Tadalafil Sun

Package Leaflet: Information for the Patient

Tadalafil SUN, 5 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 those not listed in this leaflet, 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 contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5).
Tadalafil SUN is a medicine used for the treatment of adult men with:

• erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. It has been shown that this medicine significantly improves the ability to get an erection. This medicine helps to relax the blood vessels in the penis, allowing blood to flow into the penis when you are sexually aroused. As a result, the blood flow into the penis increases, and the erection improves. Tadalafil SUN does not help patients who have no erectile dysfunction. It is important to note that Tadalafil SUN does not work if there is no sexual stimulation.
• with symptoms of benign prostatic hyperplasia (enlarged prostate). This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to pass urine, feeling like you need to pass urine more often, or feeling like you need to pass urine more often during the night. Tadalafil SUN improves blood flow and relaxes the muscles in the prostate and bladder, which can help to relieve the symptoms of an enlarged prostate. It has been shown that Tadalafil SUN can relieve these symptoms of benign prostatic hyperplasia after 1-2 weeks of treatment.

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 can increase the effects 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 a 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, increase the effects 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 talk to your doctor.
Remember that sexual activity carries a risk for patients with heart disease, as it puts extra strain on the heart.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will check you for prostate cancer before you start taking Tadalafil SUN to treat benign prostatic hyperplasia.
Tadalafil SUN is not intended for use in the treatment of prostate cancer.
Before taking the medicine, you should tell your doctor if you have any of the following:

• sickle cell anemia (a condition that affects red blood cells);
• multiple myeloma (a cancer of the bone marrow);
• leukemia (a cancer of the blood cells);
• any deformation of the penis;
• severe liver disease;
• severe kidney disease.

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

• had pelvic surgery;
• had their prostate removed (prostatectomy), in which the nerves surrounding the prostate are cut (radical prostatectomy without nerve-sparing).

If you experience any of the following side effects, stop taking tadalafil and contact your doctor immediately:
sudden loss of vision or changes in vision, such as blurred vision, double vision, or sensitivity to light.
Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known whether this is related to tadalafil, if you experience a sudden decrease or loss of hearing, 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

Tell your doctor about all the medicines you are taking, or have recently taken, and any you plan to take.
Do 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.
Tell your doctor or pharmacist if you are taking:

• alpha-blockers (used to treat high blood pressure or to treat the symptoms of 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 (used to treat fungal infections) and protease inhibitors used to treat HIV or AIDS;
• phenobarbital, phenytoin, and carbamazepine (medicines used to treat epilepsy);
• 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 talk to 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 to lead to infertility.

Driving and using machines

Some men taking Tadalafil SUN during clinical trials reported dizziness, so you should be aware of how you react to this medicine before you drive or use machines.

Tadalafil SUN contains lactose

If you have an intolerance to some sugars, you should talk to 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.
Drinking alcohol may cause a temporary drop in 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.

Treatment of erectile dysfunction

The recommended dose is one 5 mg tablet per day, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to the medicine. You should take one 2.5 mg tablet.
Do not take Tadalafil SUN more than once a day.
Taking Tadalafil SUN once a day allows you to get an erection in response to sexual stimulation at any time during the 24-hour period. Taking the medicine once a day can be helpful for men who plan to have sex twice a week or more often.
Remember that this medicine does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol can affect your ability to get an erection.

Treatment of the symptoms of benign prostatic hyperplasia

The dose is one 5 mg tablet, taken at approximately the same time each day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.
Do not take Tadalafil SUN more than once a day.

Taking a higher dose of Tadalafil SUN than prescribed

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

Missing a dose of Tadalafil SUN

You should take the missed dose as soon as you remember, but do not take a double dose to make up for a missed dose. Do not take Tadalafil SUN more than once a day.
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, a prolonged and possibly painful erection after taking Tadalafil SUN (rare). If you experience this, contact your doctor immediately;
• sudden loss of vision (rare), blurred vision, double vision, or changes in color vision (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 of stomach contents into the mouth;
• blurred vision;
• eye pain;
• difficulty breathing;
• blood in the urine;
• prolonged erections;
• palpitations;
• rapid heartbeat;
• high blood pressure;
• low blood pressure;
• nosebleeds;
• ringing in the ears;
• swelling of the hands, feet, or ankles;
• feeling tired.

Rare (may affect up to 1 in 1,000 people)

• fainting;
• seizures and transient loss of memory;
• swelling of the eyelids;
• redness of the eyes;
• sudden loss of hearing;
• hives (itchy, red welts on the skin);
• penile bleeding;
• blood in the semen;
• increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil SUN. Most of these men had heart disease before taking this medicine.
There have been reports of rare cases of partial, temporary, or permanent loss of vision in one or both eyes.
Men taking Tadalafil SUN have reported the following additional rare side effects, which were not observed during clinical trials:

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

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

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 via the national reporting system listed in the "Contact" section below.
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 5 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

Oval, biconvex, film-coated tablets, yellow in color, 8.65 x 5.65 mm in size and 3.25 mm in thickness, with the number "5" engraved on one side and "S" on the other side.
Tadalafil SUN is available in blisters containing 14, 28, or 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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