Patient Information Leaflet

Sildenafil Farmak, 50 mg, film-coated tablets
Sildenafilum
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, please ask your doctor, pharmacist, or nurse.
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, pharmacist, or nurse. See section 4.

Leaflet Contents

What Sildenafil Farmak is and what it is used for
What you need to know before taking Sildenafil Farmak
How to take Sildenafil Farmak
Possible side effects
How to store Sildenafil Farmak
Contents of the pack and other information

1. What Sildenafil Farmak is and what it is used for

Sildenafil Farmak contains the active substance sildenafil, which belongs to a group of medicines known as phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax blood vessels in the penis, thereby increasing blood flow into the penis during sexual stimulation. Sildenafil Farmak helps achieve an erection only if sexual stimulation occurs beforehand.
Sildenafil Farmak is used in the treatment of erectile dysfunction in adult men, i.e. impotence, defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Sildenafil Farmak

When not to use Sildenafil Farmak

If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
If the patient is taking nitrates, because their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if they are taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). In case of doubt, consult a doctor or pharmacist.
If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to a dangerous decrease in 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 blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as sildenafil have been shown to enhance the blood pressure-lowering effect of this drug. If the patient is taking riociguat or is unsure, they should inform their doctor.
Severe heart or liver disease.
Recent stroke or heart attack, and in cases of low blood pressure.
Hereditary degenerative retinal disorders, such as retinitis pigmentosa.
If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting treatment with Sildenafil Farmak, discuss with a doctor, pharmacist, or nurse if:

The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
The patient has been diagnosed with anatomical deformity of the penis or Peyronie's disease.
The patient has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
The patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
If sudden worsening of vision or sudden vision loss occurs, the patient should stop using Sildenafil Farmak and contact a doctor immediately.

Sildenafil Farmak should not be used together with other oral or topical treatments for erectile dysfunction.
Sildenafil Farmak should not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil Farmak should not be taken if erectile dysfunction has not been diagnosed.
Sildenafil Farmak is not a medicine intended for women.

Special considerations for patients with kidney or liver impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of Sildenafil Farmak.

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

Sildenafil Farmak and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Sildenafil Farmak may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and you require immediate medical assistance, inform the doctor, pharmacist, or nurse that you have taken Sildenafil Farmak and when it was taken. Do not take Sildenafil Farmak together with other medicines without medical advice.
Do not use Sildenafil Farmak if the patient is taking nitrates, because their concomitant use may lead to a dangerous decrease in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (chest pain).
Do not use Sildenafil Farmak if the patient is taking drugs that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with a lower dose (25 mg) of Sildenafil Farmak.
In some patients taking α-adrenolytic drugs for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have been reported in some patients taking sildenafil-containing medicines together with α-adrenolytic drugs. These symptoms are most likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, the patient should be on a stable dose of their α-adrenolytic medicine before starting Sildenafil Farmak. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Sildenafil Farmak.
Tell your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), as combination therapy with this medicine may lead to low blood pressure.

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

Pregnancy, breastfeeding, and fertility
Sildenafil Farmak is not intended for use in women.

Driving and operating machinery
Sildenafil Farmak may cause dizziness and visual disturbances. Patients should understand how they react to Sildenafil Farmak before driving or operating machinery.

Sildenafil Farmak contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the product is considered "sodium-free".

3. How to use Sildenafil Farmak

This medicine should always be taken as directed by a doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Farmak must not be taken more than once a day.
Do not take Sildenafil Farmak together with other medicines containing sildenafil.
Sildenafil Farmak should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
If you feel that the effect of Sildenafil Farmak is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Farmak enables an erection only in the presence of sexual stimulation.
The time it takes for Sildenafil Farmak 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, after taking Sildenafil Farmak, an erection does not occur or if the duration of
erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Farmak
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.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects reported with sildenafil use are usually mild or moderate in intensity and short-lived.
If any of the following serious adverse effects occur, stop taking Sildenafil Farmak and seek immediate medical help:

Allergic reaction – occurs uncommonly (may occur in 1 in 100 patients)
Symptoms: 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:
- adopt a semi-sitting position and try to relax,
- do not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – occurs rarely (may occur in 1 in 1000 patients)
If an erection lasts longer than 4 hours, contact a doctor immediately.
Sudden worsening or loss of vision – occurs 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 effects:
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, coloured vision (seeing things with a blue tinge), blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal mucosal inflammation (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, 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, lip numbness, 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 spots in the visual field, seeing halos around light sources, pupil dilation, abnormal discoloration of the white part of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss or deafness.

Since the medicine has been marketed, 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 effects, pre-existing heart conditions were present before taking this medicine. It is not possible to determine whether these adverse effects were related to the use of sildenafil.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Sildenafil Farmak

Keep this medicine out of sight and reach of children.
No special storage instructions apply for this medicine.
Do not use this medicine after the expiry date stated on the packaging after: 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Sildenafil Farmak contains

The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
The other ingredients are: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate. Coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, indigo carmine (E 132), lac.

What Sildenafil Farmak looks like and contents of the pack
Sildenafil Farmak is a blue, film-coated, elliptical-shaped tablet. The tablets are packed
in blisters containing 1, 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland

Manufacturer
Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, nº 2, Abrunheira, 2710 – 089 Sintra, Portugal
Bioeel Manufacturing S.R.L.
Str. Bega 5,
540390 Târgu Mureș, Jud. Mureș,
Romania

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Sildenafil Farmak
Portugal: Sildenafil Tecnimede
Romania: Sildenafil Bioeel 50 mg film-coated tablets