Sildenafil bluefish

Package leaflet: Information for the patient

Sildenafil Bluefish, 50 mg, film-coated tablets
Sildenafil Bluefish, 100 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Sildenafil Bluefish is and what it is 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 Sildenafil Bluefish is and what it is 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 blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Sildenafil Bluefish helps achieve an erection only when combined with sexual stimulation.
Sildenafil Bluefish is used to treat erectile dysfunction in adult men, sometimes referred to as impotence. This condition is defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Sildenafil Bluefish

When not to use Sildenafil Bluefish:

• if the patient is taking medicines called nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. The doctor should be informed if the patient is taking any medicines from this group; these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist;
• if the patient is taking nitric oxide-releasing drugs, e.g., amyl nitrite (so-called "poppers"; inhaled nitrites used recreationally), as their concomitant use may also cause dangerous lowering of blood pressure;
• if the patient is taking riociguat. This is a medicine used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high lung pressure caused by blood clots). PDE5 inhibitors such as Sildenafil Bluefish 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;
• if the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe heart or liver disease;
• if the patient has recently had a stroke or heart attack, or has low blood pressure;
• if the patient has certain rare inherited eye disorders (retinitis pigmentosa);
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil Bluefish, the patient should discuss this with their doctor, pharmacist, or nurse.

• If the patient has sickle cell anaemia (an abnormality of red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• If the patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
• If the patient has heart problems. The doctor should assess whether the condition of the heart muscle allows for the additional strain associated with sexual activity.
• If the patient has peptic ulcer disease or blood clotting disorders (such as haemophilia).
• If the patient experiences sudden worsening of vision or sudden vision loss, treatment with Sildenafil Bluefish should be stopped immediately and medical advice sought without delay.

Sildenafil Bluefish should not be taken together with other oral or topical treatments for erectile dysfunction.
Sildenafil Bluefish should not be used concurrently with arterial pulmonary hypertension (PAH) therapy 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 renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor, who may decide to prescribe a lower dose of the medicine.

Children and adolescents
Sildenafil Bluefish should not be used in individuals under 18 years of age.

Sildenafil Bluefish and other medicines
The patient should inform their doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take.
Sildenafil Bluefish film-coated tablets may interact with certain medicines, particularly those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, the doctor, pharmacist, or nurse should be informed that Sildenafil Bluefish was taken and at what time. Sildenafil Bluefish should not be taken with other medicines unless advised by a doctor.
Do not take Sildenafil Bluefish if the patient is taking nitrates, as concomitant use may lead to dangerous lowering of blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (chest pain).
Do not take Sildenafil Bluefish if the patient is taking nitric oxide-releasing medicines, e.g., amyl nitrite (so-called "poppers"), as their concomitant use may also cause dangerous lowering of blood pressure.
If the patient is taking protease inhibitors used in the treatment of HIV infection, the doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafil Bluefish.
In some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur when standing up or sitting down quickly, which may be symptoms of low blood pressure. Such symptoms have occurred in some patients taking sildenafil together with α-adrenergic blockers. These are most likely to occur within 4 hours after taking sildenafil. To reduce the possibility of these symptoms, the patient should be on a stable dose regimen of their α-adrenergic blocker before starting treatment with Sildenafil Bluefish. The doctor may decide to use a lower starting dose (25 mg) of Sildenafil Bluefish.
The patient should inform their doctor or pharmacist if they are taking medicines containing sacubitril/valsartan, used in the treatment of heart failure.

Sildenafil Bluefish with food, drink, and alcohol
Sildenafil Bluefish can be taken with or without food. However, taking Sildenafil Bluefish with a heavy meal may delay the time needed for the medicine to start working.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximise the therapeutic effect of Sildenafil Bluefish, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Sildenafil Bluefish should not be used in women.

Driving and operating machinery
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
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Sildenafil Bluefish

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. The usual starting dose is 50 mg.
Sildenafil Bluefish must 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, consult your doctor or pharmacist.
Sildenafil Bluefish enables an erection only in the presence of sexual stimulation.
The time it takes for Sildenafil Bluefish to take effect varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if no erection occurs after taking Sildenafil Bluefish, or if the duration of erection is insufficient for sexual intercourse.
The tablet may be divided into equal doses.
Taking more Sildenafil Bluefish than prescribed
Adverse effects may occur more frequently and may be more severe. Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
Missing a dose of Sildenafil Bluefish
Do not take a double dose to make up for a missed tablet.
Stopping treatment with Sildenafil Bluefish
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with sildenafil use are usually mild or
moderate in intensity and transient.
If any of the following adverse reactions occur,
discontinue taking Sildenafil Bluefish and seek immediate medical help:

• Allergic reaction – occurs uncommonly (may occur in 1 out of 100 people). Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. If chest pain occurs during or after sexual intercourse, the patient:
  • Should sit in a semi-upright position and try to relax;
  • Must not take nitrates to relieve chest pain.
• Abnormally prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1000 people). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occur rarely
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – occur rarely

Other adverse reactions:
Very common (may affect more than 1 in 10 people): headache
Common (may affect up to 1 in 10 people): nausea, sudden flushing of the face,
hot flushes (symptoms include a feeling of warmth in the upper body), indigestion, seeing coloured halos,
blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation,
eye congestion, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes,
palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness,
reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses,
nasal mucositis (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain,
gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs,
nosebleeds, feeling of warmth and feeling of fatigue.
Rare (may affect up to 1 in 1000 people): 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 lips, bleeding into the back of the eye, double vision, reduced visual acuity,
abnormal sensations inside the eye, swelling of the eyes or eyelids, small particles or
dots in the visual field, seeing halos around light sources, pupil dilation,
abnormal discoloration of the sclera, rectal bleeding, presence of blood in semen, dry nose,
nasal swelling, feeling of irritation, and sudden hearing loss or hearing impairment.
After the medicine was placed on the market, 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 adverse reactions, heart function disorders were present prior to taking this medicine.
It is not possible to determine whether these adverse reactions were related to the use of Sildenafil Bluefish.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sildenafil Bluefish

Keep this medicine out of the sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack
following “Expiry date” or “EXP”. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Sildenafil Bluefish contains
The active substance is sildenafil. Each coated tablet contains 50 mg or 100 mg of
sildenafil (as citrate).
Other ingredients are:

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

What Sildenafil Bluefish looks like and contents of the pack
Sildenafil Bluefish, 50 mg:
Blue, round, biconvex film-coated tablet, embossed with "125" on one side and "J" on the other side, with a division line.
Sildenafil Bluefish, 100 mg:
Blue, round, biconvex film-coated tablet, embossed with "126" on one side and "J" on the other side, with a division line.
Sildenafil Bluefish is supplied in the following pack sizes:
Sildenafil Bluefish, 50 mg
PVC/Aluminium blisters in a cardboard box containing 1, 4 or 24 film-coated tablets.
Sildenafil Bluefish, 100 mg
PVC/Aluminium blisters in a cardboard box containing 1, 4, 8 or 24 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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