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TADALAFIL 20 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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ZINC Ref:

Version:

EAS1419b LEA TADALAFIL 20mg FC TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
560 mm
160 mm
-

Colours Used:

TADALAFIL
T
TA
ADALA
LAFIL 20 mg
FILM-COATED TABLETS
Package leaflet: Information for the user

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

1

Template

1 What Tadalafil is and what it is
used for

Tadalafil 20 mg Film-coated Tablets are a
ttreatment for adult men with erectile
dysfunction. This is when a man cannot
get, or keep a hard, erect penis suitable
for sexual activity. Tadalafil has been
shown to significantly improve the ability
of obtaining a hard erect penis suitable
for sexual activity.
Tadalafil 20 mg Film-coated Tablets
contains the active substance tadalafil
which belongs to a group of medicines
w
called phosphodiesterase type 5
inhibitors. Following sexual stimulation
Tadalafil works by helping the blood
v
vessels in your penis to relax, allowing
tthe flow of blood into your penis. The
result of this is improved erectile
function. Tadalafil will not help you if you
do not have erectile dysfunction.






leukaemia
l k
i ((cancer off the
h bl
blood
d cells)
ll )
any deformation of your penis
a serious liver problem
a severe kidney problem.

It is not known if Tadalafil is effective in
patients who have had:
• pelvic surgery
• removal of all or part of the prostate
gland in which nerves of the prostate
are cut (radical non nerve-sparing
prostatectomy).
If you experience sudden decrease or
loss of vision, stop taking Tadalafil and
contact your doctor immediately.

Children and adolescents
Tadalafil is not intended for use by
children and adolescents under the age
of 18.
Other medicines and Tadalafil
Tell your doctor if you are taking, have
recently taken or might take any other
medicines.
Do not take Tadalafil if you are already
taking
any form of nitrates (see “Do not
t
take
Tadalafil if you:”).
t
Some medicines may be affected by
Tadalafil or they may affect how well
Tadalafil will work. Tell your doctor or
pharmacist if you are already taking:

• an alpha blocker (used to treat high
blood pressure or urinary symptoms
associated with benign prostatic
hyperplasia)
• other medicines to treat high blood
pressure
• riociguat
• a 5- alpha reductase inhibitor (used to
treat benign prostatic hyperplasia)
It is important to note that Tadalafil does • medicines such as ketoconazole tablets
(to treat fungal infections) and protease
not work if there is no sexual
inhibitors for treatment of AIDS or HIV
stimulation. You and your partner will
infection
need to engage in foreplay, just as you
w
would if you were not taking a medicine • phenobarbital, phenytoin and
carbamazepine (anticonvulsant
for erectile dysfunction.
medicines)
• rifampicin, erythromycin,
What
you
need
to
know
before
2
clarithromycin or itraconazole
you take Tadalafil
• other treatments for erectile
dysfunction.
Do not take Tadalafil if you:
• are allergic to tadalafil or any of the
Tadalafil with drink and alcohol
other ingredients of this medicine
Information on the effect of alcohol is in
(listed in section 6)
section 3. Grapefruit juice may affect
• are taking any form of organic nitrate or
how well Tadalafil will work and should
nitric oxide donors such as amyl nitrite.
be taken with caution. Talk to your doctor
This is a group of medicines (“nitrates”)
for further information.
used in the treatment of angina pectoris
(“chest pain”). Tadalafil has been shown Fertility
to increase the effects of these medicines. When
dogs were treated there was
W
If you are taking any form of nitrate or reduced sperm development in the
are unsure tell your doctor (see section testes.
A reduction in sperm was seen in
t
‘‘Other medicines and Tadalafil’’).
some men. These effects are unlikely to
• have serious heart disease or recently lead to a lack of fertility.
had a heart attack within the last
90 days
Driving and using machines
• recently had a stroke within the last
Some men taking Tadalafil in clinical
6 months
studies have reported dizziness. Check
• have low blood pressure or
carefully how you react to the tablets
uncontrolled high blood pressure
before driving or using machines.
• ever had loss of vision because of
non-arteritic anterior ischemic optic
Tadalafil contains lactose
neuropathy (NAION), a condition
If you have been told by your doctor that
described as “stroke of the eye”
you
y have an intolerance to some sugars,
• are taking riociguat. This drug is used
contact your doctor before taking this
to treat pulmonary arterial hypertension medicine.
(i.e., high blood pressure in the lungs)
and chronic thromboembolic
3 How to take Tadalafil
pulmonary hypertension (i.e., high
blood pressure in the lungs secondary
Always take this medicine exactly as
to blood clots). PDE5 inhibitors, such as A
your doctor has told you. Check with
Tadalafil, have been shown to increase y
y
your doctor or pharmacist if you are not
the hypotensive effects of this
medicine. If you are taking riociguat or sure.
are unsure tell your doctor.

