Viagra connect max

Before use, please complete the checklist included in the package!

Package leaflet: Information for the user

VIAGRA CONNECT MAX
50 mg, film-coated tablets
sildenafil
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after taking the medicine, or if the patient feels worse, contact a doctor.

Contents of the leaflet

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

What VIAGRA CONNECT MAX is
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 blood vessels in the penis, increasing blood flow to it during sexual stimulation and thereby producing an erection. VIAGRA CONNECT MAX helps achieve an erection only if sexual stimulation occurs beforehand.

What VIAGRA CONNECT MAX is used for
VIAGRA CONNECT MAX is used to treat erectile dysfunction in men aged 18 years and over.
Erectile dysfunction (also known as impotence) is the inability to achieve or maintain an erection (penile erection) sufficient for satisfactory sexual activity. Achieving an erection depends on many different factors, including adequate blood flow to the penis. Reduced blood flow to the penis may cause erectile dysfunction. Erectile dysfunction may manifest differently in different men. Some men have difficulty achieving an erection. Others may achieve an erection, but it is not strong enough to allow sexual intercourse, or the erection is lost before or during sexual activity.

2. Important information before taking VIAGRA CONNECT MAX

When not to take VIAGRA CONNECT MAX:

• if the patient does not have erection problems, as this medicine will then have no beneficial effect
• if the patient is taking medicines called nitrates to relieve chest pain or treat heart failure (see "VIAGRA CONNECT MAX with other medicines")
• if the patient is taking riociguat (or other drugs stimulating guanylate cyclase) used to treat high blood pressure in the lungs (pulmonary hypertension) (see "VIAGRA CONNECT MAX with other medicines")
• if the patient is taking ritonavir used to treat HIV infection (see "VIAGRA CONNECT MAX with 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 heart attack or stroke (within the last 6 months), unstable angina (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 manifest as fatigue, dizziness, feeling faint, cold and clammy skin, depression, difficulty concentrating, blurred vision
• if the patient has ever experienced serious vision loss due to optic nerve damage, such as anterior ischemic optic neuropathy, or if the patient has been diagnosed with an inherited eye disease such as retinitis pigmentosa (see "Warnings and precautions")
• if the patient has anatomical deformity of the penis
• in 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
During the first 6 months of using VIAGRA CONNECT MAX, the patient should schedule a follow-up visit with a doctor as soon as possible to ensure that erection problems are not caused by another serious condition.
Erectile dysfunction may be an early sign of:

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

The patient should discuss these symptoms and conditions with a doctor if not already done.
Cardiovascular risk factors
Sexual activity may place additional strain on the heart (see: "When not to take VIAGRA CONNECT MAX").
Before starting VIAGRA CONNECT MAX, the patient should talk to a doctor if:

• physical activity of low or moderate intensity (e.g. a 20-minute brisk walk or climbing two flights of stairs) causes severe shortness of breath or chest pain. In such cases, the doctor may need to assess whether the patient's heart can tolerate the additional strain of sexual activity
• the patient has a heart valve disorder (valvular heart disease)
• the patient suffers from a condition in which inflammation develops in the heart muscle, impairing its function (cardiomyopathy)
• the patient has irregular heartbeats (arrhythmia)
• the patient has undergone surgery to improve blood flow to the heart or suffers from high blood pressure that is properly treated
• the patient has uncontrolled high blood pressure

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

• the patient has ever experienced an erection lasting longer than 4 hours (priapism). Certain conditions may increase the risk of prolonged erection, such as sickle cell anaemia (a red blood cell disorder), leukaemia (a blood cancer), or multiple myeloma (a bone marrow cancer). Taking medicines for erectile dysfunction may increase the risk of priapism. Prolonged erection may lead to penile tissue damage and permanent loss of potency
• the patient suffers from stomach ulcers or a bleeding disorder (e.g. haemophilia)
• the patient has been diagnosed with mild or moderate liver disease or severe kidney disease. The use of VIAGRA CONNECT MAX should be discussed with a doctor, as this medicine may not be suitable. Patients with kidney or liver impairment should not take a sildenafil dose higher than 25 mg.

If sudden vision disturbances occur, stop taking VIAGRA CONNECT MAX and contact a doctor immediately. Cases of vision disturbances have been reported during sildenafil use.
Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age.
VIAGRA CONNECT MAX with other medicines
Tell your pharmacist or doctor about all medicines currently taken, recently taken, or planned for use. VIAGRA CONNECT MAX may affect the action of certain other medicines, and some other medicines may affect the action of VIAGRA CONNECT MAX, potentially causing adverse effects.
Do not take VIAGRA CONNECT MAX if the patient is taking:

• Medicines called nitrates: Do not take VIAGRA CONNECT MAX if taking nitrates (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) to relieve chest pain (angina) or heart failure, or if taking medicines that release nitric oxide (e.g. amyl nitrite, commonly known as "poppers", nicorandil, or sodium nitroprusside). Taking these together with VIAGRA CONNECT MAX may lead to a dangerous drop in blood pressure.
• Riociguat: Do not take VIAGRA CONNECT MAX if taking riociguat (or other drugs stimulating guanylate cyclase). Riociguat is used to treat high blood pressure in the lungs and may lead to a dangerous drop in blood pressure when taken together 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 taking ritonavir, as taking these medicines together may lead to a dangerous drop in blood pressure.

