Viagra Connect

Before taking the medicine, use the attached checklist!

Leaflet attached to the packaging: information for the user

VIAGRA CONNECT

25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by your pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should talk to your pharmacist.
• If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you have taken Viagra Connect as advised and you still have not had an erection that is sufficient for satisfactory sexual intercourse, or if your erectile dysfunction worsens, you should talk to your doctor or pharmacist.

Table of contents of the leaflet

• 1. What is Viagra Connect and what is it used for
• 2. Important information before taking Viagra Connect
• 3. How to take Viagra Connect
• 4. Possible side effects
• 5. How to store Viagra Connect
• 6. Contents of the pack and other information

1. What is Viagra Connect and what is it used for

Viagra Connect is a medicine for adult men (aged 18 and over)

with erectile dysfunction (also known as impotence).This is when you cannot get or keep an erection that allows for satisfactory sexual activity. Erection is produced by an increase in blood flow into the penis. Erectile dysfunction can occur due to a variety of reasons, including an inadequate blood flow into the penis. Viagra Connect contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). The medicine works by increasing blood flow into the penis to help get and keep an erection. Viagra Connect will only work when you are sexually stimulated.

2. Important information before taking Viagra Connect

When NOT to take Viagra Connect:

• if you do not have erectile dysfunction, as the medicine will not have any beneficial effect;
• if you are taking medicines called nitrates (such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate) or other medicines that release nitric oxide (such as amyl nitrite, also known as "poppers", nicorandil, or sodium nitroprusside), as taking these medicines with Viagra Connect can lead to a dangerous decrease in blood pressure;
• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking riociguat or other medicines that stimulate an enzyme called guanylate cyclase, used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as Viagra Connect, increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should tell your doctor;
• if you are taking ritonavir (a medicine used to treat HIV infection);
• if your doctor has advised you not to have sexual intercourse due to health problems, such as heart or blood vessel disease (e.g., if you have had a heart attack or stroke in the last 6 months, unstable angina, or severe heart failure);
• if you have ever had a loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION) or if you have a hereditary eye disease, such as retinitis pigmentosa;
• if you have low blood pressure(which may cause symptoms such as feeling faint, dizzy, or having low blood pressure, nausea, vomiting, or feeling pale);
• if you have severe liver disease;
• if you have any condition that may affect your penis, such as a condition called Peyronie's disease (a disorder of the tissue of the penis);
• if you are a woman;
• if you are under 18 years old.

Warnings and precautions

Sexual activity may put extra strain on your heart. If you have or think you may have heart problems, you should tell your doctor or pharmacist.

Within the first 6 months of taking Viagra Connect, you should have a check-up with your doctor to make sure that your erectile dysfunction is not caused by another serious medical condition.

Even if you feel well, your erectile dysfunction could be a sign of another serious medical condition. Erectile dysfunction can be a sign of:

• heart or blood vessel disease,
• diabetes,
• high blood pressure,
• high cholesterol.

You should discuss these symptoms and conditions with your doctor if you have not already done so.

Before taking Viagra Connect, you should tell your doctor if:

• physical activity, such as walking quickly or climbing stairs, causes you to become short of breath or experience chest pain.Your doctor may need to check if your heart is healthy enough for sexual activity;
• you have a heart valve problem or heart failure;
• you have a problem with your left ventricle (the main pumping chamber of your heart);
• you have a condition where the muscle in your heart becomes inflamed and does not work properly (cardiomyopathy);
• you have an irregular heartbeat (arrhythmia);
• you have a rare inherited disorder of the blood called sickle cell anemia;
• you have had an operation to improve blood flow to your heart or have poorly controlled high blood pressure;
• you have ever had an erection that lasted more than 4 hours, even without physical or psychological stimulation (a condition called priapism), or if you have any condition that may cause priapism, such as sickle cell anemia, leukemia, or multiple myeloma;
• you are taking any other medicines, including those listed in this leaflet. See section 2, "Viagra Connect with other medicines";
• you have stomach ulcers or bleeding disorders (such as hemophilia).

