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TADALAFIL 20MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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Package Leaflet: Information for the user

Tadalafil 20 mg
film-coated tablets
Tadalafil

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.
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 contains the active substance tadalafil
which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil is used to treat:
• Erectile dysfunction in adult men:
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.
• Pulmonary arterial hypertension in adults:
It works by helping the blood vessels around
your lungs relax, improving the flow of blood
into your lungs. The result of this is an improved
ability to do physical activity.

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.
- have serious heart disease or recently had a
heart attack within the last 90 days.
- have 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Tadalafil.
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.
Before taking the tablets, tell your doctor if you
have:
- any heart problems other than your pulmonary
hypertension
- problems with your blood pressure
- any hereditary eye disease
- 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 should not be used as treatment of
erectile dysfunction by women because these
are health problems specific to men.
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 or pharmacist if you are taking,

have recently taken or might take any other
medicines.
Do not take Tadalafil if you are already taking
nitrates.
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:
- bosentan (another treatment for pulmonary
aterial hypertension)
- nitrates (for chest pain)
- 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.
Pregnancy, breastfeeding and Fertility
Pregnancy
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine. Do not take tadalafil when pregnant,
unless it is strictly necessary and you have
discussed this with your doctor.
Breastfeeding
Do not breastfeed while taking these tablets as it
is not known if the medicine passes into human
breast milk. Ask your doctor or pharmacist for
advice before taking any medicine while pregnant
or breastfeeding.
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 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.
Swallow the tablet whole with some water. The
tablets can be taken with or without food.
For the treatment of erectile dysfunction
- The recommended starting dose is one 10 mg
tablet before sexual activity. However, if you
have been given the dose of one 20mg tablet is
because your doctor has decided that the
recommended dose of 10mg is too weak.
You may take a Tadalafiltablet at least 30 minutes
before sexual activity.
Tadalafil may still be effective up to 36 hours after
taking the tablet.
Do not take Tadalafil more than once a day.
Tadalafil 10 mg and 20 mg is intended for use
prior to anticipated sexual activity and is not
recommended for continuous daily use.
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.
For pulmonary arterial hypertension
Tadalafil is supplied as a 20 mg tablet. The usual
dose is two 20 mg tablets taken once a day. You
should take both tablets at the same time, one
after the other. If you have a mild or moderate
liver or kidney problem, your doctor may advise
you to take only one 20 mg tablet per day.
If you take more Tadalafil than you should
If you or anyone else takes more tablets than
they should, tell your doctor or go to a hospital
immediately, taking the medicine or pack with
you. You may experience side effects described
in section 4.
If you forget to take Tadalafil
Take your dose as soon as you remember but do
not take a double dose to make up for a forgotten
tablet. You should not take Tadalafil more than
once a day.
If you stop taking Tadalafil
For the treatment of pulmonary arterial
hypertension do not stop taking your tablets,
unless advised otherwise by your doctor.
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).
Other side effects have been reported and these
are listed below, separated by indication:

Film-coating:
Lactose monohydrate, Hypromellose, Titanium
dioxide (E171), Triacetin, Talc and Iron oxide
yellow (E172).
What Tadalafil look like and contents of the
pack
Yellow, capsule shaped, approximately 14.3 mm
in length and 7 mm in width, biconvex, bevelled
edged, film coated tablet, debossed with "T 20"
on one side and plain on other side.
Tadalafil is available in PVC/PE/PVdC clear
Aluminium blister.
Pack sizes: 2, 4, 8, 12, 56 or 60 tablets

Side effects in erectile dysfunction

Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and
Manufacturer

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.

Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner Road, North Harrow,
Middlesex HA1 4HF,
United Kingdom

Rare (may affect up to 1 in 1,000 people)
- fainting, seizures and 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).
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 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.
Side effects in pulmonary arterial
hypertension
Very common (may affect more than 1 in 10
people)
- headache, flushing, nasal and sinus congestion
(blocked nose), nausea, indigestion (including
abdominal pain or discomfort), muscle aches,
back pain and pain in the extremity (including
limb discomfort)
Common (may affect up to 1 in 10 people)
- blurred vision, low blood pressure, nosebleed,
vomiting, increased or abnormal uterine
bleeding, swelling of the face, acid reflux,
migraine, irregular heartbeat and fainting.
Uncommon (may affect up to 1in 100 people)
- seizures, passing memory loss, hives,
excessive sweating, penile bleeding, presence
of blood in semen and/or urine, high blood
pressure, fast heart rate, sudden cardiac death
and ringing in the ears.
Most but not all of those men reporting fast heart
rate, irregular heartbeat, heart attack, stroke and
sudden cardiac death had known heart problems
before taking tadalafil. It is not possible to
determine whether these events were related
directly to tadalafil.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

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 blister or carton after EXP.
The expiry date refers to the last day of that
month.
This medicine does not require any special
temperature 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 contains
- The active substance is tadalafil.
Each film-coated tablet contains 20 mg tadalafil.
- The other ingredients are:
Tablet core:
Lactose monohydrate, Croscarmellose sodium,
Hypromellose, cellulose microcrystalline,
Sorbitan stearate and Magnesium stearate

Marketing Authorisation Holder

Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary
This leaflet was approved in 04/2016

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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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