and duration of effect, make Spedra
®
an attractive option for males with ED.
1
rapid and sustained efficacy
2
Rapid onset
of action
q
Spedra
®
, 50mg, 100mg and 200mg tablets
ABBREVIATED PRESCRIBING INFORMATION
q
This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
Please consult the Summary of Product Characteristics (SPC) for full
prescribing information.
Presentation: Tablets containing 50 mg, 100 mg or 200 mg of avanafil.
Use: Treatment of erectile dysfunction in adult men. In order for
Spedra to be effective, sexual stimulation is required.
Dosage: Oral administration. Adult men: Recommended dose 100
mg, taken as needed, approximately 30 minutes before sexual ac-
tivity. Dose may be increased to a maximum dose of 200 mg or
decreased to 50 mg. Maximum recommended dosing frequency is
once per day. No dose adjustment needed for older men, mild to
moderate renal impairment or diabetes. Initiate treatment at mini-
mum efficacious dose and adjust posology based on tolerance for
mild to moderate hepatic impairment. Maximum recommended dose
should not exceed 100 mg with concomitant treatment with moder-
ate CYP3A4 inhibitors, leaving at least 48 hours between doses. If
taken with food, the onset of activity may be delayed compared to
the fasted state.
Contraindications: Hypersensitivity to active substance or excipients.
Patients using any form of organic nitrate or nitric oxide donors.
Consider potential cardiac risk of sexual activity in patients with
pre-existing cardiovascular disease before prescribing. Contra-indi-
cated in myocardial infarction, stroke, or life-threatening arrhythmia
within the last 6 months; resting hypotension (<90/50 mmHg) or
hypertension (>170/100 mmHg); unstable angina, angina with sexual
intercourse, or congestive heart failure. Severe hepatic or renal im-
pairment. Loss of vision in one eye because of non-arteritic anterior
ischemic optic neuropathy. Known hereditary degenerative retinal
disorders. Potent CYP3A4 inhibitors.
Warnings and Precautions: Undertake medical history and phys-
ical examination to diagnose erectile dysfunction and determine
potential underlying causes, before considering pharmacological
treatment. Consider the cardiovascular status of patients before
initiating treatment. Instruct patients who experience priapism to
seek immediate medical assistance. Use with caution in patients with
anatomical deformation of the penis or conditions which may pre-
dispose them to priapism. Advise patients to stop taking Spedra
and consult a physician immediately if sudden visual effects occur.
No safety information in patients with bleeding disorders or active
peptic ulceration, therefore administer to such patients only after
careful benefit-risk assessment. Advise patients to stop taking PDE5
inhibitors, including avanafil, and seek prompt medical attention
in event of sudden decrease or loss of hearing. Concomitant use
with alpha-blockers may lead to symptomatic hypotension in some
patients. Co-administration with potent inhibitors of CYP3A4, such
as ketoconazole or ritonavir is contraindicated. Concomitant use
of other treatments for erectile dysfunction has not been studied,
thus inform patients not to take avanafil in such combinations. Ad-
vise patients concurrent use of avanafil and alcohol may increase
the likelihood of hypotension, dizziness or syncope. Not studied in
erectile dysfunction due to spinal cord injury or other neurological
disorders and in subjects with severe renal or hepatic impairment.
Interactions: Administration with organic nitrate or nitric oxide donor
contraindicated. May cause symptomatic hypotension with medici-
nal products which reduces systemic blood pressure. Alpha-block-
ers, other antihypertensives, alcohol. Moderate CYP3A4 inhibitors
- maximum recommended dose 100 mg, do not exceed once every
48 hours. Avoid grapefruit juice within prior 24 hours. Concomitant
use with CYP inducers not recommended. Please consult the SPC for
more details and other interactions.
Side
-
effects: Common (1-10%): headache, flushing, nasal conges-
tion. Uncommon (0.1- 1%): dizziness, somnolence, sinus headache,
blurred vision, palpitations, hot flush, sinus congestion, exertional
dyspnoea, dyspepsia, nausea, vomiting, stomach discomfort, back
pain, muscle tightness, fatigue, hepatic enzyme increased, electro-
cardiogram abnormal, heart rate increased. Rare (0.1-0.01%): influ-
enza, nasopharyngitis, seasonal allergy, gout, insomnia, premature
ejaculation, inappropriate affect, psychomotor hyperactivity, angina
pectoris, tachycardia, hypertension, rhinorrhoea, upper respiratory
tract congestion, dry mouth, gastritis, lower abdominal pain, diar-
rhoea, rash, flank pain, myalgia, muscle spasms, pollakiuria, penis
disorder, spontaneous penile erection, genital pruritus, asthenia,
chest pain, influenza like illness, peripheral oedema, blood pres-
sure increased, blood urine present, cardiac murmur. Increased PSA,
weight, blood bilirubin, blood creatinine and body temperature.
Marketing Authorisation Number: Spedra 50 mg: EU/1/13/841/001-003;
Spedra 100 mg: EU/1/13/841/004-007; Spedra 200 mg: EU/1/13/841/008-
010. Marketing Authorisation holder: Menarini International Oper-
ations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg,
Luxembourg. Date of first authorisation: 21 June 2013. For any in-
formation about this medicinal product, please contact the local
representative of the Marketing Authorisation Holder. Detailed infor-
mation on this medicinal product is available on the website of the
European Medicines Agency
Licenced by Vivus Inc. and
Mitsubishi Tanabe Pharma
Corporation.
References: 1. Hellstrom WJG
et al.
BJU Int 2012; 111: 137-147. 2. Goldstein I
et al.
J Sex Med 2012; 9 (4): 1122-1133.
