Patient Information Leaflet

Tadalafil Medreg, 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What is Tadalafil Medreg and what is it used for

Tadalafil Medreg contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Medreg 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 Medreg has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. After sexual stimulation, Tadalafil Medreg helps dilate the blood vessels in the penis, allowing increased blood flow into the penis. As a result, erection is improved. Tadalafil Medreg does not benefit patients who do not have erectile dysfunction. It is important to understand that Tadalafil Medreg 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.
with 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, sensation of incomplete bladder emptying, and increased frequency of urination, including at night. Tadalafil Medreg improves blood flow and causes relaxation of the muscles of the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that Tadalafil Medreg alleviates these urinary symptoms within 1-2 weeks after starting treatment.

2. Important information before using Tadalafil Medreg

When not to use Tadalafil Medreg

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 Medreg 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), 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 Medreg, 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 Medreg, consult a doctor or pharmacist.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform tests to rule out prostate cancer before starting treatment with Tadalafil Medreg for symptoms of benign prostatic hyperplasia. Tadalafil Medreg is not used to treat prostate cancer.
Before taking the 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 bone marrow cancer)
leukemia (a blood cell cancer)
any deformity of the penis
severe liver disease
severe kidney disease

It is not known whether Tadalafil Medreg is effective in patients:

after pelvic surgery
after complete or partial removal of the prostate gland with nerve damage (nerve-sparing radical prostatectomy)

If sudden worsening of vision, sudden vision loss, or distorted, dimmed vision occurs during treatment with tadalafil, stop taking Tadalafil Medreg 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 loss or sudden hearing impairment occurs, stop taking Tadalafil Medreg and contact a doctor immediately.
Tadalafil Medreg is not intended for use in women.
Children and adolescents
Tadalafil Medreg is not intended for use in children and adolescents under 18 years of age.
Tadalafil Medreg and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Tadalafil Medreg if you are using nitrates.
Tadalafil Medreg may affect the action of certain medicines or other medicines may affect the action of Tadalafil Medreg. Inform 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 (anticonvulsant medicines)
rifampicin, erythromycin, clarithromycin, or itraconazole
other treatments for erectile dysfunction

Tadalafil Medreg with food, drink, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Medreg, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Tadalafil Medreg 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 Tadalafil Medreg reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Medreg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tadalafil Medreg contains macrogol glycerol hydroxystearate
This medicine may cause stomach upset and diarrhea.
Tadalafil Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Medreg

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Tadalafil Medreg tablets are intended for oral use only in men. The tablet should be swallowed whole with a small amount of water. Tadalafil Medreg tablets can be taken regardless of meals.
Consumption of alcohol may cause transient lowering of blood pressure. If a patient has taken or plans to take Tadalafil Medreg, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of experiencing dizziness upon standing.
Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily, approximately at the same time each day.
Your doctor may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil Medreg.
In such case, an alternative medicine containing 2.5 mg of tadalafil per tablet should be used.
Tadalafil Medreg must not be taken more than once a day.
Taking Tadalafil Medreg once daily allows achieving an erection following sexual stimulation at any time within 24 hours. Daily administration of Tadalafil Medreg may be beneficial for men who plan to engage in sexual activity two or more times per week.
It is important to understand that Tadalafil Medreg 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 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 dose remains unchanged at one 5 mg tablet once daily.
Tadalafil Medreg must not be taken more than once a day.
Taking a higher than recommended dose of Tadalafil Medreg
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missed dose of Tadalafil Medreg
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Tadalafil Medreg more than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

allergic reactions, including rash (uncommon)
chest pain – do not take nitrates, but seek immediate medical help (uncommon)
priapism, prolonged and possibly painful erection after taking Tadalafil Medreg (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 adverse reactions reported:
Common (may occur in up to 1 in 10 patients):

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

Uncommon (may occur in up to 1 in 100 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 erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (may occur in up to 1 in 1,000 patients):

fainting, convulsions and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, and increased sweating.

Myocardial infarction 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 have been reports of rare cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
In men taking tadalafil, a few additional rare adverse reactions have been 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 characterized by blood flow into the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

The adverse reaction of dizziness has been reported more frequently in men aged over 75 years taking tadalafil. Diarrhoea has been reported more frequently in men aged over 65 years taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 Medreg

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Medreg contains

The active substance is tadalafil. Each coated tablet contains 5 mg of tadalafil.
The other ingredients are: monohydrate lactose, copovidone, colloidal anhydrous silica, glycofurol hydroxystearate, microcrystalline cellulose (type 102), sodium croscarmellose, magnesium stearate, hypromellose 2910 (E 464), titanium dioxide (E 171), triacetin, and talc (E 553b).

What Tadalafil Medreg looks like and contents of the pack
White, round, biconvex film-coated tablets with a diameter of approximately 5.9 mm, embossed with the code "T17" on one side and "H" on the other side.
The film-coated tablets are available in transparent blisters made of PVC/PE/Aclar/aluminium foil, packed in a cardboard box.
Pack sizes: 12, 14 and 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Importer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the following countries of the European Economic Area under the following names:
Poland: Tadalafil Medreg
Czech Republic: Tadalafil Medreg
Romania: Tadalafil Gemax Pharma 5 mg comprimate filmate
Slovakia: Tadalafil Medreg 5 mg
Italy: Tadalafil Medreg