Tadalafil sun

Package leaflet: Information for the patient

Tadalafil SUN, 10 mg, coated tablets
Tadalafil SUN, 20 mg, coated tablets
Tadalafil
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, 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 or pharmacist. See section 4.

Contents of the leaflet

1. What Tadalafil SUN is and what it is used for
2. What you need to know 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 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 sufficient for sexual intercourse.
Tadalafil SUN contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. This medicine helps widen the blood vessels of the penis during sexual stimulation, allowing increased blood flow into the penis. As a result, this leads to improved erection. Tadalafil SUN does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil SUN does not work in the absence of 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.

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 in the treatment of angina (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 medicine is used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high pressure in the lungs caused by blood clots). PDE5 inhibitors such as Tadalafil SUN have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting to use Tadalafil SUN, consult a doctor.
It should be remembered that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking the medicine, the patient should inform their doctor if any of the following 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:

• who have undergone pelvic surgery;
• who have undergone total or partial removal of the prostate gland with nerve-sparing techniques (nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or blurred or distorted vision occurs during treatment with tadalafil, treatment with tadalafil should be stopped immediately and the patient should contact a doctor without delay.
In some patients taking tadalafil, worsening 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 worsening of hearing occurs, treatment with Tadalafil SUN should be stopped and the patient should 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
Tell the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take Tadalafil SUN if taking nitrates.
Tadalafil SUN may affect the action of certain medicines or other medicines may affect its action. Tell the doctor or pharmacist if the patient is taking:

• alpha-adrenergic receptor 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 ketoconazole tablets (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 with alcohol consumption
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, the medicine caused a reduction in sperm production in the testes. Reduced sperm count has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In clinical trials, some men taking Tadalafil SUN reported dizziness. Therefore, patients should understand how they react to this medicine before deciding to drive or operate machinery.
Tadalafil SUN contains lactose
If the patient has an intolerance to certain sugars, they should consult a doctor before starting treatment with this medicine.

3. How to use Tadalafil SUN

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Tadalafil SUN is intended for oral use in men only. 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 prior to planned sexual activity.
If the 10 mg dose is not sufficient, your doctor may increase the dose to 20 mg.
Tadalafil SUN tablets are intended for oral use.
The medicine can be taken at least 30 minutes before planned sexual activity. The medicine may remain
effective for up to 36 hours after taking the tablet.
Do not take Tadalafil SUN more than once a day.
Tadalafil SUN at doses of 10 mg and 20 mg is intended to be taken prior to planned sexual activity. Regular, daily use of the medicine is not recommended.
It is important to understand that this medicine will not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would when the patient is not taking a medicine for erectile dysfunction.
Alcohol consumption may affect the ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadalafil SUN, he 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.
Use of more than the recommended dose of Tadalafil SUN
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 (not common);
• chest pain – do not take nitrates, but seek immediate medical help (not common);
• 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 dim central vision, or sudden worsening of vision (frequency unknown).

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

• headache;
• back pain;
• muscle pain;
• pain in hands and feet;
• facial flushing;
• nasal mucosal congestion;
• indigestion.

Not common (observed in 1 to 10 out of 1,000 patients)

• dizziness;
• abdominal pain;
• nausea (vomiting);
• regurgitation of stomach contents 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 raised areas on the skin);
• bleeding from the penis;
• 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 conditions 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 that 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 into the eyes;
• irregular heartbeat;
• angina pectoris;
• sudden cardiac death;
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Dizziness has been reported more frequently in men over 75 years of age. Diarrhoea 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 of Adverse Drug Reactions, 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 responsible entity.
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 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 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 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: monohydrate lactose (see end of section 2), microcrystalline cellulose, crospovidone type A, hydroxypropylcellulose, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
  Film-coat Opadry II yellow: hypromellose 2910 (15 mPa·s), monohydrate lactose, titanium dioxide (E 171), polyethylene glycol 6000, talc, iron oxide yellow (E 172).

What Tadalafil SUN looks like and contents of the pack
10 mg: Yellow, oval, biconvex film-coated tablets of size 11.85 x 6.30 mm and thickness 4.60 mm, embossed with the number "10" on one side and the letter "S" on the other side.
20 mg: Yellow, oval, biconvex film-coated tablets of size 14.30 x 7.95 mm and thickness 5.975 mm, embossed with the number "20" on one side and the letter "S" on the other side.
Tadalafil SUN 10 mg is supplied in blisters containing 4 tablets.
Tadalafil SUN 20 mg is supplied in blisters containing 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
The Netherlands

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names:
Germany: Tadalafil Basics
France: Tadalafil CRISTERS LAB
Italy, United Kingdom (Northern Ireland): Tadalafil SUN