Package leaflet: Information for the patient

Permen Med, 25 mg, coated tablets
Sildenafilum
Please read the following leaflet carefully 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 directed by a physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after using the medicine, or if the patient feels worse, contact a doctor.

Leaflet contents:

What Permen Med is and what it is used for
Important information before using Permen Med
How to use Permen Med
Possible side effects
How to store Permen Med
Contents of the pack and other information

1. What Permen Med is and what it is 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 blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation.
Permen Med helps achieve an erection only if sexual stimulation is present.
Permen Med 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 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 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’). If in doubt, consult the doctor or pharmacist.
If the patient is taking medicines 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 Permen Med 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 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 hereditary degenerative retinal disorders, such as retinitis pigmentosa.
If the patient has ever experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Permen Med, discuss this with the 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).
The patient has anatomical deformation of the penis or Peyronie's disease.
The patient has heart problems. In this case, 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 haemophilia).
If sudden decrease in vision or sudden vision loss occurs, the patient should stop taking Permen Med and contact a doctor immediately.

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

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor.
Patients with impaired kidney or liver function should not take a dose of Permen Med higher than 25 mg.

Children and adolescents
Permen Med should not be used in individuals under 18 years of age.

Permen Med and other medicines
Tell the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Permen Med may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, inform the doctor, pharmacist, or nurse that Permen Med was taken and when it was taken. Do not take Permen Med with other medicines unless directed by a doctor.
Do not take Permen Med 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, which are often used to treat angina (‘chest pain’).
Do not take Permen Med if the patient is taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers), because their concomitant use may also cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
If the patient is taking protease inhibitors used in the treatment of HIV infection, treatment should be initiated with a lower dose (25 mg) of sildenafil.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have occurred in some patients taking sildenafil and alpha-blockers concomitantly. These are most likely to occur within 4 hours after taking Permen Med. To reduce the possibility of these symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting Permen Med. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Permen Med.
If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait for symptoms to subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.
If the patient is taking medicines containing sacubitril with valsartan (used in the treatment of 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.
However, taking Permen Med 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 maximise the therapeutic benefit of Permen Med, significant amounts of alcohol should not be consumed 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 taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is 25 mg. After consultation, the doctor may recommend a different dosage regimen.
Permen Med must not be taken more than once a day.
Permen Med 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 Permen Med is too strong or too weak, consult your doctor or pharmacist.
Permen Med enables an erection only in the presence of sexual stimulation.
The time it takes for Permen Med to work varies between patients, but usually ranges from half an hour to one hour.
The effect may be delayed if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Permen Med, an erection does not occur or if the duration of the erection is insufficient for sexual intercourse.
Taking more than the recommended dose of Permen Med
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 indicated in the patient leaflet.
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 reactions

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

Allergic reaction – uncommon (may occur in 1 out of 100 patients)
Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
Chest pain – uncommon
If chest pain occurs during or after sexual activity:
- Adopt a semi-sitting position and try to relax.
- Do not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – rare (may occur in 1 out of 1000 patients)

If an erection lasts longer than 4 hours, contact a doctor immediately.

Sudden decrease or loss of vision – rare
Severe skin reactions – rare
Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
Seizures or fits – rare

Other adverse reactions:
Very common (may affect more than 1 in 10 patients): headache.
Common (may affect 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include feeling of warmth in the upper body), dyspepsia, visual disturbances (seeing coloured tinge, light sensitivity, blurred vision or reduced visual acuity), stuffy nose, dizziness.
Uncommon (may affect 1 in 100 patients): vomiting, skin rash, eye irritation, eye hyperaemia, eye pain, perception of light flashes, bright vision, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, reduced sense of touch, dizziness, tinnitus, 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, feeling of fatigue.
Rare (may affect 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient ischaemic attack (temporary reduction in blood flow to part of the brain), sensation of throat tightness, lip numbness, retinal haemorrhage, double vision, decreased visual acuity, abnormal sensations inside the eye, eye or eyelid swelling, floaters or spots in the visual field, perception of 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, sudden hearing loss or deafness.

After the medicine was introduced to 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 reactions, pre-existing heart conditions were present before taking sildenafil-containing medication. It is not possible to determine whether these adverse reactions were related to the use of Permen Med.

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, Medical Devices and Biocidal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Permen Med

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 blister pack and the outer cardboard packaging after "EXP:". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
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 packaging and other information

What Permen Med contains

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

What Permen Med looks like and contents of the pack
Permen Med 25 mg is a blue, round, film-coated tablet, debossed with "25" on one side and "HJ" on the other.
Tablets are packed in PVC/Aluminium blisters containing 2 or 4 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
WALMARK, a.s.
Oldřichovice 44
739 61 Třinec
Czech Republic

For further information, please contact the representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Poland
Tel.: +48 22 737 79 20

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