Stendra

What Stendra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity. Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition. It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you. Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.

How to take Stendra

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 a 100 mg tablet, as needed. You should not take Spedra more than once a day. You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you. Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil („moderate CYP3A4 inhibitors‟) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses. You should take Spedra about 30 minutes (50 mg) or approximately 15 to 30 minutes (100 mg and 200 mg) before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated.Spedra can be taken with or without food; if taken with food, it may take longer to work. If you take more Spedra than you should If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse. If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
• an erection that will not go away (“priapism”). If you get an erection that lasts more than 4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).
• blurred vision.
• sudden decrease or loss of vision in one or both eyes.
• sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears). Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.

Other side effects include:

Common (may affect up to 1 in 10 people)
• headache
• flushing
• nasal congestion

Uncommon (may affect up to 1 in 100 people)
• feeling dizzy
• feeling sleepy or very tired
• sinus congestion
• back pain
• hot flush
• feeling out of breath when you exert yourself
• heartbeat changes seen on a heart tracing (ECG)
• increased heart beat
• feeling your heartbeat in your chest (palpitations)
• indigestion, feeling or being sick to your stomach
• blurry vision
• raised liver enzymes

Rare (may affect up to 1 in 1,000 people)
• influenza
• influenza-like illness
• stuffy or runny nose
• hayfever
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
• gout trouble sleeping (insomnia)
• premature ejaculation
• feeling strange
• feeling unable to keep still
• chest pain
• serious chest pain
• fast heart beat
• high blood pressure
• dry mouth
• stomach ache or heartburn
• pain or discomfort in the lower abdomen
• diarrhoea
• rash
• pain in the lower back or side of lower chest
• muscle aches or pains
• muscle spasms
• frequent urination
• penile disorder
• spontaneous erection without sexual stimulation
• itching in the genital area
• feeling weak or tired all the time
• swelling in the feet or ankles
• increased blood pressure
• pink or red urine, blood in the urine
• abnormal extra sound from the heart
• an abnormal blood test result for a prostate test called „PSA‟
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells
• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
• weight gain
• fever
• nosebleed

Reporting of side effects 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 (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: [email protected]

How to Store Stendra

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 blister and carton after “EXP”. The expiry date refers to the last day of that month. 6 This medicine does not require any special storage condition. 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.