SILDENAFIL 50 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Sildenafil Bluefish, 50 mg, film-coated tablets
3. Sildenafil Bluefish, 100 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Sildenafil Bluefish and what is it used for
5. Important information before taking Sildenafil Bluefish
   1. When not to take Sildenafil Bluefish:
   2. Warnings and precautions
   3. Children and adolescents
   4. Sildenafil Bluefish and other medicines
   5. Sildenafil Bluefish with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Important information about some ingredients of Sildenafil Bluefish
   9. Sildenafil Bluefish contains sodium
6. How to take Sildenafil Bluefish
   1. Taking a higher dose of Sildenafil Bluefish than recommended
   2. Missing a dose of Sildenafil Bluefish
   3. Stopping Sildenafil Bluefish treatment
7. Possible side effects
   1. If any of the following side effects occur, the patient should stop taking Sildenafil Bluefish and seek medical attention immediately:
   2. Other side effects:
   3. Reporting side effects
8. How to store Sildenafil Bluefish
9. Package contents and other information
   1. What Sildenafil Bluefish contains
   2. What Sildenafil Bluefish looks like and what the pack contains
   3. Sildenafil Bluefish is available in the following pack sizes:
   4. Sildenafil Bluefish, 50 mg
   5. Sildenafil Bluefish, 100 mg
   6. Marketing authorization holder
   7. Manufacturer/Importer
   8. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Sildenafil Bluefish, 50 mg, film-coated tablets

Sildenafil Bluefish, 100 mg, film-coated tablets

Sildenafil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents 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 phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by supporting the relaxation of blood vessels in the penis, increasing blood flow to the penis during sexual arousal. Sildenafil Bluefish helps achieve an erection only if there is simultaneous sexual stimulation. Sildenafil Bluefish is used to treat erectile dysfunction in adult men, sometimes called impotence. It is the inability to achieve or maintain an erection of the penis sufficient for sexual intercourse.

2. Important information before taking Sildenafil Bluefish

When not to take Sildenafil Bluefish:

Warnings and precautions

Before starting to take Sildenafil Bluefish, the patient should discuss it with their doctor, pharmacist, or nurse.

Sildenafil Bluefish should not be taken simultaneously with other oral or topical treatments for erectile dysfunction. Sildenafil Bluefish should not be used simultaneously with therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Sildenafil Bluefish should not be taken if erectile dysfunction has not been diagnosed. Sildenafil Bluefish should not be used in women. Special precautions for patients with kidney or liver function disordersPatients with kidney or liver function disorders 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Sildenafil Bluefish film-coated tablets may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should tell their doctor, pharmacist, or nurse about taking Sildenafil Bluefish and the time of intake. The patient should not take Sildenafil Bluefish simultaneously with other medicines without their doctor's recommendation. The patient should not use Sildenafil Bluefish if they are taking medicines called nitrates, as their simultaneous use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris (chest pain). The patient should not use Sildenafil Bluefish if they are taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers), as their simultaneous use may also cause a dangerous decrease in blood pressure. If the patient is taking protease inhibitors used to treat HIV infections, their doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafil Bluefish. In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur when standing up or sitting down quickly, which can be symptoms of low blood pressure. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking sildenafil. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting treatment with Sildenafil Bluefish. The doctor may decide to use a lower initial dose (25 mg) of Sildenafil Bluefish. The patient should tell their doctor or pharmacist if they 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 benefits of Sildenafil Bluefish, the patient should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Bluefish should not be used in women.

Driving and using machines

Sildenafil Bluefish may cause dizziness and vision disturbances. Before driving vehicles or operating machinery, the patient should find out 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 the medicine is considered "sodium-free".

3. How to take Sildenafil Bluefish

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their 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 about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water. If the patient feels that the effect of Sildenafil Bluefish is too strong or too weak, they should consult their doctor or pharmacist. Sildenafil Bluefish allows for an erection only if there is sexual stimulation. The time it takes for Sildenafil Bluefish to work varies from person to person, usually between half an hour and one hour. The effect of Sildenafil Bluefish may occur later if the medicine is taken after a heavy meal. The patient should contact their doctor if, after taking Sildenafil Bluefish, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse. The tablet can be divided into equal doses.

Taking a higher dose of Sildenafil Bluefish than recommended

Side effects may occur more frequently and may be more severe. Taking a dose greater than 100 mg does not increase the efficacy of the medicine. The patient should not take more tablets than prescribed by their doctor.The patient should contact their doctor if they have taken more tablets than recommended.

Missing a dose of Sildenafil Bluefish

The patient should not take a double dose to make up for a missed tablet.

Stopping Sildenafil Bluefish treatment

If the patient has any further doubts about taking this medicine, they should consult their 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 connection with the use of sildenafil are usually mild or moderate and short-lived.

If any of the following side effects occur, the patient should stop taking Sildenafil Bluefish and seek medical attention immediately:

• Allergic reaction - occurs uncommonly(may occur in 1 in 100 people) Symptoms include sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonlyIf it occurs during or after sexual intercourse, the patient:
  • Should sit half-up and try to relax;
  • Should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1000 people) If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or sudden vision deterioration - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs rarely

Other side effects:

Very common(may occur in more than 1 in 10 people): headache
Common(may occur in 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, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon(may occur in up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot and feeling tired.
Rare(may occur in up to 1 in 1000 people) include: fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of tightness in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss or loss of hearing. After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is essential to note that in most, but not all, men who experienced these side effects, heart function disorders existed before taking the medicine. It is not possible to determine whether these side effects were related to the use of Sildenafil Bluefish.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Sildenafil Bluefish

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicinal product. The patient should 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 stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sildenafil Bluefish contains

The active substance of the medicine is sildenafil. Each film-coated tablet contains 50 mg or 100 mg of sildenafil (as citrate). The other ingredients of the medicine are:

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

What Sildenafil Bluefish looks like and what the pack contains

Sildenafil Bluefish, 50 mg: Blue, round, biconvex film-coated tablet with "125" embossed on one side and "J" on the other, with a dividing line. Sildenafil Bluefish, 100 mg: Blue, round, biconvex film-coated tablet with "126" embossed on one side and "J" on the other, with a dividing 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