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TADALAFIL 2.5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL / TADALAFIL

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TADALAFIL 2.5 mg
FILM-COATED TABLETS

Before taking the tablets, tell your 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, pharmacist or nurse.
This includes any possible side
If you experience sudden decrease or
effects not listed in this leaflet. See
loss of vision, stop taking Tadalafil and
section 4.
contact your doctor immediately.
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 is used for treatment of erectile
dysfunction. Tadalafil contains the active
substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
Erectile dysfunction
Tadalafil 2.5 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.

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.

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
Tadalafil with drink and alcohol
for erectile dysfunction (see section 3).
Information on the effect of alcohol is in
section 3. Grapefruit juice may affect
2 What you need to know before how well Tadalafil will work and should
you take Tadalafil
be taken with caution. Talk to your doctor
for further information.
Do not take Tadalafil if you:
• are allergic to tadalafil or any of the
Fertility
other ingredients of this medicine
When dogs were treated there was
(listed in section 6)
reduced sperm development in the
• are taking any form of organic nitrate testes. A reduction in sperm was seen in
or nitric oxide donors such as amyl
some men. These effects are unlikely to
nitrite. This is a group of medicines
lead to a lack of fertility.
(“nitrates”) used in the treatment of
angina pectoris (“chest pain”).
Driving and using machines
Tadalafil has been shown to increase Some men taking Tadalafil in clinical
the effects of these medicines. If you studies have reported dizziness. Check
are taking any form of nitrate or are
carefully how you react to the tablets
unsure tell your doctor (see section
before driving or using machines.
‘‘Other medicines and Tadalafil’’).
• have serious heart disease or
Tadalafil contains lactose
recently had a heart attack within the If you have been told by your doctor that
last 90 days
you have an intolerance to some sugars,
• recently had a stroke within the last
contact your doctor before taking this
6 months
medicine.
• have low blood pressure or
uncontrolled high blood pressure
3 How to take Tadalafil
• ever had loss of vision because of
non-arteritic anterior ischemic optic
Always take this medicine exactly as
neuropathy (NAION), a condition
your doctor has told you. Check with
described as “stroke of the eye”
• are taking riociguat. This drug is used your doctor or pharmacist if you are not
sure.
to treat pulmonary arterial
hypertension (i.e., high blood
Tadalafil tablets are for oral use in men
pressure in the lungs) and chronic
only. Swallow the tablet whole with
thromboembolic pulmonary
some water. The tablets can be taken
hypertension (i.e., high blood
with or without food.
pressure in the lungs secondary to
blood clots). PDE5 inhibitors, such as
The recommended dose is one 5 mg
tadalafil, have been shown to
tablet taken once a day at approximately
increase the hypotensive effects of
the same time of the day. Your doctor
this medicine. If you are taking
may adjust the dose to 2.5 mg based on
riociguat or are unsure tell your
your response to Tadalafil. This will be
doctor.
given as a 2.5 mg tablet.
Do not take Tadalafil more than once a
Warnings and precautions
day.
Talk to your doctor before taking
Tadalafil.

Once a day dosing of Tadalafil may be
useful to men who anticipate having
Be aware that sexual activity carries a
sexual activity two or more times per
possible risk to patients with heart
disease because it puts an extra strain on week.
your heart. If you have a heart problem
you should tell your doctor.

322Kxxxxx0317

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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.

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
Contact your doctor. You may experience
side effects described in section 4.

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

5 How to store Tadalafil

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)
• penile bleeding
• presence of blood in semen
• increased sweating.

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
that month.
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 2.5 mg Film-coated Tablets
contains
• The active substance is tadalafil.
Each 2.5 mg film-coated tablet
contains 2.5 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 2.5 mg Film-coated Tablets
looks like and contents of the pack
Ochre to yellow, round shaped
film-coated tablet. On one side debossed
with “2.5” and plain on the other side.
Diameter: 5.0 mm.
Tadalafil 2.5 mg Film-coated Tablets are
available in pack sizes of 14, 28, 30 or
56 film-coated tablets in blisters or 28x1
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 00289/1880

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.

EAS1416a

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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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