Sildenafil Bluefish

Package Leaflet: Information for the Patient

Sildenafil Bluefish, 50 mg, Film-Coated Tablets

Sildenafil Bluefish, 100 mg, Film-Coated Tablets

Sildenafil

Read the Package Leaflet Carefully Before Taking the Medication, 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, pharmacist, or nurse.
• 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Sildenafil Bluefish and What is it Used For
• 2. Important Information Before Taking Sildenafil Bluefish
• 3. How to Take Sildenafil Bluefish
• 4. Possible Side Effects
• 5. How to Store Sildenafil Bluefish
• 6. Contents of the Pack and Other Information

1. What is Sildenafil Bluefish and What is it Used For

Sildenafil Bluefish contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing the flow of blood to the penis during sexual stimulation. Sildenafil Bluefish helps to achieve an erection only if there is sexual stimulation.

2. Important Information Before Taking Sildenafil Bluefish

When Not to Take Sildenafil Bluefish:

• if you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in blood pressure. Tell your doctor if you are taking any of these medicines; they are often used to relieve angina (chest pain) symptoms. If in doubt, consult your doctor or pharmacist;
• if you are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"; nitrites used for recreational purposes), as their combination may also cause a dangerous decrease in blood pressure;
• 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). It has been shown that PDE5 inhibitors, such as Sildenafil Bluefish, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, inform your doctor;
• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• if you have severe heart or liver disease;
• if you have recently had a stroke or heart attack or have low blood pressure;
• if you have certain rare inherited eye disorders (retinal pigmentosis);
• if you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and Precautions

Before taking Sildenafil Bluefish, discuss it with your doctor, pharmacist, or nurse.

• If you have sickle cell anemia (a condition affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• If you have a deformity of the penis or Peyronie's disease.
• If you have heart problems. Your doctor should assess whether your heart condition allows for the extra strain of sexual activity.
• If you have stomach ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden hearing loss, stop taking Sildenafil Bluefish and contact your doctor immediately.

Do not take Sildenafil Bluefish with other oral or topical treatments for erectile dysfunction.

Do not take Sildenafil Bluefish with pulmonary arterial hypertension treatments that contain sildenafil or other PDE5 inhibitors.

Do not take Sildenafil Bluefish if you have not been diagnosed with erectile dysfunction.

Do not take Sildenafil Bluefish if you are a woman.

Special precautions for patients with kidney or liver problems

Patients with kidney or liver problems should inform their doctor, who may decide to administer a lower dose of the medicine.

Children and Adolescents

Sildenafil Bluefish should not be used in persons under 18 years of age.

Sildenafil Bluefish and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Sildenafil Bluefish film-coated tablets may interact with some medicines, especially those used to treat chest pain.

In case of worsening of your condition, requiring immediate medical attention, tell your doctor, pharmacist, or nurse about taking Sildenafil Bluefish and the time of intake.

Do not take Sildenafil Bluefish with other medicines without consulting your doctor.

Do not take Sildenafil Bluefish if you are taking nitrates, as their combination may lead to a dangerous decrease in blood pressure.

Always inform your doctor, pharmacist, or nurse if you are taking nitrates, which are used to treat angina (chest pain).

Do not take Sildenafil Bluefish if you are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their combination may also cause a dangerous decrease in blood pressure.

If you are taking protease inhibitors for the treatment of HIV infection, your doctor may recommend starting with the lowest dose (25 mg) of Sildenafil Bluefish.

In some patients taking alpha-blockers for high blood pressure or prostate enlargement, dizziness or fainting may occur when standing up or sitting down quickly, which can be symptoms of low blood pressure.

These symptoms have occurred in some patients taking sildenafil and alpha-blockers.

Their occurrence is most likely within 4 hours of taking sildenafil.

To minimize the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-blocker before starting treatment with Sildenafil Bluefish.

Your doctor may decide to use a lower starting dose (25 mg) of Sildenafil Bluefish.

Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Sildenafil Bluefish with Food, Drink, and Alcohol

Sildenafil Bluefish can be taken with or without food.

However, taking Sildenafil Bluefish during a heavy meal may prolong the time it takes for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol.

To maximize the therapeutic effects of Sildenafil Bluefish, do not consume excessive amounts of alcohol before taking the medicine.

Pregnancy, Breast-Feeding, and Fertility

Sildenafil Bluefish should not be used by women.

Driving and Using Machines

Sildenafil Bluefish may cause dizziness and visual disturbances.

Before driving or operating machinery, the patient should be aware of how they react to Sildenafil Bluefish.

