Package leaflet: Information for the user

Tadulan, 5 mg, coated tablets
Tadalafil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
Speak to your doctor or pharmacist if you have any doubts.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Tadulan is and what it is used for

Tadulan contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadulan is used in the treatment of adult men:

with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection.

Following sexual stimulation, Tadulan helps widen the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erection.
Tadulan does not benefit men who do not have erectile dysfunction. It is important to understand that Tadulan does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.

for lower urinary tract symptoms associated with benign prostatic hyperplasia, a common condition also known as enlarged prostate. This is a condition in which the prostate gland enlarges with age. Symptoms include difficulty starting urination, feeling of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadulan improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil reduces these urinary symptoms within 1–2 weeks of starting treatment.

2. Important information before using Tadulan

When not to use Tadulan

if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6)
if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines (nitrates) used to treat angina (chest pain). It has been shown that tadalafil enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor
if the patient has severe heart disease or has had a heart attack within the last 90 days
if the patient has had a stroke within the last 6 months
if the patient has low blood pressure or uncontrolled high blood pressure
if the patient has ever experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION), also referred to as "eye stroke"
if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as tadalafil have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting to take Tadulan, consult a doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If there are any heart problems, inform the doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before starting treatment with Tadulan.
Tadulan is not used in the treatment of prostate cancer.
Before taking the medicine, the patient should inform the doctor if any of the following conditions apply:

sickle cell anaemia (abnormal shape of red blood cells)
multiple myeloma (a tumour of the bone marrow)
leukaemia (a blood cell cancer)
any deformity of the penis
severe liver disease
severe kidney disease

It is not known whether Tadulan is effective in patients:

who have undergone pelvic surgery
who have undergone total or partial removal of the prostate gland with nerve-sparing procedures severed (nerve-sparing radical prostatectomy)

If sudden worsening of vision or sudden vision loss occurs, stop taking Tadulan and contact a doctor immediately.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden hearing impairment occurs, stop taking Tadulan and contact a doctor immediately.
Tadulan is not intended for use in women.
Children and adolescents
Tadulan is not intended for use in children and adolescents under 18 years of age.
Tadulan with other medicines
Tell the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take Tadulan if you are using nitrates.
Tadulan may affect the action of certain medicines, or other medicines may affect the action of Tadulan. Inform the doctor or pharmacist if you are taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia)
other medicines used to treat high blood pressure
riociguat
5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia)
medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines)
rifampicin, erythromycin, clarithromycin, or itraconazole
other treatments for erectile dysfunction.

Tadulan, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadulan, and therefore caution should be exercised when consuming it. For further information, consult a doctor.
Fertility
In animal studies, a reduction in sperm production in the testes was observed. Reduced sperm count has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
During clinical trials, dizziness was reported in some men taking tadalafil. Patients should be aware of how they react to the tablets before deciding to drive or operate machinery.
Tadulan contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Tadulan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tadulan

This medicine should always be taken exactly as your doctor has advised. If in doubt, consult your
doctor or pharmacist.
Method of administration
Tadulan tablets are intended for oral use only in men. Swallow the tablet whole with a small amount
of water. The tablet may be taken with or without food.
Do not take Tadulan more than once a day.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken or
plans to take Tadulan, large amounts of alcohol (e.g. more than 900 ml of beer or 350 ml of wine)
should be avoided, as this may increase the risk of dizziness upon standing.
Treatment of erectile dysfunction
Dosage
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each
day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadulan. In such
case, use the 2.5 mg tablet.
Not all dosage recommendations may be achievable using only 5 mg tablets; tadalafil is also available
in 2.5 mg, 10 mg, and 20 mg tablets. Tadalafil may not be commercially available in all of these
strengths.
Note
Taking Tadulan once daily allows an erection to occur in response to sexual stimulation at any time
within 24 hours. Taking Tadulan once daily may be beneficial for men who plan to engage in sexual
activity twice a week or more frequently.
It is important to understand that Tadulan does not work in the absence of sexual stimulation. The
patient and his partner should engage in foreplay, just as they would if the patient were not taking
an erectile dysfunction medicine.
Alcohol consumption may also affect the patient's ability to achieve an erection.
Treatment of signs and symptoms of benign prostatic hyperplasia
Dosage
The dose is one 5 mg tablet taken once daily at approximately the same time each day.
If a patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains one
5 mg tablet once daily.
Taking more Tadulan than prescribed
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Tadulan
Take the missed dose as soon as you remember, but do not take a double dose to make up for the
missed tablet. Do not take Tadulan more than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the
medicine and seek immediate medical advice:

allergic reactions, including rash (uncommon)
chest pain – do not take nitrates, seek immediate medical help (uncommon)
priapism, a prolonged and possibly painful erection after taking Tadulan (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately
sudden loss of vision (rare)

Other reported adverse reactions
Common (may occur in up to 1 in 10 people):

headache
back pain
muscle pain
pain in hands and feet
facial flushing
nasal congestion
indigestion

Uncommon (may occur in up to 1 in 100 patients):

dizziness
abdominal pain
nausea
vomiting
reflux
blurred vision
eye pain
difficulty breathing
presence of blood in urine
prolonged erection
palpitations
rapid heartbeat
high blood pressure
low blood pressure
nosebleeds
ringing in the ears
swelling of hands, feet, ankles
feeling of fatigue

Rare (may occur in up to 1 in 1,000 patients):

fainting
seizures
transient memory loss
eyelid swelling
eye redness
sudden worsening or loss of hearing
urticaria (itchy, red skin swellings)
penile bleeding
presence of blood in semen
increased sweating

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
pre-existing heart problems before starting treatment with this medicine.
There have been rare reports of cases of partial, transient or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions
have been reported that were not observed during clinical trials. These include:

migraine
facial swelling
severe allergic reaction causing swelling of the face or throat
severe skin rashes
disorders characterized by blood flow to the eyes
irregular heartbeat
angina pectoris
sudden cardiac death

Dizziness has been reported more frequently in men over 75 years of age taking tadalafil.
Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tadulan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after the words
Expiry date (EXP). The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tadulan contains

The active substance is tadalafil. One coated tablet contains 5 mg of tadalafil.
The other ingredients are:
Tablet core
Monohydrate lactose
Sodium croscarmellose
Sodium lauryl sulfate
Hydroxypropylcellulose
Polysorbate 80
Microcrystalline cellulose
Magnesium stearate
Tablet coating
Hypromellose
Monohydrate lactose
Titanium dioxide (E 171)
Triacetin
Yellow iron oxide (E 172)
Talc

What Tadulan looks like and contents of the pack
Light yellow, round, biconvex coated tablets with a diameter of 6.1 ± 0.2 mm.
The medicine is available in unit dose blisters containing 14x1 and 28x1 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Netherlands Tadulan
Slovakia Tadulan
Hungary Tadulan