Children and adolescents

This medicine should not be given to children and adolescents under 18 years old.

Viagra Connect with other medicines

You should tell your pharmacist or doctor about all the medicines you are taking or have recently taken, and about any medicines you plan to take. Viagra Connect may affect the way some other medicines work, and some other medicines may affect the way Viagra Connect works.

Nitrate medicines (also called nitrates): Do not take Viagra Connect if you are taking nitrate medicines

(such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate) or other medicines that release nitric oxide (such as amyl nitrite, also known as "poppers", nicorandil, or sodium nitroprusside). These medicines are often used to treat angina (chest pain) or heart failure. Taking Viagra Connect with these medicines can lead to a dangerous decrease in blood pressure.

Before taking Viagra Connect, you should tell your doctor or pharmacist if you are taking:

• any other medicine for erectile dysfunction;
• alpha-blockers, such as alfuzosin, doxazosin, or tamsulosin, used to treat problems with the urinary system due to an enlarged prostate (benign prostatic hyperplasia) or, occasionally, used to treat high blood pressure, as taking these medicines with Viagra Connect can cause dizziness or fainting, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up quickly or sitting down. These symptoms are most likely to occur within 4 hours of taking Viagra Connect. To reduce the likelihood of these symptoms, you should take your regular dose of alpha-blocker before starting to take Viagra Connect;
• medicines that can affect the way Viagra Connect works: o protease inhibitors (such as saquinavir) used to treat HIV infection; o a medicine for indigestion called cimetidine;

o medicines called itraconazole or ketoconazole used to treat fungal infections, as well as antibiotics called erythromycin and rifampicin; o a medicine called nicorandil used to treat angina; o a medicine called sacubitril/valsartan used to treat heart failure.

• medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Viagra Connect with food and drink

Viagra Connect can be taken with or without food. Taking the medicine after a high-fat meal may delay the onset of action.

You should not eat grapefruit or drink grapefruit juice while taking Viagra Connect, as it may affect the way the medicine works.

Drinking excessive amounts of alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from the medicine, you should not drink excessive amounts of alcohol before taking it.

Pregnancy, breastfeeding, and fertility

This medicine is not intended for use by women.

Driving and using machines

Viagra Connect can cause dizziness and affect vision. If you experience these symptoms after taking the medicine, you should not drive or operate machinery.

Viagra Connect contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

Viagra Connect contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

Other important information

Certain lifestyle changes can help improve erectile function, such as regular physical activity, reducing stress, quitting smoking, and avoiding excessive alcohol consumption.

If you are feeling depressed or anxious, you should talk to your pharmacist or doctor, as they will be able to offer further advice.

3. How to take Viagra Connect

Before use, you must complete the checklist provided with the packaging.

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should talk to your pharmacist or doctor.

• You should take one tablet as needed, about an hour before planned sexual activity.
• The tablet should be swallowed whole with water.

You should not take more than one tablet in 24 hours, unless your doctor advises you to do so.

Taking Viagra Connect will not cause an erection. The medicine will only work when you are sexually stimulated. You should still engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

The time it takes for the medicine to work varies from person to person, but it normally takes between 30 minutes and 1 hour. If you take Viagra Connect with food, the onset of action may be delayed compared to taking it on an empty stomach.

You should relax and be patient. There is no need to rush. If the first attempt does not work, you should try again, remembering that you can only take one tablet in 24 hours, unless your doctor advises you to do otherwise. You should also remember that if, after several attempts, you still cannot get an erection that is sufficient for satisfactory sexual intercourse, you should talk to your doctor.

If you feel that the effect of Viagra Connect is too strong or too weak, you should talk to your pharmacist or doctor.

If you have taken Viagra Connect as advised and you still have not had an erection that is sufficient for satisfactory sexual intercourse, you should talk to your doctor.

