Spedra

• Treats symptoms of erectile dysfunction
• Effective within about 30 minutes
• Only works with sexual stimulation
• Caution with alcohol and grapefruit juice

Spedra is an erection pill. It contains the active substance avanafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. 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.

You should take Spedra about 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated. The effect of Spedra lasts several hours.

The tablet can be taken with or without food. It may take longer for the tablet to take effect if it is taken with food. Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.

Dosage

The general recommended dose in adults is:

• One 100mg tablet. Do not take more than one tablet a day.

If this dose is too weak or too strong, consult a doctor. Spedra should not be taken by children and adolescents under 18 years of age.

Alcohol/driving

Limit or stop drinking alcohol while taking this medicine as this is likely to trigger or worsen the side effects. Drinking alcohol may also decrease your ability to get an erection.

Spedra can cause side effects such as dizziness or blurred vision. Do not drive or use machinery if you experience these symptoms.

If you use more Spedra than you should

If you take more Spedra tablets than you were told to, consult your doctor or pharmacist.

Spedra tablets are not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Spedra contains').
• You are taking nitrate medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate.
• You are taking medicines for HIV or AIDS, such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir.
• You are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin.
• You have a serious cardiac problem.
• You have had a stroke or heart attack within the last six months.
• You have an irregular heartbeat (cardiac arrhythmia) or a family history of heart problems seen on a heart tracing (ECG).
• You have low blood pressure or uncontrolled high blood pressure.
• You have chest pain (angina) or you get chest pain during sexual intercourse.
• You have a serious liver or kidney problem.
• You have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischemic optic neuropathy, NAION).
• Certain serious eye problems run in your family (e.g., retinitis pigmentosa).

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking Spedra if:

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

Pregnancy and breastfeeding

Spedra is not for women.

Other medicines and Spedra

Some medicines interact with one another. See section 'When not to use Spedra' for a list of medicines you should avoid mixing Spedra with. Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.

There are also other medicines that can affect the way Spedra works. These include:

• 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.
• Certain antibiotics, such as erythromycin.
• Phenobarbital or primidone (for epilepsy).
• Carbamazepine (for epilepsy, to stabilise your mood or for certain types of pain).
• Certain medicines that may reduce the breakdown of Spedra in the body, including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil.

Please tell your doctor if you are taking, have recently taken or might take any of these or other medicines. This includes medicines obtained without a prescription and herbal medicines. Your doctor will have a list of medicines that you should avoid mixing Spedra with. See the package leaflet for more information.

Like all medicines, Spedra can cause side effects, although some people may not experience any.

Some side effects are serious. If you notice any of these symptoms, get emergency medical help immediately:

• An erection that lasts more than four 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).

Other side effects of Spedra include:

Common (may affect up to 1 in 10 people):

• Headache.
• Facial flushing.
• Nasal congestion.

Uncommon (may affect up to 1 in 100 people):

• Dizziness.
• Sleepiness, tiredness.
• Sinus congestion.
• Back pain.
• Hot flashes.
• Feeling out of breath when you exert yourself.
• heartbeat changes seen on a heart tracing (ECG), increased heartbeat, feeling your heartbeat in your chest (palpitations).
• Indigestion, nausea or vomiting.
• Blurred vision.
• Raised liver enzymes.

Rare (may affect up to 1 in 1,000 people):

• Influenza or influenza-like illness.
• Hayfever or hayfever-like symptoms.
• Runny or stuffy nose.
• Gout.
• Difficulty sleeping (insomnia).
• Premature ejaculation, spontaneous erections.
• (Severe) chest pain.
• Dry mouth.
• High blood pressure.
• Gastrointestinal problems.
• Muscle pain or cramps.
• Pain in the lower back or side of lower chest.
• Feeling of weakness.

For a complete list of side effects, see the package leaflet. Consult a doctor if you experience any side effects. This includes any possible side effects not listed in this leaflet.

The active substance is avanafil. Each tablet contains 200 mg avanafil. The other ingredients are: mannitol, fumaric acid, hydroxypropyl cellulose, hydroxypropyl cellulose low substituted, calcium carbonate, magnesium stearate and yellow iron oxide (E172).

The manufacturer of Spedra is:

Menarini - Von Heyden GmbH
Leipziger Straβe 7-13
01097 Dresden
Germany

Read the package leaflet before use.