Levitra ® (
Vardenafil
) Tablets
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Patient Information about Levitra ®
Generic name:
Vardenafil
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
There are 6 sections in this leaflet:
- What Levitra is and what it does
- Before you take Levitra
- How to take Levitra
- Possible side effects
- Storing Levitra
- Further information
Levitra 20 mg film-coated tablets
Vardenafil (as hydrochloride trihydrate)
The active substance is vardenafil (as hydrochloride trihydrate). Each tablet contains 20 mg of
vardenafil.
The other ingredients of the tablets are: In the tablet core: crospovidone, magnesium stearate,
microcrystalline cellulose, colloidal anhydrous silica. In the film coat: macrogol 400,
hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).
Marketing Authorisation holder: Bayer AG, D-51368 Leverkusen, Germany. Manufacturer: Bayer HealthCare AG, D-51368 Leverkusen, Germany.
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1. WHAT LEVITRA IS AND WHAT IT DOES
Levitra 20 mg film-coated tablets are orange with the BAYER cross on one side and the strength (20) on the other. Each pack contains 2, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Levitra is a treatment for erectile dysfunction (ED) in men - the medical name for difficulties in getting or keeping an erection.
About erection difficulties
At least one in ten men has trouble getting or keeping an erection at some time. There may be physical causes or psychological causes, or most likely, a mixture of both. Whatever the cause, the effect is the same: muscle and blood vessel changes mean that not enough blood stays in the penis to make it hard and keep it hard.
How Levitra works
Erections are usually controlled by a balance of two body chemicals. The first brings on erections; the second takes erections away. If the two chemicals are out of balance, you can lose an erection before it starts. Levitra works by reducing the action of the second chemical (called PDE-5). Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity. It is taken about 25 to 60 minutes before sexual activity and it will only work when you are sexually stimulated.
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2. BEFORE YOU TAKELEVITRA
Do not use Levitra...
If you have an allergy (if you're hypersensitive) to vardenafil or any of the other ingredients of
Levitra. See the ingredients in the box, over the page. Signs of an allergic reaction include a
rash, itching, swollen face or lips and shortness of breath.
If you take nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl
nitrite. Taking these drags with Levitra could seriously affect your blood pressure.
If you are taking ritonavir or indinavir, medicines for HIV.
If you are over 75 years of age and are taking ketaconazole 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 low blood pressure, or used to
If your family has a history of degenerative eye diseases (such as retinitis pigmentosa)
If any of these applies to you, talk to your doctor, without taking Levitra. Talk to your doctor first...
- If you have heart trouble. It may be risky for you to have sex
- If you suffer from cardiac arrythmia or any congenital cardiac disease affecting your
electrocardiogram
- If you have a physical condition affecting the shape of the penis. This includes conditions called
angulation, Peyronie 's disease and cavernosal fibrosis
- If you have an illness that can cause erections which won't go away (priapism). These include
sickle cell disease, multiple myeloma and leukaemia
- If you have stomach ulcers (also called gastric or peptic ulcers)
- If you have a bleeding disorder (such as haemophilia)
- If you are using any other treatments for erection difficulties.
If any of these applies to you, make sure you've talked to the doctor before taking Levitra. Food and drink with Levitra
- You can take Levitra 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 Levitra. It can interfere with the usual effect of
the medicine.
- Alcoholic drink can make erection difficulties worse.
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.
Levitra is for men of 18 years and over
It is not intended for use by women, children or men under 18.
Other medicines and Levitra
Tell your doctor or pharmacist about any medicine you are taking, or recently took - even products you bought without a prescription, like herbals and vitamins. Levitra will usually be fine with most medicines. But some may cause problems, especially these:
- Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these
medicines with Levitra could seriously affect your blood pressure. Talk to a doctor without
taking Levitra
- Medication for the treatment of arrythmias, such as quinidine, procainamide, amiodarone or
sotalol
- Ritonavir or indinavir, medicines for HIV. Talk to a doctor without taking Levitra
- Ketoconazole or itraconazole, anti-fungal medicines
- Erythromycin, an antibiotic
- Alpha-blockers, a type of medicine used to treat high blood pressure and benign prostatic
hyperplasia.
If you have recently taken any of these medicines, please tell your doctor or pharmacist.
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3. HOW TO TAKE LEVITRA
How much to take and how to take it
Your doctor will have suggested a suitable dose for you.
- Always take Levitra exactly as your doctor has instructed you, and check with the doctor or
pharmacist if you are unsure.
- Tell the doctor if you think Levitra is too strong or too weak. He or she may suggest a
different dose, depending on how well it works for you.
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.
- Swallow one tablet with a glass of water
- You can take Levitra with or without food - but preferably not after a heavy or high-fat
meal.
Don't use Levitra more than once a day.
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.
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4. POSSIBLE SIDE EFFECTS OF LEVITRA
Taking Levitra can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.
Very common side effects
(These may affect 1 in 10 people or more)
Common side effects
(These may affect between 1 in 10 and 1 in 100 people)
- Indigestion
- Feeling sick (nausea)
- Dizziness
- Blocked or runny nose
Uncommon side effects
(These may affect between 1 in 100 and 1 in 1000 people)
- Sensitivity of the skin to sunlight
- High or low blood pressure
- Back or muscle pain
- Effects on vision
- Bloodshot or watery eyes
Rash
- Sleepiness
- Effect in results of blood tests to check liver function
- Increase in blood of a muscle enzyme (creatine phosphokinase)
- Breathlessness
- Fast heart beat or pounding heart
- Nose bleeds
- Facial swelling
Rare side effects
(These may affect less than 1 in 1000 people)
- Fainting
- Muscle stiffness
- Increase pressure in the eye (glaucoma)
- Prolonged or painful erections
- Allergic reaction
- Effects on the heart (such as angina)
- Anxiety
- Swelling of the larynx
If any of these affects you badly, or doesn't go away as you carry on taking Levitra, tell your doctor. If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. STORING LEVITRA
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the packaging.
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