Taking more than the recommended dose of Viagra Connect

If you take more tablets than recommended, you should contact your pharmacist or doctor immediately. Taking more than the recommended dose of the medicine can increase the risk of side effects. Taking a dose higher than 100 mg does not increase the efficacy of the medicine.

If you have any further questions on the use of this medicine, you should talk to your pharmacist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects are mild to moderate.

STOP taking Viagra Connect and seek medical help immediately if you experience any of the following serious side effects:

• chest pain:uncommon. If you experience chest pain, you should sit up and try to relax. To relieve chest pain, DO NOTtake nitrates;
• prolonged and sometimes painful erections lasting more than 4 hours:rare;
• sudden loss of vision or sudden loss of hearing:rare;
• allergic reaction:uncommon. Symptoms include: sudden wheezing, coughing, or shortness of breath, swelling of the eyelids, face, lips, or throat;
• severe skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): rare. Symptoms can include: severe skin blistering, peeling, and bleeding, blistering of the mouth, genitals, and around the eyes, and fever;
• seizures or fits:rare.

Other reported side effects

Very common(may affect more than 1 in 10 people):

• headache.

Common(may affect up to 1 in 10 people):

• nausea, indigestion, feeling of a blocked nose, dizziness
• sudden flushing, hot flushes (a sudden feeling of heat in the upper body)
• visual disturbances, blurred vision, color tinge to vision.

Uncommon(may affect up to 1 in 100 people):

• vomiting, abdominal pain, reflux esophagitis (inflammation of the esophagus, also known as reflux)
• skin rash, limb pain, nosebleeds, feeling hot, feeling tired
• eye irritation, red eyes, eye pain, flashes of light, dazzle, sensitivity to light, tearing
• palpitations, rapid heartbeat
• high blood pressure
• low blood pressure (symptoms include dizziness, fainting, blurred vision, nausea, and feeling tired)
• muscle pain, somnolence, reduced sensitivity to touch, vertigo, tinnitus
• dry mouth, stuffy nose, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose)
• blood in urine.

Rare(may affect up to 1 in 1,000 people):

• fainting, stroke, heart attack, irregular heartbeat, transient ischemic attack (a temporary reduction in blood flow to part of the brain)
• dry nose, nasal oedema, nasal irritation, sudden decrease or loss of hearing
• feeling of choking, numbness in the mouth
• bleeding in the back of the eye, double vision, decreased sharpness of vision, eye discomfort, eye swelling, redness of the eye, small particles or spots in the eye, seeing halos around lights, dilated pupils, discolouration of the conjunctiva
• penile bleeding, presence of blood in semen.

After the medicine has been on the market, the following side effects have been reported: unstable angina (a heart condition) and sudden death. It should be noted that in most, but not all, cases where these side effects occurred, the men had pre-existing heart conditions. It is not possible to determine whether these events were directly related to the use of this medicine.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the representative of the marketing authorization holder or the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Viagra Connect

The medicine should be stored out of sight and reach of children.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of that month. The batch number is stated after "Batch number (Lot)".

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Viagra Connect contains

The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).

The other ingredients are:

Core: microcrystalline cellulose, calcium phosphate (anhydrous), croscarmellose sodium (see section 2: "Viagra Connect contains sodium") and magnesium stearate.

Coating: hypromellose, lactose monohydrate (see section 2: "Viagra Connect contains lactose"), titanium dioxide (E171), triacetin, and indigo carmine (E132), lake.

What Viagra Connect looks like and contents of the pack

Viagra Connect is a blue, film-coated tablet in the shape of a rounded diamond, 9.2 mm x 6.7 mm in size. One side is marked with "Pfizer", and the other side is marked with "V 25".

The tablets are packed in blisters, in cartons containing 2, 4, or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer: Fareva Amboise, Zone Industrielle 29, Route des Industries, 37530 Pocé sur Cisse, France; Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary

For further information on this medicine, you should contact your local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00

Date of last revision of the leaflet:

Other sources of information

Detailed information on this medicine is available on the website www.urpl.gov.pl