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TADALAFIL 5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL / TADALAFIL

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ZINC Ref:

EAS1417a LEA TADALAFIL 5mg FC TABS TUK Dim’s Changed?:
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560 mm
160 mm
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TADALAFIL 5 mg
FILM-COATED TABLETS

2

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Warnings and precautions
Talk to your doctor before taking
Tadalafil.

If you are being treated for erectile
dysfunction
Read all of this leaflet carefully before
you start taking this medicine because it Be aware that sexual activity carries a
contains important information for you. possible risk to patients with heart
• Keep this leaflet. You may need to read disease because it puts an extra strain on
your heart. If you have a heart problem
it again.
you should tell your doctor.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for If you are being treated for benign
you only. Do not pass it on to others. It prostatic hyperplasia
Since benign prostatic hyperplasia and
may harm them, even if their signs of
prostate cancer may have the same
illness are the same as yours.
• If you get any side effects, talk to your symptoms, your doctor will check you for
prostate cancer before starting treatment
doctor, pharmacist or nurse. This
with Tadalafil for benign prostatic
includes any possible side effects not
hyperplasia.
listed in this leaflet. See section 4.
Tadalafil does not treat prostate cancer.
What is in this leaflet:

1 What Tadalafil is and what it is
used for

Tadalafil is used for treatment of erectile
dysfunction and/or urinary symptoms
associated with benign prostatic
hyperplasia. Tadalafil contains the active
substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
Erectile dysfunction
Tadalafil 5 mg Film-coated Tablets are a
treatment 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. Following sexual
stimulation Tadalafil 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. Tadalafil will not help
you if you do not have erectile
dysfunction.
It is important to note that Tadalafil does
not work if there is no sexual
stimulation. You and your partner will
need to engage in foreplay, just as you
would if you were not taking a medicine
for erectile dysfunction (see section 3).
Benign prostatic hyperplasia
Tadalafil 5 mg is a treatment for urinary
symptoms associated with a common
condition called benign prostatic
hyperplasia.
This is when the prostate gland gets
bigger with age. Symptoms include
difficulty in starting to pass water, a
feeling of not completely emptying the
bladder and a more frequent need to
pass water even at night. Tadalafil
improves blood flow to, and relaxes the
muscles of, the prostate and bladder
which may reduce symptoms of benign
prostatic hyperplasia. Tadalafil has been
shown to improve these urinary
symptoms as early as 1-2 weeks after
starting treatment.

2 What you need to know before
you take Tadalafil

Do not take Tadalafil if you:
• are allergic to tadalafil or any of the
other ingredients of this medicine
(listed in section 6)
• are taking any form of organic nitrate
or nitric oxide donors such as amyl
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.

PANTONE® GREEN C
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Package leaflet: Information for the user

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

10 August 2017

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)
• 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.
Tadalafil is not intended for use by
women.
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
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
• riociguat
• a 5- alpha reductase inhibitor (used to
treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets
(to treat fungal infections) and protease
inhibitors for treatment of AIDS or HIV
infection
• phenobarbital, phenytoin and
carbamazepine (anticonvulsant
medicines)
• rifampicin, erythromycin,
clarithromycin or itraconazole
• other treatments for erectile
dysfunction.
Tadalafil with drink and alcohol
Information on the effect of alcohol is in
section 3. Grapefruit juice may affect
how well Tadalafil will work and should
be taken with caution. Talk to your doctor
for further information.
Fertility
When dogs were treated there was
reduced sperm development in the
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
you have an intolerance to some sugars,
contact your doctor before taking this
medicine.

3 How to take Tadalafil
Always take this medicine exactly as
your doctor has told you. Check with
your 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 or without food.

322Kxxxxx0317

ZINC Ref:

EAS1417a LEA TADALAFIL 5mg FC TABS TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
560 mm
160 mm
-

Version:
Template

Colours Used:

Erectile dysfunction
The recommended dose is one 5 mg
tablet taken once a day at approximately
the same time of the day. Your doctor
may adjust the dose to 2.5 mg based on
your response to Tadalafil. This will be
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 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
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 and may temporarily
lower your blood pressure. If you have
taken 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.

2

• 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.
Some additional rare side effects have
been reported in men taking Tadalafil
that 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
taking Tadalafil.

If you take more Tadalafil than you
should
5 How to store Tadalafil
Contact your doctor. You may experience
side effects described in section 4.
Keep this medicine out of the sight and
reach of children.
If you forget to take Tadalafil
Take your dose as soon as you
Do not use this medicine after the expiry
remember but do not take a double dose date which is stated on the carton and
to make up for a forgotten tablet. You
blister after ‘EXP’.
should not take Tadalafil more than once The expiry date refers to the last day of
a day.
that month.

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)
• 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
• 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)

PANTONE® GREEN C
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Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
Benign prostatic hyperplasia
includes any possible side effects not
The dose is one 5 mg tablet taken once a listed in this leaflet. You can also report
day at approximately the same time of
side effects directly via the Yellow Card
the day.
Scheme Website at:
If you have benign prostatic hyperplasia www.mhra.gov.uk/yellowcard or search
and erectile dysfunction, the dose
for MHRA Yellow Card in the Google Play
remains one 5 mg tablet taken once a
or Apple App Store.
day.
By reporting side effects you can help
Do not take Tadalafil more than once a
provide more information on the safety
day.
of this medicine.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

10 August 2017

This medicinal product does not require
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

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
tablet. 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
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.,
HF 62 Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
This leaflet was last revised in 08/2017.
PL 00289/1881

EAS1417a

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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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