PERMEN 25 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool!
2. Leaflet attached to the packaging: patient information
3. Permen Med, 25 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Permen Med and what is it used for
5. Important information before taking Permen Med
   1. When not to take Permen Med
   2. Warnings and precautions
   3. Children and adolescents
   4. Permen Med and other medicines
   5. Permen Med with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
6. How to take Permen Med
   1. Taking a higher dose of Permen Med than recommended
7. Possible side effects
   1. In case of any of the following serious side effects, the patient should stop taking Permen Med and seek immediate medical attention:
   2. Other side effects:
   3. Reporting side effects
8. How to store Permen Med
9. Contents of the pack and other information
   1. What Permen Med contains
   2. What Permen Med looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer and importer
   5. Date of last revision of the leaflet:

Before taking the medicine, use the attached diagnostic tool!

Leaflet attached to the packaging: patient information

Permen Med, 25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient does not improve after taking the medicine or feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Permen Med and what is it used for
• 2. Important information before taking Permen Med
• 3. How to take Permen Med
• 4. Possible side effects
• 5. How to store Permen Med
• 6. Contents of the pack and other information

1. What is Permen Med and what is it used for

Permen Med 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 blood flow to the penis during sexual stimulation. Permen Med helps to achieve an erection only if there is prior sexual stimulation. Permen Med is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Permen Med

When not to take Permen Med

• 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, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their concurrent use may also lead to a dangerous decrease in blood pressure.
• If the patient is 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 Permen Med, 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 has severe heart or liver disease.
• If the patient has recently had a stroke or heart attack, as well as in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Permen Med, the patient should discuss it with their doctor, pharmacist, or nurse if they have:

• Sickle-cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• Anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• Ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Permen Med and immediately consult their doctor.

Permen Med should not be used concurrently with other oral or topical treatments for erectile dysfunction. Permen Med should not be used concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Permen Med should not be taken if the patient has not been diagnosed with erectile dysfunction. Permen Med is not intended for women. Special considerations for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. Patients with renal or hepatic impairment should not take a dose of Permen Med higher than 25 mg.

Children and adolescents

Permen Med should not be used in persons under 18 years of age.

Permen Med 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. Permen Med may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Permen Med and the time of taking it. The patient should not take Permen Med concurrently with other medicines without their doctor's advice. The patient should not take Permen Med if they are taking nitrate medicines, as their concurrent 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 often used to treat angina pectoris ("chest pain"). The patient should not take Permen Med if they are taking medicines that release nitric oxide, such as amyl nitrite (so-called "poppers"), as their concurrent use may also cause a dangerous decrease in blood pressure. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with a lower dose (25 mg) of sildenafil. In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours after taking Permen Med. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Permen Med. The doctor may decide to use a lower initial dose (25 mg) of Permen Med. If the patient experiences symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint), they should first lie down or sit and wait for the symptoms to pass; drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly. If the patient is taking medicines containing sacubitril with valsartan (used to treat heart failure), they should inform their doctor or pharmacist.

Permen Med with food, drink, and alcohol

Permen Med can be taken with or without food. Although taking Permen Med during a heavy meal may prolong the time needed 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 Permen Med, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Permen Med is not intended for use by women.

Driving and using machines

Permen Med may cause dizziness and visual disturbances. Patients should be aware of how they react to Permen Med before driving or operating machinery.

3. How to take Permen Med

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist. The recommended dose of the medicine is 25 mg. The doctor may, after consultation, recommend a different dosing regimen Permen Med should not be taken more than once a day.Permen Med 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 Permen Med is too strong or too weak, they should consult their doctor or pharmacist. Permen Med allows for an erection only if there is prior sexual stimulation. The time it takes for Permen Med to work varies from person to person, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a heavy meal. The patient should consult their doctor if, after taking Permen Med, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Permen Med than recommended

The patient may experience more frequent side effects, and they may be more severe. Taking a dose higher than 100 mg does not increase the efficacy of the medicine. The patient should not take more tablets than indicated in the patient leaflet.The patient should consult their doctor if they have taken more tablets than recommended. If the patient has any further doubts about the use of this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Permen Med can cause side effects, although not everybody gets them. Side effects reported in connection with the use of Permen Med are usually mild or moderate and short-lived.

In case of any of the following serious side effects, the patient should stop taking Permen Med and seek immediate medical attention:

• An 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 uncommonlyIf it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1,000 patients)

If the erection lasts for more than 4 hours, the patient should immediately consult their doctor.

• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe peeling and swelling of the skin, 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 patients): headache.
Common(may occur in up to 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of heat in the upper part of the body), indigestion, visual disturbances (seeing a colored glow, increased sensitivity to light, blurred vision, or decreased sharpness of vision), stuffy nose, dizziness.
Uncommon(may occur in up to 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, decreased tactile sensitivity, dizziness, ringing in the ears, dry mouth, stuffy or congested sinuses, nasal inflammation (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 of heat, feeling of fatigue.
Rare(may occur in up to 1 in 1,000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of constriction 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 light sources, pupil dilation, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, sudden loss of hearing.

After the medicine has been 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 side effects, heart problems existed before taking the medicine containing sildenafil. It is not possible to determine whether these side effects were related to the use of Permen Med.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, Fax: 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 gathered on the safety of the medicine.

5. How to store Permen Med

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. The patient should not use this medicine after the expiry date stated on the blister pack and carton after "EXP:". The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Permen Med contains

• The active substance of Permen Med is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Tablet coating: Opadry II blue 85F505164 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine, lake (E 132)), Opadry clear 02K19253 (hypromellose 5cp (2910), triacetin).

What Permen Med looks like and contents of the pack

Permen Med, 25 mg, is blue, round, film-coated tablets with an engraving of "25" on one side and "HJ" on the other. The tablets are packaged in PVC/Aluminum blisters of 2 or 4 tablets, in a carton box. Not all pack sizes may be marketed.

Marketing authorization holder

WALMARK, a.s. Oldřichovice 44 739 61 Třinec Czech Republic To obtain more detailed information, the patient should contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o. ul. Krakowiaków 44 02-255 Warsaw Tel.: +48 22 737 79 20

Manufacturer and importer

Pharmadox Healthcare Limited, KW20A Kordin Industrial Park Paola, PLA 3000 Malta

Date of last revision of the leaflet: