Tadalafil Stada

Package Leaflet: Information for the User

Tadalafil STADA, 10 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.

Contents of the Package Leaflet

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

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

Tadalafil Stada contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil Stada 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 has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

After sexual stimulation, Tadalafil Stada works by helping the blood vessels in your penis to relax and expand, allowing blood to flow into the penis. This helps to produce and maintain an erection.

Tadalafil Stada will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Stada does not work if there is no sexual stimulation.

You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

2. Important information before taking Tadalafil Stada

When not to take Tadalafil Stada:

• 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 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 "eye stroke".
• 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, increase the effects of this medicine.

Warnings and precautions

Before taking Tadalafil Stada, talk to 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 a heart condition, tell your doctor.

Before taking the medicine, 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 Stada is effective in patients who have:

• undergone pelvic surgery
• had their prostate removed (prostatectomy)

If you experience sudden loss of vision or loss of vision in one eye during treatment with tadalafil, stop taking Tadalafil Stada and contact your doctor immediately.

In some patients, tadalafil has been associated with a sudden decrease or loss of hearing. Although it is not known if this is related to tadalafil, if you experience a decrease or loss of hearing, stop taking Tadalafil Stada and contact your doctor immediately.

Tadalafil Stada is not intended for use by women.

Children and adolescents

Tadalafil Stada is not intended for use by children and adolescents under 18 years of age.

Tadalafil Stada with 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 Stada if you are taking nitrates.

Tadalafil Stada may affect the way some medicines work, and some medicines may affect the way Tadalafil Stada works.

Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or prostate problems)
• other medicines used to treat high blood pressure
• riociguat
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia)
• certain 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 medicines used to treat erectile dysfunction

Tadalafil Stada with food and drink

Information about the effect of grapefruit juice is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Stada, and caution should be exercised when consuming grapefruit juice.

For more information, talk to your doctor.

Fertility

In animal studies, a decrease in sperm production was observed. A decrease in sperm concentration was observed in some men.

It is unlikely that this will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness.

Therefore, you should be aware of how you react to the tablets before you drive or use machines.

Tadalafil Stada contains lactose

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

Tadalafil Stada contains sodium

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

3. How to take Tadalafil Stada

This medicine should always be taken exactly as your doctor has instructed you.

If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended starting dose is one 10 mg tablet, taken before sexual activity.

If this dose is too weak, your doctor may increase the dose to 20 mg.

Not all dosage recommendations are possible with the 10 mg tablet; tadalafil may also be available as 2.5 mg, 5 mg, and 20 mg tablets.

Not all doses may be available in your country.

Method of administration

Tadalafil Stada 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.

The tablet can be split into equal doses.

Tadalafil Stada can be taken at least 30 minutes before sexual activity.

Tadalafil Stada may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Stada more than once a day.

Tadalafil Stada 10 mg and 20 mg is intended for use before anticipated sexual activity and is not recommended for continuous daily use.

Remember

It is important to note that Tadalafil Stada does not work without sexual stimulation.

You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Drinking too much alcohol can reduce your ability to get an erection and may temporarily lower your blood pressure.

If you have taken or are planning to take Tadalafil Stada, do not exceed drinking moderately (for example, no more than 900 mL of beer or 350 mL of wine).

Taking more than the recommended dose of Tadalafil Stada

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• allergic reactions, including skin rash (uncommon)
• chest pain - do not take nitrates, but seek medical help immediately (uncommon)
• priapism, a prolonged and possibly painful erection after taking Tadalafil Stada (rare). If you have an erection that lasts more than 4 hours, contact your doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or loss of vision in one eye (frequency not known)

Other reported side effects

Common(may affect up to 1 in 10 people)

• headache
• back pain
• muscle pain
• limb pain
• facial flushing
• nasal congestion
• indigestion

Uncommon(may affect up to 1 in 100 people)

• dizziness
• abdominal pain
• nausea
• vomiting
• reflux
• blurred vision
• eye pain
• difficulty breathing
• blood in urine
• prolonged erection
• palpitations
• rapid heartbeat
• high blood pressure
• low blood pressure
• nosebleeds
• ringing in the ears
• swelling of hands, feet, or ankles
• 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 loss of hearing
• hives (itchy, red welts on the skin)
• penile bleeding
• blood in semen
• increased sweating

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease.

Rarely, there have been reports of partial, temporary, or permanent decrease in vision or loss of vision in one or both eyes.

Men taking tadalafil have reported the following additional rare side effects:

• migraine
• facial swelling
• severe allergic reactions causing swelling of the face and throat
• severe skin rashes
• eye disorders
• irregular heartbeat
• angina pectoris
• sudden cardiac death
• distorted, blurred, or loss of vision (frequency not known)

Dizziness was reported more frequently in men over 75 years old taking tadalafil.

Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

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.

You can also report side effects directly to the national reporting system via the contact details listed below.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Stada

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 after "EXP". The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

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 Stada contains

• The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other ingredients are: Tablet core Lactose monohydrate Croscarmellose sodium Sodium lauryl sulfate (E 487) Hydroxypropyl cellulose Polysorbate 80 Microcrystalline cellulose Magnesium stearate

Coating

Hypromellose 2910

Lactose monohydrate

Titanium dioxide (E 171)

Triacetin

Yellow iron oxide (E 172)

Talc

What Tadalafil Stada looks like and contents of the pack

Yellow, round, biconvex film-coated tablets with a dividing line on one side, white in cross-section, 8.1 ± 0.2 mm in diameter. The tablets can be divided into equal doses.

Tadalafil Stada is available in blisters of 2x1, 4x1, 8x1, 12x1, 16x1, 20x1, 24x1, 28x1, 30x1, 36x1, 48x1, and 60x1 film-coated tablets.

Not all pack sizes may be available in your country.

Marketing Authorisation Holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

Clonmel Healthcare Ltd.

Waterford Road

E91 D768 Clonmel Co. Tipperary

Ireland

For further information on this medicine, contact your local representative of the Marketing Authorisation Holder:

STADA Poland Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands

Tadalafil STADA 10 mg filmomhulde tabletten

Bulgaria

Тадалафил Стада 10 mg филмирани таблетки

Poland

Tadalafil STADA

Date of last revision of the leaflet: 11.2024