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Levitra (vardenafil)

  • For treating Erectile Dysfunction
  • Available on prescription only.

About Levitra

What is Levitra and What Is It Used For?

Levitra is a prescription only treatment for men over 18 years of age who suffer Erectile Dysfunction (ED), also known impotence. Erectile Dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Levitra contains the active ingredient vardenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). Levitra works by helping the blood vessels in your penis relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Levitra comes in a tablet form and is taken orally. Levira 10mg Orodispersible is a dissolvable tablet and is taken orally.
 

  • Levitra does not cure Erectile Dysfunction.
  • Levitra does not increase a man’s sexual desire
  • Levitra does not protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare professional about ways to guard against sexually transmitted diseases
  • Levitra does not serve as a male form of birth control
  • Levitra is only for men over 18 years of age with Erectile Dysfunction.
  • Levitra is not for women or children.
  • Levitra must be used only under a healthcare professional's care.


Who Should Not Take Levitra?

 

  • Do not take Levitra if you take any medicines called “nitrates”.
  • Do not take Levitra if you use recreational drugs called "poppers" like amyl nitrate and butyl nitrate
  • Do not take Levitra if you have been told by your healthcare professional not to have sexual activity because you have health problems.
  • Do not take Levitra if you are allergic to vardenafil or any of the other ingredients of this medicine (listed in the manufacturers information leaflet).
  • If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.

What are The Risks of Taking Levitra?

The following are the major possible risks and side effects of Levitra therapy: Levitra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines such as nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers". A sudden drop in your blood pressure could cause you to become dizzy, faint, or have a heart attack or stroke. Tell all your healthcare professionals that you take Levitra. If you need emergency medical care for a heart problem, it will be important for your healthcare professionals to know when you last took Levitra.
 

Some common side effects with Levitra include:

  • Headache
  • Flushing
  • Stuffy or runny nose
  • Indigestion
  • Dizziness

What Should I Tell My Healthcare Professional If I Take Levitra?

Tell your healthcare professional if you:

  • Have or had heart problems
  • Have low blood pressure or have high blood pressure that is not controlled
  • Have had a stroke or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
  • Have liver problems
  • Have kidney problems and require dialysis
  • Have ever had severe vision loss
  • Have retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • Have stomach ulcers
  • Have a bleeding problem
  • Have a deformed penis shape or Peyronie’s disease
  • Have had an erection that lasted more than 4 hours (priapism)
  • Take any medicines called “alpha blockers” (alpha blockers are sometimes prescribed for prostate problems or high blood pressure)
  • Have blood cell problems, such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect Levitra?

Levitra and certain other medicines (like Cialis & Viagra) can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional. Some other medicines may be affected by Levitra, please read the manufacturers information leaflet.

 

Can Other Food, Drink and Alcohol Levitra?

Levitra can be taken with or without food. However you may find Levitra takes longer to start working if you take it with a heavy meal. Avoid drinking grapefruit juice when taking Levitra as this can interfere with the usual effect of the medicine. Drinking alcohol can temporarily impair your albility to get an erection.

 

More information can be found in the manufacturers information leaflet.
 

Genuine UK Levitra Is A Prescription Only Medication (POM)

E-Consultation


To have your private e-consultation for Levitra online, just click on the "Dosage & Prices" tab above, and select the dosage strength and quantity you prefer. (Please note that the dosage strength and quantity you have selected my not be what the doctor prescribes, or even that you will successfully obtain a private prescription. This will be determined by the doctor.) Then follow the on-screen instructions for completeing your private online e-consultation for Levitra.


Even though you are required to provide payment details (for the medication) before your e-consultation information can be submitted to our doctor, if our doctor determines that it is not suitable to issue you a private prescription for Levitra, then your card will NOT be charged, and we will inform you of the doctor's decision.


If our doctor determines that it's OK to issue you a private prescription for Levitra, then they will electronically submit your prescription to our pharmacy supplier. Our pharmacy supplier will then dispense and despatch your medication directly to you via Royal Mail Special Delivery.

Levitra (tadalafil) 10mg Tablets and 20mg Tablets

Levitra 5mg
Levitra 10mg
Levitra 10mg Orodispersible
Levitra 20mg

Pills Price
4 Pills Levitra 5mg £39.99
8 Pills Levitra 5mg £56.99
16 Pills Levitra 5mg £90.99
32 Pills Levitra 5mg £153.99
64 Pills Levitra 5mg £275.99
4 Pills Levitra 10mg £54.99
8 Pills Levitra 10mg £84.99
16 Pills Levitra 10mg £142.99
32 Pills Levitra 10mg £251.99
64 Pills Levitra 10mg £457.99
4 Pills Levitra 10mg Orodispersible £63.99
8 Pills Levitra 10mg Orodispersible £100.99
16 Pills Levitra 10mg Orodispersible £156.99
32 Pills Levitra 10mg Orodispersible £308.99
64 Pills Levitra 10mg Orodispersible £564.99
4 Pills Levitra 20mg £70.99
8 Pills Levitra 20mg £116.99
16 Pills Levitra 20mg £202.99
32 Pills Levitra 20mg £363.99
64 Pills Levitra 20mg £668.99

* Special Offer Price

 

Levitra 10 mg orodispersible 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 orodispersible tablets

Vardenafil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

  • 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 Levitra 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 ischaemic 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 Levitra 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 Levitra.

