Patient leaflet - Sildenafil Bristol Lab 50 mg film-coated tablets

1. What Sildenafil is and what it is used for

What Sildenafil is

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 and causing an erection. Sildenafil will only help you to get an erection if you are sexually excited (stimulated).

What Sildenafil is used for

Sildenafil is a treatment for men aged 18 years and older with erectile dysfunction. Erectile dysfunction, also known as impotence, is an inability to achieve or maintain an erection that is firm enough to have sex. Erections depend on many different factors, including proper blood flow to the penis. Reduced blood flow to the penis may cause erectile dysfunction. Erectile dysfunction can affect men differently. Some cannot achieve an erection. Others may achieve an erection, but not firm enough for having sex or they may lose the erection before or during sex.

2. What you need to know before you take Sildenafil

Do not take Sildenafil if you:

do not have an erection problem
take any nitrate medicine for chest pain or heart failure (see “Other medicines and Sildenafil”) • take amyl nitrite, so called “poppers” as recreational drugs
take riociguat (or other guanylate cyclase stimulators) for high blood pressure in the lungs (see “Other medicines and Sildenafil”)
take ritonavir for the treatment of HIV (see “Other medicines and Sildenafil”)
have been advised by your doctor to avoid sexual activity because of a problem with your heart or blood vessels (see “Warnings and precautions”)
have a severe heart problem such as a recent heart attack or stroke (within the last 6 months), unstable angina (chest pain) or severe cardiac failure (reduced pumping capacity of the heart)
have a severe liver problem
have low blood pressure (below 90/50 mmHg) which can cause symptoms such as tiredness, dizziness, light-headedness, feeling sick, clammy skin, depression, loss of consciousness, or blurry vision • have ever had severe vision loss because of nerve damage in the eyes, such as non-arteritic anterior ischaemic optic neuropathy (NAION); or have a rare inherited eye disease, such as retinitis pigmentosa (see “Warnings and precautions”)
have a deformed penis
are a woman
are under 18 years of age
are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

You should schedule a health check-up with your doctor as soon as possible within the first 6 months of starting to use Sildenafil to ensure that your erection problems are not caused by any serious health condition.

Erectile dysfunction may be an early sign of:

cardiovascular disease
diabetes
high blood pressure
high cholesterol

Tell your doctor about your problems if you have not already done so.

Cardiovascular risk factors

Sexual activity can put a strain on your heart (see “Do not take Sildenafil if you” above).

Talk to your doctor before taking Sildenafil if you:

get very breathless or feel any pain in the chest with light or moderate activity (e.g. walking briskly for 20 minutes or climbing two flights of stairs). Your doctor may need to check whether your heart can take the additional strain of having sex.
have a problem with a valve in your heart (valvular heart disease).
have a disease in which the heart muscle becomes inflamed and does not work as well as it should (cardiomyopathy).
have an irregular heart beat (arrhythmia).
you have had surgery to improve blood flow to your heart, or you have high blood pressure which is now adequately treated.
have high blood pressure that is not controlled.

Other risk factors:

Talk to your doctor before taking Sildenafil if you:

have ever had an erection that lasted more than 4 hours (priapism). Some conditions can increase the probability of having a persistent erection, such as sickle cell anemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow). Use of impotence medicines may increase the risk of priapism. Long lasting erection may cause damage to the tissue in the penis and permanent loss of ability to have an erection.
have a stomach ulcer or a bleeding disorder (such as haemophilia).
have previously been diagnosed with mild to moderate liver disease, or severe kidney problems. Sildenafil may not be suitable for you, you should consult your doctor before taking Sildenafil.

If you experience any sudden visual defect you should stop taking Sildenafil and contact your doctor immediately. Cases of visual effects have been reported when using Sildenafil.

Children and adolescents

This medicine should not be given to children or adolescents 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.

Some medicines may be affected by Sildenafil or they may affect how Sildenafil works and this may result in side effects.

Do not use Sildenafil if you take:

Nitrate medicines: Do not take Sildenafil if you are taking nitrate medicines (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate) against chest pain (angina pectoris) or heart failure or “poppers” as recreational drugs (nitric oxide donors (such as amyl nitrite), nicorandil or sodium nitroprusside). This is because these substances could lead to a dangerous fall in blood pressure if taken together with Sildenafil. • Riociguat: Do not take Sildenafil if you are taking a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators). Riociguat is used to treat high blood pressure in the lungs and can lead to a dangerous fall in blood pressure if taken together with Sildenafil.
Medicines to treat HIV-infections: Ritonavir is a medicine used to treat HIV-infections. Do not take Sildenafil if you are taking ritonavir since this combination can lead to a dangerous fall in blood pressure.