Before taking VIAGRA CONNECT MAX, inform the pharmacist or doctor if the patient is 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, increase the concentration of VIAGRA CONNECT MAX in the body, which may lead to adverse effects. Consult a doctor before taking VIAGRA CONNECT MAX if using these medicines.
• Medicines used to treat heartburn: Cimetidine, a medicine used to treat heartburn, increases the concentration of VIAGRA CONNECT MAX in the body, which may lead to adverse effects. Consult a 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 erectile dysfunction medicines have not been studied; therefore, concomitant use is not recommended.
• Alpha-blockers used to treat urinary problems or high blood pressure: Alpha-blockers used to treat urinary problems caused by an enlarged prostate (e.g. alfuzosin, doxazosin, or tamsulosin) may cause dizziness, lightheadedness, nausea, fatigue, difficulty concentrating, or blurred vision due to low blood pressure (symptomatic hypotension). To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting VIAGRA CONNECT MAX. The doctor may decide to start with a lower initial dose (25 mg) of VIAGRA CONNECT MAX. If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit until symptoms subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. Avoid standing up or sitting down quickly.
• Medicines containing sacubitril with valsartan, used to treat heart failure. Inform the 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 action.
Do not eat grapefruit or drink grapefruit juice while taking VIAGRA CONNECT MAX, as this may affect the medicine's action.
Drinking excessive amounts of alcohol may temporarily impair the ability to achieve an erection. To benefit from this medicine, avoid consuming large amounts of alcohol before sexual activity.
Pregnancy, breastfeeding and fertility
This medicine must not be used by women.
Driving and operating machinery
VIAGRA CONNECT MAX may 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 previously diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.
VIAGRA CONNECT MAX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take VIAGRA CONNECT MAX

This medicine should always be taken exactly as directed by a doctor or pharmacist, or as described in the patient information leaflet. If in doubt, consult a pharmacist or doctor.

• Take 1 tablet as needed, approximately one hour before sexual activity.
• Swallow the tablet whole with water.
• Do not take more than 1 tablet in 24 hours.

VIAGRA CONNECT MAX helps achieve an erection only in the presence of sexual stimulation. Appropriate sexual activity should be preceded by foreplay, just as if the patient were not taking a medicine for erectile dysfunction.
The time it takes for the medicine to work varies from person to person, but is usually between 30 and 60 minutes. The medicine can be taken up to 4 hours before planned sexual activity.
Remember to relax and be patient. If VIAGRA CONNECT MAX does not help the first time, continue trying, remembering that only 1 tablet may be taken in 24 hours, unless otherwise advised by a doctor. For most men, VIAGRA CONNECT MAX works the first or second time. If it has been some time since the patient was able to achieve and maintain an erection, several attempts may be necessary before achieving the desired effect. If the patient has taken VIAGRA CONNECT MAX but still does not get or maintain an erection, he should speak to his doctor about it.
If the patient feels that VIAGRA CONNECT MAX is working too strongly, he should discuss this with a pharmacist or doctor.

Taking more than the recommended dose of VIAGRA CONNECT MAX
If more tablets than recommended have been taken, the patient should contact a pharmacist or doctor immediately. Taking more than the recommended dose may cause adverse effects and (or) lead to their worsening. Doses higher than 100 mg do not increase the effectiveness of the medicine.
If there are any further questions about the use of this medicine, consult a pharmacist or doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Most adverse reactions are mild to moderate in intensity and resolve after a short time.
Medical help should be sought immediately if the patient experiences any of the following severe
adverse reactions:

• Chest pain: occurs uncommonly. If chest pain occurs before, during or after sexual activity: adopt a semi-sitting position and try to relax. Do NOT take nitrates to relieve chest pain;
• Prolonged and sometimes painful erection lasting more than 4 hours: occurs rarely;
• Sudden worsening of vision or sudden loss of vision: occurs rarely;
• Allergic reaction: occurs uncommonly. Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat;
• Severe skin reactions, e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis: occurs rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on the genitals and around the eyes, and fever;
• Seizures: occurs rarely.

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

• Headache.

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

• Nausea, indigestion, nasal congestion, dizziness
• Sudden flushing, hot flushes (sudden feeling of warmth in the upper body)
• Colored vision, blurred vision, visual disturbances.

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

• Vomiting, abdominal pain, reflux (including heartburn)
• Skin rash, pain in the upper or lower limbs, nosebleed, feeling of warmth, feeling of fatigue
• Eye irritation, redness of the eyes, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing
• Palpitations, rapid heartbeat
• Increased blood pressure
• Decreased blood pressure (typical symptoms include dizziness, fainting, blurred vision, nausea and feeling of fatigue)
• Muscle pain, drowsiness, reduced sensitivity to touch, vertigo, tinnitus
• Dry mouth, sinus congestion, rhinitis (symptoms include runny nose, sneezing and nasal congestion)
• Presence of blood in urine.

Rare (may affect up to 1 in 1000 people):

• Fainting, dry nose, nasal mucosal swelling, irritability, and sudden worsening or sudden loss of hearing
• Sudden, unexpected death due to cardiac arrhythmias (sudden cardiac arrest), stroke, myocardial infarction, chest pain (angina pectoris), irregular heartbeat, transient ischaemic attack
• Feeling of choking, numbness in the mouth
• Bleeding in the posterior segment of the eyeball, double vision, decreased visual acuity, sensory disturbances in the eyeball, swelling of the eyeball or eyelid, small particles or spots in the visual field, seeing halos around light sources, pupil dilation, abnormal discoloration of the sclera (white of the eye)
• Bleeding from the penis, presence of blood in semen.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder or the representative of the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine VIAGRA CONNECT MAX

Keep this medicine out of the 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 and blister after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What VIAGRA CONNECT MAX contains
The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
The other ingredients are:
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium
croscarmellose (see section 2: "VIAGRA CONNECT MAX contains sodium") and magnesium stearate.
Tablet 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 rhombus measuring 11.2 mm × 8.1 mm. On one side it is marked with "V", and on the other side with "50".
The tablets are packed in blisters containing 2 or 4 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

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 about this medicinal product, including its name in other EU countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00