Tadalafil Egis

Package Leaflet: Information for the Patient

Tadalafil Egis, 10 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as 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 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 inform 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 used to treat adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Egis has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity. Tadalafil Egis contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Egis works by helping the blood vessels in your penis to relax and increase blood flow into the penis. The result is improved erectile function. Tadalafil Egis will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Egis does not work if there is no 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 any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.

If you are taking any form of nitrate or are unsure, tell your doctor.

• if you 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 due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, increase the effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions

Before taking Tadalafil Egis, talk to your doctor. You should be aware that sexual activity carries a risk for patients with heart disease because it puts extra strain on your heart. If you have a heart condition, tell your doctor. Before taking the tablets, tell your doctor if you have:

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

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

• had pelvic surgery.
• had prostate removal (prostatectomy) in which the nerve endings of the prostate were cut (radical prostatectomy without nerve sparing).

If you experience any of the following side effects, stop taking Tadalafil Egis and contact your doctor immediately: sudden loss of vision, blurred vision, or loss of hearing. 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.

Tadalafil Egis with other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take. Do not take Tadalafil Egis if you are taking nitrates. Tadalafil Egis may affect the way some medicines work, and some medicines may affect the way Tadalafil Egis works. 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 benign prostatic hyperplasia).
• 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 in section 3. Grapefruit juice may affect the efficacy of Tadalafil Egis, and therefore, caution should be exercised when consuming grapefruit juice. For more information, ask your doctor.

Fertility

When given to dogs, a decrease in sperm production 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. Therefore, 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, contact your doctor before taking this medicine.

Tadalafil Egis contains sodium

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

3. How to take Tadalafil Egis

Always take this medicine exactly as your doctor has told you. If you are not sure, check with 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 doseis one 10 mg tablet taken before sexual activity. If the effect is too weak, your doctor may increase the dose to 20 mg. Tadalafil Egis tablets are for oral use only. You may take Tadalafil Egis at least 30 minutes before sexual activity. Tadalafil Egis may still be effective 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 before anticipated sexual activity and is not recommended for continuous daily use. It is important to note that Tadalafil Egis does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Drinking alcohol may impair your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Egis, do not exceed drinking moderate amounts of alcohol (blood alcohol level of 0.08% or greater), as this may increase the risk of dizziness when standing up.

Taking more than the recommended dose of Tadalafil Egis

Inform your doctor. You may experience side effects described in section 4. If you have any further questions on the use of this medicine, 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 normally mild to moderate.

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

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

Other reported side effects:

Common(seen in 1 to 10 in every 100 patients)

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

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

• fainting, seizures, temporary memory loss, swelling of the eyelids, redness of the eyes, sudden loss of hearing, or loss of vision (frequency not known).

Heart attack and stroke have been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease. There have been reports of rare cases of partial, temporary, or permanent loss of vision in one or both eyes. In men taking tadalafil, several additional rare side effects have been reported, including:

• migraine, face 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, sudden cardiac death.
• blurred vision, or loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Medicinal Product Agency’s website. 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 which is 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 10 mg of tadalafil.
• The other ingredients are: Core: lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate.

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 10 mg is a yellow, elongated tablet with the marking “T 10” on one side, approximately 10.7 mm in length and 5.5 mm in width. Tadalafil Egis is available in aluminum/aluminum or PVC/PVDC/aluminum blisters in cardboard boxes containing 1, 2, 4, 8, 10, 12, or 24 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer/Importer:

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

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

France (RMS): Tadalafil Egis 10 mg, comprimés pelliculés
Hungary: Tadalafil Egis 10 mg, filmtabletta
Poland: Tadalafil Egis, 10 mg, film-coated tablets
For more information on this medicine, contact the local representative of the Marketing Authorization Holder:

EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00

Date of last revision of the leaflet