Tadalafil bluescience

Package leaflet: Information for the user

Tadalafil Bluescience, 2.5 mg, coated tablets
Tadalafil
Read the entire leaflet carefully before starting to take this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If there are any doubts, consult a 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 the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

1. What Tadalafil Bluescience is and what it is used for
2. What you need to know 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 Tadalafil Bluescience is and what it is used for

Tadalafil Bluescience 2.5 mg is a medicine intended for adult men with erectile dysfunction.
This is a condition in which a man is unable to 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 intercourse.
Tadalafil Bluescience contains the active substance tadalafil, which belongs to a group of
medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil
Bluescience helps widen the blood vessels of the penis, allowing blood to flow into the penis.
This results in improved erection. Tadalafil Bluescience does not benefit patients who do not
have erectile dysfunction.
It is important to be aware 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 when the
patient is not taking a medicine for erectile dysfunction.

2. Important information before using Tadalafil Bluescience

When not to use 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 organic nitrates in any form 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 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 blood pressure in the lungs 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 disease, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Before taking this medicine, the patient should inform their doctor if any of the following apply:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity 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 with nerve cutting (non-nerve-sparing radical prostatectomy).

If sudden vision loss or sudden decrease in vision occurs, stop taking Tadalafil Bluescience and contact your doctor immediately.
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 hearing loss occurs, stop taking tadalafil and contact your 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 ketoconazole tablets (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
In some men taking tadalafil during clinical trials, dizziness was reported. Therefore, you should understand how you react to the tablets before deciding to drive or operate machinery.
Tadalafil Bluescience contains lactose:
If the patient has an intolerance to certain sugars, they should consult their doctor before starting treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Tadalafil Bluescience

This medicine should always be used exactly as your doctor has instructed. If in doubt, 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. Tadalafil Bluescience tablets may be taken with or without food.
The recommended dose is one 5 mg tablet taken once daily, approximately at the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Bluescience. In such case, the 2.5 mg tablet should be used.
Do not take Tadalafil Bluescience more often than once a day.
Daily use of Tadalafil Bluescience may benefit men who anticipate engaging in sexual activity two or more times per week.
Taking Tadalafil Bluescience once daily allows for achieving an erection following sexual stimulation at any time within 24 hours.
It is important to understand that Tadalafil Bluescience will 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 and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadalafil Bluescience, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of experiencing dizziness upon standing.
Taking more than the recommended dose of Tadalafil Bluescience
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Tadalafil Bluescience
Take the missed dose as soon as you remember, 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 you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can 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 no 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 no more than 1 in 100 patients)

• Dizziness, abdominal pain, nausea, vomiting, gastroesophageal reflux, 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 tired.

Rare (occur in no more than 1 in 1,000 patients)

• Fainting, convulsions 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 conditions 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. Diarrhea was reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
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 marketing authorization holder.
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 box 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 requirements for storage of this medicinal product.
Medicines must 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 Bluescience contains

• The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• Other ingredients: Tablet core: monohydrate lactose, microcrystalline cellulose, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, 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 are white or almost white, round, biconvex, film-coated tablets.
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 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 2.5 mg Filmtabletten
Spain: Tadalafilo Bluescience 2,5 mg comprimidos recubiertos con película EFG

November 2021

Further 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