PATIENT LEAFLET: INFORMATION FOR THE USER

Sildenafil Mylan 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Equivalent medicinal product
Please read this 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sildenafil Mylan is and what it is used for
What you need to know before taking Sildenafil Mylan
How to take Sildenafil Mylan
Possible side effects
How to store Sildenafil Mylan
Contents of the pack and other information

1. WHAT SILDENAFIL MYLAN IS AND WHAT IT IS USED FOR

Sildenafil Mylan belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) inhibitors.
It works by helping the blood vessels in the penis to relax, allowing blood to flow into the penis when sexually aroused.
Sildenafil Mylan will help you achieve an erection only if you are sexually stimulated.
Do not take Sildenafil Mylan if you do not have erectile dysfunction.
Do not take Sildenafil Mylan if you are a woman.
Sildenafil Mylan is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
This occurs when a man is unable to achieve or maintain an erection suitable for satisfactory sexual activity.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SILDENAFIL MYLAN

Do not take Sildenafil Mylan

if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
if you are taking other medicines called nitrates, as the combination may cause a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines, which are often used to treat angina pectoris (or "chest pain"). If you are unsure, ask your doctor or pharmacist;
if you are using any medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may 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 have been shown to enhance the hypotensive effect of riociguat. If you are taking riociguat or have any doubts, inform your doctor;
if you have serious heart or liver problems;
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 ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil Mylan

if you have sickle cell anaemia (a blood disorder affecting red blood cells), leukaemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow);
if you have a penile deformity or Peyronie's disease;
if you have heart problems. In such cases, your doctor should carefully assess whether your heart can tolerate the additional strain of sexual activity;
if you currently have a stomach ulcer or bleeding disorders (e.g. haemophilia);
if you experience sudden decrease or loss of vision, stop taking Sildenafil Mylan and contact your doctor immediately.

You must not use Sildenafil Mylan with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.
You must not take Sildenafil Mylan if you do not have erectile dysfunction.
You must not take Sildenafil Mylan if you are a woman.
Children and adolescents
Sildenafil Mylan must not be administered to individuals under 18 years of age.
Special considerations for patients with kidney or liver problems
Inform your doctor if you have kidney or liver problems. Your doctor may decide to prescribe a lower dose for you.
Other medicines and Sildenafil Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sildenafil Mylan may interact with certain medicines, particularly those used to treat chest pain.
In case of a medical emergency, inform the medical staff treating you that you have taken Sildenafil Mylan and when it was taken. Do not take Sildenafil Mylan with other medicines unless your doctor tells you it is safe to do so.
Do not take Sildenafil Mylan if you are taking any medicines known as nitrates or nicorandil (a nitrate), as the combination may cause a dangerous drop in blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to treat angina pectoris (or "chest pain").
Do not take Sildenafil Mylan if you are taking any medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a dangerous drop in blood pressure.
Inform your doctor or pharmacist if you are already taking riociguat.
Sildenafil may increase the effect of certain medicines such as bosentan (used to treat high blood pressure), while some medicines such as rifampicin (an antibiotic) may reduce the effect of sildenafil.
If you are taking medicines known as protease inhibitors, such as those used in the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of Sildenafil Mylan.
Some medicines such as ketoconazole, itraconazole, erythromycin, and cimetidine may increase the effect of sildenafil, while medicines such as rifampicin may reduce its effect.
Some patients receiving alpha-blockers for the treatment of high blood pressure or enlarged prostate may experience dizziness or a sensation of dizziness due to low blood pressure when sitting down or standing up quickly. Some patients have experienced these symptoms when taking sildenafil together with alpha-blockers. This is more likely to occur within 4 hours of taking Sildenafil Mylan. To reduce the risk of these symptoms, you should be on a stable daily dose of the alpha-blocker before starting Sildenafil Mylan.
Your doctor may start you on the lowest dose (25 mg) of Sildenafil Mylan.
Do not use Sildenafil Mylan with other oral or topical treatments for erectile dysfunction, including those known as PDE5 inhibitors (e.g. tadalafil).
Do not use Sildenafil Mylan with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or bosentan.
Sildenafil Mylan with food, drinks and alcohol
Sildenafil Mylan can be taken with or without food (see section 3 "How to use Sildenafil Mylan"). However, you may notice that Sildenafil Mylan takes longer to work if taken with a heavy meal.
Drinking alcohol at the same time may impair your ability to get an erection. To get the maximum benefit from your medicine, it is recommended not to drink excessive amounts of alcohol before taking Sildenafil Mylan.
Pregnancy, breast-feeding and fertility
Sildenafil Mylan is not intended for use in women.
Driving and using machines
Sildenafil Mylan may cause dizziness and may affect vision. You should be aware of how you react to Sildenafil Mylan before driving or operating machinery.

