VARDENAFIL ARISTO 20 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - VARDENAFIL ARISTO 20 MG FILM-COATED TABLETS

1. what vardenafil aristo is and what it is used for

Vardenafil Aristo contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.

Vardenafil Aristo will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Vardenafil Aristo allows an erection to last long enough for you to satisfactorily complete sexual activity.

2. what you need to know before you take vardenafil aristo

Do not take Vardenafil Aristo:

if you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
if you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil Aristo could seriously affect 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 taking ketoconazole or itraconazole, anti-fungal medicines.
if you have a severe heart or liver problem. if you are having kidney 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 ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic 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). PDE5 inhibitors, such as Vardenafil Aristo have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vardenafil Aristo.

Take special care with Vardenafil Aristo if you

have heart trouble. It may be risky for you to have sex.
suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases affecting your electrocardiogram.
have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
have stomach ulcers (also called gastric or peptic ulcers).
have a bleeding disorder (such as haemophilia).
are using any other treatments for erection difficulties, including Vardenafil orodispersible tablets (see section: Other medicines and Vardenafil Aristo).
experience sudden decrease or loss of vision, stop taking Vardenafil Aristo and contact your doctor immediately.

Children and adolescents

Vardenafil Aristo is not intended for use by children and adolescents under the age of 18.

Other medicines and Vardenafil Aristo

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Some medicines may cause problems, especially these:

nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite.

Taking these medicines with Vardenafil Aristo could seriously affect your blood pressure. Talk to a doctor without taking Vardenafil Aristo.

medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol
ritonavir or indinavir, medicines for HIV. Talk to a doctor without taking Vardenafil Aristo.
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 (as benign prostatic hyperplasia)
Riociguat.

Do not use Vardenafil Aristo film-coated tablets combined with any other treatment for erectile dysfunction, including Vardenafil orodispersible tablets.

Vardenafil Aristo with food, drink and alcohol

you can take Vardenafil Aristo with or without food – but preferably not after a heavy or high-fat meal as this may delay the effect.
don’t drink grapefruit juice when you use Vardenafil Aristo. It can interfere with the usual effect of the medicine.
alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Vardenafil Aristo is not for use by women.

Driving and using machines

Vardenafil Aristo might make some people feel dizzy or affect their vision. If you feel dizzy or if your vision is affected after taking Vardenafil Aristo, don’t drive or operate any tools or machines.

Vardenafil Aristo film-coated tablets contain tartrazine aluminium lake (E102) and sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.

3. how to take vardenafil aristo

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 10 mg.

Take a Vardenafil Aristo tablet about 25 to 60 minutes before sexual activity. With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vardenafil Aristo.

Swallow one tablet with a glass of water.

Do not take Vardenafil Aristo more than once a day.

Tell your doctor if you think Vardenafil Aristo is too strong or too weak.

If you take more Vardenafil Aristo than you should

Men who take too much Vardenafil Aristo may experience more side effects or may get severe back pain. If you take more Vardenafil Aristo than you should, tell your doctor.

If you have any further questions on 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. Most of the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients. Stop taking Vardenafil Aristo and contact your doctor immediately. Sudden decrease or loss of hearing has been reported.

Cases of sudden death, fast or altered heartbeat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to ■ parts of the brain and bleeding in the brain) have been reported in men taking vardenafil. Most of the men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The chance of having 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
flushing
blocked or runny nose
indigestion

Uncommon (may affect up to 1 in 100 people)

swelling of skin and mucous tissue including swollen face, lips or throat
sleep disorder
numbness and impaired perception of touch
sleepiness
effects on vision; redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity
ringing in the ears; vertigo
fast heart beat or pounding heart
breathlessness
stuffy nose
acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth
raised levels of liver enzymes in your blood
rash, reddened skin
back or muscle pain; increase in blood of a muscle enzyme (creatine phosphokinase), 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
increase pressure in the eye (glaucoma), lacrimation increased
effects on the heart (such as heart attack, altered heart beat or angina)
high or low blood pressure
nose bleed
effect on results of blood tests to check liver function
sensitivity of the skin to sun light
painful erections
chest pain
temporarily decreased blood flow to parts of the brain

6. Contents of the pack and other information

What Vardenafil Aristo contains

The active substance is vardenafil.

Each tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as hydrochloride trihydrate).

The other ingredients of the tablets are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone Type B, colloidal anhydrous silica, magnesium stearate

Film-coat: Opadry beige 03F570025

Composition of Opadry beige 03F570025: Hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide yellow (E172), tartrazine aluminium lake (E102), sunset yellow FCF aluminium lake (E110), iron oxide red (E172)

What Vardenafil Aristo looks like and contents of the pack

Vardenafil Aristo 5 mg is a light orange to orange, film-coated round tablets debossed with ‘L’ on one side and ‘05’ on the other side.

Vardenafil Aristo 10 mg is a light orange to orange, film-coated round tablets debossed with ‘480’ on one side and plain on the other side.

Vardenafil Aristo 20 mg is a light orange to orange, film-coated round tablets debossed with ‘481’ on one side and plain on the other side.

Vardenafil Aristo 5 mg is available in blister packs of 2, 4, 8, 12 and 20 tablets.

Vardenafil Aristo 10 mg and 20 mg is available in blister packs of 2, 4, 8, 12, 20 and 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Aristo Pharma GmbH

Wallenroder StraBe 8–10

13435 Berlin

Germany

ArIsto

This leaflet was last revised in 01/2020.

Very rare or not known (may affect ^^3 less than 1 in 10,000 people or frequency cannot be estimated from the available data)

blood in the urine (Haematuria)
penile bleeding (Penile Haemorrhage)
presence of blood in the semen (Haematospermia)
sudden death
bleeding in the brain

5. how to store vardenafil aristo

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

5mg, 10mg and 20mg (Aluminiumaluminium blister):

This medicine does not require any special storage conditions.

5mg and 10mg (Aluminium-PVC and aluminium-PVC/PVdC blister)