Spedra 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Avanafil

Available from:

A. Menarini Farmaceutica Internazionale SRL

ATC code:

G04BE11

INN (International Name):

Avanafil

Dosage:

200mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040500; GTIN: 5038227000454 5038227000492

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SPEDRA 50 MG TABLETS
SPEDRA 100 MG TABLETS
SPEDRA 200 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

Summary of Product characteristics

OBJECT 1
SPEDRA 50 MG TABLETS
Summary of Product Characteristics Updated 18-May-2018 | A. Menarini
Farmaceutica Internazionale
SRL
1. Name of the medicinal product
Spedra 50 mg tablets
Spedra 100 mg tablets
Spedra 200 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 50 mg, 100 mg or 200 mg of avanafil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Pale yellow oval tablets, debossed with “50”, “100”or
“200”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 ba