Akiris

Leaflet accompanying the packaging: patient information

Akyris, 10 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 any 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 is used to treat adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance.
It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.
Akyris contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Akyris helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection improves. Akyris does not help patients who do not have erectile dysfunction.
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 erectile dysfunction medication.

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 effects 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 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.
It should be remembered that sexual activity is associated with a possible risk to 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 Akyris, 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 deformity of the penis
• severe liver disease
• severe kidney disease.

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

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

If you experience sudden loss of vision or sudden loss of hearing, or blurred vision, during treatment with Akyris, you should stop taking Akyris 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 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

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
You should 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. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-adrenergic blocking agents (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 in tablets (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 on 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 administered to dogs, a decrease in sperm production in the testes was observed. 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 directed by your doctor. If you are unsure, you should 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.
Recommended doseis one 10 mg tablet, taken before planned sexual activity.
If this dose is not effective, your doctor may increase the dose to 20 mg.
Akyris tablets are for oral use.
Akyris can be taken at least 30 minutes before planned sexual activity.
Akyris may still be effective up to 36 hours after taking the tablet.
You should not take Akyris more than once a day. Akyris 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis.
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 erectile dysfunction medication.
Consuming alcohol may affect your ability to achieve an erection and may cause a temporary decrease in blood pressure. If you have taken Akyris or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or more), as this may increase the risk of dizziness when standing up.

Taking more Akyris than recommended

You should inform your doctor. Side effects (see section 4) may occur.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 rash (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, seek medical help immediately.
• sudden loss of vision (rare), blurred vision, or loss of 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 hearing loss, or blurred vision (frequency not known).

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.
In men taking tadalafil, several additional rare side effects have been reported, including:

• migraine, face swelling, severe allergic reactions causing face and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina, and sudden cardiac death
• blurred vision, or loss of 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 any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported 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. Side effects can be reported 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 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 10 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate, maize 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 "10" engraved on one side, smooth on the other, approximately 11 mm x 7 mm in size.
Packaged in PVC/Aclar (PCTFE)/Aluminium blisters in a cardboard box.
Available pack sizes: 2, 4, and 8 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 further information on this medicine, please 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: