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TADALAFIL KRKA 20 MG FILM COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL

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NA.TADALAFIL KRKA FOT 20 MG GB prva stran

"HIflIllifi

Package leaflet: Information for the patient

Tadalafil Krka 20 mg

70 mm ± 0,5 mm

smer branja kode

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 Krka 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

1. What Tadalafil Krka is and what it is used for
Tadalafil Krka 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 Krka contains the active substance tadalafil which
belongs to a group of medicines called phosphodiesterase type 5
inhibitors. 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.

• 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.

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Krka.

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 90 days.
• 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”.

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 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 is not intended for use by women.
Children and adolescents
Tadalafil Krka is not intended 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 (used to treat benign prostatic
hyperplasia).
• medicines such as ketoconazole tablets (to treat fungal
infections) and protease inhibitors for the treatment of AIDS or
HIV infection.
• phenobarbital, phenytoin and carbamazepine (anticonvulsant
medicines).
• rifampicin, erythromycin, clarithromycin or itraconazole.
• 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
driving or using any machinery.
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 if you are not sure.
Tadalafil Krka tablets are for oral use in men only. Swallow the
tablet whole with some water. The tablets can be taken with or
without food.

70 mm ± 0,5 mm

CONFIDENTIAL

- PMS-433U-KRKA

The recommended starting dose is 10 mg before sexual activity.
This dose can be administered either as one 10 mg tablet or by
dividing one 20 mg tablet into equal halves.
However, you have been given the dose of one 20 mg tablet if
your doctor has decided that the recommended dose of 10 mg is
too weak.
You may take Tadalafil Krka at least 30 minutes before sexual
activity.
Tadalafil Krka may still be effective up to 36 hours after taking the
tablet.
Do not take Tadalafil Krka more than once a day.
Tadalafil Krka 10 mg and 20 mg are intended for use prior to
anticipated sexual activity and is not recommended for
continuous daily use.

iKRKk
Emb. mat.: NA.TADALAFIL KRKA FOT
20 MG GB
Izdelal: D. Primc
Datum: 14.06.2017

"HIM"
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Leaflet folded on middle with visibly first side (title);
PhC that comes out of the middle of leaflet must be visible!

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DPMockUp065205_2

smer branja kode
130 mm ± 0,5 mm

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.

Other side effects have been reported:

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.

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,
prolonged erection, 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).

If you take more Tadalafil Krka 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 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).

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.

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 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 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.

What Tadalafil Krka looks like and contents of the pack
Tadalafil Krka 20 mg film-coated tablets (tablets) are: brown
yellow, biconvex, oval, film coated tablets, scored on one side and
with sign 20 on the other side. The tablet can be divided into equal
doses. Tablet dimensions: approximately 14 mm long and 9.5 mm
wide.

5. How to store Tadalafil Krka

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.

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.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto,
Slovenia
This leaflet was last revised in 06/2017

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 Krka contains
• The active substance is tadalafil.
Each film-coated tablet contains 20 mg tadalafil.
• The other ingredients are: hypromellose phtalate, mannitol,
croscarmellose sodium, sodium laurilsulfate, magnesium
stearate (E572), lactose monohydrate, hypromellose, talc
(E553b), titanium dioxide (E171), yellow iron oxide (E172) and
triacetin (E1518).
• See section 2 “ Tadalafil Krka contains lactose”.
XXXXXX

NA.TADALAFIL KRKA FOT 20 MG GB druga stran

"MInI"
smer branja kode

130 mm ± 0,5 mm

CONFIDENTIAL

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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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