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TADALAFIL 5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL

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Package leaflet: Information for the patient
Tadalafil 5 mg film-coated tablets
(tadalafil)

Read all of this leaflet carefully before you start using 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 5 mg film-coated tablets are and what are they used for
2. What you need to know before you use Tadalafil 5 mg film-coated tablets
3. How to use Tadalafil 5 mg film-coated tablets
4. Possible side effects
5. How to store Tadalafil 5 mg film-coated tablets
6. Contents of the pack and other information

1.

What Tadalafil 5 mg film-coated tablets is and what it is used for

Tadalafil 5 mg film-coated tablets contain the active substance tadalafil which belongs to
a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil 5 mg film-coated tablets are 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 5 mg film-coated tablets 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 5 mg film-coated tablets will not help you if you do not have erectile
dysfunction. It is important to note that Tadalafil 5 mg film-coated tablets 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

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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 use Tadalafil 5 mg film-coated tablets

Do not use Tadalafil 5 mg film-coated tablets 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 sometimes 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 5 mg film-coated 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 5 mg film-coated 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 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

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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 5 mg filmcoated tablets and contact your doctor immediately.
Tadalafil 5 mg film-coated tablets are not intended for use by women.
Children and adolescents
Tadalafil 5 mg film-coated tablets are not intended for use by children and adolescents
under the age of 18.
Other medicines and Tadalafil 5 mg film-coated tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines
Do not take Tadalafil 5 mg film-coated tablets if you are already taking nitrates.
Some medicines may be affected by Tadalafil 5 mg film-coated tablets or they may affect
how well Tadalafil 5 mg film-coated 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 5 mg film-coated tablets with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well
Tadalafil 5 mg film-coated 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 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 film-coated tablets contains lactose
If you have an intolerance to some sugars, contact your doctor before taking this
medicine.

3.

How to use Tadalafil 5 mg film-coated tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Tadalafil 5 mg film-coated tablets 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 5 mg film-coated 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 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 5 mg film-coated tablets. This will be given as a 2.5mg tablet.
Do not take Tadalafil 5 mg film-coated tablets more than once a day.
Tadalafil is available as 2.5, 5, 10 and 20mg film coated tablets.

When taken once a day Tadalafil 5 mg film-coated tablets allow 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 5 mg film-coated tablets may be useful to men who
anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil 5 mg film-coated tablets do 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 5 mg film-coated tablets more than once a day.
If you take more Tadalafil 5 mg film-coated tablets than you should:

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Contact your doctor. You may experience side effects described in section 4.
If you forget to take Tadalafil 5 mg film-coated tablets:
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 5 mg film-coated tablets 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).

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), 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 and 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 and 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.

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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 have 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. By reporting side effects you can
help provide more information on the safety of this medicine.

5.

How to store Tadalafil 5 mg film-coated tablets

This medicinal product does not require any special storage conditions.
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.
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 5 mg film-coated tablets contains
The active substance is tadalafil.
1 film-coated tablet contains 5 mg tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium (E468), microcrystalline
cellulose (E460), sodium lauryl sulfate, poloxamer 407, magnesium stearate (E572)
Film-coating: hypromellose (E464), hydroxypropylcellulose (E463), macrogol 8000,
titanium dioxide (E171), iron oxide yellow (E172),

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What Tadalafil 5 mg film-coated tablets looks like and contents of the pack
Yellow, almond shaped, biconvex film coated tablets. Engraved “APO” on one side,
“T5” on the other side
The film-coated tablets are packaged in:
PVC/PVdC/Al or PVC/Aclar/Al blisters in carton boxes of 28 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Apotex Europe B.V.
Darwinweg 20, 2333 CR Leiden
The Netherlands
Manufacturer:
Apotex Nederland B.V
Archimedesweg 2, 2333 CN Leiden
The Netherlands

This leaflet was last revised in November 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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