Active ingredient
- vardenafil hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 are: EU/1/03/248/008, EU/1/03/248/005, EU/1/03/248/006, EU/1/03/248/007.
Levitra 10mg film-coated tablets
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package Leaflet: Information for the user
Levitra 10 mg film-coated tablets
vardenafil
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Levitra is and what it is used for
2. What you need to know before you take Levitra
3. How to take Levitra
4. Possible side effects
5. How to store Levitra
6. Contents of the pack and other information
1. What Levitra is and what it is used for
Levitra 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.
Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.
2. What you need to know before you take Levitra
Do not take Levitra
Warnings and precautions
Talk to your doctor or pharmacist before taking Levitra.
Take special care with Levitra
Children and adolescents
Levitra is not intended for use by children or adolescents under 18.
Other medicines and Levitra
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
Do not use Levitra film-coated tablets combined with any other treatment for erectile dysfunction, including Levitra orodispersible tablets.
Levitra with food, drink and alcohol
Pregnancy and breast-feeding
Levitra is not for use by women.
Driving and using machines
Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don’t drive or operate any tools or machines.
3. How to take Levitra
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 Levitra 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 Levitra.
Do not take Levitra film-coated tablets with any other forms of Levitra.
Do not take Levitra more than once a day.
Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.
If you take more Levitra than you should
Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra 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 Levitra 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 users
Common:
may affect up to 1 in 10 users
Uncommon:
may affect up to 1 in 100 users
Rare:
may affect up to 1 in 1,000 users
Very rare or not known:
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
Malta
5. How to store Levitra
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 after “EXP”. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Levitra contains
What Levitra looks like and contents of the pack
Levitra 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on the other side. The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in 03/2020.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
v028_0
400 South Oak Way, Reading, Berkshire, RG2 6AD
+44 (0)118 206 3000