Tadalafil Bluescience

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Tadalafil Bluescience, 5 mg, film-coated tablets

Tadalafil

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Tadalafil Bluescience contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Bluescience 5 mg is used to treat adult men:

• with erectile dysfunction.This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for sexual intercourse.

After sexual stimulation, Tadalafil Bluescience helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, the erection improves.
Tadalafil Bluescience does not help patients who do not have erectile dysfunction.
It is essential to be aware that Tadalafil Bluescience does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

• with symptoms of benign prostatic hyperplasia (BPH), a common condition where the prostate gland enlarges with age. Symptoms include: difficulty starting to urinate, feeling of incomplete emptying of the bladder, and needing to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the prostate and bladder muscles, which can alleviate BPH symptoms. It has been shown that tadalafil alleviates these urinary symptoms within 1-2 weeks of starting treatment.

2. Important information before taking Tadalafil Bluescience

When not to take Tadalafil Bluescience:

• 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 nitrates in any form or other donors of nitric oxide, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effect 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 in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also 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 phosphodiesterase type 5 inhibitors, such as tadalafil, 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 take Tadalafil Bluescience, the patient should discuss it with their doctor.
It should be remembered that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so the doctor will perform a check for prostate cancer before starting Tadalafil Bluescience treatment for BPH symptoms. Tadalafil Bluescience is not used to treat prostate cancer.
Before taking the medicine, the patient should inform their doctor if they have any of the following:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known whether Tadalafil Bluescience is effective in patients:

• after pelvic surgery.
• after total or partial removal of the prostate gland, during which the prostate nerves are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Tadalafil Bluescience and contact their doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if a decrease in hearing or sudden hearing loss occurs, the patient should stop taking tadalafil and contact their doctor immediately.
Tadalafil Bluescience is not intended for use in women.

Children and adolescents

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

Tadalafil Bluescience and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tadalafil Bluescience should not be taken if the patient is taking nitrates.
Tadalafil Bluescience may affect the action of some medicines or other medicines may affect the action of Tadalafil Bluescience. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or BPH symptoms).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat BPH).
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Bluescience with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Bluescience, and caution should be exercised when consuming it. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes occurred.
A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness, so the patient should be aware of their reaction to the tablets before driving or operating machinery.

Tadalafil Bluescience contains lactose:

If the patient has an intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Tadalafil Bluescience

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Tadalafil Bluescience tablets are for oral use only in men.
The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil Bluescience or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet, taken once daily, at approximately the same time every day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Tadalafil Bluescience. In that case, the patient should take a 2.5 mg tablet.
The patient should not take Tadalafil Bluescience more than once a day.
Taking Tadalafil Bluescience once a day allows for the achievement of an erection after sexual stimulation at any time during the 24 hours. Taking Tadalafil Bluescience once a day may be beneficial for men who intend to engage in sexual activity twice a week or more often.
It is essential to be aware that Tadalafil Bluescience does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.
Consuming alcohol may affect the patient's ability to achieve an erection.

Treatment of benign prostatic hyperplasia symptoms

Doseis one 5 mg tablet, taken once daily, at approximately the same time every day. If the patient has BPH and erectile dysfunction, the dose of one 5 mg tablet per day remains unchanged.
The patient should not take Tadalafil Bluescience more than once a day.

Taking a higher dose of Tadalafil Bluescience than recommended

The patient should inform their doctor. Side effects described in section 4 may occur.

Missing a dose of Tadalafil Bluescience

The patient should take the dose as soon as they remember, but they should not take a double dose to make up for the missed tablet. The patient should not take Tadalafil Bluescience more than once a day.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately:

• allergic reactions, including skin rash (not very common).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking tadalafil (rare). If such an erection occurs and lasts for more than 4 hours, the patient should seek medical help immediately.
• sudden vision loss (rare).

Other reported side effects:
Common(occurring in less than 1 in 10 patients)

• headache, back pain, muscle pain, pain in arms and legs, flushing, nasal congestion, and indigestion.

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(occurring in less than 1 in 1000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden hearing loss, hives (itchy, red bumps on the skin), penile bleeding, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting to take this medicine.
There have been reports of rare cases of partial, transient, or permanent vision loss or blindness in one or both eyes.
Men taking tadalafil have reported a few additional rare side effects, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths.

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 side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tadalafil Bluescience

The medicine should be stored 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 month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Bluescience contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• Other ingredients: Tablet core:lactose monohydrate, microcrystalline cellulose, povidone K 30, poloxamer 188, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172)

What Tadalafil Bluescience looks like and contents of the pack

Tadalafil Bluescience 5 mg is a light brown, elongated, biconvex, film-coated tablet.
Tadalafil Bluescience 5 mg tablets are available in blisters containing 14, 28, or 84 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluescience Unipessoal, Lda.
Rua Dio, Lote 53, nº 8, 2º esq.
2685-325 Prior Velho, Lisbon
Portugal

Manufacturer/Importer

Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA SA
ul. Metalowca 2
39-460 Nowa Dęba
Pharmacare Premium Ltd.
HHF003, Hal Far Industrial State, Hal Far
BBG 3000 Birzebbugia
Malta

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

Portugal
Tadalafil Bluescience
Germany
Tadalafil Bluescience 5 mg film-coated tablets
Spain
Tadalafil Bluescience 5 mg film-coated tablets EFG

Date of last revision of the leaflet:

November 2021

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl