VARDENAFIL 10 mg Ородисперсная Таблетка

Содержание инструкции

1. Vardenafil Teva Generics 10 mg orodispersible tablets
   1. What is Vardenafil Teva Generics and what it is used for
   2. Do not take 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

Vardenafil Teva Generics 10 mg orodispersible tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Vardenafil Teva Generics 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 that involves difficulty achieving or maintaining an erection.
At least one in ten men occasionally have difficulty achieving or maintaining an erection. This may be due to physical or psychological causes or a combination of both. Whatever the cause,
not enough 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 the chemical substance, naturally present in the body, that stops the erection.
Vardenafil Teva Generics allows you to achieve and maintain an erection long enough to
satisfactorily complete 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); the signs of an allergic reaction include skin 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 alter 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 of age 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 a heart attack.
• If you have, or have had, low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have previously had a condition characterized by loss of vision due to damage to the optic nerve due to 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 secondary to blood clots). It has been shown that phosphodiesterase type 5 (PDE5) inhibitors, such as Vardenafil Teva Generics, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell 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 hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes alterations in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism), such as sickle cell anemia, multiple myeloma or leukemia.
• 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, including vardenafil film-coated tablets (see section Other medicines and Vardenafil Teva Generics).
• If you experience 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Some medicines can cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Teva Generics could dangerously alter 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 a 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 association with other treatments for
erectile dysfunction, including vardenafil film-coated tablets.

Vardenafil Teva Generics with food, beverages and alcohol

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

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

Driving and using machines
In some people Vardenafil Teva Generics may cause dizziness or alter vision. If
you experience dizziness 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 following the instructions of your doctor exactly. If you have any doubts, 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 be able to achieve an erection within 25 minutes and up to four-five hours
after taking Vardenafil Teva Generics

• Do not remove the orodispersible tablet from the blister until you are ready 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 in your mouth, on your tongue, where it will dissolve in a few seconds and will
  then be swallowed with saliva. The orodispersible tablet should be taken without any liquid.

Do not take Vardenafil Teva Generics orodispersible tabletstogether with any other
formulation of vardenafil.

Do not take Vardenafil Teva Genericsmore than once a day.
If you feel that the effect of Vardenafil Teva Generics is too strong or too weak, consult your doctor. They may advise you to take an alternative formulation of Vardenafil
Teva Generics with a different dosage, based on the effect the medicine has on you.

Ifyou take more Vardenafil Teva Generics than you should
Patients who take an excessive amount of Vardenafil Teva Genericsmay 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The 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 this occurs, stop taking Vardenafil Teva Generic and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
The likelihood of experiencing a side effect is described by the following categories:

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

• Headache

Common(may affect up to 1 in 10 people)

• Dizziness
• Hot flushes
• Blocked 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 disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision; red eyes, effects on color perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears; vertigo
• Fast heartbeat or heart with pounding sensation
• Shortness of breath
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting; nausea, dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatin phosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell

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

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased pressure in the eye (glaucoma), increased tearing
• Effects on the heart (such as heart attack, altered heartbeat or angina)
• High or low blood pressure
• Nosebleed
• Effect 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 estimated from the available data)

• Blood in the urine (hematuria)
• Bleeding from the penis (penile hemorrhage)
• Presence of blood in the semen (hematospermia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through 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 which is stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vardenafil Teva Generics 10 mg orodispersible tablets contain

• The active ingredient 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 silica, magnesium stearate, aspartame (E951), peppermint aroma, sodium stearylfumarate.

Description of the appearance of Vardenafil Teva Generics and contents of the pack
Vardenafil Teva Generics 10 mg orodispersible tablets are round tablets of
white to off-white color.
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
Netherlands
The manufacturer is:
Pharmadox Healthcare Ltd.
KW20A Corradino Industrial Estate,
Paola PLA3000,
Malta.
ChanelleMedical
Loughrea
Co. Galway
Ireland