Patient leaflet - LIBERIZE TM 50 MG FILM-COATED TABLETS, SILDENAFIL 50 MG FILM-COATED TABLETS
2. What you need to know before you take Sildenafil 50 mg Film-coated Tablets
3. How to take Sildenafil 50 mg Film-coated Tablets
4. Possible side effects
5. How to store Sildenafil 50 mg Film-coated Tablets
6. Contents of the pack and other information
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1. What Sildenafil 50 mg Film-coated Tablets are and what they are used for
Sildenafil contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing 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 excited (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 50 mg film-coated tablets
Do not take Sildenafil if you:
- are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
- are taking any medicines called nitrates as the combination may lead to a dangerous fall in
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.
- are using any of the medicines known as nitric oxide donors, (such as amyl nitrite (“poppers”),
as the as the combination may also lead to a dangerous fall in your blood pressure.
- are taking riociguat. This medicine 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.
- have a severe heart or liver problem
- have recently had a stroke or a heart attack, or if you have low blood pressure
- have certain rare inherited eye disease (such as retinitis pigmentosa)
- 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 problem (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
This medicine should not be given to individuals under the age of 18 years.
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.
Tell your doctor or pharmacist if you are already taking a medicine called riociguat.
If you are taking medicines known as protease inhibitors, such as for the treatment for 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 and 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 your vision. You should be aware of how you react to Sildenafil before you drive or use machinery.
Sildenafil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. how to take sildenafil 50mg film-coated tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your pharmacist or doctor if you are not sure. The recommended starting dose is 50 mg.
You should not take Sildenafil more than once a day.
Do not take Sildenafil film-coated tablets in combination with sildenafil-containing orodispersible tablets.
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 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 30 to 60 minutes.
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 pharmacist or doctor.
4. possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
These side effects are usually mild to moderate and of a short duration.
Stop taking Sildenafil and seek medical attention IMMEDIATELY if you experience any of the following serious side effects:
- chest pains: this occurs uncommonly. If this occurs before, 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 erection lasting longer than 4 hours: this rarely occurs
- a sudden decrease or loss of vision: this occurs rarely
- an allergic reaction: this occurs uncommonly. Symptoms include sudden wheeziness,
difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
- 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 that have been reported
Very common: may affect more than 1 in 10 people
- headache.
Common: may affect up to 1 in 10 people
- nausea, indigestion, stuffy nose, dizziness
- facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body)
- colour tinge to vision, blurred vision, visual disturbance.
Uncommon: may affect up to 1 in 100 people
- vomiting, upper abdominal pain, gastro-oesophageal reflux disease (also known as acid reflux
with symptoms including heartburn)
- skin rash, pain in the arms or legs, nosebleed, feeling hot, feeling tired
- 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 (symptoms include dizziness, fainting, blurred vision, nausea and tiredness)
- 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)
- presence of blood in urine.
Rare: may affect up to 1 in 1,000 people
- fainting, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or
loss of hearing
- 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.
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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store sildenafil 50 mg film-coated tablets
Keep this medicine out of the sight and reach of children.
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 protect the environment.
6. contents of the pack and other information
What Sildenafil 50 mg Film-coated Tablets contains
- The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as the citrate salt).
- The other ingredients are:
What Sildenafil 50 mg Film-coated Tablets looks like and contents of the pack
Sildenafil 50 mg are white, oval-shaped film-coated tablets, engraved with ‘S50’ on one side, and plain on the other side. Available in blister packs of 4 and 8 tablets.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
or
Marketing Authorisation Holder is: TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer is: Teva Operations Poland Sp. z.o.o., ul Mogilska 80. 31–546, Krakow, Poland
This leaflet was last revised in April 2020
PL 00289/2303
REG0232849
Version 0.15
Approved
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