Tadalafil Egis

Leaflet accompanying the packaging: patient information

Tadalafil Egis, 20 mg, film-coated tablets

Tadalafil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tadalafil Egis and what is it used for
• 2. Important information 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 is Tadalafil Egis and what is it used for

Tadalafil Egis is a medicine for adult men with erectile dysfunction.
This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual activity. It has been shown that Tadalafil Egis significantly improves the ability to achieve an erection sufficient for satisfactory sexual activity.
Tadalafil Egis contains tadalafil, the active substance, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). After sexual stimulation, Tadalafil Egis helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, it helps to improve erectile function. Tadalafil Egis does not help patients who do not have erectile dysfunction.
It is important to note that Tadalafil Egis will not work without sexual stimulation.

2. Important information before taking Tadalafil Egis

When not to take Tadalafil Egis:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking organic nitrates or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effect of these medicines. If you are taking nitrates in any form or are unsure, you should tell your doctor.
• if you have severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke"
• if you are 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 you are taking riociguat or are unsure, you should tell your doctor.

Warnings and precautions

Before taking Tadalafil Egis, you should discuss this with your doctor.
It should be remembered that sexual activity carries a risk for patients with heart disease, as it puts an extra strain on the heart. If you have heart problems, you should tell your doctor.
Before taking the tablets, you should tell your doctor if you have any of the following:

• sickle-cell anaemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (blood cell cancer).
• any deformation of the penis.
• severe liver disease.
• severe kidney disease.

It is not known whether tadalafil is effective in patients who have:

• undergone pelvic surgery.
• had their prostate removed (prostatectomy).

If you experience sudden loss of vision or hearing, or if your vision is distorted, you should stop taking Tadalafil Egis and contact your doctor immediately.
In some patients taking tadalafil, a decrease in 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 you experience a decrease in hearing or sudden hearing loss, you should stop taking Tadalafil Egis and contact your doctor immediately.
Tadalafil Egis is not intended for use by women.

Children and adolescents

Tadalafil Egis is not intended for use by children and adolescents under 18 years of age.

Tadalafil Egis and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Tadalafil Egis if you are taking nitrates.
Tadalafil Egis may affect the way some other medicines work or other medicines may affect the way Tadalafil Egis works. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat an enlarged prostate).
• medicines such as ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Egis with food and drink

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Egis, and therefore, caution should be exercised when consuming it. For more information, you should ask your doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed. A decrease in sperm count has been observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking Tadalafil Egis during clinical trials reported dizziness, so you should be aware of how you react to the tablets before driving or operating machinery.

Tadalafil Egis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Tadalafil Egis contains sodium

The medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Tadalafil Egis

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Tadalafil Egis tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
The recommended starting doseis one 10 mg tablet before sexual activity. If the effect of the medicine is too weak, your doctor may increase the dose to 20 mg. Tadalafil Egis tablets are for oral use.
Tadalafil Egis tablets can be taken at least 30 minutes before sexual activity. Tadalafil Egis may still be effective up to 36 hours after taking the tablet.
You should not take Tadalafil Egis more than once a day.
Tadalafil Egis 10 mg and 20 mg is intended for use before planned sexual activity and is not recommended for continuous daily use.
It is important to remember 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.
Consuming alcohol may affect your ability to achieve an erection and may cause a temporary decrease in blood pressure. If you have taken Tadalafil Egis or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking more Tadalafil Egis than you should

You should inform your doctor. You may experience side effects as described in section 4.
If you have any further questions on the use of this medicine, you should 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 usually mild or moderate.

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

• allergic reactions, including skin rash (uncommon).
• chest pain - do not take nitrates, but seek medical help immediately (uncommon).
• priapism, prolonged and possibly painful erections after taking Tadalafil Egis (rare). If you experience such an erection, and it lasts for more than 4 hours, you should contact your doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or impaired vision (frequency not known).

Other reported side effects:
Common(seen in 1 to 10 in 100 patients)

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

Uncommon(seen in 1 to 10 in 1,000 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(seen in 1 to 10 in 10,000 patients)

• fainting, seizures, transient memory loss, swelling of the eyelids, redness of the eyes, sudden hearing loss, hives (itchy, red swellings on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before taking this medicine.
There have been reports of rare cases of partial, transient, or permanent decrease in vision or loss of vision in one or both eyes.
Men taking tadalafil have reported several additional rare side effects, which 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, blurred, or impaired vision (frequency not known).

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 side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of 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
You can also report side effects to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Egis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should 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 Tadalafil Egis contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

Tablet coating: Opadry yellow II 32K520101, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), talc, yellow iron oxide (E172).

What Tadalafil Egis looks like and contents of the pack

Tadalafil Egis 20 mg is a yellow, elongated tablet with the marking "T 20" on one side, approximately 13.5 mm long and 7.0 mm wide.
Tadalafil Egis is available in blisters of aluminium/aluminium or PVC/PVDC/aluminium, in cartons containing 1, 2, 4, 8, 10, 12, or 24 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer:

Interpharma Services Ltd.
43A Cherni Vrach Bvld
1407 Sofia
Bulgaria

This medicine is authorised in the Member States of the European Economic Area under the following names:

France (RMS): Tadalafil Egis 20 mg, film-coated tablets
Hungary: Tadalafil Egis 20 mg, film-coated tablets
Poland: Tadalafil Egis, 20 mg, film-coated tablets
For further information on this medicine, you should contact the local representative of the marketing authorisation holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet