Tadalafil aurovitas

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Tadalafil Aurovitas (Tadalafil PUREN)
5 mg, coated tablets
Tadalafilum
Tadalafil Aurovitas and Tadalafil PUREN are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Tadalafil Aurovitas contains the active substance tadalafil, which belongs to a group of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil Aurovitas 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 Aurovitas has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Aurovitas helps dilate the blood vessels of the penis, allowing blood to flow into the penis. As a result, erection is improved. Tadalafil Aurovitas does not help patients who do not have erectile dysfunction. It is important to be aware that Tadalafil Aurovitas does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would when the patient is 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, a sensation of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil Aurovitas 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 Aurovitas alleviates these urinary symptoms within 1-2 weeks after starting treatment.

2. Important information before using Tadalafil Aurovitas

When not to use Tadalafil Aurovitas

• 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 to treat angina (chest pain). It has been shown that Tadalafil Aurovitas 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), also 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 pressure in the lungs caused by blood clots). PDE5 inhibitors such as Tadalafil Aurovitas 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 Tadalafil Aurovitas, consult a doctor.
Please note that sexual activity involves some risk for patients with heart conditions, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before initiating treatment with Tadalafil Aurovitas for symptoms of benign prostatic hyperplasia. Tadalafil Aurovitas is not used to treat prostate cancer.
Before taking this medicine, the patient should inform their 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 penile deformity.
• Severe liver disease.
• Severe kidney disease.

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

• After pelvic surgery.
• After total or partial removal of the prostate gland with nerve damage (nerve-sparing radical prostatectomy).

If during treatment with Tadalafil Aurovitas sudden vision deterioration or sudden vision loss occurs, or if vision becomes distorted or dimmed, treatment with Tadalafil Aurovitas should be stopped immediately and the patient should contact their doctor without delay.
In some patients taking tadalafil, hearing loss 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 loss occurs, treatment with Tadalafil Aurovitas should be stopped and the patient should contact their doctor immediately.
Tadalafil Aurovitas is not intended for use in women.
Children and adolescents
Tadalafil Aurovitas is not intended for use in children and adolescents under 18 years of age.
Tadalafil Aurovitas and other medicines
Tell your doctor about all medicines currently taken, recently taken, or planned for use.
Do not take Tadalafil Aurovitas if you are using nitrates.
Tadalafil Aurovitas may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Aurovitas. 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 Aurovitas, drinking, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Aurovitas, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Tadalafil Aurovitas 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 Aurovitas reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Aurovitas contains lactose monohydrate
If the patient has an intolerance to certain sugars, they should consult their doctor before starting treatment with this medicine.
Tadalafil Aurovitas 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 Aurovitas

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Tadalafil Aurovitas tablets are intended for oral use only in men.
The tablets should be swallowed whole with a small amount of water. Tablets may be taken
independently of meals.
Alcohol consumption may cause a temporary decrease in blood pressure. If the patient has taken
Tadalafil Aurovitas or plans to take it, 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 physician may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil Aurovitas.
In such case, the 2.5 mg tablet should be used.
Tadalafil Aurovitas should not be taken more frequently than once daily.
Taking Tadalafil Aurovitas once daily allows the achievement of an erection following sexual
stimulation at any time within 24 hours. Daily administration of Tadalafil Aurovitas 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 Aurovitas 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
Dose: One 5 mg tablet taken once daily, approximately at the same time each day. If the patient
has benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at one 5 mg
tablet once daily.
Tadalafil Aurovitas must not be taken more frequently than once daily.

Use of a higher than recommended dose of Tadalafil Aurovitas
Inform the physician. Adverse effects described in section 4 may occur.

Missed dose of Tadalafil Aurovitas
Take the missed dose as soon as remembered, but do not take a double dose to make up for a
missed tablet. Do not take Tadalafil Aurovitas more frequently than once daily.

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 rashes (uncommon).
• Chest pain – do not take nitrates, but seek immediate medical help (uncommon).
• Priapism, a prolonged and possibly painful erection after taking Tadalafil Aurovitas (rare). If such an erection occurs and lasts continuously for more than 4 hours, seek immediate medical attention;
• Sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• 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, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of 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, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), penile bleeding, presence of blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil Aurovitas.
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 Aurovitas, several 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 manifesting as blood flow to 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: dizziness was reported more frequently in men over 75 years of age taking Tadalafil Aurovitas. Diarrhoea was reported more frequently in men over 65 years of age taking Tadalafil Aurovitas.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tadalafil Aurovitas

Keep this medicine out of the sight and reach of children.
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.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Aurovitas contains

• The active substance is tadalafil. Each coated tablet contains 5 mg of tadalafil.
• The other ingredients are:
  Tablet core: copovidone, macrogol glycerol hydroxystearate, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadalafil Aurovitas looks like and contents of the pack
Coated tablets.
Light yellow, oval, film-coated tablets marked with "5" on one side and "TL" on the other side.
Tadalafil Aurovitas film-coated tablets are packed in blisters made of PVC/PVDC-Aluminium in cardboard boxes.
Pack sizes: 14 and 28 film-coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Germany, the country of export:
PUREN Pharma GmbH & Co. KG
Willy-Brandt-Allee 2
81829 Munich, Germany

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000, Malta
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo, Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo, Finland
Generis Farmacêutica S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora, Portugal

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

German Marketing Authorisation Number (country of export): 94457.00.00
Parallel Import Authorisation Number: 146/25

This medicinal product is authorised for marketing in the European Economic Area member states under the following names:
Italy: Tadalafil Aurobindo
Poland: Tadalafil Aurovitas
Portugal: Tadalafil Generis