CIAVOR tadalafil 5 mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

tadalafil, Quantity: 5 mg

Disponible desde:

Eli Lilly Australia Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

28 tablets, 7 Tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

CIAVOR 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.

Resumen del producto:

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: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

2019-07-01

Información para el usuario

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

Ficha técnica

CIAVOR vA2.0_Sep19
Supersedes vA1.0_Jul19
Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION
CIAVOR
® (TADALAFIL) TABLETS
1.
NAME OF THE MEDICINE
Tadalafil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil 5 mg, 10mg and 20 mg tablets.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
CIAVOR 5 mg tablets are light yellow, film-coated, almond-shaped
tablets for oral
administration, marked “C 5” on one side. CIAVOR 10 mg tablets are
light yellow, film-coated,
almond-shaped tablets for oral administration, marked “C 10” on
one side. CIAVOR 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
CIAVOR 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
CIAVOR is for oral use.
CIAVOR can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of CIAVOR 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. CIAVOR 10 and 20 mg is intended for use
prior to anticipated
sexual activity and is not for continuous daily use.
CIAVOR vA2.0_Sep19
Supersedes vA1.0_Jul19
Page 2 of 29
CIAVOR 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 CIAVOR (i.e. at least
twice weekly), a once daily
regimen with the lowest dose of CIAVOR might be considered suitable,
based on patient
choice and the physician’s judgem