Durex Sildenafil 50mg film-coated tablets

• Keep this leaflet. You may need to read it, again.
• Ask your pharmacist if you need more information or advice.
• 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.
• If you have taken Durex Sildenafil as directed and were NOT able to get or keep an erection hard enough for satisfactory sex, you should talk to your pharmacist or doctor.

1. What Durex Sildenafil is and what it is used for
2. What you need to know before you take Durex Sildenafil
3. How to take Durex Sildenafil
4. Possible side effects
5. How to store Durex Sildenafil
6. Contents of the pack and other information

• do not have an erection problem, as this medicine will not provide any benefit to you;
• take medicines called nitrates, or nitric oxides donors, for the relief of chest pain or heart failure or take any amyl nitrites also known as "poppers" , as the combination may lead to a dangerous fall in blood pressure (See 'Other medicines and Durex Sildenafil');
• take riociguat (or other guanylate cyclase stimulators) for high blood pressure in the lungs (see 'Others medicines and Durex Sildenafil');
• take ritonavir for the treatment of HIV (see 'Others medicines and Durex Sildenafil');
• are allergic to Sildenafil or any other ingredients of this medicine (listed in section 6);
• have been advised by your doctor to avoid sexual activity because of a problem with your heart or blood vessels, such as a recent heart attack or stroke (within the last 6 months), unstable angina or severe cardiac failure;
• have ever had loss of vision because of damage to the optic nerve such as non-arteritic anterior ischaemic optic neuropathy (NAION) or have an inherited eye disease (such as retinitis pigmentosa);
• have low blood pressure (which can cause symptoms such as tiredness, dizziness, lighted headedness, feeling sick, clammy skin, depression, loss of consciousness, or blurry vision);
• have high blood pressure that is not controlled;
• have a severe liver problem;
• have any disease or deformity of your penis (such as Peyronie's Disease);
• are a woman;
• are under 18 years of age.

It is important to have a check-up with your doctor as soon as possible within the first 6 months of using Durex Sildenafil to ensure that your erection problems are not caused by another serious health condition.

Even if you feel healthy, your erection problems may be linked to other serious health conditions.

Erectile dysfunction may be an early sign of:

• heart and blood vessel problems
• diabetes
• high blood pressure
• high cholesterol

You should discuss your symptoms and the condition with your doctor if you have not done so.

Sexual activity can put extra strain on your heart. If you have a heart problem or think you might have a heart problem, you should tell your pharmacist

To ensure this medicine is suitable for you and that you are fit enough to have sex, tell your doctor before taking Durex 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 one of the valves 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);
• have had surgery to improve blood flow to your head;
• you have high blood pressure which is now under control.
• have high blood pressure that is not controlled.

Talk to your doctor before taking Durex 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 anaemia (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. Durex Sildenafil may not be suitable for you, you should consult your doctor before taking Durex Sildenafil.

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

This medicine should not be given to children and adolescents under the age of 18.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may be affected by Durex Sildenafil or they may affect how well Durex Sildenafil will work.

Do NOT take Durex Sildenafil if you are taking

• nitrate medicines (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate) or nitric oxide donors (such as amyl nitrite ("poppers"), nicorandil or sodium nitroprusside).
  These are often used for the relief of chest pain (angina pectoris), or heart failure. Using Durex Sildenafil with any of these medicines may lead to a dangerous fall in blood pressure;
• a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators), used to treat pulmonary arterial hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs due to blood clots);
• a medicine called ritonavir, for the treatment for HIV infection.

Talk to your pharmacist or doctor before using Durex 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 Durex Sildenafil in the body and may result in side effects. You should contact your doctor before taking Durex Sildenafil if you are using these medicines.
• Heartburn treatment: The medicine to treat heartburn, cimetidine, increases the concentration of Durex Sildenafil in the body and may result in side effects. You should contact your doctor before taking Durex Sildenafil.
• Other treatments for erectile dysfunction: The safety and efficacy of combinations of Durex 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: Durex Sildenafil may not be suitable for you. You should contact your doctor or pharmacist before taking Durex Sildenafil.
• medicines that may affect the way Durex Sildenafil works such as
• protease inhibitors (saquinavir) to treat HIV infections;

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

Drinking excessive alcohol can temporarily reduce your ability to get an erection. To get the maximum benefit from your medicine, you are advised not to drink large amounts of alcohol before sexual activity.

This medicine should not be used by women.

Durex Sildenafil can cause dizziness and can affect your vision. Do not drive or use machines if you suffer from these side effects after taking this medicine.

You can improve your erectile function by making lifestyle changes; these include exercising regularly, reducing stress, giving up smoking and avoiding excessive alcohol use. If you are feeling depressed or anxious, talk to your pharmacist or doctor, who will be able to provide you with further advice.

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

You will not get an erection just by taking Durex Sildenafil. This medicine will only help you get 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.

Remember to relax and be patient. There is no rush. If you are not successful the first time, try to have sex again, but remember you can only take one tablet a day.

For most men, Durex 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 are able to achieve an erection.

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

Talk to your doctor if you have taken Durex Sildenafil as directed and are still not able to get and keep an erection.

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

• 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.
• A persistent 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 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, fever.
• Seizures or fits: this occurs rarely.

If you get any of the of the following side effects, or any side effects not listed, talk to your doctor, pharmacist or nurse.

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

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 this medicine.

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 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.

The active substance is Sildenafil. Each tablet contains 50 mg of Sildenafil (as citrate).

The other ingredients are:

Tablet core: microcrystalline cellulose, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, sodium stearyl fumarate.

Film coat: hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132).

Durex Sildenafil 50 mg film-coated tablets are blue, round (diameter approx. 9.6 mm), biconvex, film coated tablets, debossed with '8' Bisect '7' on one side and plain on the other side. The tablet can be divided into equal doses.

Pack size:

2 tablets; 4 tablets; 6 tablets; 8 tablets

Not all pack sizes may be marketed.