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TADALAFIL 10 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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Version:

EAS1418c LEA TADALAFIL 10mg FC TABS TUK Dim’s Changed?:
Length:
Width:
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Foil Width:

No
560 mm
160 mm
-

Colours Used:

1

Template

23 November 2017
PANTONE® GREEN C
BLACK

B f
Before
taking
ki the
h tablets,
bl
tell
ll your d
doctor
if you have:
• sickle cell anaemia (an abnormality of
red blood cells)
Package leaflet: Information for the user
• multiple myeloma (cancer of the
Read all of this leaflet carefully before
bone marrow)
you start taking this medicine because it • leukaemia (cancer of the blood cells)
contains important information for you. • any deformation of your penis
• Keep this leaflet. You may need to
• a serious liver problem
read it again.
• a severe kidney problem.
• If you have any further questions, ask
your doctor or pharmacist.
It is not known if Tadalafil is effective in
• This medicine has been prescribed
patients who have had:
for you only. Do not pass it on to
• pelvic surgery
others. It may harm them, even if
• removal of all or part of the prostate
their signs of illness are the same as
gland in which nerves of the prostate
yours.
are cut (radical non nerve-sparing
• If you get any side effects, talk to
prostatectomy).
your doctor or pharmacist. This
includes any possible side effects not If you experience sudden decrease or
listed in this leaflet. See section 4.
loss of vision, stop taking Tadalafil and
contact your doctor immediately.

TADALAFIL
T
TA
ADALA
LAFIL 10 mg
FILM-COATED TABLETS

What is in this leaflet:

1. What Tadalafil is and what it is used
for
2. What you need to know before you
take Tadalafil
3. How to take Tadalafil
4. Possible side effects
5. How to store Tadalafil
6. Contents of the pack and other
information

1 What Tadalafil is and what it is
used for

Tadalafil 10 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 10 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.

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
experience decreased or sudden hearing
loss, stop taking Tadalafil and contact
your
y
doctor immediately.
Tadalafil is not intended for use by
women.
w
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
t
take
Tadalafil if you:”).

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

Tadalafil tablets are for oral use in men
only. Swallow the tablet whole with
some water. The tablets can be taken
with or without food.
w

Be aware that sexual activity carries a
possible risk to patients with heart
disease because it puts an extra strain on
y
your heart. If you have a heart problem
you should tell your doctor.
y

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.

322Kxxxxx1117
3
22
2K
Kxxxxx1117
7

REG0215029

Version 1.2

Approved

Page 1 of 4

ZINC Ref:

Version:

EAS1418c LEA TADALAFIL 10mg FC TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
560 mm
160 mm
-

1

23 November 2017

Template

Colours Used:

PANTONE® GREEN C
BLACK

Tadalafil
T
d l fil tablets
bl
are ffor orall use.

Some additional
have
S
ddi i
l rare side
id effects
ff
h
been reported in men taking Tadalafil
You may take a Tadalafil tablet at least
Y
tthat were not seen in clinical trials. These
30 minutes before sexual activity.
include:
Tadalafil may still be effective up to
• migraine
36 hours after taking the tablet.
• swelling of the face
• serious skin rashes
It is important to note that Tadalafil does • some disorders affecting blood flow
not work if there is no sexual stimulation.
to the eyes
You and your partner will need to engage • irregular heartbeats
Y
in foreplay, just as you would if you were • angina
not taking a medicine for erectile
• sudden cardiac death.
dysfunction.
The side effect dizziness has been
Drinking alcohol may affect your ability
reported more frequently in men over
tto get an erection and may temporarily
75 years of age taking Tadalafil.
lower your blood pressure. If you have
Diarrhoea has been reported more
ttaken or are planning to take Tadalafil,
frequently in men over 65 years of age
avoid excessive drinking (blood alcohol ttaking Tadalafil.
level of 0.08 % or greater), since this may
increase the risk of dizziness when
Reporting of side effects
standing up.
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
leaflet. You can also report side effects
Contact your doctor. You may experience directly via the Yellow Card Scheme
side effects described in section 4.
Website at:
W
www.mhra.gov.uk/yellowcard or search
w
If you forget to take Tadalafil
for MHRA Yellow Card in the Google Play
Take your dose as soon as you
or Apple App Store.
remember but do not take a double dose By reporting side effects you can help
tto make up for a forgotten tablet. You
provide more information on the safety
should not take Tadalafil more than once of this medicine.
a day.
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.

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 10 mg Film-coated Tablets
contains
• The active substance is tadalafil.
Each 10 mg film-coated tablet
contains 10 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 10 mg Film-coated Tablets
looks like and contents of the pack
Ochre to yellow, oval shaped film-coated
ttablet. Debossed with “10” on one side.
The other side of the tablet is plain.
Length: 11.1 mm, width: 6.4 mm.
Tadalafil 10 mg Film-coated Tablets are
available in pack sizes of 4, 12, 18 or 28
film-coated tablets in blisters or 4x1 or
24x1 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
A
Actavis Export International Ltd.,
HF 62 Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
This leaflet was last revised in 11/2017.
PL 00289/1882

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
y has been rarely
y reported.
p

REG0215029

Version 1.2

Approved

EAS1418c

Page 2 of 4

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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