Permen med forte

Before taking the medicine, please consult the patient information leaflet provided!

Package leaflet: information for the patient

Permen Med Forte, 50 mg, coated tablets
Sildenafilum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact 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, medical advice should be sought from a doctor.

Leaflet contents:

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

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

Permen Med Forte 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 Forte helps achieve an erection only if the patient is sexually stimulated beforehand.
Permen Med Forte is used in the treatment of erectile dysfunction in adult men, i.e. impotence defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before using Permen Med Forte

When not to use Permen Med Forte

• 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 a 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 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 Forte 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 Forte, discuss with a 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 deformity of the penis or Peyronie's disease.
• The patient has heart problems. In such cases, the doctor should assess whether the heart condition can tolerate the additional strain associated with sexual activity.
• The patient has peptic ulcer disease or bleeding disorders (such as haemophilia).
• If sudden decrease or loss of vision occurs, the patient should stop taking Permen Med Forte and contact a doctor immediately.

Permen Med Forte should not be used concomitantly with other oral or locally applied treatments for erectile dysfunction.
Permen Med Forte should not be used together with arterial pulmonary hypertension (APH) therapies containing sildenafil or other PDE5 inhibitors.
Permen Med Forte should not be taken if erectile dysfunction has not been diagnosed.
Permen Med Forte is not a medicine intended for use in 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 Permen Med Forte.

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

Permen Med Forte and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Permen Med Forte 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 about taking Permen Med Forte and the time it was taken. Do not take Permen Med Forte together with other medicines without medical advice.
Do not take Permen Med Forte if the patient is using nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates, which are commonly used to treat angina (chest pain).
Do not take Permen Med Forte if the patient is using 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, inform the doctor or pharmacist.
For patients taking protease inhibitors (e.g. ritonavir) used in the treatment of HIV infection, it is recommended to start treatment with a lower dose (25 mg) of sildenafil.
In some patients taking alpha-blockers for high blood pressure or prostate enlargement, 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 up. Such symptoms have been observed in some patients taking sildenafil together with alpha-blockers. They are most likely to occur within 4 hours after taking Permen Med Forte. To reduce the likelihood of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Permen Med Forte. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.
If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit and wait until symptoms 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 ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), they should consult their doctor before taking Permen Med Forte.
If the patient is using medicines containing sacubitril with valsartan (used in the treatment of heart failure), they should inform their doctor or pharmacist.

Permen Med Forte with food, drink, and alcohol
Permen Med Forte can be taken with or without food.
However, taking Permen Med Forte 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 maximize the therapeutic effect of Permen Med Forte, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding and fertility
Permen Med Forte is not intended for use in women.

Driving and using machines
Permen Med Forte may cause dizziness and visual disturbances.
Patients should assess how they react to Permen Med Forte before driving or operating machinery.

3. How to use Permen Med Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the
recommended dose of this medicine is 50 mg. Otherwise, Permen Med Forte 50 mg should only be
used if the patient did not achieve the desired effect (i.e. an erection sufficient for sexual intercourse)
after taking sildenafil at a dose of 25 mg.
If treatment with a lower dose of sildenafil (25 mg) enabled an erection sufficient for sexual
intercourse, the 50 mg dose of Permen Med Forte should not be used.
Do not take Permen Med Forte together with other medicines containing sildenafil.
Permen Med Forte should not be taken more than once a day.
Permen Med Forte 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 Permen Med Forte seems too strong or too weak, consult a doctor or pharmacist.
Permen Med Forte enables an erection only in the presence of sexual stimulation. The time to onset
of effect with Permen Med Forte 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 no erection occurs after taking Permen Med Forte, or if the duration of erection
is insufficient for sexual intercourse.
Taking more than the recommended dose of Permen Med Forte
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 indicated in the patient leaflet.
Contact a doctor if more tablets than recommended have been taken.
If there are any further doubts regarding the use of this medicine, consult a 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 Forte are usually mild or moderate in intensity and transient.

If any of the following serious adverse reactions occur, stop taking Permen Med Forte immediately and seek medical help at once:

• Allergic reaction – occurs not very often (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 – occurs not very often
  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 – occurs rarely (may occur in 1 out of 1,000 patients)
  If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – occurs rarely
• Severe skin reactions – occurs rarely
  Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – occurs 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.
Not very common (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, dryness in the mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (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.
Rarely (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of throat tightness, 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 specks or spots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discoloration of the white part of the eye, rectal bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, sudden weakness or loss of hearing.

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

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 Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Permen Med Forte

Keep the medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after "EXP:". The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from moisture.
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 packaging and other information

What Permen Med Forte contains

• The active substance in Permen Med Forte is sildenafil. Each tablet contains 50 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, talc, indigo carmine, lac (E 132)), Opadry clear 02K19253 (hypromellose 5cp (2910), triacetin)

What Permen Med Forte looks like and contents of the pack
Permen Med Forte 50 mg is a blue, round, film-coated tablet, biconvex, with the imprint "50" on one side and "H" and "J" with a score line on the other side.
Tablets are packed in PVC/Aluminum blisters containing 4 tablets each.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information, please contact the local 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