Tadalafil 10mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Tadalafil

Tilgængelig fra:

Milpharm Ltd

ATC-kode:

G04BE08

INN (International Name):

Tadalafil

Dosering:

10mg

Lægemiddelform:

Tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 07040500

Indlægsseddel

PACKAGE LEAFLET:
INFORMATION FOR THE USER
TADALAFIL 10 MG
FILM-COATED TABLETS
TADALAFIL
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 Tadalafil is and what it is used for
2.
What you need to know before you
take Tadalafil
3.
How to take Tadalafil
4.
Possible side effects
5.
How to store Tadalafil
6.
Contents of the pack and other
information
1. WHAT TADALAFIL IS AND WHAT IT IS
USED FOR
Tadalafil is a treatment for adult men with
erectile dysfunction. This is when a man
cannot get, or keep a hard, erect penis
suitable for sexual activity. Tadalafil has
been shown to significantly improve the
ability of obtaining a hard erect penis
suitable for sexual activity.
Tadalafil contains the active substance
tadalafil which belongs to a group of
medicines called phosphodiesterase type
5 inhibitors. Following sexual stimulation
tadalafil works by helping the blood
vessels in your penis to relax, allowing the
flow of blood into your penis. The result of
this is improved erectile function. Tadalafil
will not help you if you do not have erectile
dysfunction.
It is important to note that tadalafil does
not work if there is no sexual stimulation.
You and your partner will need to engage
in foreplay, just as you would if you
were not taking a medicine for erectile
dysfunction.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TADALAFIL
DO NOT TAKE TADALAFIL:
•
If you are allergic to tadalafil or any of
the other ingredients of this medicine
(listed in section 6).
•
Are taking any form of organic nitrate
or nitric ox

Produktets egenskaber

OBJECT 1
TADALAFIL MILPHARM 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 11-Dec-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Tadalafil Milpharm 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg of tadalafil.
Excipient with known effect: Each 10 mg film-coated tablet contains
105 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Light yellow colored, oval shaped, film-coated tablets debossed with
'57' on one side and 'L' on other
side. The size is 10.7 mm x 6.1 mm.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile
dysfunction, sexual stimulation is
required.
Tadalafil is not indicated for use by women.
4.2 Posology and method of administration
Posology
_Erectile dysfunction in adult Men_
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without
food. In those patients in whom tadalafil 10 mg does not produce an
adequate effect, 20 mg might be
tried. It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 mg and 20 mg is intended for use prior to anticipated
sexual activity and it is not
recommended for continuous daily use.
Special populations
_Elderly men_
Dose adjustments are not required in elderly patients.
_Men with renal impairment_
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients with
severe renal impairment, 10 mg is the maximum recommended dose.
Once-a-day dosing of tadalafil is not
recommended in patients with severe renal impairment. (See sections
4.4 and 5.2).
_Men with hepatic impairment_
The recommended dose of tadalafil is 10 mg taken prior to anticipated
sexual activity and with or without
food. There is limited clinical data on the safety of tadal