Important Information About Some Ingredients of Sildenafil Bluefish

Sildenafil Bluefish Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to Take Sildenafil Bluefish

This medicine should always be taken exactly as prescribed by your doctor.

In case of doubt, consult your doctor or pharmacist.

The usual starting dose is 50 mg.

Sildenafil Bluefish should not be taken more than once a day.

Sildenafil Bluefish should be taken approximately one hour before planned sexual activity.

Swallow the tablet whole with a glass of water.

If you feel that the effect of Sildenafil Bluefish is too strong or too weak, talk to your doctor or pharmacist.

Sildenafil Bluefish will only work if you are sexually stimulated.

The time it takes for Sildenafil Bluefish to work varies from person to person, but it usually takes between half an hour to one hour.

The effect of Sildenafil Bluefish may occur later if you take it after a heavy meal.

Contact your doctor if, after taking Sildenafil Bluefish, you do not get an erection or if the erection is not sufficient for sexual intercourse.

The tablet can be divided into equal doses.

Taking More Than the Recommended Dose of Sildenafil Bluefish

Side effects may occur more often and may be more severe.

Taking a dose higher than 100 mg does not increase the efficacy of the medicine.

Do not take more tablets than prescribed by your doctor.

Contact your doctor if you have taken more tablets than prescribed.

Missing a Dose of Sildenafil Bluefish

Do not take a double dose to make up for a forgotten tablet.

Stopping Sildenafil Bluefish Treatment

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Sildenafil Bluefish can cause side effects, although not everybody gets them.

Side effects reported in association with the use of sildenafil are usually mild to moderate and short-lived.

If You Experience Any of the Following Side Effects, Stop Taking Sildenafil Bluefish and Seek Medical Help Immediately:

• Allergic reaction - occurs uncommonly(may affect up to 1 in 100 people) Symptoms include sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf this happens during or after sex, you:
• Should sit or lie down and try to relax;
• Must not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may affect up to 1 in 1000 people) If an erection lasts more than 4 hours, seek medical attention immediately.
• Sudden loss of vision - occurs rarely
• Severe skin reactions - occurs rarelySymptoms can include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or fits - occurs rarely

Other Side Effects:

Very common(may affect more than 1 in 10 people): headache

Common(may affect up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tinge on objects, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the nasal passages (symptoms include a cold, sneezing, and a stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling hot or feeling tired.

Rare(may affect up to 1 in 1000 people) include: fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around lights, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden loss of hearing.

After the medicine was made available, rare cases of unstable angina (heart disease) and sudden death have been reported.

It is important to note that in most, but not all, men who experienced these side effects, heart disease was present before taking this medicine.

It is not possible to determine whether these side effects were related to Sildenafil Bluefish.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Sildenafil Bluefish

Keep this medicine out of the sight and reach of children.

No special precautions for storage are necessary.

Do not use this medicine after the expiry date stated on the carton and blister after "Expiry Date" or "EXP".

The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the Pack and Other Information

What Sildenafil Bluefish Contains

The active substance is sildenafil.

Each film-coated tablet contains 50 mg or 100 mg of sildenafil (as citrate).

The other ingredients are:

• Core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate
• Coating: talc, hypromellose, polyvinyl alcohol, macrogol, titanium dioxide (E 171), triacetin, indigo carmine lake (E 132)

What Sildenafil Bluefish Looks Like and Contents of the Pack

Sildenafil Bluefish, 50 mg:

Blue, round, biconvex film-coated tablet with "125" engraved on one side and "J" on the other, with a score line.

Sildenafil Bluefish, 100 mg:

Blue, round, biconvex film-coated tablet with "126" engraved on one side and "J" on the other, with a score line.

Sildenafil Bluefish is Available in the Following Pack Sizes:

Sildenafil Bluefish, 50 mg

PVC/Aluminum blisters in a cardboard box containing 1, 4, or 24 film-coated tablets.

Sildenafil Bluefish, 100 mg

PVC/Aluminum blisters in a cardboard box containing 1, 4, 8, or 24 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

Manufacturer/Importer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden

Pharmadox Healthcare, Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

This Medicine is Authorized in the Member States of the European Economic Area Under the Following Names:

Portugal:

Sildenafil Bluefish 25 mg Comprimidos revestido por película

Sildenafil Bluefish 50 mg Comprimidos revestido por película

Sildenafil Bluefish 100 mg Comprimidos revestidos por película

Poland:

Sildenafil Bluefish

Date of Last Revision of the Leaflet:September 2024