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SILDENAFIL TEVA 100 MG CHEWABLE TABLETS

Active substance(s): SILDENAFIL CITRATE / SILDENAFIL CITRATE / SILDENAFIL CITRATE

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Package leaflet: Information for the user
Sildenafil 25 mg, 50 mg and 100 mg chewable 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 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. You
should not take sildenafil if you do not have erectile dysfunction.
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.
You must talk to a doctor if you do not feel better or if you feel worse.

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 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 /../ 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.
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 chewable 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.
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.
Sildenafil chewable tablets contain aspartame, a source of phenylalanine. If you suffer from
phenylketonuria (a rare, hereditary disorder of the metabolism) you should take this into account.
Sildenafil chewable tablets contain lactose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicinal product.

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. The tablet should be chewed
whole.
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.

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 /../ 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.

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 and on the blister after EXP.
The expiry date refers to the last day of that month.
Store in the original container in order to protect from light.
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
-

The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg sildenafil.
The other ingredients are: polacrilin potassium, silica colloidal anhydrous, lactose monohydrate,
povidone K-30, aspartame (E951), croscarmellose sodium, peppermint flavour, magnesium stearate,
potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

What Sildenafil looks like and contents of the pack
25 mg: White, triangular, biconvex, embossed with “25” on one side.
50 mg: White, triangular, biconvex, embossed with “50” on one side.
100 mg: White, triangular, biconvex, embossed with “100” on one side
Blisters in packages of:
25 mg: 2, 4, 8, 12 chewable tablets
50 mg: 2, 4, 8, 12, 24, 32, 36, 48 chewable tablets
100 mg: 2, 4, 8, 12, 24 , 28 chewable tablets

Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Genepharm S.A., 18th km Marathon Avenue, 15351 Pallini, Greece
Or
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
Or
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

This leaflet was last revised in 07/2016
PL 00289/1786
PL 00289/1787
PL 00289/1788
*Only the actual site of btach release will appear on the printed version of the leaflet

Expand Transcript

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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