Viagra connect

Before taking this medicine, please use the checklist provided!

Package leaflet: Information for the user

VIAGRA CONNECT
25 mg, film-coated tablets
Sildenafil
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you have taken Viagra Connect as recommended, but an erection sufficient for satisfactory sexual intercourse has not occurred or is not maintained, or if erectile problems worsen, inform your doctor or pharmacist.

Leaflet contents

1. What Viagra Connect is and what it is used for
2. What you need to know 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 Viagra Connect is and what it is used for

Viagra Connect is a medicine intended for adult men (aged 18 years and over)
who have erectile dysfunction (also known as impotence). This is the inability to achieve or
maintain an erection of the penis sufficient for satisfactory sexual activity.
Achieving an erection depends on several factors, including adequate blood flow to the penis.
Insufficient blood flow to the penis may cause erectile dysfunction. Viagra Connect contains the active substance sildenafil. It belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). The medicine works by helping to relax blood vessels in the penis, thereby increasing blood flow during sexual stimulation. Viagra Connect helps achieve an erection only if sexual stimulation is present.

2. Important information before taking Viagra Connect

When NOT to take Viagra Connect:

• if the patient does not have erectile dysfunction, as the medicine will then have no beneficial effect;
• if the patient is taking medicines called nitrates or other medicines that release nitric oxide (e.g. glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate or amyl nitrite – commonly known as poppers, nicorandil or sodium nitroprusside) to relieve chest pain or treat heart failure or to lower blood pressure, because taking them together may lead to a dangerous decrease in blood pressure;
• if the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking riociguat or other medicines belonging to the group of drugs stimulating an enzyme called guanylate cyclase. This medicine is used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as Viagra Connect have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor;
• if the patient is taking ritonavir (a medicine used to treat HIV infection);
• if the doctor has advised the patient to avoid sexual activity, e.g. due to heart or blood vessel problems (e.g. following a heart attack or stroke within the last 6 months, unstable angina or severe heart failure);
• if the patient has ever experienced vision loss due to optic nerve damage [e.g. non-arteritic anterior ischaemic optic neuropathy (NAION)] or if the patient has been diagnosed with a congenital eye disease [e.g. retinitis pigmentosa];
• if the patient has low blood pressure (which may cause symptoms such as fatigue, dizziness, feeling faint, nausea, cold sweating, depression, loss of consciousness or blurred vision);
• if the patient has severe liver disease;
• if the patient has any penile disorder or anatomical deformation of the penis (e.g. Peyronie's disease);
• if the patient is a woman;
• if the patient is under 18 years of age.

Warnings and precautions
Sexual activity can put an additional strain on the heart. If the patient has or suspects having
heart-related health problems, they should inform their doctor or pharmacist.
Within the first 6 months of taking Viagra Connect, the patient should schedule a follow-up visit
with their doctor as soon as possible to ensure that erectile problems are not caused by another
serious condition.
Even if the patient feels well, erectile problems may be due to other serious conditions. Erectile
dysfunction may be an early sign of:

• cardiovascular diseases,
• diabetes,
• high blood pressure,
• high cholesterol levels.

The patient should discuss these symptoms and conditions with their doctor if they have not done so already.
Before starting Viagra Connect, to ensure the medicine is suitable for the patient and that their health
status allows for sexual activity, the patient should inform their doctor if:

• physical activity of low or moderate intensity (e.g. a 20-minute brisk walk or climbing two flights of stairs) causes the patient severe shortness of breath or chest pain. In such cases, the doctor may need to check whether the patient's heart can tolerate the additional strain of sexual activity;
• the patient has a problem with one of the heart valves (valvular heart disease);
• the patient has a problem with the left ventricle of the heart (left ventricular dysfunction);
• the patient has a disease in which inflammation develops in the heart muscle, causing it to function less effectively than before (cardiomyopathy);
• the patient has irregular heartbeats (arrhythmia);
• the patient has a rare group of diseases called multisystem atrophy;
• the patient has undergone surgery to improve heart blood flow or suffers from poorly controlled high blood pressure;
• the patient has ever experienced an erection lasting longer than 4 hours, even without physical or psychological stimulation (a condition known as priapism), or if the patient has any condition that may cause priapism. Conditions that may lead to priapism include: sickle cell anaemia (a disorder affecting red blood cells), leukaemia (a malignant blood cell disorder) and multiple myeloma (a malignant bone marrow disorder);
• the patient is taking any of the other medicines listed in this leaflet. See section 2, subsection "Viagra Connect and other medicines";
• the patient has stomach ulcers or a bleeding disorder (e.g. haemophilia).

Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age.
Viagra Connect and other medicines
Inform your pharmacist or doctor about all medicines currently taken, recently taken, or planned to be taken. Viagra Connect may affect the action of certain other medicines, and some other medicines may affect the action of Viagra Connect.
NITRATE medicines, also known as NITRATES: Do NOT take Viagra Connect if you are taking
nitrate medicines (e.g. glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate) or medicines
that release nitric oxide (e.g. amyl nitrite, commonly known as “poppers”, nicorandil or sodium
nitroprusside). These medicines are often used to relieve symptoms of chest pain (angina) or heart failure. Taking Viagra Connect together with any of these medicines may lead to a dangerous drop in blood pressure.
Do not take Viagra Connect if you are taking riociguat (or other medicines stimulating guanylate cyclase) used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). Do not take Viagra Connect if you are taking the medicine ritonavir used to treat HIV infection.
Before taking Viagra Connect, inform your doctor or pharmacist if you are taking:

• any other medicine used to treat erectile dysfunction;

• alpha-blockers, e.g. alfuzosin, doxazosin or tamsulosin, used to treat urinary problems caused by an enlarged prostate (benign prostatic hyperplasia) or, occasionally, used to treat high blood pressure, as taking these together with Viagra Connect may cause dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. These symptoms are most likely to occur within 4 hours after taking Viagra Connect. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Viagra Connect;

• medicines that may affect the action of Viagra Connect: protease inhibitors (e.g. saquinavir) used to treat HIV infection; cimetidine, a medicine used for heartburn;

• antifungal medicines called itraconazole or ketoconazole, as well as the antibiotics erythromycin and rifampicin;

• nicorandil, a medicine used in ischaemic heart disease.

