Spedra is one of the treatments for erectile dysfunction available here at Assured Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.
This article is about Spedra. We’ll cover what Spedra is, what it is used for, how to take it, who cannot take it and any side effects you can expect from taking it.
Spedra is the brand name for a medication known as Avanafil. Each tablet of Spedra contains either 50 mg, 100 mg or 200 mg of Avanafil. Spedra comes as pale-yellow oval tablets, debossed with “50”, “100” or “200” on one side.
The legal category for Spedra is POM. This means it is a prescription only medicine and supply can only be made according to the instructions in a prescription issued by a qualified doctor or non-medical prescriber.
The other substances (excipients) in each Spedra tablet (that are inactive) include Mannitol, Fumaric acid, Hydroxypropylcellulose, Hydroxypropylcellulose – low substituted, Calcium carbonate, Magnesium Stearate, Yellow iron oxide (E172).
What is Spedra used for?
Spedra (Avanafil) is indicated for the treatment of Erectile Dysfunction in adult men.
Initially, one 100mg tablet is to be taken about 15 – 30 minutes before any sexual activity. Depending on your response and how you tolerate the tablets, you can either reduce the dosage to 50mg or increase it to 200mg as a single dose. You cannot take more than one dose per day.
For patients already on a class of medication known as alpha-blockers, the initial dose is one 50mg tablet about 15 – 30 minutes before any sexual activity. Depending on how you respond to the tablets and how you tolerate it, you can either remain on the 50mg dosage or increase the dosage to 100mg or 200mg as appropriate as a single dose. No more than one dose can be taken per day.
If you are a man aged 65 years or older, you can take Spedra as described above. There is little data available on the use of Spedra in men aged 70 years and older.
For Spedra to be effective, sexual stimulation is required.
Who cannot take Spedra?
Spedra is licensed for use in adult men only. Spedra is not licensed for use by women and children.
Adult men who are hypersensitive to the active ingredient (Avanafil) or to any of the excipients, should not take Spedra.
Adult men with some pre-existing medical conditions or those taking certain classes of medications cannot take Spedra. Therefore, it is important for you to see a doctor to discuss your individual circumstances. You can either book a consultation with your regular GP or click here to start a consultation with our in-house doctor.
It is important that during your consultation, you inform the doctor of all previous and existing conditions you have. You should also inform the doctor of all medications you are currently taking including herbal remedies and over the counter medications that you bought without needing a prescription.
The list of conditions and the list of medications that may affect the suitability of use of Spedra for your individual circumstances are outside the scope of this article. That is why it is important for you to have an in-depth consultation with a doctor before treatment is initiated. This way, you minimise the risk of any adverse effects occurring.
What side effects can I expect from taking Spedra?
Below is further information about the undesirable effects that may be seen from taking Spedra as provided by the marketing authorisation holder of Spedra.
Summary of the safety profile
The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program. The most common adverse reactions reported in clinical studies were headaches, flushing, nasal and sinus congestion and back pain. Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) <25 (normal BMI subjects).
In the long-term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Tabulated list of adverse reactions
The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse reaction (MedDRA Preferred Term)
System Organ Class
Infections and infestations
Immune system disorders
Metabolism and nutrition disorders
Nervous system disorders
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
Abdominal pain lower
Skin and subcutaneous tissue disorders
Renal and urinary disorders
Spontaneous penile erection
General disorders and administration site conditions
Influenza like illness
Hepatic enzyme increased
Heart rate increased
Blood pressure increased
Blood urine present
Prostate specific antigen increased
Blook bilirubin increased
Blood creatinine increased
Body temperature increased
Description of selected adverse reactions observed with other PDE5 inhibitors
Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors. No cases were reported during clinical trials of avanafil
Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors. No cases were reported during clinical trials of avanafil.
Haematuria, haematospermia and penile haemorrhage have been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
Hypotension has been reported post-marketing with other PDE5 inhibitors, and dizziness, a symptom commonly caused by lowered blood pressure, has been reported in clinical trials with avanafil.
Reporting of suspected adverse reactions
Reporting of all suspected adverse reactions is important. It allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and patients are asked to report any suspected adverse reactions via the Yellow Card Scheme.
You can find out more information about the Yellow Card Scheme by clicking here.
Is there anything else I need to know about Spedra?
A physical examination may be needed to diagnose the cause of your erectile dysfunction before any medication is prescribed. If taken with food, it may take a little bit longer for the effects of Spedra to be seen.
If your erection lasts longer than 4 hours, this is known as priapism, you need to seek immediate medical assistance. If you have priapism and it is not treated immediately, there is a very high probability that it could lead to damage of penile tissue and permanent loss of potency may result.
If there is a sudden decrease in your hearing or you suffer a loss of hearing, it is important that you stop taking Spedra immediately and seek urgent medical assistance. The same thing applies if you notice any changes in your vision.
You should not take Spedra and alcohol at the same time as this increases the chances of you getting dizziness, low blood pressure or a condition known as syncope. Syncope is a sudden loss of consciousness caused by a drop in blood pressure.
If you would like more information about Spedra, please click here to fill out our contact form. Alternatively, you can call us on 01625 460 621.
Should you need urgent medical assistance, please dial 999.
Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]