Package leaflet: Information for the patient

Akyris, 5 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Akyris is and what it is used for
Important information before taking Akyris
How to take Akyris
Possible side effects
How to store Akyris
Contents of the pack and other information

1. What Akyris is and what it is 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 in the treatment of adult men with:

Erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse. Following sexual stimulation, tadalafil helps widen the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil does not benefit men who do not have erectile dysfunction. It is important to understand 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 medication for erectile dysfunction.
Urinary symptoms caused by a common condition known as benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before using Akyris

When not to use Akyris

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), known 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). PDE5 inhibitors such as tadalafil have been shown to 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 treatment with Akyris, discuss this with your doctor.
Please remember that sexual activity involves a possible risk for patients with heart disease, as it places additional strain on the heart. If heart problems are present, inform your doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before starting treatment with Akyris for symptoms of benign prostatic hyperplasia.
Akyris is not used in the treatment of prostate cancer.
Before taking this medicine, the patient should inform the doctor if any of the following apply:

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

It is not known whether Akyris is effective in patients:

after pelvic surgery.
after total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If sudden vision deterioration or sudden vision loss occurs, or if vision becomes distorted or blurred during treatment with Akyris, stop taking Akyris immediately and contact a doctor without delay.
In some patients taking tadalafil, worsening 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 Akyris immediately and contact a doctor without delay.
Akyris is not intended for use in women.
Children and adolescents
Akyris is not intended for use in children and adolescents under 18 years of age.
Akyris with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Akyris if you are using nitrates.
Akyris may affect the action of certain medicines or other medicines may affect the action of Akyris. Tell your doctor or pharmacist if you are taking any of the following medicines:

alpha-adrenergic receptor blockers (used to treat high blood pressure or urinary symptoms due to 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 (antiepileptic medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Taking Akyris with food, drink, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Akyris, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Akyris was administered to dogs, a reduction in sperm production in the testes was observed.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and using machines
In clinical trials, some men taking Akyris reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Akyris contains lactose and sodium
If the patient has an intolerance to certain sugars, they should consult their doctor before starting treatment.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Akyris

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Akyris tablets are intended for oral use in men only. The tablets should be swallowed
with a small amount of water. Akyris tablets may be taken with or without food.
If the required dose cannot be achieved using Akyris, another available medicine containing tadalafil should be used instead.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken or plans to take Akyris,
large amounts of alcohol (blood alcohol concentration of 0.08% or higher) should be avoided, as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
Recommended dose: One 5 mg tablet taken once daily, approximately at the same time each day.
The doctor may adjust the dose to 2.5 mg depending on the patient's response to Akyris.
In such case, a tablet containing 2.5 mg of tadalafil should be used.
Akyris should not be taken more than once per day.
Taking Akyris once daily allows achieving an erection following sexual stimulation
at any time within 24 hours. Daily use of Akyris may be beneficial for men who plan to engage in sexual activity two or more times per week.
It is important to understand that Akyris 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.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of signs and symptoms of benign prostatic hyperplasia
The recommended dose is one 5 mg tablet taken once daily, approximately at the same time each day.
If a patient has both benign prostatic hyperplasia and erectile dysfunction, the recommended dose remains one 5 mg tablet once daily.
Akyris must not be taken more than once per day.

Use of a higher than recommended dose of Akyris
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Akyris
Take the missed dose as soon as you remember. Do not take a double dose to make up for the missed tablet.
Akyris should not be taken more than once per day.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the adverse reactions listed below occur, stop taking the
medicine and seek immediate medical advice:

allergic reactions, including rash (not common).
chest pain – do not take nitrates, but seek immediate medical help (not common).
priapism, prolonged and possibly painful erection after taking Akyris (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden loss of vision (rare), distorted, blurred, or impaired central vision, or sudden decrease in vision (frequency not known). Other reported adverse reactions:

Common (affects 1 to 10 out of 100 patients)

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

Not common (affects 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, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (affects 1 to 10 out of 10,000 patients)

fainting, seizures, transient loss of memory, 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 patients
had pre-existing heart problems before starting treatment with 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 characterised by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
distorted, blurred, or impaired central vision or sudden decrease in vision (frequency not known).

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

5. How to store Akyris

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer cardboard
package 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. This will help protect
the environment.

6. Contents of the pack and other information

What Akyris contains

The active substance is tadalafil. Each coated tablet contains 5 mg of tadalafil.
Other ingredients are:
Tablet core: monohydrate lactose, pregelatinized starch (corn), anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
Coating: hypromellose 2910, monohydrate lactose, 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 the imprint '5' on one side and smooth on the other side, approximately 10 mm x 6 mm in size.
Packaged in blisters made of PVC/Aclar (PCTFE)/aluminum, contained in cardboard boxes.
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 further information about this medicine, please contact the local 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