Tadalafil Bluescience

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Tadalafil Bluescience, 2.5 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 tell 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 2.5 mg 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 is improved. 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 engage in foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.

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 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 had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye".
• 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 tell your doctor.

Warnings and precautions

Before taking Tadalafil Bluescience, you should discuss this 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 tell your doctor.
Before taking the medicine, you should tell your doctor if you have any of the following:

• sickle cell anaemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (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 who have:

• had pelvic surgery.
• had prostate removal (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or sudden hearing loss, you should stop taking Tadalafil Bluescience and contact your 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 you experience a decrease in hearing or sudden hearing loss, you should stop taking tadalafil and contact your doctor immediately.
Tadalafil Bluescience is not intended for use by women.

Children and adolescents

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

Tadalafil Bluescience and other medicines

You should tell your doctor about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Do not take Tadalafil Bluescience if you are taking nitrates.
Tadalafil Bluescience may affect the way some other medicines work, or other medicines may affect the way Tadalafil Bluescience works. You should tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-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 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 (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Bluescience with food and drink

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Bluescience, and therefore, caution should be exercised when consuming it. 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

Some men taking tadalafil during clinical trials reported dizziness, so you should be aware of how you react 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 it is essentially "sodium-free".

3. How to take Tadalafil Bluescience

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 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.
Recommended doseis one 5 mg tablet, taken once daily, at approximately the same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Bluescience. You should take one 2.5 mg tablet.
Do not take Tadalafil Bluescience more than once a day.
Taking Tadalafil Bluescience once daily may be useful for men who anticipate having sexual intercourse twice a week or more frequently.
Taking Tadalafil Bluescience once daily allows for successful intercourse at any time point within 24 hours.
It is important to note that Tadalafil Bluescience does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking an erectile dysfunction medicine.
Consuming large amounts of alcohol may impair your ability to achieve an erection and may increase the risk of dizziness when standing up. If you have taken Tadalafil Bluescience 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.

What to do if you take more Tadalafil Bluescience than you should:

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

What to do if you forget to take Tadalafil Bluescience:

Take the dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. Do not take Tadalafil Bluescience more than once a day.
If you have any further questions on the use of this medicine, 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 (uncommon).
• chest pain - do not take nitrates, but seek medical help immediately (uncommon).
• priapism, prolonged and possibly painful erections after taking tadalafil (rare). If you experience such an erection, seek medical help immediately.
• sudden loss of vision (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, abdominal 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 1,000 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 these men had heart problems before taking this medicine.
There have been reports of rare cases of partial, temporary, or permanent decrease in vision or loss of vision in one or both eyes.
Men taking tadalafil have reported several 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. Diarrhoea was reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: mailto:ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Bluescience

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 that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 2.5 mg of tadalafil.
• The other ingredients are: tablet core:lactose monohydrate, microcrystalline cellulose, povidone K30, poloxamer type 188, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate coating:polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Tadalafil Bluescience looks like and contents of the pack

Tadalafil Bluescience 2.5 mg is a white or almost white, round, biconvex, film-coated tablet.
Tadalafil Bluescience 2.5 mg tablets are available in blisters containing 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Portugal
Tadalafil Bluescience
Germany
Tadalafil Bluescience 2.5 mg film-coated tablets
Spain
Tadalafil Bluescience 2.5 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