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TADALAFIL KAPPLER PHARMA 5 MG FILM-COATED TABLETS

Active substance(s): TADALAFIL / TADALAFIL

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

1.

What Tadalafil Kappler Pharma is and what it is used for

Tadalafil Kappler Pharma contains the active substance tadalafil which belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Kappler Pharma 5 mg is used to treat adult men with:
erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable
for sexual activity. Tadalafil Kappler Pharma has been shown to significantly improve
the ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation Tadalafil Kappler Pharma 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 Kappler Pharma will not help you if you do not have erectile dysfunction. It is
important to note that Tadalafil Kappler Pharma for the treatment of erectile dysfunction
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.

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2.

urinary symptoms associated with a common condition called benign prostatic hyperplasia.
This is when the prostate gland gets bigger with age. Symptoms include difficulty in
starting to pass water, a feeling of not completely emptying the bladder and a more
frequent need to pass water even at night. Tadalafil Kappler Pharma improves blood flow
to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of
benign prostatic hyperplasia. Tadalafil Kappler Pharma has been shown to improve these
urinary symptoms as early as 1-2 weeks after starting treatment.

What you need to know before you take Tadalafil Kappler Pharma
Do not take Tadalafil Kappler Pharma if you:

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are allergic to tadalafil 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 Kappler Pharma hasbeen shown to increase the effects of these medicines. If you
are taking any form of nitrate or are unsure tell your doctor.

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have serious heart disease or recently had a heart attack within the last 90 days.

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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”.

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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 Kappler Pharma, have beenshown 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 Kappler Pharma.
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.
Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor
will check you for prostate cancer before starting treatment with Tadalafil Kappler Pharma for
benign prostatic hyperplasia. Tadalafil Kappler Pharma does not treat prostate cancer.
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 Kappler Pharma 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 Kappler Pharma and
contact your doctor immediately.
Tadalafil Kappler Pharma is not intended for use by women.
Children and adolescents
Tadalafil Kappler Pharma is not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil Kappler Pharma

Tell your doctor if you are taking, have recently taken or might take any other medicines
Do not take Tadalafil Kappler Pharma if you are already taking nitrates.
Some medicines may be affected by Tadalafil Kappler Pharma or they may affect how well
Tadalafil Kappler Pharma will work. Tell your doctor or pharmacist if you are already taking:
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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 Kappler Pharma with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil
Kappler Pharma 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 Kappler Pharma in clinical studies have reported dizziness. Check
carefully how you react to the tablets before driving or using machines.
Tadalafil Kappler Pharma contains lactose:
If you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

How to take Tadalafil Kappler Pharma

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Tadalafil Kappler Pharma tablets are for oral use in men only. Swallow the tablet whole with
some water. The tablets can be taken with or without food.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to
take CIALIS, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may
increase the risk of dizziness when standing up.
For the treatment of erectile dysfunction
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 Kappler
Pharma. This will be given as a 2.5mg tablet.
Do not take Tadalafil Kappler Pharma more than once a day.

When taken once a day Tadalafil Kappler Pharma allows you to obtain an erection, when sexually
stimulated, at any time point during the 24 hours of the day. Once a day dosing of Tadalafil
Kappler Pharma may be useful to men who anticipate having sexual activity two or more times per
week.
It is important to note that Tadalafil Kappler Pharma 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.
For the treatment benign prostatic hyperplasia
The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the
day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg
tablet taken once a day.
Do not take Tadalafil Kappler Pharma more than once a day.
If you take more Tadalafil Kappler Pharma than you should
Contact your doctor. You may experience side effects described in section 4.
If you forget to take Tadalafil Kappler Pharma
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 Kappler Pharma 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).
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chest pain - do not use nitrates but seek immediate medical assistance (frequency
uncommon).

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prolonged and possibly painful erection after taking Tadalafil Kappler Pharma (frequency
rare). If you have such an erection, which lasts continuously for more than 4 hours you
should contact a doctor immediately.

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sudden loss of vision (frequency rare).

Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
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, 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)

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fainting, seizures and 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), 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
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 Kappler Pharma

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.
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 Kappler Pharma contains
The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium,
hydroxypropylcellulose, cellulose, microcrystalline, sodium laurilsulfate, magnesium
stearate.
Film-coat Opadry II Yellow 32K220031: hydroxypropyl methyl cellulose, lactose
monohydrate, titanium dioxide (E171), triacetin, iron oxide yellow (E172), talc.

What Tadalafil Kappler Pharma looks like and contents of the pack
Tadalafil Kappler Pharma 5 mg is a yellow coloured, oval shaped, one side scored and other side
debossed with “T 5” biconvex film coated tablet of 8.70 x 4.50 mm. The tablet can be divided into

equal doses.
Tadalafil Kappler Pharma 5 mg is available in blister packs containing 14, 28 or 84 film-coated
tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Kappler Pharma Consult GmbH
Fonyoder Straße 18
89340 Leipheim
Deutschland
Tel.: +49 8221 9160 330
Fax.: +49 8221 9160 339

Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany
Tel.: +49 30 71094-4200
Fax: +49 30 71094-4250

This leaflet was last revised in June 2017
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu

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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