PERMEN 50 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached patient information leaflet!
2. Leaflet attached to the packaging: patient information
3. Permen Med Forte, 50 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 Forte and what is it used for
5. Important information before taking Permen Med Forte
   1. When not to take Permen Med Forte
   2. Warnings and precautions
   3. Children and adolescents
   4. Permen Med Forte and other medicines
   5. Permen Med Forte with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
6. How to take Permen Med Forte
   1. Taking a higher dose of Permen Med Forte than recommended
7. Possible side effects
   1. In case of any of the following serious side effects, you should stop taking Permen Med Forte and seek immediate medical attention:
   2. Other side effects:
   3. Reporting side effects
8. How to store Permen Med Forte
9. Contents of the pack and other information
   1. What Permen Med Forte contains
   2. What Permen Med Forte 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 patient information leaflet!

Leaflet attached to the packaging: patient information

Permen Med Forte, 50 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 information leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after taking the medicine there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

• 1. What is Permen Med Forte and what is it 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 is Permen Med Forte and what is it 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 the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Permen Med Forte helps to achieve an erection only if there is prior sexual stimulation.

2. Important information before taking Permen Med Forte

When not to take Permen Med Forte

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their simultaneous intake may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult a doctor or pharmacist.
• If you are taking medicines that release nitric oxide, such as amyl nitrite (so-called poppers), as their simultaneous intake may also lead to a dangerous decrease in blood pressure.
• If you are 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 Forte, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.
• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack, and in cases of low blood pressure.
• If you have hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If you have ever had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting to take Permen Med Forte, you should discuss it with your doctor, pharmacist, or nurse if:

• You have sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• You have anatomical deformation of the penis or Peyronie's disease.
• You have heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• You have stomach ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden loss of vision, you should stop taking Permen Med Forte and immediately consult a doctor.

Permen Med Forte should not be taken with other oral or topical treatments for erectile dysfunction. Permen Med Forte should not be taken with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. Permen Med Forte should not be taken if you have not been diagnosed with erectile dysfunction. Permen Med Forte is not intended for women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. The doctor may decide to use a lower dose of Permen Med Forte.

Children and adolescents

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

Permen Med Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Permen Med Forte may interact with some medicines, especially those used to treat chest pain. If your condition worsens, requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Permen Med Forte and the time of its intake. You should not take Permen Med Forte with other medicines without a doctor's recommendation.

Permen Med Forte with food, drink, and alcohol

Permen Med Forte can be taken with or without food. Although taking Permen Med Forte 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 Forte, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Permen Med Forte is not intended for use by women.

Driving and using machines

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

3. How to take Permen Med Forte

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist. The recommended dose is 50 mg. If you have previously taken medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose of Permen Med Forte is 50 mg. Otherwise, Permen Med Forte at a dose of 50 mg should only be used if you did not experience the desired effect (i.e., did not achieve an erection sufficient for intercourse) after taking sildenafil at a dose of 25 mg.

If taking a lower dose of sildenafil (25 mg) allowed you to achieve an erection that enabled you to have sexual intercourse, you should not take the 50 mg dose. You should not take Permen Med Forte 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 you feel that the effect of Permen Med Forte is too strong or too weak, you should consult a doctor or pharmacist.

Taking a higher dose of Permen Med Forte 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 effectiveness of the medicine. You should not take more tablets than indicated in the patient information leaflet. If you have taken more tablets than recommended, you should consult a doctor.

4. Possible side effects

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

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

• 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:
• you should sit half-up and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in 1 in 1,000 patients) If an erection lasts more than 4 hours, you should seek immediate medical attention.
• Sudden vision loss or vision loss - occurs rarely
• Severe skin reactions - occurs rarelySymptoms may include severe skin peeling and swelling, 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 body), indigestion, colored vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon(may occur in up to 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, flashes of light, increased light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and stuffy nose), stomach 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, temporary reduction of blood flow to part of the brain, feeling of pressure in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased visual acuity, 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, dilated pupils, 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 weakness or loss of hearing.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to store Permen Med Forte

Store the medicine out of sight and reach of children. There are no special precautions for storing the medicine. Do 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. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Permen Med Forte contains

• The active substance of Permen Med Forte is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are:
• Core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Coating: Opadry II blue 85F505164 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, indigo carmine, lake (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, convex on both sides, with an embossing of 50 on one side and H and J with a break line on the other. The tablets are packaged in PVC/Aluminum blisters containing 4 tablets.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information, you should contact the representative of the marketing authorization holder.

Manufacturer and importer

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

Date of last revision of the leaflet: