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SILDENAFIL 20 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE / SILDENAFIL CITRATE

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Sildenafil 20 mg - UK - PIL

Review - 3
Pharma code position can chenge as per Supplier’s m/c requirement
& additional small pharma code may appear on the front /back panel

Sildenafil 20 mg
film-coated tablets
PM-xxxx

Package leaflet: Information for the user

Sildenafil 20 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 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 contains the active substance sildenafil which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Sildenafil brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Sildenafil is used to treat adults and children and adolescents from 1 to 17 years old with high
blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).

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 containing nitrates, or nitric oxide donors such as amyl nitrate
(“poppers”). These medicines are often given for relief of chest pain (or “angina pectoris”).
Sildenafil can cause a serious increase in the effects of these medicines. Tell your doctor
if you are taking any of these medicines. If you are not certain, ask your doctor or
pharmacist.
• if you are taking riociguat, the medicine which is used to treat pulmonary arterial
hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary
hypertension (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 recently had a stroke, a heart attack or if you have severe liver disease or very
low blood pressure (<90/50 mmHg).
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole
or medicines containing ritonavir (for HIV).
• if you have ever had loss of vision because of a problem with blood flow to the nerve in
the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).

Prolonged and sometimes painful erections have been reported in men after taking sildenafil.
If you have an erection, which lasts continuously for more than 4 hours, stop taking Sildenafil
and contact your doctor immediately (see also section 4).
Special considerations for patients with kidney or liver problems
Tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Children
Sildenafil should not be given to children below 1 year of age.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
• Medicines containing nitrates or nitric oxide donors such as amyl nitrate (“poppers”).
These medicines are often given for relief of angina pectoris or “chest pain” (see “Do not
take Sildenafil”).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
• Medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat
bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others,
to treat epilepsy).
• Blood thinning medicines (for example warfarin) although these did not result in any side
effect.
• Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics
used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental
depression), as your dose may need to be adjusted.
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or
prostate problems, as the combination of the two medicines may cause symptoms
resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
Sildenafil with food and drink and alcohol
You should not drink grapefruit juice while you are being treated with Sildenafil.
Pregnancy and breast-feeding and fertility
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. Sildenafil should not
be used during pregnancy unless strictly necessary.
Sildenafil should not be given to women of child bearing potential unless using appropriate
contraceptive methods.
Stop breast-feeding when you start Sildenafil treatment. Sildenafil should not be given to women
who are breast-feeding since it is not known if the medicine passes into the breast milk.
Driving and using machines
Sildenafil can cause dizziness and can affect vision. You should be aware of how you react to
the medicine before you drive or use machines.

3. How to take Sildenafil
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

Warnings and precautions
Talk to your doctor before taking Sildenafil if you:
• have a disease due to a blocked or narrow vein in the lungs rather than a blocked or
narrow artery.
• have a severe heart problem.
• have a problem with the pumping chambers of your heart.
• have high blood pressure in the blood vessels in the lungs.
• have low blood pressure at rest.
• lose a large amount of body fluids (dehydration) which can occur when you sweat a lot or
do not drink enough liquids. This can happen if you are sick with a fever, vomiting, or
diarrhoea.
• have a rare inherited eye disease (retinitis pigmentosa).
• have an abnormality of red blood cells (sickle cell anaemia), cancer of blood cells
(leukaemia), cancer of bone marrow (multiple myeloma), or any disease or deformity of
the penis.
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems
with nose bleeds.
• take medicines for erectile dysfunction.
When used to treat male erectile dysfunction (ED), the following visual side effects have been
reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden,
temporary, or permanent decrease or loss of vision in one or both eyes.
If you experience sudden decrease or loss of vision, stop taking Sildenafil and contact your
doctor immediately (see also section 4).

