Akiris

Leaflet attached to the packaging: patient information

Akyris, 5 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, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Akyris and what is it used for
• 2. Important information before taking Akyris
• 3. How to take Akyris
• 4. Possible side effects
• 5. How to store Akyris
• 6. Contents of the pack and other information

1. What is Akyris and what is it used for

Akyris contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Akyris, 5 mg is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get or keep an erection that is sufficient for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to get an erection. After sexual stimulation, tadalafil helps to relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadalafil does not help patients who do not have erectile dysfunction. It is important to note that tadalafil used to treat erectile dysfunction 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 an erectile dysfunction medicine.
• symptoms of benign prostatic hyperplasia. This is when the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, feeling like the bladder is not completely empty, and needing to urinate more often, even at night. Tadalafil improves blood flow and relaxes the muscles in the prostate and bladder, which can help to alleviate the symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms after 1-2 weeks of treatment.

2. Important information before taking Akyris

When not to take Akyris

• 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 "stroke of the eye".
• 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 phosphodiesterase type 5 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 Akyris, you should discuss this with your doctor. You should remember that sexual activity carries a possible risk for patients with heart disease because it puts extra strain on the heart. If you have problems with your heart, you should tell your doctor. Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will check for prostate cancer before you start taking Akyris to treat benign prostatic hyperplasia. Akyris is not for the treatment of prostate cancer. Before taking Akyris, you should tell your doctor if you have:

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

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

• had pelvic surgery.
• had their prostate removed (radical prostatectomy without nerve sparing).

If you experience sudden vision loss or sudden loss of vision, or distorted vision, stop taking Akyris and contact your doctor immediately. Some patients taking tadalafil have reported a decrease in hearing or sudden hearing loss. Although it is not known if this event is directly related to tadalafil, if you experience a decrease in hearing or sudden hearing loss, stop taking Akyris and contact your doctor immediately. Akyris is not intended for use by women.

Children and adolescents

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

Akyris and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. Do not take Akyris if you are taking nitrates. Akyris may affect the way some other medicines work, or other medicines may affect the way Akyris works. Tell your doctor or pharmacist if you are taking:

• alpha-blockers (used to treat high blood pressure or symptoms of 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 (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.

Taking Akyris with food, drink, and alcohol

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

Fertility

When tadalafil was given to dogs, it caused a decrease in sperm production in the testes. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

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

Akyris contains lactose and sodium

If you have an intolerance to some sugars, you should contact your doctor before taking Akyris. The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially "sodium-free".

3. How to take Akyris

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Akyris tablets are for oral use only in men. The tablets should be swallowed with a small amount of water. The tablets can be taken with or without food. If the prescribed dose cannot be achieved with Akyris, another available medicine containing tadalafil should be used. If you have taken Akyris or plan to take it, you should not drink large amounts of alcohol (blood alcohol level of 0.08% or more), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg, depending on your response to Akyris. You should then take a 2.5 mg tablet of tadalafil. Do not take Akyris more than once a day. Taking Akyris once a day allows you to get an erection after sexual stimulation at any time of the day. Taking Akyris once a day may be beneficial for men who plan to have sexual activity twice a week or more often. It is important to note that Akyris 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 an erectile dysfunction medicine. Drinking alcohol may affect your ability to get an erection.

Treatment of symptoms of benign prostatic hyperplasia

Recommended dose is one 5 mg tablet, taken once a day, at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose of one 5 mg tablet, taken once a day, remains the same. Do not take Akyris more than once a day.

Take more Akyris than prescribed

Tell your doctor. You may experience side effects described in section 4.

Miss a dose of Akyris

Take the dose as soon as you remember. Do not take a double dose to make up for a forgotten tablet. Do not take Akyris more than once a day. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Akyris can cause side effects, although not everybody gets them.

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

• allergic reactions, including rashes (not very common).
• chest pain - do not take nitrates, but seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Akyris (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 decreased vision (frequency not known). Other reported side effects:

Common (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

• 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 (affects 1 to 10 users in 10,000)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden decrease or loss of hearing, hives (itchy, red bumps on the skin), penile bleeding, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these patients 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, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted, blurred, or decreased vision (frequency not known).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Akyris

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 blister and carton 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. This will help protect the environment.

6. Contents of the pack and other information

What Akyris contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, colloidal anhydrous silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Akyris looks like and contents of the pack

Light yellow, oval, film-coated tablets, with "5" engraved on one side, and plain on the other side, approximately 10 mm x 6 mm in size. Packaged in PVC/Aclar (PCTFE)/aluminium blisters in a cardboard box. Pack sizes: 14 and 28 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Special Product’s Line S.p.A., Vita Fratta Rotonda Vado Largo 1, 03012 Anagni (FR), Italy

For more information about this medicine, contact the representative of the marketing authorisation holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, Tel. +48 (22) 375 92 00

Date of last revision of the leaflet: