TADACIP 20 tadalafil 20 mg film-coated tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

tadalafil, Quantity: 20 mg

Verfügbar ab:

Cipla Australia Pty Ltd

INN (Internationale Bezeichnung):

Tadalafil

Darreichungsform:

Tablet

Zusammensetzung:

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

Verabreichungsweg:

Oral

Einheiten im Paket:

1, 2, 8, 4

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

TADACIP 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

Produktbesonderheiten:

Visual Identification: Yellow coloured, capsule shaped, biconvex film coated tablet with "T 20" debossed on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2017-03-27

Gebrauchsinformation

TADACIP*
1
TADACIP*
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 TADACIP?
TADACIP contains the active ingredient tadalafil. TADACIP is used to
treat erectile dysfunction and urinary symptoms
associated with benign prostatic hyperplasia
For more information, see Section 1. Why am I using TADACIP? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TADACIP?
Do not use if you have ever had an allergic reaction to tadalafil or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TADACIP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TADACIP 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 TADACIP?
•
For erectile dysfunction: can be taken as either on‐ demand dosing
or once‐a‐day dosing. TADACIP on‐demand (10 mg and
20 mg) is intended for use prior to anticipated sexual activity and is
not for continuous daily use. TADACIP once‐a‐day (5
mg) is for patients who anticipate frequent use of TADACIP (i.e. at
least twice weekly).
•
For urinary symptoms associated with benign prostate hyperplasia:
TADACIP once‐a‐day (5mg) is taken daily.
More instructions can be found in Section 4. How do I use TADACIP? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TADACIP?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TADACIP.
•
If you have emergency treatment for any suspected heart condition tell
the emergency
medical or ambulance staff that you are taking TADACIP.
THINGS YOU SHOULD NOT DO
•
Do not take TADACIP to treat any other complaints unless your doctor
tells you

Fachinformation

AUSTRALIAN PRODUCT INFORMATION -
TADACIP (TADALAFIL)
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadacip 2.5 contains 2.5 mg of tadalafil.
Tadacip 5 contains 5 mg of tadalafil.
Tadacip 10 contains 10 mg of tadalafil.
Tadacip 20 contains 20 mg of tadalafil.
List of excipients with known effect: Contains sugar as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TADACIP 20 film-coated tablets are yellow coloured, capsule shaped,
biconvex film coated
tablets with “T 20” debossed on one side and plain on other side.
TADACIP 10 film-coated tablets are yellow coloured, capsule shaped,
biconvex film coated
tablets with “T 10” debossed on one side and plain on other side.
TADACIP 5 film-coated tablets are cream coloured, circular, biconvex
film coated tablets with
“T 5” debossed on one side and plain on other side.
TADACIP 2.5 film-coated tablets are cream coloured, circular, biconvex
film coated tablets with
“T 2.5” debossed on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TADACIP 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
TADACIP is for oral use.
TADACIP can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of TADACIP 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. TADACIP 10 and 20 mg is intended for use
prior to anticipated
sexual activity and is not for continuous daily use.
TADACIP 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 optim