Skip to Content

UK Edition. Click here for US version.

TADALAFIL 20 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL / TADALAFIL

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

TADALAFIL 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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.






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
1. What Tadalafil is and what it is used for children and adolescents under the age
of 18.
2.What you need to know before you
take Tadalafil
Other medicines and Tadalafil
3.How to take Tadalafil
Tell your doctor if you are taking, have
4.Possible side effects
recently taken or might take any other
5.How to store Tadalafil
medicines.
6.Contents of the pack and other
information
Do not take Tadalafil if you are already
taking any form of nitrates (See “Do not
What
Tadalafil
is
and
what
it
is
take Tadalafil if you:”).
1
What is in this leaflet:

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 20 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.

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
Tadalafil with drink and alcohol
need to engage in foreplay, just as you
would if you were not taking a medicine Information on the effect of alcohol is in
section 3. Grapefruit juice may affect
for erectile dysfunction (see section 3).
how well Tadalafil will work and should
be taken with caution. Talk to your doctor
2 What you need to know before for further information.

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.

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.
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.

Warnings and precautions
Talk to your doctor before taking Tadalafil. You may take a Tadalafil tablet at least
30 minutes before sexual activity.
Tadalafil may still be effective up to
Be aware that sexual activity carries a
36 hours after taking the tablet.
possible risk to patients with heart
disease because it puts an extra strain on
It is important to note that Tadalafil does
your heart. If you have a heart problem
not work if there is no sexual stimulation.
you should tell your doctor.
You and your partner will need to engage
Before taking the tablets, tell your doctor in foreplay, just as you would if you were
not taking a medicine for erectile
if you have:
• sickle cell anaemia (an abnormality of dysfunction.
red blood cells)
• multiple myeloma (cancer of the bone
marrow)

322Kxxxxx0317

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.

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.

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

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
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 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
tablet. On one side scored and debossed
with “2” on the left side of the score and
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
tablet 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
tablets 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.,
HF 62 Hal Far Industrial Estate,
Birzebbugia BBG3000, Malta
This leaflet was last revised in 08/2017.
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
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.
EAS1419a

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.

Hide