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TADALAFIL BIOGARAN 20 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL

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B. PACKAGE LEAFLET

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Package leaflet: Information for the user
Tadalafil Biogaran 20 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
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3.
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5.
6.

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What Tadalafil is and what it is used for
What you need to know before you take Tadalafil
How to take Tadalafil
Possible side effects
How to store Tadalafil
Contents of the pack and other information

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.
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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-nervesparing 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
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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:
If 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 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.
The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been
given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is
too weak.
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).
- 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 (seen in 1 to 10 in every 100 patients)
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- headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and
indigestion.
Uncommon (seen in 1 to 10 in every 1,000 patients)
- 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 (seen in 1 to 10 in every 10,000 patients)
- 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 blending, 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.
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 medicine 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 tablet contains 20 mg of tadalafil.
- The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, sodium laurilsulfate,
hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

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Film-coat: Opadry yellow II 32K520101: hypromellose, lactose monohydrate, titanium dioxide
(E171), triacetin (E1518), talc, iron oxide yellow (E172).
What Tadalafil looks like and contents of the pack
Tadalafil 20 mg is a yellow oblong tablet, marked "T 20" on one side, approximately 13.5 mm long
and 7.0 mm wide.
Tadalafil 20 mg is available in blister packs containing 2, 4 or 8 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder :
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
FRANCE
Manufacturers :
SYNERLAB DEVELOPPEMENT
1 RUE CHARLES DE COULOMB
45077 ORLEANS CEDEX 2
FRANCE
GE PHARMACEUTICALS, LTD.
INDUSTRIAL ZONE CHEKANITSA SOUTH AREA
2140 BOTEVGRAD
BULGARIE
This medicinal product is authorised in the Member States of the EEA under the following
names :
United Kingdom: TADALAFIL BIOGARAN 20 mg film-coated tablets
France : TADALAFIL BIOGARAN 20 mg, comprimé pelliculé
Italy : TADALAFIL BIOGARAN
This leaflet was last revised in
May 2017

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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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