General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some common
questions about CIALIS. 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
CIALIS against the benefits they expect it will
have for you.
If you have any concerns
about taking this medicine, talk to your doctor or
pharmacist.
Keep this leaflet with the
medicine. You may need to read it again.
What CIALIS is used for
CIALIS is used to
treat erectile dysfunction, also known as
impotence, in men. This is when a man cannot get,
or maintain, a hard erect penis suitable for
sexual activity.
The active ingredient in
CIALIS tablets, tadalafil, belongs to a group of
medicines called phosphodiesterase type 5
inhibitors.
Following sexual stimulation,
CIALIS works by helping the blood vessels in your
penis to relax, allowing the flow of blood into
your penis. The result of this is improved
erectile function.
CIALIS will not help you
if you do not have erectile dysfunction.
CIALIS will only work if you are sexually
aroused.
CIALIS Once-A-Day is for patients
who anticipate frequent use of CIALIS (i.e. at
least twice weekly). Your Doctor can advise on the
appropriateness of once-a-day treatment.
Ask your doctor if you have any questions
about why CIALIS has been prescribed for you. Your
doctor may have prescribed it for another reason.
CIALIS is available only with a doctor's
prescription.
CIALIS is not intended for
use by women or by children under the age of 18
years.
Before you take CIALIS
When you
must not take it
Do not take CIALIS if you are
currently taking any nitrates or amyl nitrite.
Nitrates are medicines used for the treatment of
angina ("chest pain") or other heart conditions.
CIALIS has been shown to increase the effects of
these medicines.
If you are taking any form
of nitrate or are unsure talk to your doctor.
Do not take CIALIS:
if you have heart
or blood vessel problems that make sexual
intercourse inadvisable.
Sexual activity
carries a possible risk to patients with a
heart
condition because it puts extra strain on
the heart
if you have suffered a heart
attack or stroke in the last 6 months
if your
blood pressure is unusually high or low or is not
effectively treated
if you have vision loss in
one
eye because of non-arteritic interior
ischaemic optic neuropathy (NAION)
if you use
recreational drugs called "poppers" or "amyl" like
amyl nitrite and butyl nitrite that are normally
taken through inhalation
Do not take CIALIS if
you have an allergy to:
any of the
ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic
reaction may include shortness of breath, wheezing
or difficulty breathing; swelling of the face,
lips, tongue or other parts of the body; rash,
itching or hives on the skin.
Do not take
this medicine after the expiry date printed on the
pack.
If it has expired, return it to your
pharmacist for disposal.
Do not take this
medicine if the packaging is torn or if the seals
over the carton ends are missing or broken. There
are no seals over the carton ends of the 5mg
physician sample pack.
If it is damaged,
return it to your pharmacist for disposal.
If you are not sure whether you should start
taking CIALIS, talk to your doctor.
Before
you start to take it
Tell your doctor if you
have allergies to any other medicines, foods,
preservatives or dyes. CIALIS tablets contain a
small amount of lactose.
Tell your doctor
if you have or have had any of the following
medical conditions:
liver or kidney
problems
heart problems such as angina,
arrhythmias (changes in the rhythm or rate of the
heart beat), heart failure, or if you have had a
heart attack
blood vessel problems
sickle
cell anaemia (an abnormality of red blood cells)
multiple myeloma (cancer of the bone marrow)
leukaemia (cancer of the blood cells)
any
deformation of the penis (such as angulation,
cavernosal fibrosis or Peyronie's disease)
loss of vision in one or both eyes
If you
have not told your doctor or pharmacist about any
of the above, tell them before you start taking
CIALIS.
Taking other medicines
Tell your
doctor or pharmacist if you are taking any other
medicines, including any that you get without a
prescription from your pharmacy, supermarket or
health food shop. Some medicines may be affected
by CIALIS or may affect how it works. These
include:
Nitrates, medicines such as
glyceryl trinitrate used to treat angina and other
heart conditions
Some antibiotic medicines such
as rifampicin, erythromycin and
clarithromycin
Some medicines used to treat
seizures such as phenytoin, phenobarbitone and
carbamazepine
Some medicines used to
treat
fungal infections such as ketoconazole
and itraconazole
Protease inhibitors used to
treat HIV such as ritonavir and
saquinavir
Medicines used to treat hypertension
(high blood pressure)
Alpha blockers (used to
treat hypertension and some prostate problems)
Warfarin, a medicine used to prevent or treat
blood clots
High doses of alcohol
Grapefruit
juice
These medicines may be affected by CIALIS
or may affect how well it works. You may need
different amounts of your medicines or you may
need to take different medicines.
