Cilatil

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Tadalafil 10mg;  

Saadav alates:

Viatris Limited

INN (Rahvusvaheline Nimetus):

Tadalafil 10 mg

Annus:

10 mg

Ravimvorm:

Film coated tablet

Koostis:

Active: Tadalafil 10mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose Opadry yellow 32K520043 Poloxamer Povidone Purified water Sodium laurilsulfate

Retsepti tüüp:

Prescription

Valmistatud:

Mylan Laboratories Limited

Näidustused:

· Erectile dysfunction (ED) in adult men. In order for Cilatil 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.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, PVC/Aclar/Al or PVC/PE/PVDC/Al - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al or PVC/PE/PVDC/Al - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al or PVC/PE/PVDC/Al - 8 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2012-12-13

Infovoldik

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CILATIL
®
_TADALAFIL FILM COATED TABLET 5 MG, 10 MG & 20 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Cilatil.
This leaflet answers some common
questions about Cilatil.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cilatil against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT CILATIL IS USED
FOR
Cilatil is used to treat:
•
erectile dysfunction (ED) in
adult men
•
lower urinary tract symptoms
(LUTS) associated with benign
prostatic hyperplasia (BPH)
•
co-existing ED and LUTS
associated with BPH.
Cilatil contains the active ingredient
tadalafil. It belongs to a group of
medicines called
phosphodiesterase type 5 inhibitors
It works by helping the blood
vessels in the penis to relax,
allowing the flow of blood into the
penis, resulting in improved erectile
function.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
CILATIL
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE CILATIL IF YOU ARE
•
allergic any medicine containing
tadalafil
•
allergic any of the ingredients
listed at the end of this leaflet
•
currently taking any nitrates,
medicines used to treat angina
(chest pain) or other heart
conditions. Cilatil has been
shown to increase the effects of
these medicines
•
using recreational drugs called
“poppers” or “amyl” like amyl
nitrite and butyl nitrite that are
normally taken through
inhalation
•
using guanylate cyclase
stimulators such as riociguat to
treat pulmonary arterial
hypertension
•
having h

Toote omadused

Page 1 of 18
NEW ZEALAND DATA SHEET
CILATIL
®
1. PRODUCT NAME
Cilatil 2.5 mg film coated tablets.
Cilatil 5 mg film coated tablets.
Cilatil 10 mg film coated tablets.
Cilatil 20 mg film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of
tadalafil as the active ingredient.
Excipient with known effect: Cilatil tablets contain lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
2.5 mg:
A yellow-orange film-coated, almond shaped, biconvex tablet debossed
with ‘M’ on
one side of the tablet and ‘TL5’ on the other side.
5 mg:
A yellow film-coated, almond shaped, biconvex tablet debossed with
‘M’ on one side
of the tablet and ‘TL6’ on the other side.
10 mg:
A yellow film-coated, almond shaped, biconvex tablet debossed with
‘M’ on one side
of the tablet and ‘TL7’ on the other side.
20 mg:
A yellow film-coated, almond shaped, biconvex tablet debossed with
‘M’ on one side
of the tablet and ‘TL8’ on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Cilatil is indicated for the treatment of:

erectile dysfunction (ED) in adult men. In order for Cilatil 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 _
Cilatil film coated tablets are for oral use.
Cilatil can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MEN - ON-DEMAND DOSING
The maximum recommended dose of Cilatil is 20 mg, taken prior to
anticipated sexual activity. The
maximum recommended dosing frequency is once per day. Cilatil may be
taken between 30 minutes
and 36 hours prior to anticipated sexual activity. Patients may
initiate sexual activity at varying time
Page 2 of 18
points relative to dosing in order to determine their own optimal
window of res