Tadulan

Package leaflet: Information for the user

Tadulan, 10 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.
• Please talk to your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Tadulan is and what it is used for
2. What you need to know before taking Tadulan
3. How to take Tadulan
4. Possible side effects
5. How to store Tadulan
6. 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 help patients 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.

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, e.g. 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 known 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 treatment with Tadulan, consult a doctor.
Please note 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.
Before taking the medicine, the patient should inform the doctor if any of the following apply:

• sickle cell anaemia (abnormal shape of red blood cells)
• multiple myeloma (a bone marrow cancer)
• 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:

• after pelvic surgery
• after total or partial removal of the prostate gland with nerve damage (non-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 worsening or sudden hearing loss 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 and other medicines
Tell the doctor about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
Do not take Tadulan if taking nitrates.
Tadulan may affect the action of certain medicines or other medicines may affect the action of Tadulan. Tell the doctor or pharmacist if taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or urinary symptoms due to 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 ketoconazole tablets (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 caution should be exercised when consuming it. For more information, consult a doctor.
Fertility
In animal studies, a reduction in sperm production in the testes was observed. A decrease in sperm count has been observed in some men. It is unlikely that this would lead to infertility.
Driving and using machines
Dizziness has been reported in some men taking tadalafil during clinical trials. The patient should understand 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 their 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 as directed by a doctor. If in doubt, consult a doctor or pharmacist.

Dosage
The recommended starting dose is one tablet containing 10 mg of tadalafil, taken prior to planned sexual activity. If this dose is not sufficient, the doctor may increase the dose to 20 mg.
It may not be possible to follow all dosage recommendations using only 10 mg tablets; tadalafil is also available in tablets of 2.5 mg, 5 mg, and 20 mg. Tadalafil may not be commercially available in all of these strengths.

Method of administration
Tadulan tablets are intended for oral use only in men. Swallow the tablet with a small amount of water. The tablet may be taken with or without food.
The tablet may be divided into equal doses.

Tadulan may be taken at least 30 minutes before planned sexual activity. Tadulan may remain effective for up to 36 hours after taking the tablet.

Do not take Tadulan more than once a day. Tadulan 10 mg and 20 mg are intended for use prior to planned sexual activity. Regular, daily use of the medicine is not recommended.

Important information
It is important to be aware 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.

Alcohol consumption may also affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadulan, he should avoid consuming large amounts of alcohol (e.g., more than 900 ml of beer or 350 ml of wine), as this may increase the risk of dizziness upon standing.

Taking more than the recommended dose of Tadulan
Inform your doctor if this occurs. Adverse effects described in section 4 may occur.

If there are any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
These effects are usually mild or moderate.
If any of the adverse effects 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 effects
Common (may occur in up to 1 in 10 people):

• headache
• back pain
• muscle pain
• pain in arms and legs
• 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)
• rectal 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 conditions 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 effects
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 rash
• disorders characterized by blood flow to the eyes
• irregular heartbeat
• angina
• 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 effects
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 after the words
Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Divided tablets should not be used more than 4 weeks after splitting.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Tadulan contains

• The active substance is tadalafil. One coated tablet contains 10 mg of tadalafil.
• The other ingredients are:
  Tablet core
  Monohydrate lactose
  Sodium croscarmellose
  Sodium lauryl sulfate
  Hydroxypropylcellulose
  Polysorbate
  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
Yellow, round, biconvex, film-coated tablets with a dividing line on one side, white in cross-section, with a diameter of 8.1 ± 0.2 mm. The tablets may be divided into equal doses.
The medicine is available in unit dose blisters containing 4x1, 8x1, and 12x1 film-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 in the following names in the Member States of the European Economic Area:
Netherlands: Tadulan
Romania: Tadulan 10 mg comprimate filmate
Hungary: Tadulan