Package leaflet: Information for the user

Tadalafil Bluescience, 20 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. 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 them, 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 achieve an erection
adequate for sexual intercourse.
Tadalafil Bluescience contains, as the active substance, tadalafil, which belongs to a group of
medicines called phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation,
Tadalafil Bluescience helps widen the blood vessels of the penis, allowing increased blood flow into
the penis. As a result, erection is improved. 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. What you need to know before taking Tadalafil Bluescience

Do not 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 in any form or other nitric oxide donors, such as amyl nitrite. These are a group of medicines (‘nitrates’) used to treat angina (‘chest pain’). Tadalafil has been shown to enhance the effects of these medicines. If you are taking nitrates in any form or are unsure, you must inform your doctor.
if you have severe heart disease or have had a heart attack within the last 90 days.
if you have had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), sometimes referred to as “eye stroke”.
if you are 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 you are taking riociguat or are unsure, inform your doctor.

Warnings and precautions
Before taking Tadalafil Bluescience, discuss it 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 heart problems, inform your doctor.
Before taking this medicine, you should inform your doctor if any of the following apply to you:

sickle cell anaemia (abnormal shape of red blood cells).
multiple myeloma (a cancer of the bone marrow).
leukaemia (a blood 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 with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If you experience sudden worsening of vision or sudden vision loss, stop taking Tadalafil Bluescience
immediately and contact your doctor without delay.
In some patients taking tadalafil, worsening of hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to tadalafil use, if you experience
worsening of hearing or sudden hearing loss, stop taking Tadalafil Bluescience 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 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, food, and alcohol
Information on the effect of alcohol is provided in section 3. Grapefruit juice may affect the
effectiveness of Tadalafil Bluescience, and caution should therefore be exercised when consuming
it. For further information, consult your doctor.
Fertility
When administered to dogs, the medicine caused reduced sperm production in the testes.
Reduced sperm concentration has been observed in some men. It is unlikely that this leads to
infertility.
Driving and using machines
Dizziness has been reported in some men taking tadalafil during clinical trials. Therefore, you
should understand your response to the tablets before deciding to drive a car or operate machinery.
Tadalafil Bluescience contains lactose:
If you have an intolerance to certain sugars, consult your doctor before starting this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered “sodium-free”.

3. How to use Tadalafil Bluescience

This medicine should always be taken as prescribed by a doctor. If in doubt, consult a doctor or pharmacist.
Tadalafil Bluescience tablets are intended for oral use only in men.
Tablets should be swallowed whole with a small amount of water. Tadalafil Bluescience tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If the doctor determines that the 10 mg dose is insufficient, then one 20 mg tablet should be taken as directed by the doctor.
Tadalafil Bluescience may be taken at least 30 minutes before planned sexual activity. The effect of Tadalafil Bluescience may last 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 of the medicine is not recommended.
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 avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
The break line on the tablet is not intended for splitting the tablet.
Taking more than the recommended dose of Tadalafil Bluescience
Inform the doctor immediately. Adverse effects described in section 4 may occur.
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 no more than 1 in 10 patients)

Headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal mucosa 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, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

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 loss of vision 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, 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 the sewage system 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 packaging and other information

What Tadalafil Bluescience contains

The active substance is tadalafil. Each tablet of the medicinal product contains 20 mg of tadalafil.
Other components: 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, yellow iron oxide (E 172), red iron oxide (E 172).

What Tadalafil Bluescience looks like and contents of the pack
Tadalafil Bluescience 20 mg are light pink, elongated, biconvex, film-coated tablets with a score line on one side.
Tadalafil Bluescience 20 mg tablets are available in blisters containing 2, 4, 8, 12, 24, 36 or 48 tablets.

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 20 mg Filmtabletten
Spain: Tadalafilo Bluescience 20 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