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TADALAFIL 5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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EAS1417b LEA TADALAFIL 5mg FC TABS TUK Dim’s Changed?:
Length:
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No
560 mm
160 mm
-

Colours Used:

TADALAFIL
T
TA
ADALA
LAFIL 5 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

23 November 2017

Template

PANTONE® GREEN C
BLACK

Be aware that
B
h sexual activity
i
carries
i 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
Since benign prostatic hyperplasia and
prostate cancer may have the same
symptoms, your doctor will check you for
prostate cancer before starting treatment
with Tadalafil for benign prostatic
w
hyperplasia.
Tadalafil does not treat prostate cancer.

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)
• leukaemia (cancer of the blood cells)
What is in this leaflet:
• any deformation of your penis
• a serious liver problem
1. What Tadalafil is and what it is used for
• a severe kidney problem.
2.What you need to know before you
take Tadalafil
It is not known if Tadalafil is effective in
3.How to take Tadalafil
patients who have had:
4.Possible side effects
• pelvic surgery
5.How to store Tadalafil
• removal of all or part of the prostate
6.Contents of the pack and other
gland in which nerves of the prostate
information
are cut (radical non nerve-sparing
prostatectomy).
What Tadalafil is and what it is

1

used for

Tadalafil 5 mg Film-coated Tablets
contains the active substance tadalafil
which belongs to a group of medicines
w
called phosphodiesterase type 5
inhibitors.

If you experience sudden decrease or
loss of vision, stop taking Tadalafil and
contact your doctor immediately.

Decreased or sudden hearing loss has
been noted in some patients taking
tadalafil.
t
Although it is not known if the
event is directly related to tadalafil, if you
Tadalafil 5 mg Film-coated Tablets is used experience decreased or sudden hearing
tto treat adult men with:
loss, stop taking Tadalafil and contact
y
your
doctor immediately.
• erectile dysfunction. This is when a
man cannot get, or keep a hard, erect
Tadalafil is not intended for use by
penis suitable for sexual activity.
w
women.
Tadalafil has been shown to
Children and adolescents
significantly improve the ability of
Tadalafil is not intended for use by
obtaining a hard erect penis suitable
children and adolescents under the age
for sexual activity.
of 18.
Following sexual stimulation Tadalafil
works by helping the blood vessels in
Other medicines and Tadalafil
your penis to relax, allowing the flow
Tell your doctor if you are taking, have
of blood into your penis. The result of
recently taken or might take any other
this is improved erectile function.
medicines.
Tadalafil will not help you if you do not
have erectile dysfunction. It is
Do not take Tadalafil if you are already
important to note that Tadalafil for the taking
t
any form of nitrates (see “Do not
treatment of erectile dysfunction does take
t
Tadalafil if you:”).
not work if there is no sexual
stimulation. You and your partner will Some medicines may be affected by
need to engage in foreplay, just as you Tadalafil or they may affect how well
Tadalafil will work. Tell your doctor or
would if you were not taking a
pharmacist if you are already taking:
medicine for erectile dysfunction.
• an alpha blocker (used to treat high
• urinary symptoms associated with a
blood pressure or urinary symptoms
common condition called benign
associated with benign prostatic
prostatic hyperplasia. This is when the
hyperplasia)
prostate gland gets bigger with age.
Symptoms include difficulty in starting • other medicines to treat high blood
pressure
to pass water, a feeling of not
completely emptying the bladder and a • riociguat
more frequent need to pass water even • a 5- alpha reductase inhibitor (used to
treat benign prostatic hyperplasia)
at night. Tadalafil improves blood flow
• medicines such as ketoconazole tablets
to, and relaxes the muscles of, the
(to treat fungal infections) and protease
prostate and bladder which may
inhibitors for treatment of AIDS or HIV
reduce symptoms of benign prostatic
infection
hyperplasia. Tadalafil has been shown
to improve these urinary symptoms as • phenobarbital, phenytoin and
carbamazepine (anticonvulsant
early as 1-2 weeks after starting
medicines)
treatment.
• rifampicin, erythromycin,
clarithromycin or itraconazole
2 What you need to know before
• other treatments for erectile
you take Tadalafil
dysfunction.
Do not take Tadalafil if you:
Tadalafil with drink and alcohol
• are allergic to tadalafil or any of the
Information on the effect of alcohol is in
other ingredients of this medicine
section 3. Grapefruit juice may affect
(listed in section 6)
how well Tadalafil will work and should
• are taking any form of organic nitrate
be taken with caution. Talk to your doctor
or nitric oxide donors such as amyl
for further information.
nitrite. This is a group of medicines









(“nitrates”) used in the treatment of
angina pectoris (“chest pain”). Tadalafil
has been shown to increase the effects
of these medicines. If you are taking
any form of nitrate or are unsure tell
your doctor (see section ‘‘Other
medicines and Tadalafil’’).
have serious heart disease or recently
had a heart attack within the last
90 days
recently had a stroke within the last
6 months
have low blood pressure or
uncontrolled high blood pressure
ever had loss of vision because of
non-arteritic anterior ischemic optic
neuropathy (NAION), a condition
described as “stroke of the eye”
are taking riociguat. This drug is used
to treat pulmonary arterial
hypertension (i.e., high blood pressure
in the lungs) and chronic
thromboembolic pulmonary
hypertension (i.e., high blood pressure
in the lungs secondary to blood clots).
PDE5 inhibitors, such as Tadalafil, have
been shown to increase the
hypotensive effects of this medicine. If
you are taking riociguat or are unsure
tell your doctor.

