Tadalafil Medreg

Package leaflet: Information for the patient

Tadalafil Medreg 5 mg film-coated tablets

tadalafil
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Tadalafil Medreg is and what it is used for
2. What you need to know 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 contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Medreg 5 mg is a treatment for men with:

• Erectile dysfunction. This condition occurs when 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 suitable for sexual activity. Following sexual stimulation, Tadalafil Medreg helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil Medreg will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Medreg for the treatment of erectile dysfunction has no effect without sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of not completely emptying the bladder, and a more frequent need to urinate, including during the night. Tadalafil Medreg improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil Medreg has been shown to improve these urinary symptoms within 1–2 weeks after starting treatment.

2. What you should know before taking Tadalafil Medreg

Do not take Tadalafil Medreg if:

• You are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• You are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that Tadalafil Medreg enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• You have severe heart disease or have recently had a heart attack (within the last 90 days).
• You have recently had a stroke (within the last 6 months).
• You have low blood pressure or uncontrolled high blood pressure.
• You have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• You are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Medreg, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Medreg.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts additional strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Medreg for benign prostatic hyperplasia.
Tadalafil Medreg does not cure prostate cancer.
Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells),
• multiple myeloma (a malignant bone marrow tumor),
• leukemia (a malignant blood cell disorder),
• any deformity of the penis,
• severe liver problems,
• severe kidney problems.

It is not known whether Tadalafil Medreg is effective in patients who have undergone:

• pelvic surgery,
• removal of all or part of the prostate gland with damage to the nerves of the prostate (radical prostatectomy without nerve-sparing technique).

If you experience sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking tadalafil, stop taking Tadalafil Medreg and contact your doctor immediately.
Sudden decrease or loss of hearing has been observed in some patients taking tadalafil.
Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Medreg and contact your doctor immediately.
Tadalafil Medreg is not intended for use by women.
Children and adolescents
Tadalafil Medreg is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Medreg if you are already taking nitrates.
Some medicines may be affected by Tadalafil Medreg or may themselves affect how Tadalafil Medreg works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia),
• other medicines for high blood pressure,
• riociguat,
• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia),
• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection,
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

Tadalafil Medreg with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Medreg works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking tadalafil in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Medreg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Tadalafil Medreg contains macrogol glycerol hydroxystearate
It may cause gastrointestinal disturbances and diarrhea.
Tadalafil Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tadalafil Medreg

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Medreg tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
Drinking alcohol may temporarily cause a reduction in your blood pressure.
If you have taken or intend to take Tadalafil Medreg, avoid excessive consumption of alcoholic beverages (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Medreg. This lower dose will be provided as a 2.5 mg tadalafil tablet.
Do not take Tadalafil Medreg more than once a day.
When taken once daily, Tadalafil Medreg allows you to achieve an erection, if there is sexual stimulation, at any time during the 24 hours following administration. Daily administration of Tadalafil Medreg may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Medreg does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily at approximately the same time each day.
If you have both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
Do not take Tadalafil Medreg more than once a day.

If you take more Tadalafil Medreg than you should
Contact your doctor. You may experience side effects described in section 4.

If you forget to take Tadalafil Medreg
Take your dose as soon as you remember, but do not take a double dose to make up for the missed tablet. You must not take Tadalafil Medreg more than once a day.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical assistance:

• allergic reactions, including skin rash (uncommon frequency),
• chest pain – do not use nitrates but seek immediate medical assistance (uncommon frequency),
• priapism, a prolonged and possibly painful erection after taking Tadalafil Medreg (rare frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately,
• sudden loss of vision (rare frequency), distorted central vision, blurred, hazy or sudden decrease in vision (frequency not known).

Other side effects that have been reported:
Common (may affect up to 1 in 10 people):

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion and digestive disturbances.

Uncommon (may affect up to 1 in 100 people):

• dizziness, stomach discomfort, nausea, vomiting, reflux, blurred vision, eye irritation,
  breathing difficulties, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds,
  ringing in the ears, swelling of the hands, feet or ankles and feeling of fatigue.

Rare (may affect up to 1 in 1,000 people):

• fainting, seizures and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in the semen and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had pre-existing heart conditions before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted central vision, blurred, hazy or sudden decrease in vision (frequency not known).

The side effect 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help 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.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after “Exp.” and/or “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadalafil Medreg contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other components are: monohydrate lactose, copovidone, anhydrous colloidal silica, macrogol glyceryl hydroxystearate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, and talc (E553b).

Description of the appearance of Tadalafil Medreg and package contents
White, biconvex, round film-coated tablets of approximately 5.9 mm in diameter, marked with "T17" on one side and "H" on the other.
The film-coated tablets are available in blisters made of transparent PVC/PE/Aclar/Al, packed in cardboard cartons.
Pack sizes: 12, 14 and 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturers:
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 authorized in the European Economic Area countries under the following names:
Italy: Tadalafil Medreg
Poland: Tadalafil Medreg
Czech Republic: Tadalafil Medreg
Romania: Tadalafil Gemax Pharma 5 mg film-coated tablets
Tadalafil Gemax Pharma 10 mg film-coated tablets
Tadalafil Gemax Pharma 20 mg film-coated tablets
Slovakia: Tadalafil Medreg 5 mg
Tadalafil Medreg 10 mg
Tadalafil Medreg 20 mg

Package leaflet: Information for the patient

Tadalafil Medreg 10 mg film-coated tablets, 20 mg film-coated tablets

tadalafil
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Tadalafil Medreg is and what it is used for
2. What you need to know 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 a treatment for adult men with erectile dysfunction. This condition occurs when 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 suitable for sexual activity.
Tadalafil Medreg contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Medreg helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil Medreg will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil Medreg has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Medreg

Do not take Tadalafil Medreg if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6),
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Medreg has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor,
• you have a severe heart disease or have had a heart attack recently, within the last 90 days,
• you have had a stroke recently, within the last 6 months,
• you have low blood pressure or uncontrolled high blood pressure,
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye",
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Medreg, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Medreg.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

• sickle cell anaemia (an abnormality of red blood cells),
• multiple myeloma (a malignant tumour of the bone marrow),
• leukaemia (a malignant tumour of blood cells),
• any deformity of the penis,
• a serious liver problem,
• a serious kidney problem.

It is not known whether Tadalafil Medreg is effective in patients who have undergone:

• pelvic surgery,
• removal of all or part of the prostate gland where the nerves to the prostate have been cut (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking tadalafil, stop taking Tadalafil Medreg and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
Although it is not known whether this event is directly related to tadalafil, if sudden decrease or loss of hearing occurs, stop taking Tadalafil Medreg and contact your doctor immediately.
Tadalafil Medreg is not intended for use by women.
Children and adolescents
Tadalafil Medreg is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Medreg if you are already taking nitrates.
Some medicines may be affected by Tadalafil Medreg or may themselves affect how Tadalafil Medreg works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems associated with benign prostatic hyperplasia),
• other medicines for treating high blood pressure,
• riociguat,
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia),
• medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection,
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

Tadalafil Medreg with food, beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Medreg works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking tadalafil in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Medreg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Tadalafil Medreg contains macrogol glycerol hydroxystearate
It may cause gastrointestinal disturbances and diarrhoea.
Tadalafil Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tadalafil Medreg

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Medreg tablets are for oral use and are intended only for men. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet taken prior to sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Medreg tablets are for oral use.
You may take the Tadalafil Medreg tablet at least 30 minutes before 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 is intended to be used prior to anticipated sexual activity and is not recommended for daily continuous use.
It is important to note that Tadalafil Medreg will not work without sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take Tadalafil Medreg, avoid excessive alcohol consumption (blood alcohol levels of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Tadalafil Medreg than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking the medicine and seek
immediate medical help:

• allergic reactions, including skin rash (frequency not common),
• chest pain – do not take nitrates but seek immediate medical help (frequency not common),
• priapism, a prolonged and possibly painful erection after taking Tadalafil Medreg (frequency rare). If you have an erection lasting more than 4 hours, you must contact a doctor immediately,
• sudden loss of vision (frequency rare), distorted central vision, blurred, hazy or sudden decrease in vision (frequency not known).

Other side effects have been reported:
Common (may affect up to 1 in 10 people):

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion and digestive disturbances.

Uncommon (may affect up to 1 in 100 people):

• dizziness, stomach discomfort, nausea, vomiting, reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles, and feeling tired.

Rare (may affect up to 1 in 1,000 people):

• fainting, seizures and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), penile bleeding, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had pre-existing heart conditions before taking the medicine.
Rarely, cases of partial, temporary or permanent reduction or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted central vision, blurred, hazy or sudden decrease in vision (frequency not known).

The side effect 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help 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.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after “Exp.” and/or “EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Medreg contains

• The active substance is tadalafil. Each film-coated tablet contains 10 mg or 20 mg of tadalafil.
• The other components are monohydrate lactose, copovidone, anhydrous colloidal silicon dioxide, macrogol glycerol hydroxystearate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose 2910 (E464), titanium dioxide (E171), triacetin, and talc (E553b).

Description of the appearance of Tadalafil Medreg and contents of the pack
Tadalafil Medreg 10 mg:
Film-coated tablet, white in colour, capsule-shaped, biconvex, approximately 10.1 mm x 5.1 mm,
with "T16" engraved on one side and "H" on the other side.
Tadalafil Medreg 20 mg:
Film-coated tablet, white in colour, capsule-shaped, biconvex, approximately 12.2 mm x 6.1 mm,
with "T15" engraved on one side and "H" on the other side.
The film-coated tablets are available in blisters made of transparent PVC/PE/Aclar/Al, packed in cardboard cartons.
Pack sizes: 2, 4, 8 and 12 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
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 European Economic Area countries under the following names:
Italy: Tadalafil Medreg
Poland: Tadalafil Medreg
Czech Republic: Tadalafil Medreg
Romania: Tadalafil Gemax Pharma 5 mg film-coated tablets
Tadalafil Gemax Pharma 10 mg film-coated tablets
Tadalafil Gemax Pharma 20 mg film-coated tablets
Slovakia: Tadalafil Medreg 5 mg
Tadalafil Medreg 10 mg
Tadalafil Medreg 20 mg