Tadalafil durofil

Package leaflet: Information for the patient

Tadalafil Egis, 10 mg, film-coated tablets
Tadalafilum
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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Tadalafil Egis is and what it is used for
2. What you need to know before taking Tadalafil Egis
3. How to take Tadalafil Egis
4. Possible side effects
5. How to store Tadalafil Egis
6. Contents of the pack and other information

1. What Tadalafil Egis is and what it is used for

Tadalafil Egis is a medicine intended for adult men with erectile dysfunction.
This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil Egis has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.
Tadalafil Egis contains tadalafil, the active substance, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, Tadalafil Egis helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil Egis does not help patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil Egis will not work without 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.

2. Important information before taking Tadalafil Egis

When not to take Tadalafil Egis:

• 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 in the treatment of 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 ischemic optic neuropathy (NAION), referred to as "eye stroke".

• if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as tadalafil, 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 Tadalafil Egis, discuss this with your doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Before taking the tablets, the patient should inform the doctor if any of the following apply:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (a bone marrow cancer).
• leukemia (a blood cell cancer).
• any deformity of the penis.
• severe liver disease.
• severe kidney disease.

It is not known whether tadalafil is effective in patients:

• after pelvic surgery.
• after total or partial removal of the prostate gland, where nerves to the prostate are cut (non-nerve-sparing radical prostatectomy).

If during treatment with tadalafil sudden vision deterioration or sudden vision loss occurs, or the image appears distorted or dimmed, stop taking Tadalafil Egis and
contact a doctor immediately.
In some patients taking tadalafil, hearing deterioration 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 deterioration or sudden hearing loss occurs, stop taking Tadalafil Egis and
contact a doctor immediately.
Tadalafil Egis is not intended for use in women.
Children and adolescents
Tadalafil Egis is not intended for use in children and adolescents under 18 years of age.
Tadalafil Egis and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Tadalafil Egis if you are taking nitrates.
Tadalafil Egis may affect the action of certain medicines or other medicines may affect the action of Tadalafil Egis. Tell your 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 in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Egis with food and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Egis, and therefore caution should be exercised when consuming it. For more information, consult your doctor.
Fertility
When the medicine was administered to dogs, a reduction in sperm production in the testes occurred.
Reduced sperm count has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In some men taking Tadalafil Egis during clinical trials, dizziness was reported; therefore, patients should be aware of their response to the tablets before deciding to drive or operate machinery.
Tadalafil Egis contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
Tadalafil Egis contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Tadalafil Egis

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Tadalafil Egis tablets are intended for oral use only in men. Swallow the tablet whole with a small
amount of water. Tadalafil Egis tablets may be taken with or without food.
The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If the effect of
the medicine is too weak, your doctor may increase the dose to 20 mg. Tadalafil Egis tablets are
intended for oral administration.
Tadalafil Egis tablets may be taken at least 30 minutes before sexual activity. Tadalafil Egis may
remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Egis more than once a day.
Tadalafil Egis 10 mg and 20 mg is intended for use prior to planned sexual activity and is not
recommended for continuous daily use.
It is important to understand that Tadalafil Egis 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.
Drinking alcohol may 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 Tadalafil Egis, he should not
consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may
increase the risk of dizziness upon standing.
Taking more than the recommended dose of Tadalafil Egis
Inform your doctor immediately. Adverse effects described in section 4 may occur.
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 everybody will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop using the medicine
and seek immediate medical advice:

• allergic reactions, including rash (occurs uncommonly).
• chest pain – do not use nitrates, but seek immediate medical help (occurs uncommonly).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Egis (occurs rarely). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (occurs rarely), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 100 patients)

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon (observed in 1 to 10 out of 1,000 patients)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure,
  nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (observed in 1 to 10 out of 10,000 patients)

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

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
heart problems before starting this medicine.
There have been reports of rare cases of partial, transient or permanent visual impairment or
loss of vision 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 reactions causing swelling of the face and throat, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, sudden cardiac death,
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

The adverse reaction dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Egis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and
blister pack following: EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Tadalafil Egis contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other ingredients are: Tablet core: monohydrate lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

Tablet coating: Opadry yellow II 32K520101, hypromellose, monohydrate lactose,
titanium dioxide (E171), triacetin (E1518), talc, yellow iron oxide (E172).
What Tadalafil Egis looks like and contents of the pack
Tadalafil Egis 10 mg is a yellow, oblong tablet marked “T 10” on one side, approximately
10.7 mm in length and 5.5 mm in width.
Tadalafil Egis is available in blisters made of Aluminium/Aluminium or PVC/PVDC/Aluminium foil,
packaged in cardboard boxes containing 1, 2, 4, 8, 10, 12 or 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary
Manufacturer/Importer:
Interpharma Services Ltd.
43A Cherni Vrach Bvld
1407 Sofia
Bulgaria
This medicinal product is authorised in the European Economic Area countries under the following names:
France (RMS): Tadalafil Egis 10 mg, comprimés pelliculés
Hungary: Tadalafil Egis 10 mg, filmtabletta
Poland: Tadalafil Egis, 10 mg, tabletki powlekane
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00