Talk to your pharmacist or doctor before using Sildenafil if you are taking:

Medicines to treat fungal infections and antibiotics: Medicines to treat fungal infections called itraconazole or ketoconazole and an antibiotic called erythromycin increase the concentration of Sildenafil in the body and may result in side effects. You should contact your doctor before taking Sildenafil if you are using these medicines.
Heartburn treatment: The medicine to treat heartburn, cimetidine, increases the concentration of Sildenafil in the body and may result in side effects. You should contact your doctor before taking Sildenafil. • Other treatments for erectile dysfunction: The safety and efficacy of combinations of Sildenafil with other treatments for erectile dysfunction have not been studied and this combination is therefore not recommended. • Alpha-blockers used to treat urinary problems or high blood pressure: Alpha-blockers used to treat urinary problems due to enlarged prostate (such as alfuzosin, doxazosin or tamsulosin) may lead to dizziness, light-headedness, nausea, fainting, lack of concentration, or blurred vision due to low blood pressure (symptomatic hypotension).
Medicines containing sacubitril/valsartan, used to treat heart failure: You should contact your doctor or pharmacist before taking Sildenafil.

Sildenafil with food, drink and alcohol

Sildenafil can be taken with or without food. When this medicine is taken after a high-fat meal, it may take a little longer to start working.

10 mm

160 mm

160 x560 mm

Back

10 mm V2 12-12-23 D0

Do not take Sildenafil with grapefruit or grapefruit juice, because this can affect how the medicine works.

Drinking excessive 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 sexual activity.

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. Do not drive or use machines if you suffer from these side effects after taking this medicine.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take 1 tablet, as needed, approximately 1 hour before sexual activity.
Swallow the tablet whole with water.
Do not take more than 1 tablet a day.

Sildenafil will only help you achieve an erection if you are sexually aroused. You and your partner should engage in foreplay just as you would if you were not taking a medicine for erectile dysfunction.

The amount of time this medicine takes to work varies from person to person, but it normally takes between 30 to 60 minutes. You may take it up to 4 hours before sexual activity.

Relax and be patient if Sildenafil does not help you the first time. You can try again later but remember you can only take 1 tablet a day. For most men, Sildenafil will work the first or second time they try it. If it has been some time since you were able to get or keep an erection, it may take a couple of attempts before you achieve the desired effect. Talk to your doctor if you have tried Sildenafil, and are still not able to get and keep an erection.

If you feel the effect of Sildenafil is too strong, talk to your pharmacist or doctor.

If you take more Sildenafil than you should

If you take more tablets than recommended, contact your pharmacist or doctor immediately. Taking more than the recommended dose may result in side effects and/or more severe side effects.

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.

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 sexual activity: Get in a semi-sitting position and try to relax. Do NOT use nitrates to treat your chest pain.
A prolonged and sometimes painful erection lasting longer than 4 hours: this occurs rarely. • 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 such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Syndrome (TEN): this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes and 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, indigestion, stuffy nose, dizziness
facial flushing, hot flush (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, acid reflux (including heartburn)
skin rash, pain in the arms or legs, nosebleed, feeling hot, feeling tired (fatigue)
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 (typical signs are 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 (can be experienced as 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 • sudden unexpected death caused by loss of heart function (sudden cardiac arrest), stroke, heart attack, chest pains (angina), 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

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 Website: www.mhra.gov.uk/yellowcard 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

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.
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 tablet contains

Each tablet contains 50 mg of sildenafil (as citrate).
The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, hydroxypropylmethyl-cellulose/hypromellose colloidal anhydrous silica and magnesium stearate. In addition, the coating of the tablets contain hydroxypropylmethylcellulose/hypromellose, polydextrose, titanium dioxide (E171), indigo carmine (E132), talc, maltodextrin, medium chain triglycerides, iron oxide yellow (E172) and triacetin.

What Sildenafil tablets look like and contents of the pack

Blue, triangular, biconvex, film-coated tablets, debossed with “50” on one side and “BL” on the other side. The tablets are provided in blister packs containing: 2, 4 and 8 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd.,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, HP4 1EG, UK

Tel: 0044 (0) 1442200922

Fax: 0044 (0) 1442873717

Email: info@bristol-labs.co.uk

Manufacturer

Bristol Laboratories Ltd.

Laporte Way, Luton,

LU4 8WL, United Kingdom.

Sildenafil 50 mg film-coated tablets; PL 17907/0683

This leaflet was last revised in December 2023.

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.