You
should not take CIALIS together with any other
treatments for erectile dysfunction.
Your
doctor and pharmacist have more information on
medicines to be careful with or avoid while taking
this medicine.
How to take CIALIS
Follow
all directions given to you by your doctor or
pharmacist carefully. They may differ from the
information contained in this leaflet.
CIALIS can be taken as either
on-demand
dosing or once-a-day dosing. Do not take once-a-
day dosing and on-demand dosing concurrently.
If you do not understand the instructions on
the pack, ask your doctor or pharmacist for help.
How much to take
On-Demand Dosing
You should not take CIALIS more than once a
day.
CIALIS 10 and 20 mg is intended for
use prior to anticipated sexual
activity and is
not for continuous daily use.
The maximum
recommended dose of CIALIS is one 20 mg tablet
taken before sexual activity.
If you have
kidney disease, the recommended dose of CIALIS is
one 10 mg tablet. This dose may be increased up to
20 mg. For patients with severe renal impairment
10 mg is the maximum recommended dose.
If
you have liver disease, the recommended dose of
CIALIS is one 10mg tablet. Patients with severe
hepatic impairment should follow their doctor's
advice.
Once-A-Day Dosing
You should
not take CIALIS more than once a day.
Always take CIALIS exactly as your doctor has
told you. Check with
your doctor or pharmacist
if you are not sure.
The recommended dose
of CIALIS is one 5 mg tablet taken once per day.
Dosage adjustments are not required in
patients with kidney disease. Once-a-day dosing of
CIALIS is not recommended in patients with severe
renal impairment.
Patients with liver
disease should follow their doctor's advice.
No special consideration is needed for the
elderly or people with diabetes.
How to
take it
Swallow the tablet whole with a full
glass of water.
When to take it
On-
Demand Dosing
CIALIS can be taken with or
without food or alcohol.
CIALIS should be
taken prior to anticipated sexual activity.
The amount of time CIALIS takes to work varies
from person to person.
In some men CIALIS
can work as early as 30 minutes after taking
the
tablet but it is recommended that you allow
1 hour the first time you take it. CIALIS has been
proven to be effective for up to 36 hours. This
means you can take CIALIS and choose when you want
to have sex over the next 36 hours.
For
example, you can take CIALIS at Friday lunchtime
and you can choose to engage in sexual activity on
Friday afternoon, Friday night or anytime
on
Saturday including Saturday night.
Sometimes if you're feeling anxious or nervous
you may not respond to the first tablet. Don't
give up, it may take a few doses before you get
the full benefit of CIALIS.
CIALIS will
only work if you are sexually aroused.
Once-A-Day Dosing
Take CIALIS with
water every day at approximately the same time,
either with or without food.
When taken
once a day, CIALIS allows you to obtain an
erection, when sexually stimulated, at any time
point during the 24 hours of the day. You and your
partner will need to engage in foreplay, just as
you would if you were not taking a medicine for
erectile dysfunction.
Drinking alcohol may
affect your ability to get an erection, so avoid
excessive drinking with CIALIS.
If you have
any questions about taking CIALIS, ask your doctor
or pharmacist.
If you take too much
(overdose)
Immediately telephone your doctor or
the Australian Poisons Information Centre
(telephone 13 11 26) or the New Zealand National
Poisons Centre (0800 POISON or 0800 764 766), or
go to Accident and Emergency at the nearest
hospital, if you think that you or anyone else may
have taken too much CIALIS.
Do this even if
there are no signs of discomfort or poisoning. You
may
need urgent medical attention. Symptoms of
an overdose may include headache, dyspepsia
(indigestion), back pain, muscular aches, nasal
congestion and facial flushing.
While you
are taking CIALIS
Things you must do
If you
are about to be started on any new medicine,
remind your doctor and pharmacist that you are
taking CIALIS. Tell any other doctors, dentists
and pharmacists who treat you that you are taking
CIALIS.
Things you must not do
Do not
take CIALIS to treat any other complaints unless
your doctor tells you to.
Do not give your
medicine to anyone else, even if they have the
same condition as you.
Things to be careful
of
Be careful driving or operating machinery
until you know how CIALIS affects you.
Side
effects
Tell your doctor or pharmacist as soon
as possible if you do not feel well while you are
taking CIALIS. CIALIS helps most people with
erectile dysfunction, but it may have unwanted
side effects in a few people. All medicines can
have side effects.
