SENTALIS 20 MG Film-coated tablets

Land: Zuid-Afrika

Taal: Engels

Bron: South African Health Products Regulatory Authority (SAHPRA)

Beschikbaar vanaf:

Macleods Pharmaceuticals SA (Pty) Ltd

Dosering:

Not Indicated

farmaceutische vorm:

Film-coated tablets

Samenstelling:

Each tablet contains TADALAFIL 20,0 mg

Autorisatie-status:

Registered

Autorisatie datum:

2023-11-08

Bijsluiter

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
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SENTALIS 5 MGTadalafil
SENTALIS 20 MG Tadalafil
Contains lactose:
Each 5 mg film coated tablet contains50 mg lactose (as monohydrate).
Each 20 mg film coated tablet contains 200 mg lactose (as
monohydrate).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SENTALIS
•
Keep this leaflet. You may need to read itagain.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
SENTALIS has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same
asyours.
WHAT IS IN THIS LEAFLET
1.
What SENTALIS is and what it is usedfor
2.
What you need to know before you takeSENTALIS
3.
How to takeSENTALIS
4.
Possible sideeffects
5.
How to storeSENTALIS
6.
Contents of the pack and otherinformation
1. WHAT SENTALIS IS AND WHAT IT IS USEDFOR
SENTALIS contains the active substancetadalafil.
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SENTALIS is a treatment for men with erectile dysfunction. This when a
man cannot get or keep a hard,
erect penis suitable for sexual activity.
_ _
Tadalafil belongs to a group of medicines called phosphodiesterase
type 5inhibitors.
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 an improved
erection. Tadalafil will not help you if you do
not have erectile dysfunction. It is important to note that tadalafil
for the treatment of erectile dysfunction
does not work if there is no sexual stimulation. You and your partner
will need to engage in foreplay, just
as you wouldif you were not taking any medicines for
erectiledysfunction.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SENTALIS
DO NOT TAKE SENTALIS:
•
if you are hypersensitive (allergic) to tadalafil or any of the other
ingredients of SENTALIS(listed in
section6.1)
•
if you are taking any form of a group of

Productkenmerken

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PROFESSIONAL INFORMATION
SCHEDULING STATUS
1. NAME OF THEMEDICINE
SENTALIS 5 MG (Tadalafil 5 mg tablets)
SENTALIS 20 MG (Tadalafil 20 mg tablets)
2. QUALITATIVE ANDQUANTITATIVECOMPOSITION
Each SENTALIS 5MG film coated tablet contains 5 mg tadalafil.
Each SENTALIS20MGfilm coated tablet contains 20 mg tadalafil.
Contains lactose:
Each 5 mg film coated tablet contains 50 mg lactose (as monohydrate).
Each 20 mg film coated tablet contains 200mg lactose (as monohydrate)
Contains sodium:
Each 5 mg film coated tablet contains 2,0242 mg sodium.
Each 20 mg film coated tablet contains 8,097 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICALFORM
Film coated tablets.
SENTALIS 5 MG:
Yellow coloured, almond shaped, biconvex film coated tablets having
‘L 62’ debossed on one side and
plain on other side.
SENTALIS 20 MG:
Yellow coloured, almond shaped, biconvex film coated tablets having
‘L 64’ debossed on one side and
plain on other side.
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4. CLINICALPARTICULARS
4.1 THERAPEUTIC INDICATIONS
SENTALIS is indicated for the treatment of erectile dysfunction. In
order for SENTALIS to be effective,
sexual stimulation is required.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_In adult men: _
The recommended dose is 5 mg taken once a day taken approximately the
same time and without
regard to food.
The recommended maximum dose of SENTALIS is 20 mg taken prior to
anticipated sexual activity and
without regard to food – taken up to 36 hours and as early as 16
minutes prior to sexual activity. Patients
may initiate sexual activity at varying time points relative to dosing
in order to determine their own
optimal window of responsiveness.
The maximum recommended dosing frequency of SENTALIS is once per day.
Special populations
_Renal impairment _
Dosage adjustments are not required in patients with mild or moderate
renal impairment. Once-a-day
dosing of SENTALIS is not recommended in patients with severe renal
imp