Tadalafil Bluescience

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Tadalafil Bluescience, 20 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 is a medicine used for the treatment of adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain a hard erection sufficient for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a hard 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 the blood vessels in the penis to relax and expand, allowing more 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.

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 nitric oxide donors, such as amyl nitrite. These are medicines used to treat angina (chest pain). Tadalafil has been shown to increase the effects of these medicines.
• 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 (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs due to blood clots). Tadalafil has been shown to increase the effects of this medicine.

Warnings and precautions

Before taking Tadalafil Bluescience, talk to your doctor. You should be aware that sexual activity carries a risk for patients with heart disease, because it puts extra strain on the heart. If you have a heart condition, tell your doctor. Before taking the medicine, tell your doctor if you have any of the following:

• sickle-cell anaemia (a disease of the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukaemia (a cancer of the blood cells).
• any deformation of the penis.
• severe liver disease.
• severe kidney disease.

It is not known if 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 loss of hearing, stop taking Tadalafil Bluescience and contact your doctor immediately. Some patients taking tadalafil have reported a sudden loss of hearing. Although it is not known if this event is directly related to tadalafil, if you experience a sudden loss of hearing, stop taking Tadalafil Bluescience 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.

Tadalafil Bluescience and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take. Do not take Tadalafil Bluescience if you are taking nitrates. Tadalafil Bluescience may affect the way some medicines work, and some medicines may affect the way Tadalafil Bluescience works. 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 an enlarged prostate).
• medicines such as ketoconazole (used to treat fungal infections) and protease inhibitors (used to treat AIDS or HIV infection).
• phenobarbital, phenytoin and carbamazepine (medicines used to treat epilepsy).
• 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 grapefruit juice. For more information, talk to your doctor.

Fertility

When tadalafil was given to dogs, it caused a decrease in sperm production in the testes. A decrease in sperm concentration was observed in some men. It is unlikely that this will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness. Therefore, 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, contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Tadalafil Bluescience

Always take this medicine exactly as your doctor has told you. If you are not sure, check with 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. The recommended doseis one 10 mg tablet taken before planned sexual activity. If your doctor has prescribed the 10 mg dose and you find it is too weak, you can take one 20 mg tablet. Tadalafil Bluescience can 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 is intended for use before planned sexual activity and is not recommended for continuous, daily use. It is important to note that Tadalafil Bluescience does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Drinking alcohol may impair your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Bluescience, do not drink too much alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up. The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.

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

Contact your doctor. You may experience side effects described in section 4. 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 (not very common).
• chest pain - do not take nitrates, but seek medical help immediately (not very common).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you have an erection that lasts more than 4 hours, contact your doctor immediately.
• sudden loss of vision (rare).

Other reported side effects:

Common(affecting up to 1 in 10 people)

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

Uncommon(affecting up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, 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(affecting up to 1 in 1,000 people)

• fainting, seizures and transient memory loss, swelling of the eyelids, redness of the eyes, sudden loss of hearing, hives (itchy, red welts on the skin), bleeding from the penis, 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 disease. There have been rare reports of partial, temporary, or permanent loss of vision in one or both eyes. Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials, including:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders of the blood vessels that supply the eyes, irregular heartbeat, angina and sudden cardiac death.

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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below. 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. The batch number is stated after Lot. There are no special storage conditions 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. 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 20 mg of tadalafil.
• The other ingredients are: Tablet core:lactose monohydrate, microcrystalline cellulose, povidone K 30, poloxamer type 188, sodium lauryl sulfate, croscarmellose sodium, 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 is a light pink, elongated, biconvex, film-coated tablet with a score line on one side. Tadalafil Bluescience 20 mg tablets are available in blisters of 2, 4, 8, 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 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 20 mg Filmtabletten
Spain
Tadalafilo Bluescience 20 mg comprimidos recubiertos con película 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