Tadalafil Bluescience

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Tadalafil Bluescience, 10 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 or pharmacist.
• 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, please inform your 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 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 activity. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual activity.
Tadalafil Bluescience contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Bluescience helps to widen the blood vessels in 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 important to note 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.

2. Important information before taking Tadalafil Bluescience

When not to take Tadalafil Bluescience:

• 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 enhances the effect of these medicines. If you are taking nitrates in any form or are unsure, you should inform 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 had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "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 phosphodiesterase type 5 inhibitors, such as tadalafil, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Tadalafil Bluescience, you should discuss it with your doctor.
It should be remembered that sexual activity carries a risk for patients with heart disease, as it puts an extra strain on the heart. If you have heart problems, you should inform your doctor.
Before taking the medicine, the patient should inform the doctor if any of the following conditions occur:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any deformation of the penis.
• 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 nerves of the prostate gland are cut (radical prostatectomy without nerve sparing).

If sudden vision loss or sudden loss of vision occurs, you should stop taking Tadalafil Bluescience and immediately contact your doctor.
In some patients taking tadalafil, a worsening or sudden loss of hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if a worsening or sudden loss of hearing occurs, you should stop taking tadalafil and immediately contact your doctor.
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

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

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat an enlarged prostate).
• 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 therefore should be consumed with caution. For more information, you should consult your doctor.

Fertility

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

Driving and using machines

In some men taking tadalafil during clinical trials, dizziness was reported, so you should be aware of your reaction to the tablets before driving or operating machinery.

Tadalafil Bluescience contains lactose:

If you have an intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tadalafil Bluescience

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Tadalafil Bluescience tablets are intended 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.
The recommended initial doseis one 10 mg tablet, taken before planned sexual activity. If this dose is not effective, your doctor may increase the dose to 20 mg.
Tadalafil Bluescience can be taken at least 30 minutes before planned sexual activity. Tadalafil Bluescience may still be effective up to 36 hours after taking the tablet.
You should not take Tadalafil Bluescience more than once a day. Tadalafil Bluescience 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine continuously, on a daily basis.
It is important to note 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 your ability to achieve an erection and may cause a temporary decrease in blood pressure. If you have taken Tadalafil Bluescience or plan to take it, you 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.
The dividing line on the tablet is not intended to break the tablet.

Overdose of Tadalafil Bluescience

You should inform your doctor. Adverse reactions described in section 4 may occur.
If you have any further questions about the use of this medicine, you should consult 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 rash (not very common).
• chest pain - do not take nitrates, but seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erection after taking tadalafil (rare). If such an erection occurs and lasts continuously for more than 4 hours, you should contact your doctor 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 nausea.

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, 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 worsening or loss of hearing, 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 taking 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 of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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: Expiry date (EXP). The expiry date refers to the last day of the month stated.
There are no special requirements for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Bluescience contains

• The active substance of the medicine is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other ingredients: Core:lactose monohydrate, microcrystalline cellulose, povidone K 30, poloxamer type 188, sodium lauryl sulfate, sodium croscarmellose, 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 10 mg is a light orange, elongated, biconvex, film-coated tablet with a dividing line on one side.
Tadalafil Bluescience 10 mg tablets are available in blisters containing 4, 12, 24, 36, or 48 tablets.

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 10 mg film-coated tablets
Spain
Tadalafil Bluescience 10 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