Levitra 10 mg orodispersible tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

VARDENAFIL HYDROCHLORIDE

Boleh didapati daripada:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

VARDENAFIL HYDROCHLORIDE

Unit dalam pakej:

2tablet Tablets; 1tablet Tablets; 4tablet Tablets

Dikeluarkan oleh:

BAYER AG

Risalah maklumat

LEVITRA
®
ORODISPERSIBLE TABLETS
Vardenafil (10 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Levitra_
is used for
2.
How
_Levitra_
works
3.
Before you use
_Levitra_
4.
How to use
_Levitra_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Levitra_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _LEVITRA_ IS USED FOR
_Levitra_
contains vardenafil, a member of
a class of medicines called
phosphodiesterase type 5 inhibitors.
They are used for the treatment of
erectile dysfunction in adult men, a
condition which implies difficulties in
getting or keeping an erection.
At least one in ten men has trouble
getting or keeping an erection at some
time. There may be physical or
psychological causes, or a mixture of
both. Whatever the cause is, due to
muscle and blood vessel changes not
enough blood stays in the penis to make
it hard and keep it hard.
HOW _LEVITRA_ WORKS
_Levitra_
will only work when you are
sexually stimulated. It reduces the action
of the natural chemical in your body
which makes erections go away.
_Levitra_
allows an erection to last long enough for
you to satisfactorily complete sexual
activity.
BEFORE YOU USE _LEVITRA _
-
When you must not use it
DO NOT TAKE _LEVITRA_
-
If you are allergic (hypersensitive) to
vardenafil or any of the other
ingredients of
_Levitra_
. See the
ingredients in section Ingredients.
Signs of an allergic reaction include a
rash, itching, swollen face or lips and
shortness of breath.
-
If you are taking medicines containing
nitrates, such as glycerol trinitrate for
angina, or nitric oxide donors, such as
amyl nitrite. Taking these medicines
with
_Levitra_
could seriously affect
your blood pressure.
-
If you are taking ritonavir or indinavir,
medicines used to treat human
immunodeficiency virus (HIV)
infections.
-
If you are taking riociguat. This drug is
used to treat pulmonary arterial
hypertension (e.g. high blood pressure
in the lungs) and chronic
thromboembolic p

Ciri produk

Date of Revision: 14
th
May 2020
Reference: CCDS 18/14
th
May 2020-EU Dependency
LEVITRA 10 MG ORODISPERSIBLE TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Levitra 10 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg of vardenafil (as
hydrochloride).
Excipients:
7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per
orodispersible tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
White round tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION(S)
Treatment of erectile dysfunction (inability to achieve or maintain
penile erection sufficient for
satisfactory sexual performance).
In order for Levitra to be effective, sexual stimulation is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Levitra 10 mg orodispersible tablet is not bioequivalent to Levitra 10
mg film-coated tablet (see
section 5.1). The maximum dose for Levitra orodispersible tablet is 10
mg/day.
_Use in adult men _
Levitra 10 mg orodispersible tablets are taken as needed approximately
25-60 minutes before
sexual activity.
_Special populations _
_Elderly _
(
≥
65 years old)
Dose adjustments are not required in elderly patients. However, an
increase to a maximum dose
of Levitra 20 mg film-coated tablets should be carefully considered
depending on the individual
tolerability (see sections 4.4 and 4.8).
Date of Revision: 14
th
May 2020
Reference: CCDS 18/14
th
May 2020-EU Dependency
_Hepatic impairment _
Levitra 10 mg orodispersible tablets are not indicated as a starting
dose in patients with mild
hepatic impairment (Child-Pugh A).
Patients with mild hepatic impairment should start treatment with
Levitra 5 mg film-coated
tablets.
Based on tolerability and efficacy, the dose may be increased to
Levitra 10 mg and 20 mg film-
coated tablets, or Levitra 10 mg orodispersible tablets.
The maximum dose recommended in patients with moderate hepatic
impairment (Child-Pugh B)
is Levitra 10 mg as film-coated tablets (see section 5.2).