For adults, the recommended dose is 20 mg (1 tablet) three times a day (taken 6 to 8 hours
apart) taken with or without food.
Use in children and adolescents
For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg
three times a day for children and adolescents ≤ 20 kg or 20 mg (1 tablet) three times a day for
children and adolescents having weight more than 20 kg, taken with or without food. Higher doses
should not be used in children. This medicine should be used only in case of administration of 20
mg three times a day. Other pharmaceutical forms may be more appropriate for administration to
patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
If you take more Sildenafil than you should
You should not take more medicine than your doctor tells you to.
If you take more medicine than you have been told to take contact your doctor immediately.
Taking more Sildenafil than you should may increase the risk of known side effects.
If you forget to take Sildenafil
If you forget to take Sildenafil, take a dose as soon as you remember, then continue to take your
medicine at the usual times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sildenafil
Suddenly stopping your treatment with Sildenafil may lead to your symptoms getting worse.
Do not stop taking Sildenafil unless your doctor tells you to. Your doctor may tell you to reduce
the dose over a few days before stopping completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Size : 350 x 240 mm, Colour:
Date: 09/05/17

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Sildenafil 20 mg - UK - PIL

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6. Contents of the pack and other information

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects stop taking Sildenafil and contact a
doctor immediately (see also section 2):
- sudden decrease or loss of vision (frequency not known)
- an erection, which lasts continuously for more than 4 hours. Prolonged and sometimes
painful erections have been reported in men after taking sildenafil (frequency not known).
Adults:
Very common (may affect more than 1 in 10 people): headache, facial flushing, indigestion,
diarrhoea and pain in the arms or legs.
Common (may affect up to 1 in 10 people): infection under the skin, flu-like symptoms,
inflammation of the sinuses, reduced number of red blood cells (anaemia), fluid retention,
difficulty sleeping, anxiety, migraine, shaking, “pins and needles”-like sensation, burning
sensation, reduced sense of touch, bleeding at the back of the eye, effects on vision, blurred
vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes,
vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation,
gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the
skin, night sweats, muscle aches, back pain and increased body temperature.
Uncommon (may affect 1 in 100 people): reduced sharpness of vision, double vision, abnormal
sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast
enlargement in men.
Not known (frequency cannot be estimated from the available data): skin rash and sudden
decrease or loss of hearing and decreased blood pressure.
Children and adolescents
Serious side effects:
If your child experiences any of the following side effects stop giving Sildenafil and
contact a doctor immediately.

What Sildenafil contains
• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as the citrate).
• The other ingredients are:
Tablet core: Cellulose Microcrystalline, Anhydrous Calcium Hydrogen Phosphate,
Croscarmellose Sodium, Hypromellose, Magnesium Stearate.
Film coat: Polyvinyl alcohol-Partially Hydrolyzed, Titanium Dioxide (E171),
Macrogol 4000, Talc
What Sildenafil looks like and contents of the pack
Sildenafil film coted tablets are white to off white and round in shape, around 6.7 mm in
diameter. The tablets are debossing ‘AN 1017’ on one side and plain on the other side. The
tablets are provided in blister packs containing 90 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2, Ireland
Manufacturer:
Amneal Netherlands B.V.
Emmaplein 4D
5211 VW ’s-Hertogenbosch
The Netherlands
&
Amneal Nordic ApS
Kanalholmen 14-18
DK-2650 Hvidovre
Denmark
This leaflet was last revised in 05/2017.

Common (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart
related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection,
bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth
cavities.
Uncommon (may affect up to 1 in 100 people): allergic reaction (such as skin rash, swelling of
the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular
heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract,
wheezing due to disrupted airflow.
Other side effects:
Very common (may affect more than 1 in 10 people): headache, vomiting, infection of the
throat, fever, diarrhoea, flu and nose bleed.
Common (may affect up to 1 in 10 people): nausea, increased erections, pneumonia and runny
nose.
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 Sildenafil
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 carton after EXP. The
expiry date refers to the last day of that month.
Store in the original package, in order to protect from moisture.
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.

Size : 350 x 240 mm, Colour:
Date: 09/05/17

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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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