• 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.

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

• 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.
• 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 could seriously affect your blood pressure.
• you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
• you have a severe heart or liver problem.
• you are having kidney dialysis.
• you have recently had a stroke or heart attack.
• you have or have had low blood pressure.
• your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• 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).
• 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 have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Talk to your doctor or pharmacist before taking Vardenafil if you

• have heart trouble. It may be risky for you to have sex.
• suffer from irregular heart beat (cardiac arrhythmia) 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- containing orodispersible tablets (see section “Other medicines and Vardenafil”).
• experience sudden decrease or loss of vision. Stop taking Vardenafil and contact your doctor immediately.

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:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil could seriously affect your blood pressure.
• Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, anti-fungal medicines.
• Erythromycin, or clarithromycin, macrolide antibiotics.
• α-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 film-coated tablets combined with any other treatment for erectile dysfunction, including vardenafil-containing orodispersible tablets.

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.

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 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.

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.