CIALIS tadalafil 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tadalafil, Quantity: 5 mg

Available from:

Eli Lilly Australia Pty Ltd

INN (International Name):

Tadalafil

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; magnesium stearate; sodium lauryl sulfate; purified talc; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; titanium dioxide; hypromellose; triacetin; iron oxide yellow

Administration route:

Oral

Units in package:

7 tablets, 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CIALIS 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: light yellow, almond shaped tablet, debossed with "C5"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2008-02-14

Patient Information leaflet

CIALIS
®
C
I
A
L
I
S
®
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 CIALIS?
CIALIS contains the active ingredient tadalafil. CIALIS 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 CIALIS? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIALIS?
Do not use if you have ever had an allergic reaction to CIALIS or any
of the ingredients listed at the end of the CMI.
Do not take CIALIS 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 TAKE ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before I use
CIALIS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CIALIS 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 CIALIS?
•
Always take CIALIS 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 CIALIS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIALIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CIALIS.
•
If you have emergency treatment for any suspected heart condition tell
the emergency medical or
ambulance staff that you are taking CIALIS.
THINGS YOU
SHOULD NOT DO
•
Do not take CIALIS to treat any other complaints.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how CIALIS
affects you.
DRINKING
ALCOHOL
•
CIALIS can be taken with or without food or alcohol. However, drinking
alcohol may affect your a

Summary of Product characteristics

CIALIS vA14_Jun19
SUPERSEDES: CIALIS-v13_27Oct17
Page 1 of 28
CIALIS
® (TADALAFIL) TABLETS
1.
NAME OF THE MEDICINE
Tadalafil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil 2.5 mg, 5 mg, 10mg and 20 mg tablets.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
CIALIS 2.5 mg tablets are light orange-yellow, film-coated,
almond-shaped tablets for oral
administration, marked “C 2 ½” on one side.
CIALIS 5 mg tablets are light yellow, film-coated, almond-shaped
tablets for oral
administration, marked “C 5” on one side.
CIALIS 10 mg tablets are light yellow, film-coated, almond-shaped
tablets for oral
administration, marked “C 10” on one side.
CIALIS 20 mg tablets are yellow, film-coated, almond-shaped tablets
for oral administration,
marked “C 20” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CIALIS 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
CIALIS is for oral use.
CIALIS can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of CIALIS 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. CIALIS 10 and 20 mg is intended for use
prior to anticipated sexual
activity and is not for continuous daily use.
CIALIS vA14_Jun19
SUPERSEDES: CIALIS-v13_27Oct17
Page 2 of 28
CIALIS 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 of
responsiveness.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ONCE-A-DAY DOSING
In patients who anticipate a frequent use of Cialis (i.e. at least
twice weekly), a once dail