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SILDENAFIL AJANTA PHARMA 50 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Package leaflet: Information for the patient
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
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, 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 Tablets are and what they are used for
2.
What you need to know before you take Sildenafil Tablets
3.
How to take Sildenafil Tablets
4.
Possible side effects
5.
How to store Sildenafil Tablets
6.
Contents of the pack and other information

1.

What Sildenafil Tablets are and what they are used for

Sildenafil Tablet 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 Tablets
will only help you to get an erection if you are sexually stimulated. Sildenafil Tablets are 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 Tablets

Do not take Sildenafil Tablets
-

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 Tablets
- 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 Tablets and
contact your doctor immediately.

You should not use Sildenafil Tablets with any other oral or local treatments for erectile dysfunction.
You should not take Sildenafil Tablets if you do not have erectile dysfunction.
You should not take Sildenafil Tablets 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 Tablets should not be given to individuals under the age of 18.
Other medicines and Sildenafil Tablets
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 Tablets and when you did. Do not take Sildenafil Tablets with other medicines unless your
doctor tells you that you can.
You should not take Sildenafil Tablets 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 Tablets 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).
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 Tablets with alpha-blockers. This is most likely to happen within 4 hours
after taking Sildenafil Tablets. 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 Tablets. Your
doctor may start you on a lower dose (25 mg).
Sildenafil Tablets with food and drink and alcohol
Sildenafil Tablets can be taken with or without food. However, you may find that Sildenafil Tablets
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 Tablets.
Pregnancy, breast-feeding and fertility
Sildenafil Tablets are not indicated for use by women.
Driving and using machines
Sildenafil Tablets can cause dizziness and can affect vision. You should be aware of how you react
to Sildenafil Tablets before you drive or use machinery.
3.

How to take Sildenafil Tablets

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 Tablets more than once a day.
You should take Sildenafil Tablets 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 Tablets is too strong or too weak, talk to your doctor or
pharmacist.
Sildenafil Tablets will only help you to get an erection if you are sexually stimulated. The amount of
time Sildenafil Tablets takes to work varies from person to person, but it normally takes between
half an hour and one hour. You may find that Sildenafil Tablets take longer to work if you take it
with a heavy meal.
If Sildenafil Tablets do 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 Tablets 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 Tablets are usually mild to moderate and of
a short duration.
If you experience any of the following serious side effects stop taking Sildenafil Tablets and
seek medical help immediately:


An allergic reaction (this occurs rarely)
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 (frequency unknown)
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 (frequency unknown)



Serious skin reactions (frequency unknown)

Symptoms may include severe peeling and swelling of the skin, blistering of the mouth,
genitals and around the eyes, fever.


Seizures or fits (frequency unknown)

Other side effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect up to 1 in 10 people) : facial flushing, indigestion, effects on vision (including
colour tinge to vision, light sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and
dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, bleeding at the back of the eye,
eye irritation, bloodshot eyes /red eyes, eye pain, double vision, abnormal sensation in the eye,
watery eyes, pounding heartbeat, rapid heartbeat, muscle pain, feeling sleepy, reduced sense of
touch, vertigo, ringing in the ears, nausea, dry mouth, penile bleeding, presence of blood in semen
and/or urine, chest pain and feeling tired.
Rare (may affect up to 1in 1,000 people): high blood pressure, low blood pressure, fainting, stroke,
heart attack, irregular heartbeat, nosebleed and sudden decrease or loss of hearing.
Not known (frequency cannot be estimated from the available data):
Additional side effects reported from post-marketing experience include:
Unstable angina (a heart condition), sudden death, temporary decreased blood flow to parts of the
brain. 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 (see details below). By
reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5.

How to store Sildenafil Tablets

Keep out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the
original package, in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the blister and carton 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 to protect the environment.

6.

Contents of the pack and other information

What Sildenafil Tablets contains
-

The active substance is sildenafil. Each film-coated tablet contains 50 mg or 100 mg of
sildenafil (as the citrate salt).
The other ingredients are:
-Tablet core: Sodium Starch Glycolate, Povidone, Microcrystalline Cellulose,
Talc, Magnesium Stearate.
-Film coat: Hypromellose, Titanium Dioxide (E171), Instacoat Sol IC-S-3788 Green
[Instacoat Sol IC-S-3788 Green comprises of Hypromellose, Polyethylene
Glycol, Talc, Lake Brilliant Blue (E133), Lake Quinoline Yellow (E104) and
Titanium Dioxide (E171)]

What Sildenafil Tablets looks like and contents of the pack
Sildenafil film-coated tablets are green, with an oval shape. They are marked “ap” on one side and
“50” or “100” on the other side.
The tablets are provided in blister packs containing 4 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder of Sildenafil Tablets is Ajanta Pharma UK Limited, 2 Cabot House,
Compass Point Business Park, St. Ives, Cambridgeshire, PE27 5JL, UK.
The manufacturer of Sildenafil Tablets is Wave Pharma Limited, 4th Floor, Cavendish House, 369
Burnt Oak Broadway, Edgware, HA8 5AW, United Kingdom
PL 39315/0001 & PL 39315/0002
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
United Kingdom
Ajanta Pharma UK Limited
Tel: 0044 1480465755
This leaflet was last revised in 01/2016

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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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