Tadalafil tablets are for oral use in men
only. Swallow the tablet whole with
Warnings and precautions
Talk to your doctor before taking Tadalafil. some water. The tablets can be taken
w
with or without food.
Be aware that sexual activity carries a
possible risk to patients with heart
disease because it puts an extra strain on
your heart. If you have a heart problem
y
you should tell your doctor.
y
Before taking the tablets, tell your doctor
if you have:
• sickle cell anaemia (an abnormality of
red blood cells)
• multiple myeloma (cancer of the bone
marrow)

PANTONE® GREEN C
BLACK

Decreased or sudden hearing loss has
been noted in some patients taking
t
tadalafil.
Although it is not known if the
event is directly related to tadalafil, if you
What is in this leaflet:
experience decreased or sudden hearing
1. What Tadalafil is and what it is used for loss, stop taking Tadalafil and contact
y
your
doctor immediately.
2.What you need to know before you
take Tadalafil
Tadalafil is not intended for use by
3.How to take Tadalafil
w
women.
4.Possible side effects
5.How to store Tadalafil
6.Contents of the pack and other
information

23 November 2017

The recommended starting dose is one
10 mg tablet before sexual activity. If the
effect of this dose is too weak your
doctor may increase the dose to 20 mg.
Tadalafil tablets are for oral use.
You may take a Tadalafil tablet at least
Y
30 minutes before sexual activity.
Tadalafil may still be effective up to
36 hours after taking the tablet.

322Kxxxxx1117
3
22
2K
Kxxxxx1117
7

ZINC Ref:

Version:

EAS1419b LEA TADALAFIL 20mg FC TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
560 mm
160 mm
-

1

23 November 2017

Template

Colours Used:

BLACK

I is
It
i important
i
to note that
h Tadalafil
T d l fil does
d
not work if there is no sexual stimulation.
You and your partner will need to engage
Y
in foreplay, just as you would if you were
not taking a medicine for erectile
dysfunction.

• serious skin
k rashes
h
• some disorders affecting blood flow to
the eyes
• irregular heartbeats
• angina
• sudden cardiac death.

Drinking alcohol may affect your ability
tto get an erection and may temporarily
lower your blood pressure. If you have
ttaken or are planning to take Tadalafil,
avoid excessive drinking (blood alcohol
level of 0.08 % or greater), since this may
increase the risk of dizziness when
standing up.

