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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0708.
Vardenafil 5mg 10mg & 20mg film-coated tablets
Vardenafil Zentiva 5 mg film-coated tablets
Vardenafil Zentiva 10 mg film-coated tablets
Vardenafil Zentiva 20 mg film-coated tablets
vardenafil
1. What Vardenafil is and what it is used for
2. What you need to know before you take Vardenafil
3. How to take Vardenafil
4. Possible side effects
5. How to store Vardenafil
6. Contents of the pack and other information
The name of your medicine is Vardenafil Zentiva 5 mg, 10 mg and 20 mg film- coated tablets (called Vardenafil throughout this leaflet). It 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 have 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 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 allows an erection to last long enough for you to satisfactorily complete sexual activity.
Talk to your doctor or pharmacist before taking Vardenafil if you
Vardenafil is not intended for use by children or adolescents under 18.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may cause problems, especially these:
You can take Vardenafil 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. It can interfere with the usual effect of the medicine.
Alcoholic drink can make erection difficulties worse.
Vardenafil is not for use by women.
Vardenafil might make some people feel dizzy or affect their vision. If you feel dizzy or if your vision is affected after taking Vardenafil don’t drive or operate any tools or machines.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 10 mg.
Take a Vardenafil 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.
Swallow one tablet with a glass of water.
Do not take Vardenafil film-coated tablets with any other forms of vardenafil.
Do not take Vardenafil more than once a day. Tell your doctor if you think Vardenafil is too strong or too weak. He or she may suggest a switch to an alternative vardenafil formulation with a different dose, depending on how well it works for you.
Men who take too much Vardenafil may experience more side effects or may get severe back pain. If you take more vardenafil than you should, tell your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, fast or altered heart beat, 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):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 on the blister after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is: vardenafil (as hydrochloride trihydrate) 5 mg, 10 mg or 20 mg.
The other ingredients are:
Tablet core: Cellulose, microcrystalline; Silica colloidal anhydrous; Crospovidone (type A); Stearic acid.
Tablet coating: Hypromellose; Macrogol 400; Titanium dioxide (E171); Iron oxide yellow (E172); Iron oxide red (E172).
5 mg: Slightly yellow to slightly brown round tablets of size approx. 6 mm, embossed with “5” on one side.
10 mg: Yellow-orange round tablets of size approx. 6 mm, embossed with “10” on one side and with decorative line on the other side. The score line is only to facilitate for ease of swallowing and not to divide into equal doses.
20 mg: Orange round tablets of size approx. 8 mm, embossed with “20” on one side and with decorative line on the other side. The score line is only to facilitate for ease of swallowing and not to divide into equal doses.
Blisters in packages of:
5 mg: 2, 4, 8, 12 and 24 film-coated tablets.
10 mg: 2, 4, 8, 12, 24, 48 and 60 film-coated tablets
20 mg: 2, 4, 8, 12, 24, 48 and 60 film-coated tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in June 2020
ZV/642 58
64258 PIL Vardenafil GB.indd