Vardenafil Mylan

Package leaflet: Information for the patient

Vardenafil Mylan 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

vardenafil
Generic medicine
Please read all of this leaflet carefully before you take 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 yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vardenafil Mylan is and what it is used for

Vardenafil Mylan contains the active substance vardenafil, which belongs to a class of medicines
called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of
erectile dysfunction in adult men, a condition characterized by difficulty in achieving or
maintaining an erection.
At least one man in ten occasionally experiences difficulty in achieving or maintaining an erection. This may
be due to physical or psychological causes, or a combination of both. Whatever the cause,
an insufficient amount of blood remains in the penis to allow and maintain an erection,
due to changes in the muscles and blood vessels.
Vardenafil Mylan works only in the presence of sexual stimulation. The medicine reduces the action
of a chemical substance naturally present in the body that causes the erection to subside. Vardenafil Mylan enables
the achievement and maintenance of an erection long enough to allow satisfactory completion of
sexual intercourse.

2. What you need to know before taking Vardenafil Mylan

Do not take Vardenafil Mylan

• If you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath.
• If you have ever developed a severe skin rash or peeling, blisters, and/or mouth ulcers after taking Vardenafil Mylan.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Vardenafil Mylan could dangerously lower your blood pressure.
• If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have, or have had, low blood pressure.
• If there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have previously experienced a condition characterized by loss of vision due to damage to the optic nerve from insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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 vardenafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

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

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart conditions that affect the electrocardiogram.
• If you have a physical condition that causes changes in the shape of the penis. These include conditions known as curvature, Peyronie's disease, and cavernosal fibrosis.
• If you have a disease that may cause prolonged erections (priapism), such as sickle cell anemia, multiple myeloma, or leukemia.
• If you are elderly.
• If you have low potassium levels in your blood.
• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have a bleeding disorder (such as hemophilia).
• If you are using other treatments for erectile difficulties (see section “Other medicines and Vardenafil Mylan”).

Your doctor will review your medical history and perform a physical examination before you start taking Vardenafil Mylan to help identify the cause of erectile dysfunction.
During treatment
Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with vardenafil treatment. Stop taking Vardenafil Mylan and seek immediate medical help if you notice any symptoms indicating these severe skin reactions described in section 4.
If you experience a sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Vardenafil Mylan, stop taking Vardenafil Mylan and contact your doctor immediately.
Children and adolescents
Vardenafil Mylan is not intended for use in children or adolescents under 18 years of age.
Other medicines and Vardenafil Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take Vardenafil Mylan with the following medicines:

• Nitrates, medicines for angina such as nicorandil or nitroglycerin, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Mylan could dangerously lower your blood pressure.
• Riociguat.
• Ritonavir or indinavir, HIV medicines.

Some medicines may cause problems, particularly these:

• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ketoconazole or itraconazolo, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia), including tamsulosin, terazosin, and alfuzosin.
• Nifedipine, used to treat high blood pressure and angina.

Do not use Vardenafil Mylan film-coated tablets in combination with other treatments for erectile dysfunction.
Vardenafil Mylan with food, beverages and alcohol

• You may take Vardenafil Mylan with or without food – but preferably not after a heavy or fatty meal, as this may delay its effect.
• Do not drink grapefruit juice when taking Vardenafil Mylan. It may interfere with the medicine's effect.
• Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
Vardenafil Mylan is not intended for use in women.
Driving and using machines
In some people, Vardenafil Mylan may cause dizziness or affect vision. If you feel dizzy or notice vision problems after taking Vardenafil Mylan, do not drive or operate tools or machinery.

3. How to take Vardenafil Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take one tablet of Vardenafil Mylan approximately 25–60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking Vardenafil Mylan and up to four to five hours afterwards.

• Swallow the tablet with a glass of water.

Do not take Vardenafil Mylan more than once a day.
If you feel that the effect of Vardenafil Mylan is too strong or too weak, talk to your doctor. Your doctor may recommend a different dosage based on how the medicine affects you.
If you have liver problems or severe kidney problems, your doctor may start you on a lower dose.
If you take more Vardenafil Mylan than you should
Patients who take an excessive amount of Vardenafil Mylan may experience more side effects or severe back pain. If you take more Vardenafil Mylan than you should, consult your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The effects are mostly mild or moderate.
Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and problems with cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Many of the men who experienced these side effects already had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.
Contact your doctor immediately and do not take Vardenafil Mylan if you experience any of the following:
Uncommon (may affect more than 1 user in 100)

• Swelling of the face, mouth, lips, tongue, throat or neck with difficulty breathing or swallowing

Rare (may affect more than 1 user in 1,000)

• Seizures
• Sudden chest pain that may spread to the neck or arm, with shortness of breath and a sweating sensation. These may be signs of a heart attack
• Rapid heartbeat
• Feeling of tightness or pressure in the chest with chest pain and increased breathlessness during physical activity (these may be signs of heart problems such as angina)
• Temporary reduction in blood flow to parts of the brain

Not known (frequency cannot be estimated from the available data)

• Partial, sudden, temporary or permanent decrease or loss of vision, or blurred, hazy or distorted central vision in one or both eyes has been reported by patients
• Sudden decrease or loss of hearing
• Sudden death
• Cerebral haemorrhage
• Bleeding from the penis

Patients who have taken medicines similar to Vardenafil Mylan have also reported the following:

• Numbness or weakness in the arms or legs, drooping on one side of the face, headache, dizziness, confusion, difficulty speaking or vision problems. These are signs that blood flow to the brain has been interrupted, resulting in a stroke, or if these signs are temporary, a transient ischaemic attack.

Other side effects include:
Very common (may affect more than 1 user in 10)

• Headache

Common (may affect up to 1 user in 10)

• Dizziness
• Flushing
• Stuffy or runny nose
• Indigestion

Uncommon (may affect up to 1 user in 100)

• Sleep disorders
• Numbness, pain or tingling sensation in the arms, legs, hands or feet (pins and needles)
• Drowsiness
• Vision disturbances; red eyes, changes in colour perception, eye pain and discomfort, light sensitivity
• Ringing in the ears (tinnitus), sensation of spinning (vertigo) when standing or sitting
• Rapid heartbeat or pounding heart
• Shortness of breath
• Stuffy nose
• Acid reflux, inflamed stomach (gastritis). You may experience pain, nausea, vomiting, vomiting with blood or blood in the stools
• Abdominal or intestinal pain, diarrhoea, vomiting, nausea, dry mouth
• Increased levels of liver enzymes in the blood, which can be detected by a blood test
• Rash, red skin
• Back or muscle pain
• Increased levels of a muscle enzyme (creatine phosphokinase) in the blood, which can be detected by a blood test
• Muscle stiffness, cramps
• Prolonged erections
• Malaise

Rare (may affect up to 1 user in 1,000)

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Fainting
• Memory loss
• Increased eye pressure, increased tear production
• High or low blood pressure
• Nosebleeds
• Increased skin sensitivity to sunlight
• Painful erections that may last a long time
• Chest pain

Not known (frequency cannot be estimated from the available data)

• Blood in the urine (haematuria)
• Presence of blood in the semen (haemospermia)
• Flat, non-elevated, target-like or circular red spots on the trunk, often with central blisters, peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
• Distorted, blurred or hazy central vision or sudden decrease in vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vardenafil Mylan

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Vardenafil Mylan contains
The active substance is vardenafil.
Each Vardenafil Mylan 5 mg film-coated tablet contains 5 mg of vardenafil (as hydrochloride
trihydrate).

The other components of the tablets are:
Tablet core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica,
magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron
oxide (E172).
Description of the appearance of Vardenafil Mylan and pack contents
Vardenafil Mylan 5 mg: a brown, round, biconvex film-coated tablet with bevelled edges, marked “M5” on one side and “VL” on the other.
Vardenafil Mylan 10 mg: a brown, round, biconvex film-coated tablet with bevelled edges, marked “M” above “10” on one side and “VL” on the other.
Vardenafil Mylan 20 mg: a brown, round, biconvex film-coated tablet with bevelled edges, marked “M” above “20” on one side and “VL” on the other.
The tablets are available in packs of 2, 4, 8, 12 or 20 tablets and in unit-dose divisible blisters of 4 x 1 and 8 x 1 tablets. Vardenafil Mylan 20 mg tablets are also available in unit-dose divisible blister packs of 12 x 1 and 20 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturer
Mylan Hungary Kft / Mylan Hungary Ltd, Mylan utca 1, Komarom, H-2900 Hungary.
This medicinal product is authorised in the European Economic Area countries with the following
names:
Czech Republic: VARDENAFIL MYLAN
France: VARDENAFIL Viatris 5 mg, film-coated tablet
VARDENAFIL Viatris 10 mg, film-coated tablet
VARDENAFIL Viatris 20 mg, film-coated tablet
Portugal VARDENAFIL MYLAN
United Kingdom: VARDENAFIL MYLAN 5 mg, film coated tablets;
VARDENAFIL MYLAN 10 mg, film coated tablets
VARDENAFIL MYLAN 20 mg, film coated tablets