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TADALAFIL 5MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL / TADALAFIL

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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 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.
Benign prostatic hyperplasia
Tadalafil 5 mg is a treatment for 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.

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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 the active substance 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 tadalafil. If you
are taking riociguat or are unsure tell your doctor.
Warnings and precautions
Talk to your doctor 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).

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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 (used to to treat pulmonary arterial hypertension (i.e., high
blood pressure in the lungs and chronic thromboembolic pulmonary
hypertension).
• 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.
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Package leaflet: Information for the patient

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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not

In UK: via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.
In 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
carton and blister after ‘EXP’. The expiry date refers to the last day of
that month.
• This 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 ingredients are:
Tablet core: hydroxypropylcellulose, lactose monohydrate,
croscarmellose sodium, sodium laurilsulfate, povidone K-25, silica colloidal
anhydrous, magnesium stearate,
Tablet Coat: hypromellose, titanium dioxide (E171), macrogol, talc, iron
oxide yellow (E172).
What Tadalafil looks like and contents of the pack
• Yellow to light yellow, round shaped, bevelled edge, film-coated tablets
debossed with ‘337’ on one side and plain on other side. The tablet
dimensions are 2.70 mm ± 0.40 mm.
• This medicine is available in blister packs containing 14, 28 and 84
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Tadalafil 5 mg Film-coated Tablets; PL 17907/0569 & PA 1240/030/002
This leaflet was last revised in May 2017
To request a copy of this leaflet in Braille, large print or audio format, please
contact the marketing authorisation holder at the address (or telephone,
fax, email) above.
V7 12-05-17 D0

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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.
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 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 2.5 mg
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.
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.

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).
• Priapism, 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 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
tadalafil.
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 as below

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Tadalafil tablets contain lactose
f you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

Expand Transcript

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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