Vardenafil Teva Generics

Patient Information Leaflet: Information for the User

Vardenafil Teva Generics 10 mg orodispersible tablets

Equivalent medicinal product
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Contents of this leaflet:

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

1. What Vardenafil Teva Generics is and what it is used for

Vardenafil Teva Generics belongs to a class of medicines called phosphodiesterase type 5 (PDE5) 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. Regardless of the cause, an insufficient amount of blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Vardenafil Teva Generics works only in the presence of sexual stimulation. The medicine reduces the action of a naturally occurring chemical in the body that causes the erection to subside.
Vardenafil Teva Generics enables the achievement and maintenance of an erection long enough to allow satisfactory completion of sexual intercourse.

2. Do not take Vardenafil Teva Generics

• 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 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 Teva Generics 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 renal 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 ever had a condition characterized by sudden vision loss due to damage of 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). Phosphodiesterase type 5 (PDE5) inhibitors, such as Vardenafil Teva Generics, 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 Teva Generics

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart diseases that affect the electrocardiogram.
• If you have a physical condition causing changes in the shape of the penis. These include conditions called 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 have stomach ulcers (also known as gastric or peptic ulcers).
• If you have a bleeding disorder (such as hemophilia).
• If you are using other treatments for erectile difficulties, including film-coated vardenafil tablets (see section Other medicines and Vardenafil Teva Generics).
• If you notice a sudden decrease or loss of vision, stop taking Vardenafil Teva Generics and contact your doctor immediately.

Children and adolescents
Vardenafil Teva Generics is not intended for use in children or adolescents under 18 years of age.

Other medicines and Vardenafil Teva Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may cause problems, particularly the following:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Teva Generics could dangerously lower your blood pressure. Do not take Vardenafil Teva Generics—consult a doctor.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Consult your doctor before taking Vardenafil Teva Generics.
• Ketoconazole or itraconazole, 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).
• Riociguat.

Do not use Vardenafil Teva Generics orodispersible tablets in combination with other treatments for erectile dysfunction, including film-coated vardenafil tablets.

Vardenafil Teva Generics with food, drinks, and alcohol

• You may take Vardenafil Teva Generics orodispersible tablets with or without food, but do not take this medicine with liquids.
• Do not drink grapefruit juice when taking Vardenafil Teva Generics. It may interfere with the usual effect of the medicine.
• Alcoholic beverages may worsen erectile difficulties.

Pregnancy, breastfeeding, and fertility
Vardenafil Teva Generics is not intended for use in women.

Driving and use of machines
In some people, Vardenafil Teva Generics may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Vardenafil Teva Generics, do not drive or operate tools or machinery.

Vardenafil Teva Generics contains aspartame
Aspartame is a source of phenylalanine. It may be harmful for people with a disease called phenylketonuria.

3. How to take Vardenafil Teva Generics

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 Teva Generics 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 Teva Generics and lasting up to four to five hours.

• Do not remove the orodispersible tablet from the blister pack until it is time to take it. With dry hands, lift the edge of the blister foil and gently press on the top to release the tablet onto your hand. Do not crush the tablet.
• Place the entire orodispersible tablet on the tongue, where it will dissolve within seconds and be swallowed with saliva. The orodispersible tablet must be taken without any liquid.

Do not take Vardenafil Teva Generics orodispersible tablets together with any other formulation of vardenafil.
Do not take Vardenafil Teva Generics more than once a day.
If you feel that the effect of Vardenafil Teva Generics is too strong or too weak, talk to your doctor. Your doctor may recommend switching to another formulation of Vardenafil Teva Generics with a different dosage, based on how the medicine affects you.

If you take more Vardenafil Teva Generics than you should
Patients who take an excessive amount of Vardenafil Teva Generics may experience more side effects or severe back pain. If you take more Vardenafil Teva Generics than you should, consult your doctor.
If you have any doubts about how to use this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes.
If any of these cases occur, stop taking Vardenafil Teva Generic and contact your doctor immediately.
Sudden decrease or loss of hearing has also been reported.

The likelihood of experiencing a side effect is described using the following categories:

Very common (may affect more than 1 in 10 people)

• Headache

Common (may affect up to 1 in 10 people)

• Dizziness
• Flushing
• Stuffy or runny nose
• Indigestion

Uncommon (may affect up to 1 in 100 people)

• Swelling of the skin and mucous membranes, including swelling of the face, lips or throat
• Sleep disturbance
• Numbness and reduced tactile sensation
• Drowsiness
• Visual disturbances; red eyes, disturbances in colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears; dizziness
• Rapid heartbeat or pounding sensation in the chest
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; nausea, dry mouth
• Increased levels of liver enzymes in the blood
• Rash, red skin
• Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Malaise

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

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Seizure
• Increased eye pressure (glaucoma), increased tear production
• Effects on the heart (such as heart attack, irregular heartbeat or angina)
• High or low blood pressure
• Nosebleeds
• Effects on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain

Very rare (may affect less than 1 in 10,000 people) or not known (frequency cannot be determined from the available data)

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haemospermia)

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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vardenafil Teva Generics

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
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 Vardenafil Teva Generics 10 mg orodispersible tablets contain

• The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other components of the tablet are: microcrystalline cellulose, sodium glycolate starch, anhydrous colloidal silicon dioxide, magnesium stearate, aspartame (E951), peppermint flavour, sodium stearyl fumarate.

Description of the appearance of Vardenafil Teva Generics and contents of the pack
Vardenafil Teva Generics 10 mg orodispersible tablets are round, white to off-white tablets.
The tablets are available in packs of 4 or 8 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

The manufacturer is:
Pharmadox Healthcare Ltd.
KW20A Corradino Industrial Estate,
Paola PLA3000,
Malta.
Chanelle Medical
Loughrea
Co. Galway
Ireland