Cialis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tadalafil 5mg;  

Available from:

Eli Lilly and Company (NZ) Limited

INN (International Name):

Tadalafil 5 mg

Dosage:

5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Tadalafil 5mg   Excipient: Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 32K12891 Purified talc Sodium laurilsulfate

Units in package:

Blister pack, PVC/PE/PCTFE/Al, Sample Pack, 7 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Lilly del Caribe Inc

Therapeutic indications:

Cialis is indicated for the treatment of: · erectile dysfunction (ED) in adult men. In order for Cialis to be effective in treating ED sexual stimulation is required · moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men ·adult men with co-existing ED and LUTS associated with BPH.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PCTFE (Aclar)/Al - 7 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 7 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PCTFE (Aclar)/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2006-08-03

Patient Information leaflet

CIALIS®
1
CIALIS
®
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 abili

Summary of Product characteristics

NEW ZEALAND DATASHEET
CIALIS DS vA12_18MAR2020
Supersedes v11_15FEB2018
Page 1 of 21
1. CIALIS
®
CIALIS 2.5 mg film-coated tablets*
CIALIS 5 mg film-coated tablets
CIALIS 10 mg film-coated tablets
CIALIS 20 mg film-coated tablets
_* Not available _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg tadalafil as the
active ingredient.
Excipient with known effect: CIALIS tablets contain lactose (as
monohydrate).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
2.5 mg: light orange-yellow, almond-shaped, film-coated tablet marked
with “C 2 ½” on one
side.
5 mg: light yellow, almond-shaped, film-coated tablet marked with “C
5” on one side.
10 mg: light yellow, almond-shaped, film-coated tablet marked with
‘C 10’ on one side.
20 mg: yellow, almond-shaped, film-coated tablet marked with ‘C
20’ on one side.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CIALIS is indicated for the treatment of:
•
erectile dysfunction (ED) in adult men. In order for Cialis to be
effective in treating
ED, sexual stimulation is required.
•
moderate to severe lower urinary tract symptoms (LUTS) associated with
benign
prostatic hyperplasia (BPH) in adult men
•
adult men with co-existing ED and LUTS associated with BPH_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
CIALIS tablets are for oral use.
CIALIS can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MEN - ON-DEMAND DOSING
The maximum recommended dose of CIALIS is 20 mg, taken prior to
anticipated
sexual activity. The maximum recommended dosing frequency is once per
day.
CIALIS may be taken between 30 minutes and 36 hours prior to
anticipated sexual
activity. Patients may initiate sexual activity at varying time points
relative to dosing in
order to determine their own optimal window of responsiveness. The
dose may be
lowered to 10 mg based on individual response and tolerability. CIALIS
may be taken
CIALIS DS vA12_18MAR2020
Supersedes v11_15FEB2018
Page 2 of 21
without regard to foo