Take special care with Levitra

  • If you have heart trouble. It may be risky for you to have sex.
  • If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases 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, including Levitra film-coated tablets (see section: Other medicines and Levitra).
  • If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor immediately.

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:

  • 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.
  • 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 Levitra.
  • Ketoconazole or itraconazole, anti-fungal 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 Levitra orodispersible tablets combined with any other treatment for erectile dysfunction, including Levitra film-coated tablets.

Levitra with food, drink and alcohol

  • You can take Levitra orodispersible tablets with or without food, but do not take this medicine with any liquid.
  • 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.

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.

Levitra 10 mg orodispersible tablets contains Aspartame and Sorbitol.

  • Aspartame is a source of phenylalanine, and may be harmful for people with a disorder called phenylketonuria.
  • Sorbitol: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Levitra orodispersible tablets

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 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 remove the orodispersible tablet from the blister until you are going to take it.. With dry hands press gently to release the tablet on your hand. Do not crush the tablet.
  • Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take Levitra orodispersible 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.

The chance of having a side effect 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
  • Flushing
  • Blocked or runny nose
  • Indigestion

Uncommon:

may affect up to 1 in 100 users

  • 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 users

  • Inflammation of the eyes (conjunctivitis)
  • Allergic reaction
  • Anxiety
  • Fainting
  • Amnesia
  • Seizure
  • Increased 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

Very rare or not known:

may affect less than 1 in 10,000 users 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)

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

Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:www.hpra.ie
e-mail:medsafety@hpra.ie

Malta

ADR Reporting
Website:www.medicinesauthority.gov.mt/adrportal

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.

Store in the original package in order to protect from humidity and light.

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 orodispersible tablets contains

  • The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride).
  • The other ingredients of the tablets are:
    Magnesium stearate, aspartame (E951), peppermint flavour, mannitol (E421) sorbitol (E420), crospovidone and silica colloidal hydrated.

What Levitra 10 mg orodispersible tablets looks like and contents of the pack

Levitra 10 mg orodispersible tablets are round and white. They are provided in packs of:

1 x 1 orodispersible tablet in alu/alu perforated unit dose blister,

2 x 1 orodispersible tablets in alu/alu perforated unit dose blisters,

4 x 1 orodispersible tablets in alu/alu perforated unit dose blisters,

8 x 1 orodispersible tablets in alu/alu perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bayer Pharma AG
13342 Berlin
Germany

Manufacturer

Bayer Pharma AG
51368 Leverkusen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Bayer plc
Tel: +44-(0)1635-56 3000

This leaflet was last revised in 07/2016.

Detailed information on this medicine is available on the European Medicines Agency web site:http://www.ema.europa.eu

v011_0

Levitra 5mg, 10mg, 20mg 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 5mg, 10 mg, 20mg film-coated tablets

Vardenafil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

  • 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 Levitra 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 Levitra 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 Levitra.

Take special care with Levitra

  • If you have heart trouble. It may be risky for you to have sex.
  • If you suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases 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, including Levitra orodispersible tablets (see section: Other medicines and Levitra).
  • If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor immediately.

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:

  • 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.
  • Medicine 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 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 Levitra film-coated tablets combined with any other treatment for erectile dysfunction, including Levitra orodispersible tablets.

Levitra with food, drink and alcohol

  • 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.

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.

  • Swallow one tablet with a glass of water

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.

The chance of having a side effect 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
  • Flushing
  • Blocked or runny nose
  • Indigestion

Uncommon:

may affect up to 1 in 100 users

  • 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 users

  • 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

Very rare or notknown:

may affect less than 1 in 10,000 users 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)

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

Yellow Card Scheme

Website:www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website:www.hpra.ie

e-mail: medsafety@hpra.ie

Malta

ADR Reporting

Website:www.medicinesauthority.gov.mt/adrportal

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

  • The active substance is vardenafil. Each tablet contains 5mg, 10 mg or 20mg of vardenafil (as hydrochloride).
  • The other ingredients of the tablets are:
    Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
    Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).

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.
Levitra 5 mg film-coated tablets are orange with the BAYER cross on one side and the strength (5) on the other side.
Levitra 20 mg film-coated tablets are orange with the BAYER cross on one side and the strength (20) 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

Bayer Pharma AG
13342 Berlin
Germany

Manufacturer

Bayer Pharma AG
51368 Leverkusen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

Bayer plc

Tel: +44-(0)1635-56 3000

This leaflet was last revised in 12/2015.

Detailed information on this medicinal product is available on the European Medicines Agency web site:http://www.ema.europa.eu.

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