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TADALAFIL KRKA 2.5 MG FILM COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL

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NA. TADALAFIL 2,5mg tbl GB prva stran

1. What Tadalafil Krka is and what it is used for

Package leaflet: Information for the patient

Tadalafil Krka 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 is and what it is used for
2. What you need to know before you take Tadalafil Krka
3. How to take Tadalafil Krka
4. Possible side effects
5. How to store Tadalafil Krka
6. Contents of the pack and other information

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Tadalafil Krka contains the active substance tadalafil which belongs
to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Krka 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. Following sexual stimulation Tadalafil
Krka 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 Krka 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 Krka

Do not take Tadalafil Krka:
• if you are allergic to tadalafil or any of the other ingredients of
this medicine (listed in section 6).
• if you 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.
• if you have serious heart disease or recently had a heart attack
within the last 3 months.
• if you have recently had a stroke within the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.

• if you have ever had loss of vision because of non-arteritic
anterior ischemic optic neuropathy (NAION), a condition
described as “stroke of the eye”.
• if you 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 Krka, 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 or pharmacist before taking Tadalafil Krka.
Be aware that sexual activity carries a possible risk to patients with
heart disease because it puts an extra strain on the heart. If you
have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
• sickle cell anemia (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 Krka 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 Krka and contact your doctor immediately.
Tadalafil Krka 2.5 mg is not intended for use by women.
Children and adolescents
Tadalafil Krka is not indicated for use by children and adolescents
under the age of 18.

Other medicines and Tadalafil Krka
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
Do NOT take Tadalafil Krka if you are already taking nitrates.
Some medicines may be affected by Tadalafil Krka or they may
affect how well Tadalafil Krka 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 (to treat some forms of pulmonary hypertension).
• a 5-alpha reductase inhibitor (to treat benign prostatic hyperplasia).
• protease inhibitors for the treatment of AIDS or HIV infection
(e.g. ritonavir).
• phenobarbital, phenytoin and carbamazepine (anticonvulsant
medicines).
• rifampicin, erythromycin, clarithromycin (to treat bacterial infections).
• medicines such as ketoconazole or itraconazole (to treat fungal
infections)
• other treatments for erectile dysfunction.
Tadalafil Krka with drink and alcohol
Information on the effect of alcohol is in section 3.
Grapefruit juice may affect how well Tadalafil Krka 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 testicles. 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 medicine before

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driving or using machines.
Tadalafil Krka contains lactose monohydrate
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 Krka
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Tadalafil Krka 2.5 mg 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 Krka. This
will be given as one 2.5 mg tablet.
Do not take Tadalafil Krka more than once a day.
Once a day dosing of Tadalafil Krka may be useful to men who
anticipate having sexual activity two or more times per week.
When taken once a day Tadalafil Krka 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 Krka 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 Krka, avoid excessive drinking (blood
alcohol level of 0.08 % or greater), since this may increase the risk
of dizziness when standing up.

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If you take more Tadalafil Krka than you should
Contact your doctor. You may experience any of the side effects
described in section 4.
If you forget to take Tadalafil Krka
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 Krka 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
Krka (frequency uncommon). 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, reflux, nausea, vomiting, blurred
vision, eye pain, difficulty breathing, presence of blood in urine,

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pounding heartbeat sensation, a fast heart rate, high blood
pressure, low blood pressure, nose bleeds, ringing in the ears,
feeling tired (fatigue), swelling of the hands, feet or ankles
(peripheral oedema).
Rare (may affect up to 1 in 1,000 people):
• fainting, passing memory loss, swelling of the eyelids, red eyes,
sudden decrease or loss of hearing, hives (itchy red welts on the
surface of the skin), increased sweating, bleeding from the penis
and presence of blood in semen.
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, seizures, 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 and diarrhoea have been reported more
frequently in men over 75 years of age taking tadalafil for the
treatment of benign prostatic hyperplasia. Diarrhoea has been
reported more frequently in men over 65 years of age taking
tadalafil for the treatment of erectile dysfunction.
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 Yellow Card Scheme, Website:
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 Krka
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 packaging 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.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto,
Slovenia
This leaflet was last revised in 02/2017

6. Contents of the pack and other information

What Tadalafil Krka contains
• The active substance is tadalafil. Each film-coated tablet
contains 2.5 mg tadalafil.
• The other ingredients are: hypromellose phtalate, mannitol,
croscarmellose sodium, sodium laurilsulfate, magnesium
stearate (E572), lactose monohydrate (See section 2 “ Tadalafil
Krka contains lactose”), hypromellose, talc (E553b), titanium
dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)
and triacetin (E1518).
What Tadalafil Krka looks like and contents of the pack
Tadalafil Krka 2.5 mg film-coated tablets (tablets) are: light orange,
round, slightly biconvex, film-coated tablets with bevelled edges.
Tablet diameter: approximately 5 mm.
Tadalafil Krka is available in boxes containing 2, 4, 8, 12, 14, 28,
56 and 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.
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NA. TADALAFIL 2,5mg tbl GB druga stran

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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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