TADALAFIL 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tadalafil Aurovitas, 5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Tadalafil Aurovitas and what is it used for
4. Important information before taking Tadalafil Aurovitas
   1. When not to take Tadalafil Aurovitas
   2. Warnings and precautions
   3. Children and adolescents
   4. Tadalafil Aurovitas and other medicines
   5. Tadalafil Aurovitas with food and drink
   6. Fertility
   7. Driving and using machines
   8. Tadalafil Aurovitas contains lactose
   9. Tadalafil Aurovitas contains sodium
5. How to take Tadalafil Aurovitas
   1. Treatment of erectile dysfunction
   2. Treatment of symptoms of benign prostatic hyperplasia
   3. Taking more than the recommended dose of Tadalafil Aurovitas
   4. Missing a dose of Tadalafil Aurovitas
6. Possible side effects
   1. If you experience any of the following side effects, stop taking Tadalafil Aurovitas and contact your doctor immediately:
   2. Reporting side effects
7. How to store Tadalafil Aurovitas
8. Contents of the pack and other information
   1. What Tadalafil Aurovitas contains
   2. What Tadalafil Aurovitas looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 10/2023

Package Leaflet: Information for the Patient

Tadalafil Aurovitas, 5 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Tadalafil Aurovitas and what is it 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 is Tadalafil Aurovitas and what is it 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 to treat adult men with:

• Erectile dysfunction.This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Aurovitas has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity. After sexual stimulation, Tadalafil Aurovitas works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erections. Tadalafil Aurovitas does not work if you do not have erectile dysfunction. It is important to note that Tadalafil Aurovitas does not work without sexual stimulation.
• Symptoms of benign prostatic hyperplasia.This is when the prostate gland is enlarged, which can cause problems with the flow of urine. Symptoms include difficulty starting to urinate, feeling like you need to urinate more often, or feeling like you need to urinate during the night. Tadalafil Aurovitas improves blood flow and relaxes the muscles in the prostate and bladder, which can help to relieve the symptoms of benign prostatic hyperplasia. It has been shown that Tadalafil Aurovitas can relieve these symptoms within 1-2 weeks of starting treatment.

2. Important information before taking Tadalafil Aurovitas

When not to take Tadalafil Aurovitas

• If you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). Tadalafil Aurovitas has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• If you have had a heart attack within the last 90 days.
• If you have had a stroke within the last 6 months.
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye".
• If you are 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 due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as Tadalafil Aurovitas, increase the effects of this medicine. If you are taking riociguat, or are unsure, tell your doctor.

Warnings and precautions

Before taking Tadalafil Aurovitas, tell your doctor.
Remember that sexual activity carries a risk for patients with heart disease, because it puts extra strain on your heart. If you have heart problems, tell your doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will check you for prostate cancer before you start taking Tadalafil Aurovitas to treat benign prostatic hyperplasia. Tadalafil Aurovitas is not for the treatment of prostate cancer.
Before taking Tadalafil Aurovitas, tell your doctor if you have:

• Sickle cell anemia (abnormal red blood cells).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any deformation of the penis.
• Severe liver disease.
• Severe kidney disease.

It is not known if Tadalafil Aurovitas is effective in patients who have:

• Had pelvic surgery.
• Had their prostate removed (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or loss of vision, or blurred vision, stop taking Tadalafil Aurovitas and contact your doctor immediately.
In some patients taking tadalafil, a sudden decrease or loss of hearing has been reported. Although it is not known if this event is related to tadalafil, if you experience a decrease or loss of hearing, stop taking Tadalafil Aurovitas and contact your doctor immediately.
Tadalafil Aurovitas is not intended for use by women.

Children and adolescents

Tadalafil Aurovitas is not intended for use by children and adolescents under 18 years.

Tadalafil Aurovitas and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take.
Do not take Tadalafil Aurovitas if you are taking nitrates.
Tadalafil Aurovitas may affect, or be affected by, other medicines. Tell your doctor or pharmacist if you are taking:

• Alpha-blockers (used to treat high blood pressure or symptoms of 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 ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Tadalafil Aurovitas with food and drink

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Aurovitas, and therefore, caution should be exercised when consuming it. For more information, ask your doctor.

Fertility

When tadalafil was given to dogs, it caused a decrease in sperm production in the testes. A decrease in sperm count has been observed in some men. It is unlikely to cause infertility.

Driving and using machines

Some men taking Tadalafil Aurovitas reported dizziness during clinical trials. Therefore, you should be aware of how you react to the tablets before driving or operating machinery.

Tadalafil Aurovitas contains lactose

If you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Tadalafil Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Tadalafil Aurovitas tablets are for oral use only in men.
Swallow the tablet whole with a small amount of water. The tablets can be taken with or without food.
Drinking alcohol may cause a temporary drop in blood pressure. If you have taken Tadalafil Aurovitas or plan to take it, you should avoid drinking large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet taken once a day, at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Aurovitas. You should take one 2.5 mg tablet.
Do not take Tadalafil Aurovitas more than once a day.
Taking Tadalafil Aurovitas once a day allows you to get an erection at any time during the 24 hours, after sexual stimulation. Taking Tadalafil Aurovitas once a day may be useful for men who anticipate having sexual activity twice a week or more frequently.
It is important to note that Tadalafil Aurovitas does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking erectile dysfunction treatment.
Drinking alcohol may affect your ability to get an erection.

Treatment of symptoms of benign prostatic hyperplasia

Doseis one 5 mg tablet taken once a day, at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.
Do not take Tadalafil Aurovitas more than once a day.

Taking more than the recommended dose of Tadalafil Aurovitas

Tell your doctor. You may experience side effects described in section 4.

Missing a dose of Tadalafil Aurovitas

Take a dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. Do not take Tadalafil Aurovitas more than once a day.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are usually mild to moderate.

If you experience any of the following side effects, stop taking Tadalafil Aurovitas and contact your doctor immediately:

• Allergic reactions, including skin rash (uncommon).
• Chest pain - do not take nitrates, but seek medical help immediately (uncommon).
• Priapism, prolonged and possibly painful erections after taking Tadalafil Aurovitas (rare). If you have an erection that lasts more than 4 hours, contact your doctor immediately;
• Sudden loss of vision (rare), blurred vision, or loss of vision (frequency not known).

Other reported side effects:
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, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of 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, eye redness, sudden loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, 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 disease.
There have been reports of rare cases of partial, temporary, or permanent loss of vision or blindness in one or both eyes.
In men taking Tadalafil Aurovitas, several additional rare side effectshave been reported, which were not observed in clinical trials. These include:

• Migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• Blurred vision, or loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking Tadalafil Aurovitas. Diarrhea was reported more frequently in men over 65 years old taking Tadalafil Aurovitas.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 carton and blister after EXP.
The expiry date refers to the last day of that month.
No special storage conditions are required.
Medicines should 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 film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are: Core:copovidone, hydroxypropylcellulose, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Coating:hypromellose 2910 (6cp), titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadalafil Aurovitas looks like and contents of the pack

Film-coated tablet.
Light yellow, oval film-coated tablets, with "5" engraved on one side and "TL" on the other side.
Tadalafil Aurovitas film-coated tablets are packaged in PVC/PVDC/Aluminum blisters, in a cardboard box.
Package sizes: 14 and 28 film-coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora, Lisbon
Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Italy:
Tadalafil Aurobindo
Poland:
Tadalafil Aurovitas
Portugal:
Tadalafil Generis

Date of last revision of the leaflet: 10/2023