Sildenafil 25mg Film-Coated Tablets
Package leaflet: Information for the patient
Sildenafil 25 mg film-coated tablets Sildenafil 50 mg film-coated tablets Sildenafil 100 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, please 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 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 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 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 are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
- 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.
Children and adolescents
Sildenafil tablets should not be given to individuals under the age of 18.
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.
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 any health care professional treating your condition 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 products may cause a potentially dangerous decrease in your blood pressure. Always tell your doctor or pharmacist 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 drugs known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a potentially dangerous decrease 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 tablets.
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 occur within 4 hours after taking Sildenafil tablets. In order to reduce the likelihood that these symptoms occur, 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) of Sildenafil tablets.
Sildenafil tablets with food, drink and alcohol
Sildenafil tablets can be taken with or without food. However, you may find that Sildenafil tablets take longer to start working it you take them 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.
Sildenafil tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor before taking Sildenafil tablets.
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 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 take 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)
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
• 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 1 in 1000 people
• high blood pressure
• low blood pressure
• fainting
• stroke
• heart attack
• irregular heartbeat
• nosebleed
• 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: Irregular heartbeat, 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 side effects not listed in this leaflet. You can also report side effects directly via
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.
How to store Sildenafil tablets
5.
Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the 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 tablets contain
- The active substance is sildenafil. Each tablet contains 25mg, 50mg or 100mg of sildenafil (as the citrate salt)
- The other ingredient(s) are: lactose monohydrate, microcrystalline cellulose, povidone K29-32, croscarmellose sodium, magnesium stearate, hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo carmine, aluminium lake (E132).
What Sildenafil tablests look like and contents of the pack
Film-coated tablets
The 25 mg are blue elliptical, biconvex, film-coated tablets, marked “SL25” on one side.
The 50 mg are blue elliptical, biconvex, film-coated tablets, marked “SL50” on one side.
The 100 mg are blue elliptical, biconvex, film-coated tablets, marked “SL100” on one side.
The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer:
Actavis Limited
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta