Spedra

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

avanafil

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

G04BE10

INN (International Name):

avanafil

Therapeutic group:

Drugs used in erectile dysfunction

Therapeutic area:

Erectile Dysfunction

Therapeutic indications:

Treatment of erectile dysfunction in adult men.In order for Spedra to be effective, sexual stimulation is required.

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2013-06-21

Patient Information leaflet

54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SPEDRA 50 MG TABLETS
avanafil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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.
WHAT IS IN THIS LEAFLET
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
1.
WHAT SPEDRA IS AND WHAT IT IS USED FOR
Spedra contains the active substance avanafil. It belongs to a group
of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for
adult men suffering from
erectile dysfunction (also known as impotence). This is when you
cannot get, or keep a hard, erect
penis suitable for sexual activity.
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.
Spedra is not for women.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPEDRA
DO NOT TAKE SPEDRA:
•
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
trinitrat

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Spedra 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of avanafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pale yellow oval tablets, debossed with “50” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult men.
In order for Spedra to be effective, sexual stimulation is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adult men _
The recommended dose is 100 mg taken as needed approximately 15 to 30
minutes before sexual
activity (see section 5.1). Based on individual efficacy and
tolerability, the dose may be increased to a
maximum dose of 200 mg or decreased to 50 mg. The maximum recommended
dosing frequency is
once per day. Sexual stimulation is required for a response to
treatment.
_Special populations _
_Elderly(≥ 65 years old) _
Dose adjustments are not required in elder patients. Limited data are
available in elder patients aged
70 years or above.
_Renal impairment _
Dose adjustments are not required in patients with mild to moderate
renal impairment (creatinine
clearance ≥ 30 mL/min). Spedra is contraindicated in patients with
severe renal impairment (creatinine
clearance < 30 mL/min) (see sections 4.3 and 5.2). Patients with mild
or moderate renal impairment
(creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled
in phase 3 studies showed
decreased efficacy compared to those with normal renal function.
_Hepatic impairment _
Spedra is contraindicated in patients with severe hepatic impairment
(Child Pugh class C) (see
sections 4.3 and 5.2). Patients with mild to moderate hepatic
impairment (Child-Pugh class A or B)
should initiate treatment with the minimum efficacious dose and adjust
posology based on tolerance.
_Use in men with diabetes _
Dose adjustments are not required in diabetic patients.
3
_Paediatric population _
There is no relevant use of Spedra i