Spedra-pil Leaflet

• 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 Spedra is and what it is used for
2. What you need to know before you take Spedra
3. How to take Spedra
4. Possible side effects
5. How to store Spedra
6. Contents of the pack and other information

What Spedra is and what it is used for

What you need to know before you take Spedra

Do not take Spedra:

1. • If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
   • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure
   • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
   • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
   • If you have a serious cardiac problem
   • If you have had a stroke or heart attack in the last 6 months
   • If you have low blood pressure or high blood pressure not controlled by medicines
   • If you have chest pain (angina) or you get chest pain during sexual intercourse
   • If you have a serious liver or kidney problem
   • If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischemic optic neuropathy [NAION])
   • If certain serious eye problems run in your family (such as retinitis pigmentosa).
   • If you are taking riociguat. This medicine 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 have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

• If you have heart trouble. It may be risky for you to have sexual intercourse
• If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.
• If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie‟s disease or cavernosal fibrosis)
• If you have any bleeding disorder or active peptic ulceration.

• so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol
• antibiotics for infections such as erythromycin
• phenobarbital or primidone – for epilepsy
• carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain
• other medicines that may reduce the breakdown of Spedra in the body („moderate CYP3A4 inhibitors‟) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
• riociguat

How to take Spedra

Possible side effects

• an erection that will not go away (“priapism”). If you get an erection that lasts more than

• 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).

• headache
• flushing
• nasal congestion

• 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

• 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

How to store Spedra

Contents of the pack and other information

What Spedra contains

1. • The active substance is avanafil. Each tablet contains 50 mg, 100 mg or 200 mg of avanafil.
   • The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).