Sildenafil Viatris

Package leaflet: Information for the patient

Sildenafil Viatris 25 mg, 50 mg or 100 mg film-coated tablets

Generic medicine
Read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Sildenafil Viatris is and what it is used for
2. What you need to know before taking Sildenafil Viatris
3. How to take Sildenafil Viatris
4. Possible side effects
5. How to store Sildenafil Viatris
6. Contents of the pack and other information

1. What Sildenafil Viatris is and what it is used for

Sildenafil Viatris contains the active substance sildenafil (as citrate), which belongs to a class of
medicines known as phosphodiesterase type 5 (PDE5) inhibitors. It helps relax blood vessels in the
penis, allowing blood flow into the penis when sexually stimulated. This medicine will help you achieve
an erection only if you are sexually stimulated.
This medicine is a treatment for adult men who have erectile dysfunction, sometimes called impotence.
This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse.

2. What you need to know before taking Sildenafil Viatris

Do not take Sildenafil Viatris
If you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
If you are taking medicines called nitrates, because this combination may lead to a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain"). If you have any doubts, consult your doctor or pharmacist.
If you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure.
If you are taking riociguat. 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). PDE5 inhibitors such as Sildenafil Viatris have been shown to enhance the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
If you have a serious heart or liver condition.
If you have recently had a stroke or heart attack, or if you have low blood pressure.
If you have a rare inherited eye disease (such as retinitis pigmentosa).
If you have previously experienced vision loss caused by non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sildenafil Viatris
If you have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cell tumor), or multiple myeloma (a bone marrow tumor).
If you have a penile deformity or Peyronie's disease.
If you have heart problems. Your doctor must carefully assess whether your heart condition allows you to tolerate the physical strain of sexual activity.
If you currently have a stomach ulcer or coagulation disorders (such as hemophilia).
If you experience a sudden decrease or loss of vision, stop taking this medicine immediately and contact your doctor without delay.
You must not use this medicine together with other oral or topical treatments for erectile dysfunction.
You must not use this medicine together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
You must not take Sildenafil Viatris if you do not have erectile dysfunction.
You must not take Sildenafil Viatris if you are a woman.

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, inform your doctor. Your doctor may decide to prescribe a lower dose.

Children and adolescents
This medicine must not be given to individuals under 18 years of age.

Other medicines and Sildenafil Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Viatris tablets may interact with certain medicines, particularly those used to treat chest pain. In case of a medical emergency, you must inform the doctor, pharmacist, or nurse that you have taken this medicine and when. Do not take this medicine together with other medicines unless authorized by your doctor.
Do not take this medicine if you are taking medicines called nitrates, because combining them may lead to a dangerous drop in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris attacks (or "chest pain").
Do not take this medicine if you are using medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), because this combination may also cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
If you are taking protease inhibitors, such as medicines used to treat HIV, your doctor may initially prescribe the lowest dose of this medicine (25 mg).
Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or a sensation of "empty head," which may be due to low blood pressure when sitting down or standing up quickly. Some patients have reported these symptoms when taking Sildenafil Viatris together with alpha-blockers. This is most likely to occur within 4 hours after taking this medicine. To reduce the likelihood of these symptoms, you should already be on a stable daily dose of the alpha-blocker before starting treatment with this medicine. Your doctor may start you on a lower dose of this medicine (25 mg).

Sildenafil Viatris with food, drinks, and alcohol
This medicine can be taken with or without food. However, you may notice that the onset of action of this medicine is slower if taken after a heavy meal.
Drinking alcohol may temporarily impair your ability to achieve an erection. To obtain the maximum benefit from this medicine, it is advisable to avoid consuming large amounts of alcohol before using it.

Pregnancy, breastfeeding, and fertility
This medicine is not indicated for use in women.

Driving and using machines
This medicine may cause dizziness and may affect vision. Before driving or operating machinery, make sure you know how you react to this medicine.

Sildenafil Viatris contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, consult your doctor before taking this medicine.

3. How to take Sildenafil Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Viatris must not be taken more than once a day.
Take this medicine approximately one hour before planned sexual activity. Swallow the
tablet whole with a glass of water.
If you feel the effect of this medicine is too strong or too weak, consult your doctor or
pharmacist.
This medicine will help you achieve an erection only if you are sexually stimulated. The time needed
for this medicine to take effect may vary from person to person, but generally ranges from
half an hour to one hour. The effect of this medicine may take longer if you have recently eaten a heavy meal.
If this medicine does not help you achieve an erection, or if the erection does not last long enough to complete sexual intercourse, inform your doctor.
If you take more Sildenafil Viatris than you should:
You may experience an increase in the frequency and severity of side effects. Doses higher than
100 mg do not increase effectiveness.
Do not take more tablets than prescribed by your doctor.
If you take more tablets than prescribed, contact your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects reported with this medicine are usually mild to moderate in severity and short-lived.
If you experience any of the following serious side effects, stop taking Sildenafil Viatris and contact your doctor immediately:

• Allergic reaction – occurs uncommonly (may affect up to 1 in 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. If this occurs during or after sexual activity:
  • Sit in a semi-upright position and try to relax.
  • Do not use nitrates to treat chest pain.
• Prolonged and sometimes painful erections – occur rarely (may affect up to 1 in 1,000 people). If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
• Sudden decrease or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area and around the eyes, fever.
• Seizures or fits – occur 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, facial flushing, hot flushes (symptoms include a sudden feeling of heat in the upper body), indigestion, increased intensity of colours in vision, blurred vision, visual disturbances, nasal congestion and dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, rash, eye irritation, eye redness, eye pain, light flashes, increased light sensitivity, photophobia, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, vertigo, ringing in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth and fatigue.
Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary reduction in blood supply to certain areas of the brain, sensation of throat tightness, numbness of the mouth, bleeding at the back of the eye, double vision, reduced visual acuity, abnormal eye sensitivity, swelling of the eyes or eyelids, appearance of spots or floaters in the visual field, seeing halos around lights, pupil dilation, change in the colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling of the nasal mucosa, irritability and sudden decrease or loss of hearing.

From post-marketing experience, cases of unstable angina (a heart condition) and sudden death have been reported. It should be noted that most of the men who experienced these side effects, but not all, already had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events are directly related to the use of this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Viatris

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not use this medicine after the expiry date stated on the packaging and blister after
EXP. The expiry date refers to the last day of that month.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sildenafil Viatris contains
The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil
(as citrate salt).
The other components are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), sodium
croscarmellose, magnesium stearate.
Film coating: hypromellose, lactose (see section 2 “Sildenafil Viatris contains lactose”), triacetin, titanium dioxide (E171).
Description of the appearance of Sildenafil Viatris and package contents
Sildenafil Viatris film-coated tablets are white to off-white, diamond-shaped with rounded corners, and are marked on one side with “25”, “50” or “100”. The tablets are available in blister packs containing 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
The manufacturer of this medicinal product is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

This leaflet was last updated on: