Tadulan

Package leaflet: Information for the user

Tadulan, 20 mg, film-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 contact your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not give it 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, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Tadulan is and what it is used for
2. Important information 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 is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection.

After 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 patients who do not have erectile dysfunction. It is important to understand that Tadulan does not work without 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 Tadulan, consult a doctor.
Please note that sexual activity involves some risk for patients with heart conditions, as it places additional strain on the heart. If there are any heart problems, inform the doctor.
Before taking Tadulan, the patient should inform their doctor if any of the following conditions apply:

• sickle cell anaemia (abnormal shape of red blood cells)
• multiple myeloma (a bone marrow cancer)
• leukaemia (a blood cell cancer)
• any penile deformity
• 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-sparing techniques (nerve-sparing radical prostatectomy)

If sudden vision loss or sudden decrease in vision occurs, stop taking Tadulan and contact a doctor immediately.
In some patients taking tadalafil, decreased hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if decreased hearing 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 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 taking nitrates.
Tadulan may affect the action of certain medicines or other medicines may affect the action of Tadulan. Inform the doctor or pharmacist if 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 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 therefore be exercised when consuming it. For more information, consult a doctor.
Fertility
In animal studies, reduced 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 using machines
In clinical trials, some men taking tadalafil reported dizziness. Therefore, patients 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 an 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended starting dose is one 10 mg tadalafil tablet taken before planned sexual activity.
If your doctor finds that the recommended dose of one 10 mg tablet is too weak, you will be given a dose of one 20 mg tablet.
It is not possible to achieve all dosing recommendations using only 20 mg tablets; tadalafil is also available in 2.5 mg, 5 mg, and 10 mg tablets. 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; to do so, press the tablet with one finger against a hard surface to break it in half.
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 is intended for use before planned sexual activity. Regular, daily use of the medicine is not recommended.
Warning
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 when the patient is 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 not consume 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.
Use of a higher than recommended dose of Tadulan
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• allergic reactions, including rash (uncommon)
• chest pain – do not take nitrates, seek immediate medical help (uncommon)
• priapism, 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 arms and legs
• facial flushing
• nasal mucosa 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 duration of 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 raised areas on the skin surface)
• bleeding from the penis
• presence of blood in semen
• increased sweating

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
heart problems before starting treatment with this medicine.
There are rare reports of cases of partial, transient or permanent
visual impairment or loss of vision in one or both eyes.
In men taking tadalafil, a few 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 rash
• disorders manifested 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, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

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.
No special storage conditions are required for this medicine.
Divided tablets should not be used after 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This 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 20 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 film-coated tablets with a score line on both sides, with a white cross-section and a diameter of 10.1 ± 0.2 mm. The tablets can be divided into equal doses.
The medicine is available in unit dose blisters containing 2x1, 4x1, 8x1 and 12x1 film-coated tablets.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Netherlands Tadulan
Romania Tadulan 20 mg comprimate filmate
Slovakia Tadulan
Hungary Tadulan