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TADALAFIL SANDOZ 10 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL / TADALAFIL

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Package leaflet: Information for the patient

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Tadalafil 2.5 mg Film-coated Tablets
Tadalafil 5 mg Film-coated Tablets
Tadalafil 10 mg Film-coated Tablets
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 2.5 mg, 5 mg, 10 mg and 20 mg is
used to treat 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 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.
Tadalafil 5 mg is used to treat adult men with
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.
Tadalafil 20 mg is used to treat 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
• 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 before taking Tadalafil.
If you are treated for erectile dysfunction or
benign prostatic hyperplasia: 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.
If you are treated for benign prostatic
hyperplasia: 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 for benign prostatic hyperplasia.
Tadalafil 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, or unwanted or
persistent erections lasting more than 4 hours
• a serious liver problem
• a severe kidney problem

• any hereditary eye disease
• any heart problems other than your
pulmonary hypertension
• problems with your blood pressure
It is not known if Tadalafil in treatment of erectile
dysfunction 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 or benign prostatic
hyperplasia 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 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:
• an alpha blocker (used to treat high blood
pressure or urinary symptoms associated with
benign prostatic hyperplasia)
• other medicines to treat high blood pressure
• nitrates (for chest pain)
• riociguat
• a 5- alpha reductase inhibitor (used to treat
benign prostatic hyperplasia)
• protease inhibitors for treatment of AIDS or
HIV infection (ritonavir)
• phenobarbital, phenytoin and carbamazepine
(anticonvulsant medicines)
• rifampicin, erythromycin or clarithromycin (to
treat bacterial infections)
• medicines such as ketoconazole or
itraconazole (to treat fungal infections)
• bosentan (another treatment for pulmonary
arterial hypertension)
• other treatments for erectile dysfunction
(PDE5 inhibitors)
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist 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.
Do not breast-feed 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 breast-feeding.
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 un-chewed with some water.
Tadalafil 10 mg and 20 mg tablets can be
divided into equal doses.
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, 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
• Flexible-dose, on demand:
The recommended starting dose is one 10 mg
tablet before sexual activity. If the effect of this
dose is too weak
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your doctor may increase the dose to 20 mg.
Tadalafil tablets are for oral use.
You may take Tadalafil tablet at least 30
minutes before sexual activity. Tadalafil may
still be effective up to 36 hours after taking the
tablet.
Tadalafil 10 mg and 20 mg is intended for use
prior to anticipated sexual activity and is not
recommended for continuous daily use.
• Once a day dosing:
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. Once a day dosing of Tadalafil may be
useful to men who anticipate having sexual
activity two or more times per week.
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.
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.
For the treatment benign prostatic
hyperplasia
The dose is one 5 mg 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 5 mg
tablet taken once a day.
Do not take Tadalafil more than once a day.
For the treatment of pulmonary arterial
hypertension
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 any of the side effects
described in section 4.
If you forget to take Tadalafil
Take your dose as soon as you remember if it is
within 8 hours of when you should have taken
your dose. 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
common, may affect up to 1 in 10 people)
• chest pain - do not use nitrates but seek
immediate medical assistance (frequency
common, may affect up to 1 in 10 people)
• prolonged and possibly painful erection
after taking Tadalafil (frequency uncommon,
may affect up to 1 in 100 people)
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, may
affect up to 1 in 1,000 people)
Other side effects have been reported and these
are listed below, separated by indication:
Side effects in erectile dysfunction or benign
prostatic hyperplasia
Common (may affect up to 1 in 10 people)
• headache, back pain, muscle aches, pain in
arms and legs, facial flushing, nasal
congestion and indigestion
Uncommon (may affect up to 1 in 100 people)
• 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, ringing in the ears,
swelling of the hands, feet or ankles and
feeling tired
Rare (may affect up to 1 in 1,000 people)
• fainting, passing memory loss, swelling of the
eyelids, red eyes, sudden decrease or loss of
hearing, hives (itchy red welts on the surface
of the skin), penile bleeding, presence of
blood in semen and 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, seizures, 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 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.

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 1 in 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 (see paragraph
“Side effects in erectile dysfunction and benign
prostatic hyperplasia” above).
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 the Yellow Card
Scheme (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

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 contains
Tadalafil 2.5 mg film-coated tablets
The active substance is tadalafil. Each
film-coated tablet contains 2.5 mg of tadalafil.
Tadalafil 5 mg film-coated tablets
The active substance is tadalafil. Each
film-coated tablet contains 5 mg of tadalafil.
Tadalafil 10 mg film-coated tablets
The active substance is tadalafil. Each
film-coated tablet contains 10 mg of tadalafil.
Tadalafil 20 mg film-coated tablets
The active substance is tadalafil. Each
film-coated tablet contains 20 mg of tadalafil.
The other excipients are:
Tablet core:
Lactose monohydrate, sodium laurilsulfate,
povidone K-12, crospovidone (Type B), sodium
stearyl fumarate
Film-coating:
Polyvinyl alcohol, macrogol 3350, titanium
dioxide (E171), talc, iron oxide yellow (E172)
What Tadalafil looks like and contents of the
pack
Tadalafil 2.5 mg film-coated tablets
Ochre to yellow, round shaped film coated tablet
of approximately 5 mm in diameter. On one side
debossed with “2.5” and plain on the other side.
Tadalafil 5 mg film-coated tablets
Ochre to yellow, oval shaped film coated
tablet of approximately 8 x 4 mm. On one side
debossed with “5” and plain on the other side.
Tadalafil 10 mg film-coated tablets
Ochre to yellow, oval shaped film coated tablet
of approximately 11 x 7 mm. On one side scored
and debossed with “1” 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. The tablet
can be divided into equal halves.
Tadalafil 20 mg film-coated tablets
Ochre to yellow, oval shaped film coated tablet
of approximately 14 x 8 mm. 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. The
tablet can be divided into equal halves.
Alu-Alu (Al-OPA/Al/PVC) blisters:
PVC/ACLAR/PVC – Alu blisters
PVC/ACLAR/PVdC/PVC– Alu blisters
Pack sizes:
Tadalafil 2.5 mg film-coated tablets
28 film-coated tablets.
Tadalafil 5 mg film-coated tablets
14, 24, 28, 84 film-coated tablets.
Tadalafil 10 mg film-coated tablets
4, 12, 24 film-coated tablets.
Tadalafil 20 mg film-coated tablets
4, 8, 12, 24, 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK
Manufacturer
Lek Pharmaceuticals d.d., Verovškova ulica 57,
1526 Ljubljana, Slovenia
This leaflet was last revised in 05/2017
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Date prepared:
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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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