CILATIL tadalafil 10mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tadalafil, Quantity: 10 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

4, 2, 8

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CILATIL 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 TL3 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

CILATIL
C
I
L
A
T
I
L
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 CILATIL?
CILATIL contains the active ingredient tadalafil. CILATIL 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 CILATIL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CILATIL?
Do not use if you have ever had an allergic reaction to CILATIL or any
of the ingredients listed at the end of the CMI.
Do not take CILATIL 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
CILATIL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CILATIL 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 CILATIL?
•
Always take CILATIL 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 CILATIL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CILATIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you are using CILATIL.
•
If you have emergency treatment for any suspected heart condition,
tell the emergency medical or
ambulance staff that you are taking CILATIL.
THINGS YOU
SHOULD NOT DO
•
Do not take CILATIL 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 CILATIL
affects you.
DRINKING
ALCOHOL
•
CILATIL can be taken with or without food, or alcohol. However,
drinking alcohol may

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CILATIL
_tadalafil film coated tablets _
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CILATIL 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
2.5 mg: 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
CILATIL 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
CILATIL is for oral use.
CILATIL can be taken with or without food.
ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of CILATIL 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.
CILATIL 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 of responsiveness.
TADALAFIL – PRODUCT INFORMATION
2
ERECTILE DYSFUNCTION IN ADULT MALE