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TADALAFIL ACTAVIS 5MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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T00075-01 Malta Zejtun 190x380 PIL

Package leaflet: Information for the user

Tadalafil 5mg
Film-coated Tablets
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.
• The full name of this medicine is Tadalafil 5mg
Film-coated Tablets but within the leaflet it will
be referred to as Tadalafil Tablets.
What is in this leaflet
1. What Tadalafil Tablets are and what they
are used for
2. What you need to know before you take
Tadalafil Tablets
3. How to take Tadalafil Tablets
4. Possible side effects
5. How to store Tadalafil Tablets
6. Contents of the pack and other information
1. What Tadalafil Tablets are and what they
are used for
Tadalafil Tablets contain the active substance tadalafil
which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil 5mg Tablets are used to treat adult men with:
•e
 rectile 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 for the treatment of
erectile dysfunction 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.
• 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 Tablets
Do not take Tadalafil Tablets:

• if you are allergic to tadalafil or any of the other
ingredients of this medicine (listed in section 6)
• if you 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 Tablets has been shown
to increase the effects of these medicines. If you are
taking any form of nitrate or are unsure tell your doctor
• if you have serious heart disease or recently had a
heart attack within the last 90 days
• if you recently had a stroke within the last 6 months
• if you have low blood pressure or uncontrolled high
blood pressure
• if you ever had loss of vision because of non-arteritic
anterior ischemic optic neuropathy (NAION), a
condition described as “stroke of the eye”

• if you 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 Tablets, 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 Tablets.
Be aware that sexual activity carries a possible risk to
patients with heart disease because it puts an extra
strain on your heart. If you have a heart problem you
should tell your doctor.
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 Tablets for benign prostatic hyperplasia.
Tadalafil Tablets 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)
• any deformation of your penis
• a serious liver problem
• a severe kidney problem.
It is not known if Tadalafil Tablets are 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-nervesparing prostatectomy).
If you experience sudden decrease or loss of vision,
stop taking Tadalafil Tablets and contact your doctor
immediately.
Tadalafil Tablets are not intended for use by women.

Children and adolescents

Tadalafil Tablets are not intended for use by children and
adolescents under the age of 18.

Other medicines and Tadalafil Tablets

Tell your doctor if you are taking, have recently taken or
might take any other medicines.
Do not take Tadalafil Tablets if you are already taking
nitrates.
Some medicines may be affected by Tadalafil Tablets or
they may affect how well Tadalafil Tablets 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 Tablets with drink and alcohol

Information on the effect of alcohol is in section 3.
Grapefruit juice may affect how well Tadalafil Tablets
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 Tablets in clinical studies
have reported dizziness. Check carefully how you react
to the tablets before driving or using machines.

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Tadalafil 5 mg Tablets PIL UK

1. black

item no:

AAAI9547

dimensions:

print proof no:

7

pharmacode:

origination date: 19.4.16
approved for print/date

colours/plates:

min pt size:

190 x 380

2.
3.
4.

9.5 pt

originated by:

db

revision date:

28.6.16

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Malta Zejtun

approved:

n/a

5.
6.
Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

T00075-01 Malta Zejtun 190x380 PIL

Tadalafil Tablets contain lactose

If you have been told by our doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

3. How to take Tadalafil Tablets
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.
Drinking alcohol may temporarily lower your blood
pressure. If you have taken or are planning to take
Tadalafil Tablets, avoid excessive drinking (blood alcohol
level of 0.08% or greater), since this may increase the
risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended dose is one 5mg tablet taken once
a day at approximately the same time of the day. Your
doctor may adjust the dose to 2.5mg based on your
response to Tadalafil Tablets. This will be given as a
2.5mg tablet.
Do not take Tadalafil Tablets more than once a day.
When taken once a day Tadalafil Tablets allows you to
obtain an erection, when sexually stimulated, at any
time point during the 24 hours of the day. Once a day
dosing of Tadalafil Tablets may be useful to men who
anticipate having sexual activity two or more times per
week.
It is important to note that Tadalafil Tablets 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.
For the treatment benign prostatic hyperplasia
The dose is one 5mg tablet taken once a day at
approximately the same time of the day. If you have
benign prostatic hyperplasia and erectile dysfunction,
the dose remains one 5mg tablet taken once a day.
Do not take Tadalafil Tablets more than once a day.

If you take more Tadalafil Tablets than you
should

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

If you forget to take Tadalafil Actavis

Take your dose as soon as you remember. Do not take
a double dose to make up for a forgotten tablet. You
should not take Tadalafil Tablets more than once a day.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Rare (may affect up to 1 in 1,000 people)
• fainting, seizures and passing memory loss, visual
field changes, swelling of the eyelids, red eyes, sudden
decrease or loss of hearing and hives (itchy red welts
on the surface of the skin).
Heart attack and stroke have also been reported rarely
in men taking Tadalafil Tablets. 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 Tablets that were not seen in
clinical trials. These include:
• migraine, swelling of the face, serious allergic reaction
which causes swelling of the face or throat, serious
skin rashes, some disorders affecting blood flow to the
eyes, irregular heartbeats, angina and sudden cardiac
death.
The side effects dizziness and diarrhoea have been
reported more frequently in men over 75 years of age
taking Tadalafil Tablets.
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 side
effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Tadalafil Tablets
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 medicine 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 Tablets contain

• The active substance is tadalafil.
Each tablet contains 5mg of tadalafil.
• The other ingredients are:
Tablet core: lactose monohydrate, pregelatinised
starch, colloidal anhydrous silica, croscarmellose
sodium, sodium laurilsulfate, magnesium stearate.
Film-coat: hypromellose, lactose monohydrate,
titanium dioxide (E171), triacetin, talc (E553b), iron
oxide yellow (E172), iron oxide red (E172).

What Tadalafil Tablets look like and contents of
the pack

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 Tablets (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).
Other side effects have been reported:
Common (may affect up to 1 in 10 people)
• headache, back pain, muscle aches, pain in arms and
legs, facial flushing, nasal congestion, indigestion and
reflux.
Uncommon (may affect up to 1 in 100 people)
• dizziness, stomach ache, blurred vision, eye pain,
increased sweating, difficulty in breathing, penile
bleeding, presence of blood in semen and/or urine,
pounding heartbeat sensation, a fast heart rate, high
blood pressure, low blood pressure, nose bleeds and
ringing in the ears.

Tadalafil 5mg Tablets are a pale yellow, oval shaped,
film-coated tablet, debossed with ‘5’ on one side and
plain on the other side. The tablet is 10mm x 6.0mm in
diameter and 3.3 – 3.9mm in thickness.

Pack sizes

Tadalafil 5mg Tablets are available in blister packs
containing 28 tablets.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
This leaflet was last revised in June 2016.

If you would like a
leaflet with larger text,
please contact
01271 385257.

Continued top of next column
AAAI9547

Actavis, Barnstaple, EX32 8NS, UK

Tadalafil 5 mg Tablets PIL UK

1. black

item no:

AAAI9547

dimensions:

print proof no:

7

pharmacode:

origination date: 19.4.16
approved for print/date

colours/plates:

min pt size:

190 x 380

2.
3.
4.

9.5 pt

originated by:

db

revision date:

28.6.16

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Malta Zejtun

approved:

n/a

5.
6.
Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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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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