TADALAFIL 10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Tadalafil SUN, 10 mg, film-coated tablets
3. Tadalafil SUN, 20 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Tadalafil SUN and what is it used for
5. Important information before taking Tadalafil SUN
   1. When NOT to take Tadalafil SUN
   2. Warnings and precautions
   3. Children and adolescents
   4. Tadalafil SUN and other medicines
   5. Tadalafil SUN with food and drink
   6. Fertility
   7. Driving and using machines
   8. Tadalafil SUN contains lactose
6. How to take Tadalafil SUN
   1. Taking a higher dose of Tadalafil SUN than recommended
7. Possible side effects
   1. If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:
   2. Common (seen in 1 to 10 in every 100 patients)
   3. Uncommon (seen in 1 to 10 in every 1,000 patients)
   4. Rare (seen in 1 to 10 in every 10,000 patients)
   5. Reporting of side effects
8. How to store Tadalafil SUN
9. Contents of the pack and other information
   1. What Tadalafil SUN contains
   2. What Tadalafil SUN looks like and contents of the pack
   3. Marketing authorisation holder/Importer
   4. This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Leaflet accompanying the packaging: patient information

Tadalafil SUN, 10 mg, film-coated tablets

Tadalafil SUN, 20 mg, film-coated tablets

Tadalafil

Read the 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Tadalafil SUN is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that this medicine significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance. Tadalafil SUN contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). This medicine helps to relax the blood vessels in the penis after sexual stimulation, allowing blood to flow into the penis. As a result, it helps to improve erectile function. Tadalafil SUN does not help patients who do not have erectile dysfunction. It is important to note that Tadalafil SUN does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as when the patient is not taking erectile dysfunction medication.

2. Important information before taking Tadalafil SUN

When NOT to take Tadalafil SUN

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking organic nitrates or other nitric oxide donors, such as amyl nitrite. This is a group of medicines (‘nitrates’) used to treat angina pectoris (‘chest pain’). It has been shown that Tadalafil SUN enhances the effect of these medicines. If you are taking nitrates in any form, or are unsure, you should tell your doctor;
• if you have severe heart disease or have had a heart attack in the last 90 days;
• if you have had a stroke in the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure;
• if you have ever lost your vision due to non-arteritic anterior ischemic optic neuropathy (NAION), so-called ‘eye stroke’;
• 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 caused by blood clots). It has been shown that PDE5 inhibitors, such as Tadalafil SUN, enhance the blood pressure lowering effect of this medicine. If you are taking riociguat, or are unsure, you should tell your doctor.

Warnings and precautions

Before taking Tadalafil SUN, you should tell your doctor. You should remember that sexual activity carries a risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, you should tell your doctor. Before taking the medicine, you should tell your doctor if you have any of the following:

• sickle cell anaemia (a disorder of red blood cells);
• multiple myeloma (a cancer of the bone marrow);
• leukaemia (a cancer of blood cells);
• any deformation of the penis;
• severe liver disease;
• severe kidney disease.

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

• had pelvic surgery;
• had prostate removal (radical prostatectomy without nerve-sparing).

If you experience sudden loss of vision or loss of vision or blurred vision while taking tadalafil, you should stop taking tadalafil and contact your doctor immediately. Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known if this event is directly related to tadalafil, if you experience a decrease or sudden loss of hearing, you should stop taking Tadalafil SUN and contact your doctor immediately. Tadalafil SUN is not intended for use by women.

Children and adolescents

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

Tadalafil SUN and other medicines

You should tell your doctor about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. You should not take Tadalafil SUN if you are taking nitrates. Tadalafil SUN may affect the way some medicines work, or some medicines may affect the way Tadalafil SUN works. You should tell your doctor or pharmacist if you are taking:

• alpha-blockers (used to treat high blood pressure or to relieve symptoms of an enlarged prostate);
• other medicines used to treat high blood pressure;
• riociguat, used to treat pulmonary hypertension;
• 5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia);
• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic drugs);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Tadalafil SUN with food and drink

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

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 that this will lead to infertility.

