VARDENAFIL 10 mg Orodispersible Tablet

Зміст інструкції

1. Vardenafil Aristo Pharma 10 mg orodispersible tablets
   1. What is Vardenafil Aristo Pharma and what is it used for
   2. Possible side effects
   3. How to store Vardenafil Aristo Pharma
   4. Contents of the pack and other information

Vardenafil Aristo Pharma 10 mg orodispersible tablets

Vardenafil

Generic medicine

Read this leaflet carefully before you start 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 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 Aristo Pharma is and what it is used for
• 2. What you need to know before you take Vardenafil Aristo Pharma
• 3. How to take Vardenafil Aristo Pharma
• 4. Possible side effects
• 5. How to store Vardenafil Aristo Pharma
• 6. Contents of the pack and other information

1. What is Vardenafil Aristo Pharma and what is it used for

Vardenafil Aristo Pharma belongs to a class of medicines called type 5 phosphodiesterase 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 man in ten occasionally has difficulty achieving or maintaining an erection. This may depend on physical or psychological causes or a combination of the two. Whatever the cause, an insufficient amount of blood is retained in the penis to allow and maintain an erection, due to changes at the level of the muscles and blood vessels.
Vardenafil Aristo Pharma only works in the presence of sexual stimulation. The medicine reduces the action of the chemical naturally present in the body, which stops the erection. Vardenafil Aristo Pharma allows you to achieve and maintain an erection long enough to satisfactorily complete sexual intercourse.

• 2. What you need to know before you take Vardenafil Aristo Pharma

Do not take Vardenafil Aristo Pharma

• If you are allergic to vardenafil or 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 Aristo Pharma could seriously 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 serious heart or liver problems.
• If you are going to undergo renal dialysis.
• If you have recently had a stroke or 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 suffered from 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 drug 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 type 5 phosphodiesterase (PDE5) inhibitors, such as Vardenafil Aristo Pharma, increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil Aristo Pharma

• 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 changes in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you suffer from a disease that can cause erections that persist (priapism). This may be sickle cell anemia, multiple myeloma and 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 in the form of film-coated tablets (see section: Other medicines and Vardenafil Aristo Pharma).
• If you experience a sudden decrease or loss of vision, stop taking Vardenafil Aristo Pharma and contact your doctor immediately.

Children and adolescents
Vardenafil Aristo Pharma should not be used in children and adolescents under the age of
18 years.

Other medicines and Vardenafil Aristo Pharma
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, especially these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Aristo Pharma could seriously alter your blood pressure. Talk to your doctor before taking Vardenafil Aristo Pharma.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV. Talk to your doctor before taking Vardenafil Aristo Pharma.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (such as benign prostatic hyperplasia).
• Riociguat. Do not use Vardenafil Aristo Pharma orodispersible tablets in association with other treatments for erectile dysfunction, including vardenafil in the form of film-coated tablets.

Vardenafil Aristo Pharma with food, drinks and alcohol

• You can take Vardenafil Aristo Pharma orodispersible tablets with or without food, but it is essential that the medicine is not taken with any liquids.
• Do not drink grapefruit juice when taking Vardenafil Aristo Pharma. It may interfere with the usual effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy, breastfeeding and fertility
Vardenafil Aristo Pharma is not intended for use in women.

Driving and operating machinery
Vardenafil Aristo Pharma may cause dizziness or alter vision. If you feel
dizzy or notice vision problems after taking Vardenafil Aristo Pharma, do not drive or
operate tools or machinery.

Vardenafil Aristo Pharma contains aspartame
Aspartame is a source of phenylalanine. It may be harmful to people with a disease
called phenylketonuria.

• 3. How to take Vardenafil Aristo Pharma

Always take this medicine exactly as your doctor has told you. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of Vardenafil Aristo Pharma approximately 25-60 minutes before sexual activity. If you are sexually stimulated, you may be able to get an erection after 25 minutes and up to
four to five hours after taking Vardenafil Aristo Pharma.

• Do not remove the orodispersible tablet from the blister until you are about to use it. With dry hands, pull the edge of the blister out of its container and gently press to release the tablet onto your hand. Do not crush the tablet.
• Place the whole orodispersible tablet in your mouth, on your tongue, where it will dissolve in a few seconds, then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take the orodispersible tablets of Vardenafil Aristo Pharmatogether with any
other formulation of vardenafil.

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

If you take more Vardenafil Aristo Pharma than you should
Patients taking an excessive amount of Vardenafil Aristo Pharma may have
more side effects or experience severe back pain. If you take more Vardenafil
Aristo Pharma than you should, contact your doctor.
If you have any doubts about using this medicine, talk to 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 usually mild or moderate.
Some patients have reported partial, sudden, temporary or permanent
decrease or loss of vision, in one or both eyes. If this happens, stop taking
Vardenafil Aristo Pharma and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
The likelihood of an adverse reaction occurring is described by the following categories:

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

• Headache

Common(may affect up to 1 in 10 users)

• Dizziness
• Hot flushes
• Blocked or runny nose
• Indigestion

Uncommon(may affect up to 1 in 100 users)

• 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 a pounding sensation
• Shortness of breath
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting; feeling unwell (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 (creatinophosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Discomfort

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

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased eye pressure (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) or not known (frequency cannot be
defined based on available data)

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

Reporting of side effects
If you experience any side effects, including 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 Aristo Pharma

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 packaging after the
wording 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 VardenafilChanelle 10 mg orodispersible tablets contain

• The active ingredient is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as vardenafil trihydrate hydrochloride).
• The other components of the tablet are: Microcrystalline cellulose, sodium carboxymethylamide, anhydrous colloidal silica, magnesium stearate, aspartame (E951), peppermint aroma and sodium stearylfumarate.

Description of the appearance of Vardenafil Aristo Pharma and contents of the pack
Vardenafil Aristo Pharma 10 mg orodispersible tablets are presented in the form of
round, flat tablets with a colour varying from white to off-white.
The medicinal product is available in blisters of 1, 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

MMarketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8 - 10
13435 Berlin
Germany
Manufacturer
Chanelle Medical,
Dublin Road
Loughrea
Co. Galway
Ireland
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Spain: Levatik 10 mg Bucodispersable Tablets
Germany: Vardenafil Aristo 10 mg Schmelztabletten
Italy: Vardenafil Aristo Pharma 10 mg
Ireland: Vardenafil Chanelle 10 mg Orodispersible Tablets
United Kingdom: Vardenafil Chanelle 10 mg Orodispersible Tablets