Tadalafil sun

Package leaflet: Information for the patient

Tadalafil SUN, 5 mg, film-coated tablets
Tadalafil
Please read the entire leaflet carefully before using this 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 further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Tadalafil SUN contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Tadalafil SUN is a medicine intended for adult men with:

• Erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. This medicine has been shown to significantly improve the ability to achieve an erection adequate for sexual activity. Tadalafil SUN helps increase blood flow to the penis during sexual stimulation, which enables an erection. Tadalafil SUN does not benefit men who do not have erectile dysfunction. It is important to understand that Tadalafil SUN will 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.
• Urinary symptoms caused by a common condition called benign prostatic hyperplasia (BPH). This is a condition in which the prostate gland enlarges with age. Symptoms include difficulty starting urination, sensation of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil SUN improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. Tadalafil SUN has been shown to relieve these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before using Tadalafil SUN

When NOT to use Tadalafil SUN

• 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 pectoris ("chest pain"). It has been shown that Tadalafil SUN 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 lost vision due to non-arteritic anterior ischemic optic neuropathy, 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 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 effects of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadalafil SUN, consult a doctor.
Please note that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before starting treatment with Tadalafil SUN for symptoms of benign prostatic hyperplasia.
Tadalafil SUN is not used to treat prostate cancer.
Before taking this medicine, the patient should inform the doctor if any of the following conditions apply:

• sickle cell anemia (an abnormality 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 SUN is effective in patients:

• after pelvic surgery;
• after total or partial removal of the prostate gland with nerve-sparing not performed (radical prostatectomy without nerve-sparing).

If sudden vision loss or sudden decrease in vision occurs, or if vision becomes blurred or distorted, stop taking tadalafil and contact a doctor immediately.
In some patients taking tadalafil, decreased 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 decrease in hearing occurs, stop taking Tadalafil SUN and contact a doctor immediately.
Tadalafil SUN is not intended for use in women.

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

Tadalafil SUN and other medicines
Inform the doctor about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
Do not take Tadalafil SUN if using nitrates.
Tadalafil SUN may affect the action of certain medicines, or other medicines may affect its action. Inform the doctor or pharmacist if the patient is taking:

• alpha-blockers (used for high blood pressure or to relieve urinary symptoms caused by benign prostatic hyperplasia);
• 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 oral ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Tadalafil SUN, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil SUN, and therefore caution should be exercised when consuming it. Consult a doctor for further information.

Fertility
When administered to dogs, a reduction in sperm production in the testes was observed. Reduced sperm count has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In some men taking Tadalafil SUN, dizziness has been reported during clinical trials; therefore, patients should be aware of their individual response to the medicine before deciding to drive or operate machinery.

Tadalafil SUN contains lactose
If the patient has an intolerance to certain sugars, consult a doctor before starting treatment with this medicine.

3. How to use Tadalafil SUN

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Tadalafil SUN is intended for oral use in men only. Tablets should be swallowed whole with a small amount of water. The medicine may be taken with or without food.
Alcohol consumption may cause a temporary decrease in blood pressure. If you have taken or plan to take Tadalafil SUN, you should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to the medicine. In such case, the 2.5 mg tablet should be used.
Do not take Tadalafil SUN more than once a day.
Taking Tadalafil SUN once daily allows for achieving an erection following sexual stimulation within 24 hours. Daily dosing may be beneficial for men who plan to engage in sexual activity twice a week or more.
It is important to understand that this medicine does not work without 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.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of signs and symptoms of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily, at approximately the same time each day. If the patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at one 5 mg tablet once daily.
Do not take Tadalafil SUN more than once a day.

Use of a higher than recommended dose of Tadalafil SUN
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Tadalafil SUN
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Tadalafil SUN more than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience 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 SUN (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
• sudden loss of vision (rare), distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 100 patients)

• headache;
• back pain;
• muscle pain;
• pain in arms and legs;
• facial flushing;
• nasal mucosa congestion;
• indigestion.

Uncommon (observed in 1 to 10 out of 1,000 patients)

• dizziness;
• abdominal pain;
• nausea (vomiting);
• gastric contents regurgitating into the oesophagus;
• blurred vision;
• eye pain;
• difficulty breathing;
• presence of blood in urine;
• prolonged erection;
• sensation of heart palpitations;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• nosebleeds;
• ringing in the ears;
• swelling of hands, feet or ankles;
• feeling of fatigue.

Rare (observed in 1 to 10 out of 10,000 patients)

• fainting;
• seizures and transient memory loss;
• eyelid swelling;
• eye redness;
• sudden worsening or loss of hearing;
• urticaria (itchy, red skin swellings);
• rectal bleeding;
• presence of blood in semen;
• increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking Tadalafil SUN. Most of these men
had pre-existing heart disease 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 SUN, 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 or throat;
• severe rashes;
• disorders characterized by blood flow to the eyes;
• irregular heartbeat;
• angina pectoris;
• sudden cardiac death;
• distorted, blurred, or impaired central vision or sudden worsening of vision (frequency not known).

Dizziness has been reported more frequently in men over 75 years of age. Diarrhea has been reported
more frequently in men over 65 years of age.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil SUN

Keep this medicine out of 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 the stated month. The batch number is indicated after the word Lot.
This medicine does not require any special storage conditions.
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 packaging and other information

What Tadalafil SUN contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• Other ingredients are:
  Tablet core: monohydrate lactose (see end of section 2), microcrystalline cellulose, crospovidone type A, hydroxypropylcellulose, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
  Opadry II yellow film-coating: hypromellose 2910 (15 mPa∙s), monohydrate lactose, titanium dioxide (E 171), polyethylene glycol 6000, talc, yellow iron oxide (E 172).

What Tadalafil SUN looks like and contents of the pack
Yellow, oval-shaped, biconvex, film-coated tablets, measuring 8.65 x 5.65 mm and 3.25 mm thick, with the number "5" embossed on one side and "S" on the other.
The medicine is available in blister packs containing 14, 28 or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorised in the European Economic Area countries
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