What is ED (Erectile Dysfunction or Impotence)?

Erectile Dysfunction (ED) as doctors prefer to call it, is when a man is not able to achieve or maintain an erection to complete sexual intercourse or another chosen sexual activity. It is one of the most common sexual problems in men and most will experience ED at least once during their lives, however, few actually talk about it.

Impotence problems may occur every time sexual activity is attempted or can be variable. For example you may be able to achieve an erection but fail to get one, or lose it as soon as you try to have sex.

Impotence is usually nothing to worry about, however, most men do worry about it and become so preoccupied with previous erection failures that they are unable to relax and enjoy sexual stimulation. Usually, men who suffer from impotence can feel great mental stress that can damage their personal relationships. Also most men don’t like admitting or discussing the fact that they have a problem and are also too embarrassed to seek help and all this makes the problem worse.

Impotence can happen at any age although it is more common with increasing age.

What causes ED?

Very often ED Impotence has more than one cause. The causes of impotence can be divided into two categories, psychological and physical or it may be a combination of the two.

A psychological cause can be temporary or long standing and is a more common cause of impotence in men under 35. The most common psychological factors that can cause impotence are as follows:

• Stress.
• Depression.
• Guilt.
• Sexual Confusion.
• Relationship difficulties.
• Sexual boredom.
• Bereavement – the loss of a loved one is a common cause of impotence.
• Mental exhaustion and tiredness.
• Worry.

The cause of impotence in men over 35 years of age is usually a physical problem. The most common physical problems that can cause impotence are as follows:

• High blood pressure.
• A specific illness, such as diabetes or multiple sclerosis.
• Injury or major surgery to the pelvic area.
• High cholesterol.
• Age – as men get older there can be changes in circulation or occasionally testosterone levels can fall.
• Atherosclerosis – a condition where the arteries which supply blood to the penis are hardened (blocked) and so the blood flow to the penis is reduced.
• Smoking.
• Drinking too much alcohol, also called “Brewers Droop”.
• Drug
• Side effects of medical treatment, such as drugs used to treat blood pressure.

What are the drugs given to help with ED?

There are several drugs used to help treat ED and they have become commonplace and used correctly can provide the right solution for short term erection problems that have no obvious or diagnosed underlying cause.

The two most popular treatments are Sildenafil (Viagra) and Tadalafil (Cialis) – both are regularly prescribed but Sildenafil is now available as an over the counter drug from the pharmacy and is known as Viagra Connect. It is generally considered that Tadalafil has less side effects than Sildenafil but this can vary from person to person.

Though you can take the medicine regularly and repeat purchases are normal you should always visit your doctor if you continue to have problems or are worried. This is especially true if erection difficulties continue in the first 6 months in case there is an undiagnosed underlying reason for the problems you are having.

It is important that you read and fully understand the Patient Information leaflet before purchasing this item.

Before you use this product

Do not use this product if you

• do not have an erection problem, as this medicine will not provide any benefit to you;
• take any medicines called nitrates or nitric oxide donors, (such as glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate for the relief of chest pain, or heart failure oramyl nitrite also known as “poppers”, nicorandil or sodium nitroprusside), as thecombination may lead to a dangerous fall in blood pressure;
• are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• take riociguat or other medicines of a group called guanylate cyclase stimulators. 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 due to blood clots);
• take ritonavir for the treatment of HIV infection;
• 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, lightheadedness, feeling sick, clammy skin, depression, loss of consciousness, or blurry vision) or 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.

Before taking Viagra Connect, in order to ensure this medicine is suitable for you and that you are fit enough to have sex, tell your doctor 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)
• you have had surgery to improve blood flow to your heart, or you have high blood pressure which is now under control;
• have ever had an erection that lasted more than 4 hours even without any physical or psychological stimulation; (called priapism) or have any condition which can cause priapism. Conditions which can cause priapism include sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
• take any other medicines listed in this leaflet. Please refer to section 2 ‘Other medicines and Viagra Connect’;
• have a stomach ulcer or a bleeding disorder (such as haemophilia);
• have previously diagnosed mild to moderate liver disease, or severe kidney problems.

Viagra Connect may not be suitable for you. Ask your pharmacist or doctor about a  25 mg tablet which may be more suitable for you.

Children and adolescents

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

Other medicines and Viagra Connect

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

NITRATE medicines:

Do NOT take Viagra Connect 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 Viagra Connect with any of these medicines may lead to a dangerous fall in blood pressure.

Do not take Viagra Connect if you are taking a medicine called riociguat (or other medicines of a group called guanylate cyclase stimulators), 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 due to blood clots). In addition, do not take Viagra Connect if you are taking a medicine called ritonavir, for the treatment for HIV infection.

Tell your pharmacist or doctor before using Viagra Connect if you are taking:

• any other treatment for erectile dysfunction;
• alpha-blockers such as alfuzosin, doxazosin or tamsulosin, which are medicines used to treat urinary problems due to an enlarged prostate (benign prostatic hyperplasia) or occasionally high blood pressure, as Viagra Connect may not be suitable for you;
• medicines that may affect the way Viagra Connect works such as:
• protease inhibitors (saquinavir) to treat HIV infections;
• the heartburn treatment cimetidine;
• medicines to treat fungal infections called itraconazole or ketoconazole, and an antibiotic called erythromycin.

Viagra Connect may not be suitable for you. Ask your pharmacist or doctor about a 25 mg tablet which may be more suitable for you.

Viagra Connect with food and drink

Viagra Connect 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 Viagra Connect 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.

Pregnancy, breast-feeding and fertility

This medicine should not be used by women.

Driving and using machines

Viagra Connect 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.

Important information about some of the ingredients of Viagra Connect.

If you have been told by your doctor that you have intolerance to some sugars, such as lactose, speak to your pharmacist or doctor before taking this medicine.

Other important information

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.

Usage

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

• take one tablet, as needed, approximately 1 hour before sexual activity;
• swallow the tablet whole with water;
• do not take more than one tablet a day.

You will not get an erection just by taking Viagra Connect. 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. The amount of time this medicine takes to work varies from person to person, but it normally takes between 30 to 60 minutes to work. You may take it up to 4 hours before sexual activity.

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 1 tablet a day. For most men, Viagra Connect 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 Viagra Connect is too strong or too weak, talk to your pharmacist or doctor.

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

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

• The other ingredients are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium and magnesium stearate Film coat: hypromellose, titanium dioxide (E171), lactose, triacetin and indigo carmine aluminium lake (E132) et and keep an erection.

Ingredients

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

The other ingredients are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium and magnesium stearate Film coat: hypromellose, titanium dioxide (E171), lactose, triacetin and indigo carmine aluminium lake (E132)

Precautions

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.

It is important to have a check-up with your doctor as soon as possible within the first 6 months of using Viagra Connect 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 these conditions with your doctor if you have not already done so.

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 Viagra Connect 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.
• 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.

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 (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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed here 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 product.

 Other Information

If you need more advice consult your doctor or pharmacist.
Keep all medicines out of the sight and reach of children.