Sildenafil farmak

Patient Information Leaflet: Information for the User

Sildenafil Farmak, 100 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 someone else, 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.

Contents of the leaflet

1. What Sildenafil Farmak is and what it is used for
2. What you need to know before taking Sildenafil Farmak
3. How to take Sildenafil Farmak
4. Possible side effects
5. How to store Sildenafil Farmak
6. 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 the blood vessels
in the penis, thereby increasing blood flow to the penis during sexual stimulation.
Sildenafil Farmak helps achieve an erection only if sexual stimulation occurs beforehand.
Sildenafil Farmak is used to treat erectile dysfunction in adult men, that is, 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 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 drugs that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to a dangerous reduction 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 myocardial infarction, and in cases of low blood pressure.

• Inherited degenerative retinal disorders, such as 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 Farmak, discuss this with a doctor, pharmacist, or nurse if:

• The patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with penile anatomical deformity 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 ulcers or bleeding disorders (such as hemophilia).
• If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking Sildenafil Farmak immediately and contact a doctor without delay.

Sildenafil Farmak should not be used concomitantly 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 use by women.

Special considerations for patients with renal or hepatic 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
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Sildenafil Farmak may interact with certain medicines, especially 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 about the use of Sildenafil Farmak and the time of its administration. Do not take Sildenafil Farmak with other medicines unless directed by a doctor.
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 reduction 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 agents 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 agents. These symptoms are most likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of such symptoms, the patient should be on a stable dose regimen 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.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), because combination therapy with this medicine may lead to a reduction in 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 onset of the medicine's effect.
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 by women.

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

Sildenafil Farmak contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. 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 in doubt,
consult a 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 the effect of Sildenafil Farmak seems too strong or too weak, consult a 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 a doctor if, after taking Sildenafil Farmak, an erection does not occur or
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 medicine's effectiveness.
Do not take more tablets than prescribed by the doctor.
Contact a doctor if more tablets have been taken than recommended.
If in doubt about any other aspects of using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects reported with sildenafil use are usually mild to 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:

  • sit in a semi-upright 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 decrease or loss of vision – occurs rarely

• Severe skin reactions – occurs 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 – occurs rarely

Other adverse effects:
Very common (may affect more than 1 in 10 people): headache.
Common (may affect 1 in 10 people): nausea, sudden flushing of the face, hot flushes (symptoms include feeling of warmth in the upper part of the body), dyspepsia, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect 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 mucositis (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 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, decreased visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discolouration of the white of the eye, penile bleeding, blood in semen, dry nose, nasal swelling, feeling of irritation, and sudden hearing loss or deafness.

Since the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse effects, cardiac disorders were present prior to 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, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Sildenafil Farmak

Keep this medicine out of the sight and reach of children.
There are no special requirements for the storage of this medicine.
Do not use this medicine after the expiry date stated on the pack 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 required. Such measures help protect the environment.

6. Contents of the package and other information

What Sildenafil Farmak contains

• The active substance is sildenafil. Each tablet contains 100 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), lacquer.

What Sildenafil Farmak looks like and contents of the pack
Sildenafil Farmak is a blue, film-coated, elliptical-shaped tablet with an embossed "+" sign on one side.
The tablets are packed in blisters containing 1, 2, 4, 8 or 12 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

Manufacturers
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 Targu Mures, Jud. Mures,
Romania

This medicinal product is authorised in the European Economic Area under the following names:
Poland: Sildenafil Farmak
Portugal: Sildenafil Tecnimede
Romania: Sildenafil Bioeel 100 mg film-coated tablets