The side effect dizziness has been
reported more frequently in men over
75 years of age taking Tadalafil.
Diarrhoea has been reported more
frequently in men over 65 years of age
ttaking Tadalafil.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
If you take more Tadalafil than you
possible side effects not listed in this
should
Contact your doctor. You may experience leaflet. You can also report side effects
directly via the Yellow Card Scheme
side effects described in section 4.
Website at:
W
If you forget to take Tadalafil
www.mhra.gov.uk/yellowcard or search
w
Take your dose as soon as you
for MHRA Yellow Card in the Google Play
remember but do not take a double dose or Apple App Store.
tto make up for a forgotten tablet. You
By reporting side effects you can help
should not take Tadalafil more than once provide more information on the safety
a day.
of this medicine.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4 Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them. These effects are
normally mild to moderate in nature.
If you experience any of the following
side effects stop using the medicine and
seek medical help immediately:
• allergic reactions including rashes
(frequency uncommon)
• chest pain - do not use nitrates but
seek immediate medical assistance
(frequency uncommon)
• priapism, a prolonged and possibly
painful erection after taking Tadalafil
(frequency rare). If you have such an
erection, which lasts continuously for
more than 4 hours you should contact
a doctor immediately
• sudden loss of vision (frequency rare)
• serious allergic reaction which causes
swelling of the face or throat
• blistering of the skin, mouth, eyes and
genitals (Stevens-Johnson syndrome).
Other side effects have been reported:
Common: seen in 1 to 10 in every 100
patients
• headache
• back pain
• muscle aches
• pain in arms and legs
• facial flushing
• nasal congestion
• indigestion.
Uncommon: seen in 1 to 10 in every
1,000 patients
• dizziness
• stomach ache
• feeling sick
• being sick (vomiting)
• reflux
• blurred vision
• eye pain
• difficulty in breathing
• presence of blood in urine
• prolonged erection
• pounding heartbeat sensation, a fast
heart rate, high blood pressure, low
blood pressure
• nose bleeds and ringing in the ears
• swelling of the hands, feet or ankles
and feeling tired.
Rare: seen in 1 to 10 in every 10,000
patients
• fainting
• seizures
• passing memory loss
• swelling of the eyelids, red eyes,
sudden decrease or loss of hearing and
hives (itchy red welts on the surface of
the skin)
• penile bleeding
• presence of blood in semen
• increased sweating.

5 How to store Tadalafil
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and
blister after ‘EXP’.
The expiry date refers to the last day of
tthat month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
w
wastewater or household waste. Ask
your pharmacist how to throw away
y
medicines you no longer use. These
measures will help protect the
environment.

6 Contents of the pack and other
information

What Tadalafil 20 mg Film-coated Tablets
contains
• The active substance is tadalafil.
Each 20 mg film-coated tablet contains
20 mg of tadalafil.
• The other ingredients are lactose
monohydrate, sodium laurilsulfate,
povidone, crospovidone and sodium
stearyl fumarate.
• The tablet coating is made of poly(vinyl
alcohol), macrogol, titanium dioxide
(E171), talc and iron oxide yellow
(E172).
What Tadalafil 20 mg Film-coated Tablets
looks like and contents of the pack
Ochre to yellow, oval shaped film-coated
ttablet. On one side scored and debossed
with “2” on the left side of the score and
w
w
with “0” on the right side of the score.
The other side of the tablet is plain.
Length: 14.0 mm, width: 8.0mm. The
ttablet can be divided into equal doses.
Tadalafil 20 mg Film-coated Tablets are
available in pack sizes of 2, 4, 5, 8, 10, 12,
15, 18, 24, 28, 36, 48 or 56 film-coated
ttablets in blisters or 2x1, 4x1, 8x1, 12x1,
24x1 or 36x1 film-coated tablets in
perforated unit-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
BN22 9AG, UK
Manufacturer
Actavis Export International Ltd.,
A
HF 62 Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
This leaflet was last revised in 11/2017.
PL 00289/1883

Heart attack and stroke have also been
reported rarely in men taking Tadalafil.
Most of these men had known heart
problems before taking this medicine.
Partial, temporary, or permanent
decrease or loss of vision in one or both
eyes has been rarely reported.
Some additional rare side effects have
been reported in men taking Tadalafil
tthat were not seen in clinical trials. These
include:
• migraine
• swelling of the face

PANTONE® GREEN C

EAS1419b

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