Tadalafil Alphapharm tadalafil 20mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tadalafil, Quantity: 20 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose; colloidal anhydrous silica; povidone; poloxamer; croscarmellose sodium; sodium lauryl sulfate; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow

Administration route:

Oral

Units in package:

4, 8, 2, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tadalafil Alphapharm is indicated for the treatment of:,? erectile dysfunction (ED) in adult males,? moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males

Product summary:

Visual Identification: A light yellow, film-coated, round, biconvex tablet debossed with M on one side of the tablet and TL4 on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-02-03

Patient Information leaflet

TADALAFIL ALPHAPHARM
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TADALAFIL ALPHAPHARM?
TADALAFIL ALPHAPHARM contains the active ingredient tadalafil.
TADALAFIL ALPHAPHARM is used to treat erectile dysfunction
and urinary symptoms associated with benign prostatic hyperplasia in
adult men.
For more information, see Section 1. Why am I using TADALAFIL
ALPHAPHARM? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TADALAFIL ALPHAPHARM?
Do not use if you have ever had an allergic reaction to TADALAFIL
ALPHAPHARM or any of the ingredients listed at the end of the
CMI.
Do not take TADALAFIL ALPHAPHARM if you are currently taking any
nitrates or amyl nitrite.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS SUCH AS
HEART PROBLEMS OR IF YOU TAKE ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
TADALAFIL ALPHAPHARM? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TADALAFIL ALPHAPHARM and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TADALAFIL ALPHAPHARM?
•
Always take TADALAFIL ALPHAPHARM exactly as your doctor has told you.
•
Follow all directions given to you by your doctor or pharmacist.
More instructions can be found in Section 4. How do I use TADALAFIL
ALPHAPHARM? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TADALAFIL ALPHAPHARM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you are using TADALAFIL
ALPHAPHARM.
•
If you have emergency treatment for any suspected heart condition,
tell the emergency medical or
ambulance staff that you are taking TADALAFIL ALPHAPHARM.
THINGS YOU
SHOULD NOT DO
•
Do not take TADALAFIL ALPHAPHARM to treat any other complaints.
•
Do not give your medicine to anyone else, even if they have

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TADALAFIL ALPHAPHARM
_Tadalafil film coated tablets _
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TADALAFIL ALPHAPHARM film-coated tablet contains 2.5 mg, 5 mg, 10
mg or 20 mg of tadalafil
as the active ingredient.
Excipients of known effect: Sugars (as lactose).
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
2.5mg: a light yellow, film-coated, round, biconvex tablet debossed
with ‘M’ on one side of the tablet and ‘TL
over 1’ on the other side.
5 mg: a light yellow, film-coated, round, biconvex tablet debossed
with ‘M’ on one side of the tablet and ‘TL
over 2’ on the other side.
10 mg: a light yellow, film-coated, round, biconvex tablet debossed
with ‘M’ on one side of the tablet and
‘TL3’ on the other side.
20 mg: a light yellow, film-coated, round, biconvex tablet debossed
with ‘M’ on one side of the tablet and
‘TL4’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TADALAFIL ALPHAPHARM is indicated for the treatment of:
•
erectile dysfunction (ED) in adult males
•
moderate to severe lower urinary tract symptoms (LUTS) associated with
benign prostatic hyperplasia
(BPH) in adult males
4.2
DOSE AND METHOD OF ADMINISTRATION
TADALAFIL ALPHAPHARM is for oral use.
TADALAFIL ALPHAPHARM can be taken with or without food.
ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of TADALAFIL ALPHAPHARM is either 10 mg or 20 mg,
taken prior to anticipated
sexual activity. The maximum recommended dose is 20 mg. The maximum
recommended dosing frequency
is once per day. TADALAFIL ALPHAPHARM 10 and 20 mg is intended for use
prior to anticipated sexual
activity and is not for continuous daily use.
Tadalafil has been proven effective up to 36 hours after dosing and,
in some patients, as early as 16 minutes
after dosing. Patients may initiate sexual activity at varying time
points relative to dosing in order to determine
their own optimal window