Spedra Tablets

Spedra (Avanafil) Tablet Warnings

Do NOT take Spedra:

• 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 allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
• If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• If you have a serious cardiac problem
• 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 had a stroke or heart attack in the last 6 months
• If you have an irregular heartbeat (“arrhythmia”) or heart problems that run in your family, as shown on a heart tracing (ECG)
• 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).

Do NOT take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Spedra Warning and Precautions

Talk to your doctor or pharmacist before taking Spedra:

• 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 heart trouble. It may be risky for you to have sexual intercourse
• 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.

If any of the above applies to you, talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Problems with sight or hearing

Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.

Spedra 50mg, 100mg, 200mg Tablet Patient Information Leaflet

For more information about Spedra Tablets, please take a look at the information leaflet below. It is important you read the Patient Information Leaflet (PIL) before taking Spedra:

• Spedra Tablets

Spedra dosage & Directions of use 

Spedra Dosage Options 

• Spedra tablets are available in three doses: 50mg, 100mg, and 200mg

Usage Instructions for Spedra 

Spedra is an oral pill that can be taken with or without food. It is important to follow your GP's instructions and never take more than one dose daily (24-period). When you take Spedra, it depends on when you need it: 

• For ED treatment, take Spedra at least 20 minutes and up to 4 hours before you need it
• Spedra can work in 20 minutes; however, it may take longer (up to 60 to 90 minutes) if you take the medication after a big meal
• Spedra may not work the first time you take it; you may need to try it up to several times

Spedra Ingredients 

Spedra Tablet Ingredients: 

Active ingredient: Avanafil 

Other ingredients: 

• Mannitol
• Calcium carbonate 
• Fumaric acid
• Hydroxy propylcellulose
• Magnesium stearate 
• Ferric oxide yellow (E172)
• Low-substituted hydroxypropyl cellulose

Spedra Side Effects 

All medications have side effects ranging from mild to severe. Understanding the common side effects of Spedra can help determine how suitable the medication is for you. Mild and command side effects of Spedra include: 

• Indigestion
• Headache 
• Facial flushing 
• Nasal congestion 
• Back and muscle pain

Common side effects of Spedra should go away within a few hours, days, or weeks after use. Talk to your GP or pharmacist if mild side effects persist or are uncomfortable. More severe side effects of Spedra are uncommon; however, if they do present, you should treat them seriously and contact your GP immediately if you experience any of the following side effects: 

• An allergic reaction 
• Sudden and significant changes in loss of hearing 
• An erection lasting more than four hours or is painful 
• Changes in blood pressure 

One way to decrease the chances of experiencing side effects is to take Spedra exactly as prescribed by your GP and pharmacist. 

Spedra Warnings 

Before taking Spedra, tell your doctor if: 

• You are allergic to Avanafil or any of the ingredients in Spedra 
• You have had a heart attack or stroke in the last six months 
• You are taking nitrate medications 
• You have chest pain or get chest pain during sex 
• You have a serious cardiac (heart) problem
• You have low blood pressure or high blood pressure that is uncontrolled 
• You have serious liver or kidney problems 
• You have an irregular heartbeat 
• You are taking medications for HIV or AIDs
• You are taking medication for fungal infections 
• You are taking antibiotics 

Do not take Spedra if you have any of the following mentioned above. If you have any other questions, talk to your GP or pharmacist. 

Spedra Drug Interactions 

Discuss all medications (prescription or OTC), supplements, or herbal remedies that you are taking with your GP and pharmacist. 

Tell your doctor if you are taking any of the following types of medications: 

• Antibiotics 
• Nitrates 
• Alpha-blockers 
• Riociguat 
• Antifungals 
• HIV medications (Protease inhibitors) 
• High blood pressure medications 

Do not take Spedra if you are taking other medications for erectile dysfunction. 

For more information about Spedra Tablets, please take a look at the information leaflet below. It is important you read the Patient Information Leaflet (PIL) before taking Spedra:

• Spedra Tablets