Tadalafil medreg

Package leaflet: Information for the patient

Tadalafil Medreg, 10 mg, film-coated tablets
Tadalafil Medreg, 20 mg, film-coated tablets
Tadalafilum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• 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 identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Tadalafil Medreg is used in adult men with erectile dysfunction. This is a condition in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil Medreg has been shown to significantly improve the ability to obtain an erection adequate for sexual intercourse.
Tadalafil Medreg contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Medreg helps widen the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil Medreg does not benefit patients who do not have erectile dysfunction.
It is important to be aware 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.

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 pectoris ("chest pain"). It has been shown that Tadalafil Medreg intensifies 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). It has been shown that PDE5 inhibitors, such as Tadalafil Medreg, 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 to use Tadalafil Medreg, consult a doctor or pharmacist.
Please note that sexual activity involves some risk for patients with heart disease,
as it places additional strain on the heart. If heart problems are present, inform the doctor.
Before taking the medicine, the patient should inform the doctor if any of the
following conditions apply:

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

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

• after pelvic surgery
• after total or partial removal of the prostate gland with nerve-sparing techniques (nerve-sparing radical prostatectomy)

If sudden worsening of vision, sudden vision loss, or distorted, blurred vision occurs during treatment with tadalafil, stop taking Tadalafil Medreg immediately and contact a doctor without delay.
In some patients taking tadalafil, hearing loss or sudden decrease in hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden decrease in hearing occurs, stop taking Tadalafil Medreg immediately and contact a doctor without delay.
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-blockers (used to treat high blood pressure or urinary symptoms caused by 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 to treat 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 operating machinery
In clinical trials, some men taking Tadalafil Medreg reported dizziness. Therefore, patients should understand their response to the tablets before deciding to drive a car 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 directed by your doctor. If you have any doubts, 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. Tablets may be taken with or without food.
The recommended starting dose is one 10 mg tablet, taken prior to planned sexual activity. If this dose
is not sufficient, your doctor may increase the dose to 20 mg. Tadalafil Medreg tablets are intended for
oral administration.
Tadalafil Medreg may be taken at least 30 minutes before planned sexual activity. Tadalafil Medreg may
still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Medreg more than once a day. Tadalafil Medreg 10 mg and 20 mg are intended
for use prior to planned sexual activity. Regular, daily use of the medicine is not recommended.
It is important to be aware 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 and may cause transient
lowering of blood pressure. If the 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
dizziness upon standing.
Use of a higher than recommended dose of Tadalafil Medreg
Inform your doctor immediately. Adverse effects described in section 4 may occur.
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 experiences 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, a 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 vision loss (rare), distorted, blurred, or dim 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 congestion, and indigestion.

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 tired.

Rare (may occur in up to 1 in 1,000 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 problems 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
not observed during clinical trials have been reported. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders manifesting as blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, dim central vision or sudden worsening of vision (frequency not known).

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 effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store Tadalafil Medreg

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the cardboard packaging and
blister after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures 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 10 mg or 20 mg of tadalafil.
• The other ingredients are: monohydrate lactose, copovidone, anhydrous colloidal silicon dioxide, macrogol glycerol 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
Tadalafil Medreg 10 mg:
White, biconvex, film-coated tablet, capsule-shaped, approximately 10.1 mm x 5.1 mm, with the imprint “T16” on one side and “H” on the other.
Tadalafil Medreg 20 mg:
White, biconvex, film-coated tablet, capsule-shaped, approximately 12.2 mm x 6.1 mm, with the imprint “T15” on one side and “H” on the other.
The film-coated tablets are available in transparent PVC/PE/Aclar/aluminium blisters, packed in a cardboard box.
Pack sizes: 2, 4, 8 and 12 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 Member States of the European Economic Area under the following names:
Poland: Tadalafil Medreg
Czech Republic: Tadalafil Medreg
Romania: Tadalafil Gemax Pharma 10 mg comprimate filmate
Tadalafil Gemax Pharma 20 mg comprimate filmate
Slovakia: Tadalafil Medreg 10 mg
Tadalafil Medreg 20 mg
Italy: Tadalafil Medreg