Driving and using machines

Some men taking Tadalafil SUN during clinical trials reported dizziness. You should be aware of how you react to this medicine before driving or operating machinery.

Tadalafil SUN contains lactose

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

3. How to take Tadalafil SUN

This medicine should always be taken exactly as your doctor has instructed you. If you are unsure, you should ask your doctor or pharmacist. Tadalafil SUN is for oral use only in men. The tablets should be swallowed whole with a small amount of water. The medicine can be taken with or without food. The recommended starting dose is one 10 mg tablet, taken before planned sexual activity. If the 10 mg dose is not effective, your doctor may increase the dose to 20 mg. Tadalafil SUN tablets are for oral use. The medicine can be taken at least 30 minutes before planned sexual activity. The medicine may still be effective up to 36 hours after taking the tablet. You should not take Tadalafil SUN more than once a day. Tadalafil SUN 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis. It is important to note that this medicine does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as when the patient is not taking erectile dysfunction medication. Drinking alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken Tadalafil SUN or plan to take it, you should not drink large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking a higher dose of Tadalafil SUN than recommended

You should inform your doctor. You may experience side effects as described in section 4. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

• allergic reactions, including skin rash (not very common);
• chest pain - do not take nitrates, but seek medical help immediately (not very common);
• priapism, prolonged and possibly painful erections after taking Tadalafil SUN (rare). If you experience such an erection, which lasts for more than 4 hours, you should contact your doctor immediately;
• sudden loss of vision (rare), blurred vision, or loss of vision (frequency not known).

Other reported side effects:

Common (seen in 1 to 10 in every 100 patients)

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

Uncommon (seen in 1 to 10 in every 1,000 patients)

• dizziness;
• abdominal pain;
• nausea (vomiting);
• reflux;
• blurred vision;
• eye pain;
• difficulty breathing;
• blood in urine;
• prolonged erections;
• palpitations;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• epistaxis;
• tinnitus;
• peripheral oedema;
• fatigue.

Rare (seen in 1 to 10 in every 10,000 patients)

• fainting;
• seizures and transient loss of memory;
• eyelid swelling;
• eye redness;
• sudden loss of hearing;
• urticaria (itching, red lumps on the skin);
• penile haemorrhage;
• haematospermia;
• increased sweating.

Myocardial infarction and stroke were rarely reported in men taking Tadalafil SUN. Most of these men had pre-existing heart disease before taking this medicine. There have been reports of rare cases of partial, transient, or permanent decrease in vision or loss of vision in one or both eyes. Men taking Tadalafil SUN have reported several additional rare side effects, which were not observed in clinical trials. These include:

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

Dizziness was reported more frequently in men over 75 years of age. Diarrhoea was reported more frequently in men over 65 years of age.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil SUN

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. The batch number is stated after the batch number. This medicine does not require any special storage conditions. 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 SUN contains

• The active substance is tadalafil. Each tablet contains 10 mg or 20 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate (see end of section 2), microcrystalline cellulose, crospovidone type A, hydroxypropylcellulose, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
• Opadry II yellow: hypromellose 2910 (15 mPa∙s), lactose monohydrate, titanium dioxide (E 171), macrogol 6000, talc, yellow iron oxide (E 172).

What Tadalafil SUN looks like and contents of the pack

10 mg: Yellow, oval, biconvex, film-coated tablets, 11.85 x 6.30 mm in size, 4.60 mm in thickness, with the number ‘10’ embossed on one side and the letter ‘S’ on the other. 20 mg: Yellow, oval, biconvex, film-coated tablets, 14.30 x 7.95 mm in size, 5.975 mm in thickness, with the number ‘20’ embossed on one side and the letter ‘S’ on the other. Tadalafil SUN 10 mg is available in blisters of 4 tablets. Tadalafil SUN 20 mg is available in blisters of 2, 4, 8, 10, or 12 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder/Importer

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, Netherlands

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Tadalafil Basics, France: Tadalafil CRISTERS LAB, Italy, United Kingdom (Northern Ireland): Tadalafil SUN

Date of last revision of the leaflet: 16.02.2024