Tadalafil Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tadalafil 20mg

Available from:

Sandoz New Zealand Limited

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Tadalafil 20mg Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 32K520009 Sorbitan stearate

Prescription type:

Prescription

Therapeutic indications:

Tadalafil Sandoz is indicated for the treatment of: · erectile dysfunction (ED) in adult men. In order for Tadalafil Sandoz to be effective in treating ED, sexual stimulation is required. · moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men · adult men with co-existing ED and LUTS associated with BPH.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC/Al - 8 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2020-12-02

Patient Information leaflet

Tadalafil Sandoz
®
1
TADALAFIL SANDOZ
®
_tadalafil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tadalafil Sandoz. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tadalafil
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TADALAFIL SANDOZ
IS USED FOR
Tadalafil Sandoz is used to treat:
•
erectile dysfunction, also known
as impotence, in men. This is
when a man cannot get, or
maintain, a hard erect penis
suitable for sexual activity.
Following sexual stimulation,
Tadalafil Sandoz 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 Sandoz will
only treat erectile dysfunction if
you are sexually aroused. You
and your partner will need to
engage in foreplay, just as you
would if you were not taking a
medicine for erectile
dysfunction.
•
urinary symptoms associated
with a common condition called
benign prostatic hyperplasia.
This is when the prostate gland
gets bigger with age. Symptoms
include difficulty in starting to
pass urine, a feeling of not
completely emptying the bladder
and a more frequent need to pass
urine even at night. Tadalafil
Sandoz improves blood flow to,
and relaxes the muscles of, the
prostate and bladder which may
reduce symptoms of benign
prostatic hyperplasia.
Your doctor may have prescribed
you Tadalafil Sandoz to treat either,
or both of these conditions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TADALAFIL
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason. Tadalafil Sandoz
is available only with a doctor's
prescription.
Tadalafil Sandoz is not int

Summary of Product characteristics

230320-tadalafilsandoz-ds
Page 1 of 21
NEW ZEALAND DATA SHEET
TADALAFIL SANDOZ
® (TADALAFIL)
1.
PRODUCT NAME
Tadalafil Sandoz 5 mg film-coated tablets
Tadalafil Sandoz 10 mg film-coated tablets
Tadalafil Sandoz 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg, 10 mg or 20 mg tadalafil as the active
ingredient.
_Excipient(s) with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
5 mg: light yellow, capsule-shaped, biconvex, bevel-edged, film-coated
tablet debossed with
‘T 5’ on one side and plain on the other side.
10 mg: light yellow, capsule-shaped, biconvex, bevel-edged,
film-coated tablet marked with
‘T 10’ on one side and plain on the other side.
20 mg: yellow, capsule-shaped, biconvex, bevel-edged, film-coated
tablet marked with ‘T 20’
on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Tadalafil Sandoz is indicated for the treatment of:
•
erectile dysfunction (ED) in adult men. In order for Tadalafil Sandoz
to be effective in
treating ED, sexual stimulation is required.
•
moderate to severe lower urinary tract symptoms (LUTS) associated with
benign
prostatic hyperplasia (BPH) in adult men
•
adult men with co-existing ED and LUTS associated with BPH.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Tadalafil Sandoz tablets are for oral use.
Tadalafil Sandoz can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MEN - ON-DEMAND DOSING
The maximum recommended dose of Tadalafil Sandoz is 20 mg, taken prior
to anticipated
sexual activity. The maximum recommended dosing frequency is once per
day. Tadalafil
Sandoz may be taken between 30 minutes and 36 hours prior to
anticipated 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 dose may be
lowered to 10 mg
based on individual response and tolerability. Tadalafi