Package leaflet: Information for the patient

Tadalafil MENSIL MED, 5 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Tadalafil MENSIL MED is and what it is used for

The active substance in Tadalafil MENSIL MED is tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil MENSIL MED 5 mg is intended for use 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 achieve an erection adequate for sexual activity. Following sexual stimulation, Tadalafil MENSIL MED helps widen the blood vessels of the penis, allowing increased blood flow into the penis. As a result, erectile function improves. Tadalafil MENSIL MED does not benefit patients who do not have erectile dysfunction. It is important to understand that Tadalafil MENSIL MED 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;
with urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, sensation of incomplete bladder emptying, and increased frequency of urination, even at night. Tadalafil MENSIL MED 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 Tadalafil MENSIL MED

When not to use Tadalafil MENSIL MED:

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, e.g. amyl nitrite. This is a group of medicines ("nitrates") used to treat 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 myocardial infarction (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, irregular heartbeat, or uncontrolled high blood pressure;
if the patient has ever experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION), also referred to 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 Tadalafil MENSIL MED, discuss this with your doctor.
Please note that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, your doctor will perform tests to rule out prostate cancer before starting treatment with Tadalafil MENSIL MED for symptoms of benign prostatic hyperplasia.
Tadalafil MENSIL MED is not used to treat prostate cancer.
Before taking this medicine, the patient should inform the doctor if any of the following apply:

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

It is not known whether tadalafil is effective in patients:

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

If sudden vision loss or sudden decrease in vision occurs while taking tadalafil, or if vision becomes blurred or distorted, stop taking Tadalafil MENSIL MED immediately and contact your doctor without delay.
In some patients taking tadalafil, worsening of hearing or sudden hearing loss has been observed.
Although it is not known whether these events are directly related to tadalafil use, if hearing loss or sudden decrease in hearing occurs, stop taking Tadalafil MENSIL MED and contact your doctor immediately.
Tadalafil MENSIL MED 5 mg is not intended for use in women.
Children and adolescents
Tadalafil MENSIL MED is not intended for use in children and adolescents under 18 years of age.
Tadalafil MENSIL MED and other medicines
Tell your doctor about all medicines you are currently using, have recently used, or plan to use.
Do not take Tadalafil MENSIL MED if you are using nitrates.
Tadalafil MENSIL MED may affect the action of certain medicines, or other medicines may affect the action of Tadalafil MENSIL MED. Inform your doctor or pharmacist if you are taking any of the following medicines:

alpha-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 symptoms of 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);
ritonavir, saquinavir, rifampicin, erythromycin, clarithromycin, or itraconazole;
other medicines used to treat erectile dysfunction.

Tadalafil MENSIL MED, food and alcohol
Information regarding the effect of alcohol is provided in section 3.
Grapefruit juice may affect the efficacy of Tadalafil MENSIL MED and caution should therefore be exercised when consuming it. For further information, consult your doctor.
Pregnancy, breastfeeding and fertility
Tadalafil MENSIL MED 5 mg is not intended for use in women.
When administered to dogs, the medicine caused a reduction in sperm production in the testes.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
Dizziness has been reported in some men taking tadalafil during clinical trials. Therefore, patients should understand how they react to the medicine before deciding to drive a car or operate machinery.
Tadalafil MENSIL MED contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Tadalafil MENSIL MED

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
Tadalafil MENSIL MED tablets are intended for use in men only. The tablet should be swallowed whole with a small amount of water. The tablets may be taken regardless of meals.
Alcohol consumption may cause a temporary decrease in blood pressure. If the patient has taken or plans to take Tadalafil MENSIL MED, 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 at approximately the same time each day. The physician may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil MENSIL MED. In such case, the 2.5 mg tablet should be used.
Tadalafil MENSIL MED should not be taken more frequently than once a day.
Taking Tadalafil MENSIL MED once daily allows achieving an erection following sexual stimulation at any time within 24 hours. Daily administration of Tadalafil MENSIL MED may be beneficial for men who plan to engage in sexual activity two or more times per week.
It is important to be aware that Tadalafil MENSIL MED 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 erectile dysfunction medication.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia
Dose: One 5 mg tablet taken once daily at approximately the same time each day. If the patient has both benign prostatic hyperplasia and erectile dysfunction, the dose

of one 5 mg tablet once daily remains unchanged. Tadalafil MENSIL MED must not be taken more frequently than once a day.

Use of a higher than recommended dose of Tadalafil MENSIL MED
If a higher than recommended dose has been taken, the doctor should be informed immediately. Adverse effects described in section 4 may occur.

Missed dose of Tadalafil MENSIL MED
Take the missed dose as soon as remembered, but do not take a double dose to make up for the missed tablet. Tadalafil MENSIL MED should not be taken more than once a day.
If there are any further questions about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine
and seek medical advice immediately:

allergic reactions, including rashes (uncommon);
chest pain – do not take nitrates, seek immediate medical help (uncommon);
priapism, a prolonged and possibly painful erection after taking Tadalafil MENSIL MED (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
sudden loss of vision (rare), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 100 patients):

headache, back pain, muscle pain, pain in arms and legs, sudden flushing of the face, nasal mucosal congestion, and indigestion.

Uncommon (observed in 1 to 10 out of 1,000 patients):

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, breathing difficulties, presence of blood in urine, prolonged duration of erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (observed in 1 to 10 out of 10,000 patients):

fainting, seizures and transient memory loss, 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 men
had pre-existing heart conditions before starting treatment with this medicine.
There are rare reports of cases involving partial, transient or permanent
visual impairment or loss of vision in one or both eyes.
In men taking tadalafil, several additional adverse reactions
have been rarely reported, 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 manifesting as ocular hyperaemia, irregular heartbeat and angina pectoris, as well as sudden cardiac death;
distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

Adverse reaction: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions
not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tadalafil MENSIL MED

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicinal product.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Tadalafil MENSIL MED contains

The active substance is tadalafil. One tablet contains 5 mg of tadalafil.
Other ingredients (excipients) are: Tablet core: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, sodium croscarmellose, magnesium stearate. Coating Opadry II Blue 85F30605: polyvinyl alcohol partially hydrolyzed, titanium dioxide (E171), polyethylene glycol 3350 and 4000, talc, indigo carmine, aluminium lake of indigo carmine (E132).

What Tadalafil MENSIL MED looks like and contents of the pack
Tadalafil MENSIL MED is a light blue, round, biconvex film-coated tablet with a diameter of 7 mm, imprinted on one side with the letter "C".
One pack contains 1, 2, 4, 8, 10, 12 or 28 film-coated tablets in blisters, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław, Poland

Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]