Viagra Connect Max

Before use, please fill out the checklist included in the packaging!

Leaflet included in the packaging: information for the user

VIAGRA CONNECT MAX

50 mg, film-coated tablets

Sildenafil

Please read carefully 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 directed by a doctor or pharmacist.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, please contact a pharmacist.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient does not feel better or feels worse after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

1. What is VIAGRA CONNECT MAX and what is it used for

What is VIAGRA CONNECT MAX

VIAGRA CONNECT MAX contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). The medicine works by relaxing the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation, and causing an erection. VIAGRA CONNECT MAX helps achieve an erection only if there is prior sexual stimulation.

What is VIAGRA CONNECT MAX used for

VIAGRA CONNECT MAX is used to treat erectile dysfunction in men over 18 years of age.
Erectile dysfunction (also known as impotence) is the inability to achieve or maintain an erection (erection) of the penis that would allow for satisfactory sexual activity. The occurrence of an erection depends on many different factors, including proper blood flow to the penis. Reduced blood flow to the penis can cause erectile dysfunction. Erectile dysfunction can manifest differently in each man. Some have problems achieving an erection. Others achieve an erection, but it is not strong enough to have sex, or the erection disappears before or during intercourse.

2. Important information before taking VIAGRA CONNECT MAX

When not to take VIAGRA CONNECT MAX:

• If the patient does not have problems with erections, as the medicine will not have any beneficial effect in this case
• If the patient is taking medicines called nitrates (nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) to relieve chest pain or to treat heart failure (see "VIAGRA CONNECT MAX and other medicines")
• If the patient is taking riociguat (or other medicines that stimulate guanylate cyclase) used to treat high blood pressure in the lungs (see "VIAGRA CONNECT MAX and other medicines")
• If the patient is taking ritonavir used to treat HIV infection (see "VIAGRA CONNECT MAX and other medicines")
• If the doctor has advised the patient to avoid sexual activity, e.g., due to heart or blood vessel problems (see "Warnings and precautions")
• If the patient has severe heart disease, such as: recent myocardial infarction or stroke (within the last 6 months), unstable angina pectoris (chest pain), or severe heart failure (reduced ability of the heart to pump blood)
• If the patient has severe liver disease
• If the patient has low blood pressure (below 90/50 mmHg), which may cause fatigue, dizziness, feeling of emptiness in the head, moist skin, depression, loss of concentration, or blurred vision
• If the patient has ever experienced severe vision loss due to optic nerve damage, such as anterior ischemic optic neuropathy, or if the patient has been diagnosed with a congenital eye disease, such as retinitis pigmentosa (see "Warnings and precautions")
• If the patient has a penile deformity
• In the case of women
• If the patient is under 18 years of age
• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Within the first 6 months of taking VIAGRA CONNECT MAX, the patient should visit their doctor as soon as possible to ensure that their erectile dysfunction is not caused by another serious condition.
Erectile dysfunction can be an early sign of:

• cardiovascular disease
• diabetes
• high blood pressure
• high cholesterol.

The patient should discuss these symptoms and conditions with their doctor if they have not already done so.
Factors that increase the risk of cardiovascular disease
Sexual activity can put an extra strain on the heart (see "When not to take VIAGRA CONNECT MAX").
Before starting to take VIAGRA CONNECT MAX, the patient should talk to their doctor if:

• physical activity of low or moderate intensity (e.g., a 20-minute brisk walk or climbing 2 flights of stairs) causes the patient to experience severe shortness of breath or chest pain. The doctor may need to check if the patient's heart can handle the extra strain of sexual activity
• the patient has a heart valve problem (heart valve disorder)
• the patient has a disease that affects the heart muscle and leads to inflammation and reduced heart function (cardiomyopathy)
• the patient has irregular heartbeats (arrhythmia)
• the patient has had surgery to improve blood flow to the heart or has high blood pressure that is being treated
• the patient has uncontrolled high blood pressure

Other risk factors
Before starting to take VIAGRA CONNECT MAX, the patient should talk to their doctor if:

• the patient has ever experienced an erection that lasted longer than 4 hours (priapism). Certain conditions can increase the likelihood of prolonged erections, such as sickle cell anemia (a disorder affecting red blood cells), leukemia (a cancer of blood cells), or multiple myeloma (a cancer of bone marrow). Taking medicines for erectile dysfunction can increase the risk of priapism. Prolonged erections can lead to tissue damage and permanent loss of potency
• the patient has stomach ulcers or bleeding disorders (e.g., hemophilia)
• the patient has been diagnosed with mild or moderate liver disease or severe kidney disease. Before taking VIAGRA CONNECT MAX, the patient should consult their doctor, as this medicine may not be suitable for them. Patients with kidney or liver problems should not take a dose of sildenafil higher than 25 mg.

In case of sudden vision loss, the patient should stop taking VIAGRA CONNECT MAX and contact their doctor immediately. There have been reports of vision loss in patients taking sildenafil.

Children and adolescents

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

VIAGRA CONNECT MAX and other medicines

The patient should tell their pharmacist or doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. VIAGRA CONNECT MAX may affect the way some other medicines work, and some other medicines may affect the way VIAGRA CONNECT MAX works, which can cause side effects.
Do not take VIAGRA CONNECT MAX if the patient is taking:

• Medicines called nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) to relieve chest pain or to treat heart failure (see "When not to take VIAGRA CONNECT MAX")
• Riociguat: Do not take VIAGRA CONNECT MAX if the patient is taking riociguat (or other medicines that stimulate guanylate cyclase). Riociguat is used to treat high blood pressure in the lungs and can cause a dangerous drop in blood pressure if taken with VIAGRA CONNECT MAX.
• Medicines used to treat HIV infection: Ritonavir is a medicine used to treat HIV infection. Do not take VIAGRA CONNECT MAX if the patient is taking ritonavir, as taking these medicines together can cause a dangerous drop in blood pressure.

Before taking VIAGRA CONNECT MAX, the patient should tell their pharmacist or doctor if they are taking:

• Medicines used to treat fungal infections and antibiotics: Medicines used to treat fungal infections, such as itraconazole or ketoconazole, and antibiotics, such as erythromycin, can increase the levels of VIAGRA CONNECT MAX in the body, which can cause side effects. Before taking VIAGRA CONNECT MAX, the patient should consult their doctor if they are taking these medicines.
• Medicines used to treat heartburn: The medicine cimetidine, used to treat heartburn, can increase the levels of VIAGRA CONNECT MAX in the body, which can cause side effects. The patient should consult their doctor before taking VIAGRA CONNECT MAX.
• Other medicines used to treat erectile dysfunction: The safety and efficacy of VIAGRA CONNECT MAX in combination with other medicines used to treat erectile dysfunction have not been studied, so taking them together is not recommended.
• Alpha-blockers used to treat problems with the urinary system or high blood pressure: Alpha-blockers used to treat problems with the urinary system caused by an enlarged prostate (e.g., alfuzosin, doxazosin, or tamsulosin) can cause dizziness, lightheadedness, nausea, fatigue, loss of concentration, or blurred vision due to low blood pressure (symptomatic hypotension). To reduce the risk of these symptoms, the patient should take their alpha-blocker medicine regularly before starting to take VIAGRA CONNECT MAX. The doctor may decide to use a lower initial dose (25 mg) of VIAGRA CONNECT MAX. If the patient experiences symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint), they should lie down or sit down and wait for the symptoms to pass. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly.
• Medicines containing sacubitril with valsartan, used to treat heart failure. The patient should inform their doctor or pharmacist before taking VIAGRA CONNECT MAX.

VIAGRA CONNECT MAX with food and drink

VIAGRA CONNECT MAX can be taken with or without food.
Taking this medicine after a fatty meal may delay the onset of its effect.
The patient should not eat grapefruits or drink grapefruit juice while taking VIAGRA CONNECT MAX, as it may affect the way the medicine works.
Consuming excessive amounts of alcohol can temporarily impair the ability to achieve an erection. To benefit from taking this medicine, the patient should not consume large amounts of alcohol before sexual activity.

Pregnancy, breastfeeding, and fertility

This medicine should not be taken by women.

Driving and using machines

VIAGRA CONNECT MAX can cause dizziness and affect vision. If the patient experiences these symptoms after taking this medicine, they should not drive or operate machinery.

VIAGRA CONNECT MAX contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

VIAGRA CONNECT MAX contains sodium

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

3. How to take VIAGRA CONNECT MAX

This medicine should always be taken exactly as directed by the doctor or pharmacist, or as described in the patient leaflet. If the patient is unsure, they should consult their pharmacist or doctor.

• The patient should take 1 tablet as needed, about 1 hour before sexual activity.
• The tablet should be swallowed whole with water.
• The patient should not take more than 1 tablet in 24 hours.

VIAGRA CONNECT MAX helps achieve an erection only if there is prior sexual stimulation. The patient should engage in foreplay before taking the medicine, just as they would if they were not taking an erectile dysfunction medicine.
The time it takes for the medicine to start working varies from person to person, but it is usually between 30 and 60 minutes. The medicine can be taken up to 4 hours before planned sexual activity.
The patient should relax and be patient. If VIAGRA CONNECT MAX does not help the patient the first time, they should try again, remembering that they can take only 1 tablet in 24 hours, unless their doctor advises otherwise. In most men, VIAGRA CONNECT MAX works the first or second time. If it has been a while since the patient was able to achieve and maintain an erection, it may take a few attempts before the desired effect is achieved. If the patient takes VIAGRA CONNECT MAX but still does not achieve or maintain an erection, they should talk to their doctor.
If the patient feels that VIAGRA CONNECT MAX is working too strongly, they should talk to their pharmacist or doctor.

Taking a higher dose of VIAGRA CONNECT MAX than recommended

If the patient takes more tablets than recommended, they should contact their pharmacist or doctor immediately. Taking a higher dose of the medicine than recommended can cause side effects and (or) make them worse. Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
If the patient has any further questions about taking this medicine, they should contact their pharmacist or doctor.

4. Possible side effects

Like all medicines, VIAGRA CONNECT MAX can cause side effects, although not everybody gets them.
Most side effects are mild to moderate and go away after a short time.

The patient should seek medical help immediately if they experience any of the following serious side effects:

• Chest pain: occurs not very often. If it occurs before, during, or after intercourse: the patient should sit half-up and try to relax. To relieve chest pain, they should NOT take nitrates;
• Prolonged and sometimes painful erections lasting more than 4 hours: occurs rarely;
• Sudden vision loss or sudden hearing loss: occurs rarely;
• Allergic reaction: occurs not very often. Symptoms include: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat;
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis: occurs rarely. Symptoms can include: severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, as well as fever;
• Seizures: 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
• Sudden flushing, hot flushes (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 (including heartburn)
• Flushing, limb pain, nosebleeds, feeling hot, feeling tired
• Eye irritation, redness of the eyes, eye pain, flashes of light, blurred vision, sensitivity to light, tearing
• Palpitations, rapid heartbeat
• High blood pressure
• Low blood pressure (typical symptoms include dizziness, fainting, blurred vision, nausea, and fatigue)
• Muscle pain, somnolence, reduced sensitivity to touch, vertigo, tinnitus
• Dry mouth, stuffy sinuses, runny nose (symptoms include sneezing, runny nose, and stuffy nose)
• Blood in the urine.

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

• Fainting, dry nose, nasal congestion, irritability, and sudden hearing loss
• Sudden, unexpected death due to heart problems (sudden cardiac arrest), stroke, heart attack, chest pain (angina pectoris), irregular heartbeat, transient reduction in blood flow to parts of the brain
• Feeling of choking, numbness in the mouth
• Bleeding in the back of the eye, double vision, decreased sharpness of vision, disturbances of sensation in the eye, swelling of the eye or eyelid, small particles or spots in the field of vision, seeing halos around lights, dilated pupils, abnormal discoloration of the white of the eye
• Bleeding from the penis, blood in the semen.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can also be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store VIAGRA CONNECT MAX

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Store in the original package to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VIAGRA CONNECT MAX contains

The active substance of the medicine is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
Other ingredients are:
Core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose (see section 2: "VIAGRA CONNECT MAX contains sodium") and magnesium stearate.
Coating: hypromellose, lactose monohydrate (see section 2: "VIAGRA CONNECT MAX contains lactose"), titanium dioxide (E171), triacetin, and indigo carmine (E132).

What VIAGRA CONNECT MAX looks like and contents of the pack

VIAGRA CONNECT MAX is a blue, film-coated tablet in the shape of a rounded diamond, measuring 11.2 mm x 8.1 mm. One side of the tablet is marked with "V", and the other side is marked with "50".
The tablets are packaged in blisters of 2 or 4 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

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
To obtain more detailed information about this medicine, including its name in other EU countries, the patient should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

phone: 22 546 64 00

Date of last revision of the leaflet:

Other sources of information:

Detailed information about this medicine is available on the website: http://www.urpl.gov.pl/