythromycin (antibiotic), cimetidine (used to treat peptic ulcers), your doctor may start you on
the lowest dose (25 mg) of Sildenafil.
Sildenafil may interact with medicines used to treat high blood pressure in the blood vessels in
the lungs (pulmonary artery hypertension) such as bosentan or medicines used to treat bacterial
infections such as rifampin.
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.
Sildenafil contains E124 ponceau 4R aluminium lake
Sildenafil contains colouring agent E124 ponceau 4R aluminium lake, that may cause allergic
reactions.
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.
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, pharmacist or
nurse.
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.
Serious side effects
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 1000
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, 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 1000 people) include: 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, eye irritation, short sightedness, strain in
eye, high pressure in the eye, disorder of the coloured part of the eye, eye problems, 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
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. 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 to protect the
environment.
6. Contents of the pack and other information
What Sildenafil contains
- The active substance is Sildenafil. Each film-coated tablet contains 25 mg sildenafil, as
the sildenafil citrate.
- The other ingredients are:
o Tablet core: microcrystalline cellulose, calcium hydrogen phosphate
(anhydrous), croscarmellose sodium, magnesium stearate,
o Film coat: hypromellose, ponceau 4R aluminium lake (E124), macrogol 400,
titanium dioxide (E171), iron oxide red (E172), índigo carmine aluminium lake
(E132).
What Sildenafil looks like and contents of the pack
Sildenafil 25 mg Film-coated tablets are red coloured, rounded triangular shaped, with “S21”
engraved on one side and plain on the other side.
The tablets are provided in blister packs containing 1, 2, 4, 8, 12, 60 or 90 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Buidling 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE
United Kingdom
Manufacturer
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co-Tipperary
Republic of Ireland
Terapia S.A
Str. Fabricii nr. 124
Cluj Napoca, 400 632
Romania

This leaflet was last revised in September 2014.

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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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