Sometimes they are
serious, most of the time they are not. You may
need medical attention if you get some of the side
effects.
Do not be alarmed by the
following
list of possible side effects. You
may not experience any of them.
Ask your
doctor or pharmacist to answer any questions you
may have.
The following side effects are
usually mild and short-lived. In clinical trials,
the number of patients taking CIALIS who
discontinued due to side effects (1.7%) was not
different from the number of patients taking
placebo (dummy treatment) (1.1%).
Tell your
doctor or pharmacist if you notice any of the
following and they worry you:
facial
flushing
indigestion
back pain
chest
pain
muscle aches
diarrhoea
heart
burn
stomach pain
allergic reactions,
including skin rash, swelling of the face and
hives
sweating
headache or migraine
nasal
congestion
dizziness
infection
sore
throat and discomfort when swallowing
red eyes,
eye pain and swelling of eyelids are
uncommon
changes in colour vision are
rare
decreases or loss of vision are very
rare
blurred vision
bleeding
nose
prolonged erection
fainting
If you
experience chest pain during or after sexual
activity, stop what you are doing, sit up and sit
forward. Call an ambulance if the pain does not
resolve. Do not use nitrates.
In rare
instances it is possible that a prolonged and
possibly painful erection may occur after taking
CIALIS.
If you have an erection which lasts
longer than usual, you should contact a doctor
immediately.
When taking CIALIS with large
amounts of alcohol, some men may experience
dizziness.
Sudden loss or decrease in
hearing has been reported in people taking CIALIS.
It is not possible to determine whether these
events are related directly to the CIALIS, to
other diseases or medications, to other factors,
or to a combination of factors.
If you
experience these symptoms, stop taking CIALIS and
contact a doctor immediately.
This is not a
complete list of all possible side effects. Others
may occur in some people and there may be side
effects not yet known.
Potential withdrawal
effects from daily use have not been examined. It
is recommended that patients continue to be
monitored by their doctor after discontinuation of
CIALIS.
If you notice any symptoms that
worry you, check with your doctor.
Ask your
doctor or pharmacist if you don't understand
anything on this list.
After taking
CIALIS
Storage
Keep your tablets in the
original pack until it is time to take them. If
you take the tablets out of the pack they may not
keep as well.
Keep your tablets in a cool
dry place where the temperature stays below 25 °C.
Do not store CIALIS or any other medicine
in the bathroom or near a sink. Do not leave it on
a window sill or in the car. Heat and dampness can
destroy some medicines.
Keep your medicine
where children cannot reach. A locked cupboard at
least
one-and-a-half metres above the ground is
a good place to store medicines.
Disposal
If your doctor tells you to stop
taking this medicine or the expiry date has
passed, ask your pharmacist what to do with any
medicine that is left over.
Product
description
What it looks like
CIALIS 5 mg
tablets are yellow, film coated, almond shaped
tablets, marked "C5" on one side.
CIALIS 10
mg tablets are light yellow, film coated, almond
shaped tablets, marked "C10" on one side.
CIALIS 20 mg tablets are yellow, film coated,
almond shaped tablets, marked "C20" on one side.
Ingredients
Active Ingredients
5
mg tablet - tadalafil 5 mg
10 mg tablet -
tadalafil 10 mg
20 mg tablet - tadalafil 20
mg
Other Ingredients
croscarmellose
sodium
hydroxypropylcellulose
hypromelloseiron oxide yellow
CI77492
lactose
magnesium
stearate
cellulose - microcrystalline
sodium
lauryl sulfate
talc - purified
titanium
dioxide
glycerol triacetate (triacetin)
Opadry II complete film coating system Y-30-
12863-A Yellow
This medicine does not contain
sucrose, gluten, tartrazine or any other azo dyes.
Supplier
CIALIS is a product of:
Eli Lilly Australia Pty Limited
112 Wharf
Road
WEST RYDE, NSW 2114
AUSTRALIA
CIALIS is distributed in New Zealand by:
Eli Lilly and Company (NZ) Limited
Level 3,
Axon House
414-422 Khyber Pass Road,
Newmarket
PO Box 109 197,
Newmarket
Auckland
NEW ZEALAND
® =
Registered Trademark
Australian
Registration Number
CIALIS 5 mg tablet - AUST R
128496
CIALIS 10 mg tablet - AUST R
90590
CIALIS 20 mg tablet - AUST R
81137
Further Information
For further
information on this product please visit the
following websites
Australian residents:
www.cialis.com.au
This leaflet was
revised in May 2008
CIALIS®