Package leaflet: Information for the user

Tadalafil Bluescience, 10 mg, coated tablets
Tadalafil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Tadalafil Bluescience is and what it is used for
What you need to know before taking Tadalafil Bluescience
How to take Tadalafil Bluescience
Possible side effects
How to store Tadalafil Bluescience
Contents of the pack and other information

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

Tadalafil Bluescience 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 obtain 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 men 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 if the patient
were not taking medication for erectile dysfunction.

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, such as 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 blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as tadalafil have been shown to 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 in patients with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking this medicine, the patient should inform their doctor if any of the following conditions apply:

sickle cell anemia (abnormal shape of red blood cells).
multiple myeloma (a bone marrow tumor).
leukemia (a blood cell cancer).
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, during which nerves to the prostate are severed (non-nerve-sparing radical prostatectomy).

If sudden vision deterioration or sudden vision loss occurs, treatment with Tadalafil Bluescience should be discontinued and the patient should contact their doctor immediately.
In some patients taking tadalafil, worsening 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 deterioration 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
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 the patient is taking any of the following medicines:

alpha-adrenergic receptor blockers (used to treat high blood pressure or urinary symptoms caused by 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 to treat AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Bluescience and alcohol consumption
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 further 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, patients should understand how they react to the tablets before deciding to drive a car or operate machinery.
Tadalafil Bluescience contains lactose:
If the patient has an intolerance to certain sugars, they should consult their 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 exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Tadalafil Bluescience tablets are intended for oral use in men only.
The tablets should be swallowed whole with a small amount of water. The tablets may be taken with or without food.
Recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is not sufficient, your doctor may increase the dose to 20 mg.
Tadalafil Bluescience may be taken at least 30 minutes before planned sexual activity. Tadalafil Bluescience may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Bluescience more than once a day. Tadalafil Bluescience 10 mg and 20 mg are intended to be used prior to planned sexual activity. Regular daily use is not recommended.
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 erectile dysfunction medication.
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 dizziness upon standing.
The breakline on the tablet is not intended for dividing the tablet.
Taking more than the recommended dose of Tadalafil Bluescience
Inform your doctor immediately. Adverse effects described in section 4 may occur.
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 they do not occur in everyone.
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 skin rash (uncommon).
chest pain – do not take 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, 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, ringing in the ears, swelling of hands, feet or ankles, and feeling tired.

Rare (occur in no 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
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 which 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 manifesting as blood flow 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 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 for 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 marketing authorisation 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 carton and blister after: EXP.
The expiry date refers to the last day of the stated month. The batch number is indicated after:
Lot.
No special storage conditions are required for this medicinal product.
Medicines must 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 10 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, iron oxide yellow (E 172), iron oxide red (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 division line on one side.
Tadalafil Bluescience 10 mg tablets are available in blisters containing 4, 12, 24, 36 or 48 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 10 mg Filmtabletten
Spain: Tadalafilo Bluescience 10 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