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

Taking Viagra Connect with food and drink
Viagra Connect may be taken regardless of meals. Taking this medicine after a fatty meal may delay the onset of its action.
Do not eat grapefruit or drink grapefruit juice while taking Viagra Connect, as this may affect the medicine's action.
Drinking excessive amounts of alcohol may temporarily impair the ability to achieve an erection. To get the maximum benefit from this medicine, avoid consuming large 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 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 contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Viagra Connect contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
Other important information
Certain lifestyle changes may positively affect erectile function, such as regular physical exercise, stress reduction, quitting smoking and avoiding excessive alcohol consumption.
If the patient feels low mood or anxiety, they should talk to their pharmacist or doctor, who can provide further advice.

3. How to take the medicine Viagra Connect

Before use, complete the checklist included in the package.
This medicine should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a pharmacist or doctor.

• Take one tablet as needed, approximately one hour before planned sexual activity.
• Swallow the tablet whole with water.
• Do not take more than 1 tablet in any 24-hour period, unless otherwise instructed by a doctor.

Taking Viagra Connect alone will not cause an erection. This medicine helps achieve an erection only if preceded by sexual stimulation. Sexual activity should be preceded by foreplay, just as if the patient were not taking medication for erectile dysfunction.
The time it takes for the medicine to start working varies between individuals, but is usually between 30 and 60 minutes. If Viagra Connect is taken with food, the onset of action may be delayed compared to taking it on an empty stomach.
Remember to relax and be patient—there is no need to rush. If the first attempt is unsuccessful, continue trying, remembering that only 1 tablet should be taken per day, unless otherwise directed by a doctor. Also remember that if, after several attempts under different circumstances, the patient is still unable to achieve an erection sufficient for satisfactory sexual activity, he should consult a doctor.
If the patient feels that Viagra Connect is working too strongly or too weakly, he should discuss this with a pharmacist or doctor.
If the patient has taken Viagra Connect as recommended, but still does not achieve or maintain an erection, he should speak to a doctor.
Taking more than the recommended dose of Viagra Connect
If more tablets than recommended have been taken, the patient should contact a pharmacist or doctor immediately. Taking a higher dose than recommended may lead to an increased number and/or severity of adverse effects. Taking a dose higher than 100 mg does not increase the medicine’s effectiveness.
For any further questions about the use of this medicine, consult a pharmacist or doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Most adverse effects are mild to moderate in intensity and resolve after a short time.

STOP taking Viagra Connect and seek immediate medical help if the patient experiences any of the following SERIOUS adverse effects:

• Chest pain: occurs uncommonly. If chest pain occurs before, during or after sexual intercourse, 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 decrease in vision or sudden vision loss: 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 (SJS), Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN), toxic epidermal necrolysis: occur rarely. Symptoms may include: severe skin peeling and swelling, formation of blisters in the mouth, on genital organs and around the eyes, and fever;
• Seizures or convulsions: occur rarely.

Other reported adverse 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 of the face, hot flushes (sudden feeling of warmth in the upper body);
• seeing coloured halos, blurred vision, visual disturbances.

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

• vomiting, abdominal pain, gastroesophageal reflux disease (commonly known as reflux, presenting e.g. with heartburn);
• skin rash, pain in upper or lower limbs, nosebleeds, feeling of warmth, feeling of fatigue;
• eye irritation, redness of the eyes, eye pain, seeing flashes of light, bright vision, photophobia (sensitivity to light), tearing;
• palpitations, rapid heartbeat;
• increased blood pressure;
• decreased blood pressure (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 blocked nose);
• presence of blood in urine.

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

• fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to certain parts of the brain;
• dry nose, swelling of nasal mucosa, irritation, sudden worsening or sudden loss of hearing;
• feeling of suffocation, numbness in the mouth;
• bleeding in the back of the eye, double vision, decreased visual acuity, sensory disturbances inside the eye, swelling of the eyes or eyelids, small particles or spots in the visual field, seeing halos around light sources, pupil dilation, abnormal discoloration of the sclera (white part of the eye);
• bleeding from the penis, presence of blood in semen.

Since the medicine has been placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse effects, heart function disorders were already present before taking sildenafil. It is not possible to determine whether these effects were directly related to the use of this medicine.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C; 02-222 Warsaw
Tel.: +48 22 4921 301, Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the representative of the responsible entity or to the responsible entity itself.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Viagra Connect

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 after "Expiry date (EXP)". The expiry date refers to the last day of the stated month. The batch number is indicated after "Batch number (Lot)".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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:
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose (see section 2: "Viagra Connect contains sodium"), and magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate (see section 2: "Viagra Connect contains lactose"), titanium dioxide (E171), triacetin, and indigo carmine (E132), lacquer.

What Viagra Connect looks like and contents of the pack
Viagra Connect is a blue, film-coated tablet in the shape of a rounded rhombus, measuring 9.2 mm × 6.7 mm. On one side it is marked "Pfizer", and on the other side "V 25".
The tablets are packed in blisters of 2, 4, or 8 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The Netherlands

Manufacturers:
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 medicine, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel. 22 546 64 00

Other sources of information
Detailed information on this medicine is available on the website: www.urpl.gov.pl