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TADALAFIL 20MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL / TADALAFIL

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24 mm

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.
This medicine 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 the active substance or any of the other ingredients of this
medicine (listed in section 6).

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• 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.
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.

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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 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.
Tadalafil tablets contain lactose
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.

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Tadalafil 10 mg Film-coated Tablets
Tadalafil 20 mg Film-coated Tablets

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Package leaflet: Information for the patient

24 mm

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).
• 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

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• 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.

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.

What Tadalafil contains
• The active substance is tadalafil. Each film-coated tablet 10 mg or 20 mg
of tadalafil.
• The other ingredients are:
Tablet core: hydroxypropyl cellulose, 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).

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
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.

6. Contents of the pack and other information

What Tadalafil looks like and contents of the pack
• 10 mg: Yellow to light yellow, round shaped, bevelled edge, film-coated
tablets debossed with ‘338’ on one side and plain on other side. The
tablet dimensions are 3.90 mm ± 0.40 mm.
• 20 mg: Yellow to light yellow, round shaped, bevelled edge, film-coated
tablets debossed with ‘L339’ on one side and plain on other side. The
tablet dimensions are 5.10 mm ± 0.40 mm.
• This medicine is available in blister packs containing 4 tablets.
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
E-mail:
info@bristol-labs.co.uk
Tadalafil 10 mg Film-coated Tablets; PL 17907/0570 &
PA 1240/030/003
Tadalafil 20 mg Film-coated Tablets; PL 17907/0571 &
PA 1240/030/004
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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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.

• 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.

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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.

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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