Skip to Content

TADALAFIL MILPHARM 5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Tadalafil 5 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 5 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.
- 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
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

Black

(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.
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.
- 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.

P15XXXXX

Package leaflet:
Information for the user

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.
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
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 2.5mg tablet.
Do not take Tadalafil more than once a
day.
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.
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.
If you take more Tadalafil than you
should
Contact your doctor. 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 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 label, carton or
bottle 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 5 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, filmcoated tablets debossed with ‘5’ on one
side and ‘TL’ on other side.
Tadalafil film-coated tablets are available
in clear PVC/PVDC-Aluminium foil blister
packs and in HDPE container packs.
Blister pack sizes: 4, 8, 12, 14, 28, 30, 56,
84 and 90 film-coated tablets
Bottle pack sizes: 100 and 250 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

3. How to take Tadalafil

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide