Tadalafil bluescience

Patient Information Leaflet: Instructions for Use

Tadalafil Bluescience, 5 mg, film-coated tablets
Tadalafil
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 tadalafil as the active substance, which belongs to a group of medicines known as phosphodiesterase type 5 inhibitors.
Tadalafil Bluescience 5 mg is used in the treatment of adult men:

• with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection adequate for sexual activity.

Following sexual stimulation, Tadalafil Bluescience helps widen the blood vessels in the penis, allowing increased blood flow. This results in improved erection.
Tadalafil Bluescience does not benefit patients who do not have erectile dysfunction.
It is important to understand that Tadalafil Bluescience does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.

• with urinary symptoms caused by a common condition called benign prostatic hyperplasia (BPH). This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, sensation of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before using Tadalafil Bluescience

When not to use Tadalafil Bluescience:

• if the patient is allergic to tadalafil or to 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, e.g. amyl nitrite. This group of medicines ("nitrates") is used in the treatment of angina pectoris (chest pain). It has been shown that tadalafil 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 experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), also 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 lung pressure caused by blood clots). It has been shown that PDE5 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 treatment with Tadalafil Bluescience, discuss this with your doctor.
Please remember that sexual activity involves some risk for patients with heart conditions, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform tests to rule out prostate cancer before starting treatment with Tadalafil Bluescience for symptoms of benign prostatic hyperplasia. Tadalafil Bluescience is not used to treat prostate cancer.
Before taking the medicine, the patient should inform the doctor if any of the following apply:

• sickle cell anemia (abnormal shape 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 Bluescience 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 vision loss or sudden decrease in vision occurs, stop taking Tadalafil Bluescience immediately and contact a doctor without delay.
In some patients taking tadalafil, hearing loss 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 sudden decrease in hearing occurs, stop taking tadalafil and contact a 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
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Tadalafil Bluescience if you are using nitrates.
Tadalafil Bluescience may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Bluescience. Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
• medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Bluescience, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Bluescience, and therefore caution should be exercised when consuming it. For more information, consult your doctor.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
Dizziness has been reported in some men taking tadalafil during clinical trials; therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Bluescience contains lactose:
If the patient has intolerance to certain sugars, consult a doctor before starting treatment.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Bluescience

This medicine should always be taken as directed by the doctor. If in doubt, consult a 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. Tadalafil Bluescience tablets can be taken with or without food.
Alcohol consumption may cause a temporary decrease in blood pressure. If the patient has taken or plans to take Tadalafil Bluescience, large amounts of alcohol (blood alcohol concentration of 0.08% or higher) should not be consumed, as this may increase the risk of experiencing dizziness upon standing.

Treatment of erectile dysfunction
Recommended dose: one 5 mg tablet taken once daily at approximately the same time each day. The doctor may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil Bluescience. In such case, the 2.5 mg tablet should be used.
Tadalafil Bluescience should not be taken more than once a day.
Taking Tadalafil Bluescience once daily allows for achieving an erection following sexual stimulation at any time within 24 hours. Daily administration of Tadalafil Bluescience may be beneficial for men who plan to engage in sexual activity two or more times per week.
It is important to understand that Tadalafil Bluescience does not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia
Dose: one 5 mg tablet taken once daily at approximately the same time each day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at one 5 mg tablet once daily.
Tadalafil Bluescience must not be taken more than once a day.

Use of a higher than recommended dose of Tadalafil Bluescience
Inform the doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Tadalafil Bluescience
Take the missed dose as soon as remembered, but do not take a double dose to make up for the missed tablet. Do not take Tadalafil Bluescience more than once a day.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience 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 (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare).

Other reported adverse reactions:
Common (occur in not more than 1 in 10 patients)

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

Uncommon (occur in not more than 1 in 100 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, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (occur in not more than 1 in 1000 patients)

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had
pre-existing heart problems 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, 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 and throat, severe skin rashes, disorders characterized by blood rush to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.

Adverse reaction: dizziness was reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the
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: mailto:[email protected]
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 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 the stated month. The batch number is indicated after: Lot.
There are no special storage requirements for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you 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 components:
  Tablet core: monohydrate lactose, microcrystalline cellulose, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate
  Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172), iron oxide red (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 blister packs containing 14, 28 or 84 tablets.
Not all pack sizes may be marketed.

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 Estate, 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 5 mg Filmtabletten
Spain: Tadalafilo Bluescience 5 mg comprimidos recubiertos con película EFG

November 2021

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