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TADALAFIL MILPHARM 10 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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Tadalafil 10 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 is 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.
Tadalafil contains the active substance
tadalafil which belongs to a group of
medicines called phosphodiesterase type
5 inhibitors. 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.
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 or pharmacist before
taking Tadalafil.

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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:
- 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.
Decreased or sudden hearing loss has
been noted in some patients taking
tadalafil. Although it is not known if the
event is directly related to tadalafil, if you
experience decreased or sudden hearing
loss, 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 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.
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.
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 monohydrate.
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 or pharmacist 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.

P15XXXXX

Package leaflet:
Information for the user

You may take a Tadalafil tablet 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.
If you take more Tadalafil than you
should
Contact your doctor. You may experience
side effects described in section 4.
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).
- Priapsim, a 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:
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, prolonged erection,
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, seizures and 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, 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.
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 at:
www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or
Apple App Store.
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 after
EXP. The expiry date refers to the last day
of that month.
The 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 contains
- The active substance is tadalafil. Each
film-coated tablet contains 10 mg of
tadalafil.
- The other ingredient s are
Tablet core: Copovidone,
macrogolglycerol hydroxystearate,
lactose monohydrate, silica, colloidal
anhydrous, cellulose, microcrystalline,
croscarmellose sodium, magnesium
stearate.
Tablet coating: Hypromellose ,
titanium dioxide (E 171), talc (E553b),
yellow iron oxide (E172), triacetin.
What Tadalafil looks like and contents
of the pack
Film-coated tablet.
Light yellow colored, oval shaped,
film-coated tablets debossed with ‘10’ on
one side and ‘TL’ on other side.
Tadalafil film-coated tablets are available
in clear PVC/PVdC-Aluminium foil blister
packs.
Blister pack sizes: 2, 4, 8, 12, 24, 28 and
56 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
or
Orion Corporation Orion Pharma
Orionintie 1, Espoo, FI-02200
Finland
This leaflet was last revised in 08/2017.
P15XXXXX

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.

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