3. HOW TO TAKE SILDENAFIL MYLAN

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
Do not take Sildenafil Mylan more than once a day.
Take Sildenafil Mylan approximately one hour before sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Mylan is too strong or too weak, speak to your doctor or pharmacist. Sildenafil Mylan will help you achieve an erection only if you are sexually stimulated. The time required for Sildenafil Mylan to take effect varies from person to person, but normally takes between 30 minutes and one hour. You may notice that Sildenafil Mylan takes longer to work if taken with a heavy meal.
If Sildenafil Mylan 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 Mylan than you should
You may experience an increase in the frequency and severity of side effects, such as headache, facial flushing, dizziness, indigestion, nasal congestion, and visual disturbances (including light sensitivity, blurred vision, or reduced visual acuity). Doses higher than 100 mg do not increase effectiveness.
Do not take more tablets than your doctor has prescribed.
Contact your doctor if you take more tablets than prescribed. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. The adverse reactions reported with the use of Sildenafil Mylan are generally mild to moderate and short-lived.
If you experience any of the following serious adverse reactions, stop taking
Sildenafil Mylan and contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people):

Allergic reaction Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain If this occurs during or after sexual intercourse, sit in a semi-upright position and try to relax. Do not use nitrates to treat chest pain.

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

Stroke Symptoms include numbness or weakness in the arms or legs, headache, dizziness and confusion, visual disturbances, difficulty swallowing, difficulty speaking and loss of speech.
Heart attack Symptoms include a feeling of pain in the chest spreading to the jaw, neck, arms and back, shortness of breath, feeling of weakness and/or dizziness, sweating, weakness.
Prolonged and sometimes painful erections If this type of erection persists continuously for more than 4 hours, contact your doctor immediately.
Sudden decrease or loss of vision.
Severe skin reactions Symptoms may include severe peeling and swelling of the skin, blisters in the mouth, genital area and around the eyes, fever.
Seizures or convulsions
Unstable angina (a heart condition).

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

Headache

Common (may affect from 1 to 10 people):

Nausea (feeling unwell), facial flushing, hot flushes (symptoms include a sudden feeling of warmth in the upper body), indigestion, visual disturbances (including blurred colour vision, blurred vision, visual disturbances), nasal congestion and dizziness.

Uncommon (may affect from 1 to 100 people):

Vomiting, skin rashes, bloodshot eyes/red eyes, eye irritation, eye pain, flashes of light, increased perception of light, light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensitivity to touch, dizziness, tinnitus, dry mouth, blocked or congested nasal sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), pain in arms or legs, nosebleeds, blood in urine, feeling of warmth and feeling of fatigue.

Rare (may affect from 1 to 1,000 people):

Fainting, irregular heartbeat, temporary reduction in blood flow to parts of the brain, sensation of tightness in the throat, numbness of the mouth, bleeding behind the eye, double vision, reduced visual acuity, abnormal sensation in the eye, swelling of the eyes or eyelid, appearance of spots or floaters in the visual field, seeing halos around lights, pupil dilation, changes in the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inner nose, irritability and hearing loss.

Additional adverse reactions reported from post-marketing experience include:
Cases of sudden death due to heart failure (sudden cardiac death). Most of the men who experienced these adverse reactions, but not all, 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 sildenafil.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SILDENAFIL MYLAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. PACK CONTENTS AND OTHER INFORMATION

What Sildenafil Mylan contains

The active substance is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as sildenafil citrate).
The other excipients are:
• Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate.
• Film coating: hypromellose (E464), titanium dioxide (E171), indigo carmine aluminium lake (E132), triacetin.

Description of the appearance of Sildenafil Mylan and pack contents
The 25 mg tablets are blue, film-coated, round, biconvex tablets, with “M” printed on one side and “SL” and “25” on the other side.
The 50 mg tablets are blue, film-coated, round, biconvex tablets, with “M” printed on one side and “SL” and “50” on the other side.
The 100 mg tablets are blue, film-coated, round, biconvex tablets, with “M” printed on one side and “SL” and “100” on the other side.
Sildenafil Mylan 25 mg film-coated tablets are available in blisters containing 1, 2, 4, 8 or 12 tablets.
Sildenafil Mylan 50 mg and 100 mg film-coated tablets are available in blisters containing 1, 2, 4, 8, 12, 24 or 36 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano, Italy

Responsible Pharmacist for Batch Release
McDermott Laboratories Limited c/o Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary
Generics [UK] Limited,
Station Close, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom

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