TADALAFIL 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tadalafil Aurovitas, 20 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet:
3. What Tadalafil Aurovitas is and what it is 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 with 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. If you take more Tadalafil Aurovitas than you should
6. Possible side effects
   1. Stop taking the medicine and contact a doctor immediately if you experience any of the following:
   2. Reporting of 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 Authorisation Holder:
   4. Manufacturer:
   5. This medicinal product is authorised 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, 20 mg, Film-Coated Tablets

Tadalafil

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

• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package 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 is a medicine 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.

Tadalafil Aurovitas contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Aurovitas works by helping the blood vessels in your penis to relax and increase blood flow into your penis. The result is improved erectile function. Tadalafil Aurovitas will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Aurovitas does not work if there is no sexual stimulation.

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 in the treatment of angina pectoris (“chest pain”). Tadalafil Aurovitas has been shown to increase the effects of these medicines.
• If you have severe heart disease or 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 arterial 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.

Warnings and precautions

Before taking Tadalafil Aurovitas, tell your doctor if you have sickle cell anemia (a disease of the red blood cells), multiple myeloma (a cancer of the bone marrow), or leukemia (a cancer of the blood cells), or any deformation of the penis.

You should be aware that sexual activity carries a risk for patients with heart disease because it puts extra strain on your heart. If you have a heart condition, tell your doctor.

Tadalafil Aurovitas is not intended for use by women.

Children and adolescents

Tadalafil Aurovitas is not intended for use by children and adolescents under the age of 18.

Tadalafil Aurovitas with other medicines

Do not take Tadalafil Aurovitas if you are already taking nitrates.

Tadalafil Aurovitas may affect the way other medicines work, and other medicines may affect the way Tadalafil Aurovitas works.

Tadalafil Aurovitas with food and drink

Grapefruit juice may affect how Tadalafil Aurovitas works, and should be taken with caution.

Fertility

There is no evidence that Tadalafil Aurovitas affects the ability to produce sperm.

Driving and using machines

Some men taking Tadalafil Aurovitas in clinical studies have reported dizziness. Check that you are okay to drive or operate machinery.

Tadalafil Aurovitas contains lactose

If you have an intolerance to some sugars, contact your doctor before taking Tadalafil Aurovitas.

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 Tadalafil Aurovitas exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose is one 10 mg tablet before sexual activity. If you have problems with your kidneys or liver, or you are taking certain medicines, your doctor may prescribe a lower dose.

You may take Tadalafil Aurovitas with or without food.

Do not take Tadalafil Aurovitas more than once a day.

If you take more Tadalafil Aurovitas than you should

Consult a doctor. You may experience side effects described in section 4.

4. Possible side effects

Like all medicines, Tadalafil Aurovitas can cause side effects, although not everybody gets them.

These effects are normally mild to moderate in nature.

Stop taking the medicine and contact a doctor immediately if you experience any of the following:

• Allergic reactions, including skin rash (uncommon).
• Chest pain (uncommon).
• Prolonged and possibly painful erections (rare). If you experience this, contact a doctor immediately.
• Sudden loss of vision (rare), distorted vision, blurred vision, or loss of vision in one or both eyes (frequency not known).

Other reported side effects include:

• Common (may affect up to 1 in 10 people): headache, back pain, muscle ache, flushing, and indigestion.
• Uncommon (may affect up to 1 in 100 people): dizziness, stomach upset, feeling sick, being sick, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, increased heart rate, 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, temporary memory loss, swelling of the eyelids, redness of the eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, presence of blood in semen, and increased sweating.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 20 mg of tadalafil.
• The other ingredients are: Core:copovidone, hydroxypropyl cellulose, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Coating:hypromellose, 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, marked with “20” on one side and “TL” on the other side.

Tadalafil Aurovitas is available in blisters of 2, 4, 8, and 12 film-coated tablets.

Marketing Authorisation Holder:

Aurovitas Pharma Polska Sp. z o.o.

Manufacturer:

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 medicinal product is authorised 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