Warnings and precautions
Talk to your doctor before taking
Tadalafil.

Fertility
W
When
dogs were treated there was
reduced sperm development in the
t
testes.
A reduction in sperm was seen in
some men. These effects are unlikely to
lead to a lack of fertility.
Driving and using machines
Some men taking Tadalafil in clinical
studies have reported dizziness. Check
carefully how you react to the tablets
before driving or using machines.
Tadalafil contains lactose
If you have been told by your doctor that
y have an intolerance to some sugars,
you
contact your doctor before taking this
medicine.

3 How to take Tadalafil
Always take this medicine exactly as
A
your doctor has told you. Check with your
y
doctor or pharmacist if you are not sure.
Tadalafil tablets are for oral use in men
only. Swallow the tablet whole with
some water. The tablets can be taken
with
w or without food.
Drinking alcohol may temporarily lower
your
blood pressure. If you have taken or
y
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.
322Kxxxxx1117
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2K
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ZINC Ref:

Version:

EAS1417b LEA TADALAFIL 5mg FC TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
560 mm
160 mm
-

F the
For
h treatment off erectile
il d
dysfunction
f
i
The recommended dose is one 5 mg
ttablet taken once a day at approximately
tthe same time of the day. Your doctor
may adjust the dose to 2.5 mg based on
your response to Tadalafil. This will be
y
given as a 2.5 mg tablet. Do not take
Tadalafil more than once a day.
Once a day dosing of Tadalafil may be
useful to men who anticipate having
sexual activity two or more times per
week. When taken once a day Tadalafil
w
allows you to obtain an erection, when
sexually stimulated, at any time point
during the 24 hours of the day.
It is important to note that Tadalafil does
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.
Drinking alcohol may affect your ability
tto get an erection.

1

23 November 2017

Template

Colours Used:

PANTONE® GREEN C
BLACK

S
ddi i
l rare side
id effects
ff
h
Some additional
have
been reported in men taking Tadalafil
tthat were not seen in clinical trials. These
include:
• migraine
• swelling of the face
• serious skin rashes
• some disorders affecting blood flow to
the eyes
• irregular heartbeats
• angina
• sudden cardiac death.
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
possible side effects not listed in this
leaflet. You can also report side effects
For the treatment of benign prostatic
directly via the Yellow Card Scheme
hyperplasia
Website at:
The dose is one 5 mg tablet taken once a W
w
www.mhra.gov.uk/yellowcard or search
day at approximately the same time of
for MHRA Yellow Card in the Google Play
tthe day.
If you have benign prostatic hyperplasia or Apple App Store.
By reporting side effects you can help
and erectile dysfunction, the dose
provide more information on the safety
remains one 5 mg tablet taken once a
of this medicine.
day.
Do not take Tadalafil more than once a
day.

5 How to store Tadalafil

Keep this medicine out of the sight and
If you take more Tadalafil than you
reach of children.
should
Contact your doctor. You may experience
Do not use this medicine after the expiry
side effects described in section 4.
date which is stated on the carton and
blister after ‘EXP’.
If you forget to take Tadalafil
The expiry date refers to the last day of
Take your dose as soon as you
remember but do not take a double dose tthat month.
tto make up for a forgotten tablet. You
This medicinal product does not require
should not take Tadalafil more than once
any special storage conditions.
a day.
Do not throw away any medicines via
If you have any further questions on the
wastewater or household waste. Ask
w
use of this medicine, ask your doctor or
y
your pharmacist how to throw away
pharmacist.
medicines you no longer use. These
measures will help protect the
4 Possible side effects
environment.
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.

6 Contents of the pack and other
information

What Tadalafil 5 mg Film-coated Tablets
contains
• The active substance is tadalafil.
Each 5 mg tablet contains 5 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 5mg Film-coated Tablets
looks like and contents of the pack
Ochre to yellow, oval shaped film-coated
ttablet. On one side debossed with “5”
and plain on the other side. Length:
8.1 mm, width: 4.1 mm.
Tadalafil 5 mg Film-coated Tablets are
available in pack sizes of 14, 18, 28, 30 or
84 film-coated tablets in blisters or 14x1,
28x1, 84x1, 98x1 or 112x1 film-coated
ttablets in perforated unit-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
BN22 9AG, UK
Manufacturer
A
Actavis Export International Ltd.,
HF 62 Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
This leaflet was last revised in 11/2017.
PL 00289/1881

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.
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.
EAS1417b

REG0215022

Version 1.2

Approved

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