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TADALAFIL FARMAPROJECTS 2.5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL

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Package leaflet: Information for the user
Tadalafil Farmaprojects 2.5 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 Farmaprojects is and what it is used for
2.
What you need to know before you take Tadalafil Farmaprojects
3.
How to take Tadalafil Farmaprojects
4.
Possible side effects
5.
How to store Tadalafil Farmaprojects
6.
Contents of the pack and other information

1.

What Tadalafil Farmaprojects is and what it is used for

Tadalafil Farmaprojects 2.5 mg 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 Farmaprojects 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 Farmaprojects will not help you if you do not have erectile
dysfunction.
It is important to note that Tadalafil Farmaprojects 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 Farmaprojects

Do not take Tadalafil Farmaprojects 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.

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- 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.
Warnings and precautions
Talk to your doctor before taking Tadalafil Farmaprojects.
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 Farmaprojects 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 nonnerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking this medicine 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 Farmaprojects and contact your doctor immediately.
Tadalafil Farmaprojects is not intended for use by women.
Children and adolescents
Tadalafil Farmaprojects is not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil Farmaprojects
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tadalafil Farmaprojects if you are already taking nitrates.
Some medicines may be affected by Tadalafil Farmaprojects or they may affect how well Tadalafil
Farmaprojects 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).

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- 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 Farmaprojects with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil
Farmaprojects 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 Farmaprojects contains lactose:
If you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

How to take Tadalafil Farmaprojects

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Tadalafil Farmaprojects 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 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 Farmaprojects.
This will be given as a 2.5mg tablet.
Do not take Tadalafil Farmaprojects more than once a day.
Once a day dosing of Tadalafil Farmaprojects may be useful to men who anticipate having sexual
activity two or more times per week.
When taken once a day Tadalafil Farmaprojects allows you to obtain an erection, when sexually
stimulated, at any time point during the 24 hours of the day.
It is important to note that Tadalafil Farmaprojects 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 Farmaprojects, 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 Farmaprojects than you should
Contact your doctor. You may experience side effects described in section 4.
If you forget to take Tadalafil Farmaprojects
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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 Farmaprojects 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).
- priapism, a prolonged and possibly painful erection after taking this medicine (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 1000 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.
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 System website:
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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 Farmaprojects

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.
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 Farmaprojects contains
-

The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, povidone,
poloxamer, sodium laurilsulfate, croscarmellose sodium, silica colloidal anhydrous and
magnesium stearate.
Film coat: polyvinyl alcohol, macrogol, talc and titanium dioxide (E171)

What Tadalafil Farmaprojects looks like and contents of the pack
Tadalafil Farmaprojects 2.5 mg tablets are white or almost white, round, biconvex, film-coated
tablets, approximately 5 mm in diameter.
Tadalafil Farmaprojects 2.5 mg film-coated tablets are available in aluminium/PVC/PVDC blister
packs in cartons containing 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmaprojects S.A.
Santa Eulàlia 240-242
08902 L`Hospitalet de Llobregat
Barcelona
Spain
Manufacturers
Zakłady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works POLPHARMA SA)
19, Pelplińska Street
83-200 Starogard Gdański
Poland
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial State,
Hal Far Birzebbugia,
BBG 3000
Malta
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This medicinal product is authorised in the Member States of the EEA under the following
names:
DK
DE
IT
PL
EL
ES

Tadalafil Farmaprojects
Tadalafil Farmaprojects 2,5 mg Filmtabletten
Tadalafil Pensa
Tadalafil Mendana
Tadalafil Ariti 2,5 mg δισκία επικαλυμμένα με λεπτό υμένιο
Tadalafilo Tarbis 2,5 mg comprimidos recubiertos con película EFG

This leaflet was last revised in May 2017.
Other sources of information
Detailed information on this medicine is available on the website of {name of MS Agency (link)}

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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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