Doppelsil Max

PATIENT INFORMATION LEAFLET

Before taking the medicine, read the leaflet carefully and familiarize yourself with the attached

"Diagnostic Tool". To ensure safe use of the medicine, please answer all questions contained in the "Diagnostic Tool".

Leaflet attached to the packaging: patient information

DoppelSil MAX, 50 mg, chewable tablets

Sildenafil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If the medicine does not improve or you feel worse after taking it, contact your doctor.

Table of contents of the leaflet

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

1. What is DoppelSil MAX and what is it used for

DoppelSil MAX contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5 inhibitors). The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. DoppelSil MAX helps achieve an erection only if there is prior sexual stimulation.

DoppelSil MAX is used in adult men (aged 18 and over) to treat erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking DoppelSil MAX

Before taking DoppelSil MAX, in addition to the leaflet, familiarize yourself with the attached "Diagnostic Tool". To ensure safe use of the medicine, please answer all questions contained in the "Diagnostic Tool".

When not to take DoppelSil MAX:

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates (under different trade names):
• nitroglycerin
• isosorbide mononitrate
• isosorbide dinitrate
• pentaerythritol tetranitrate, as their concurrent use may lead to a dangerous decrease in blood pressure. Inform your doctor if you are taking any of these medicines - they are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult your doctor or pharmacist.
• If you are taking medicines or other agents 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 you are 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). It has been shown that PDE5 inhibitors, such as DoppelSil MAX, 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 and when your doctor has advised you to avoid sexual activity.
• 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

It is essential to rule out other serious diseases that may be the cause of erectile dysfunction, such as:

• heart and blood vessel diseases
• diabetes
• high blood pressure
• high cholesterol

Before taking DoppelSil MAX, discuss with your doctor or pharmacist if you have ever had:

• An erection lasting more than 4 hours, even without sexual stimulation, called priapism. Priapism can be caused by sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• Anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• Ulcer disease.
• Bleeding disorders (such as hemophilia). If you experience sudden vision loss or sudden blindness, stop taking DoppelSil MAX and contact your doctor immediately.

DoppelSil MAX should not be taken with other oral or topical treatments for erectile dysfunction.

DoppelSil MAX should not be taken with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors (e.g., tadalafil).

DoppelSil MAX should not be taken if you do not have erectile dysfunction.

DoppelSil MAX is not intended for women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should consult their doctor before taking DoppelSil MAX.

Patients with kidney or liver function disorders should not take a higher dose of sildenafil than 25 mg.

Children and adolescents

DoppelSil MAX should not be taken by persons under 18 years of age.

DoppelSil MAX and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or plan to take.

DoppelSil MAX may interact with certain medicines, especially those used to treat chest pain.

In case of worsening health, requiring immediate medical attention, inform the medical emergency responder or nurse about taking DoppelSil MAX and the time of its administration.

Do not take DoppelSil MAX with other medicines without a doctor's recommendation.

Do not take DoppelSil MAX if you are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure.

Always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina pectoris ("chest pain").

Do not take DoppelSil MAX if you are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure.

Do not take DoppelSil MAX with other medicines containing sildenafil.

If you are already taking riociguat, inform your doctor or pharmacist.

When taking protease inhibitors (e.g., ritonavir) used to treat HIV infections, consult your doctor before taking DoppelSil MAX.

When taking alpha-adrenergic blockers (e.g., doxazosin, tamsulosin, alfuzosin, terazosin, silodosin) before taking DoppelSil MAX, consult your doctor.

In some patients taking alpha-adrenergic blockers (e.g., doxazosin, tamsulosin, alfuzosin, terazosin, silodosin) for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure.

To minimize the risk of these symptoms, you should regularly take your fixed dose of alpha-adrenergic blocker before starting DoppelSil MAX.

Your doctor may decide to use a lower initial dose (25 mg) of sildenafil.

In case of low blood pressure symptoms (dizziness, lightheadedness, feeling of impending faint), lie down or sit and wait for the symptoms to pass.

Drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help.

Avoid standing up or sitting quickly.

If you are taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult your doctor before taking DoppelSil MAX.

If you are taking medicines containing sacubitril with valsartan, used to treat heart failure, inform your doctor or pharmacist.

DoppelSil MAX with food and drink or alcohol

DoppelSil MAX can be taken with or without food.

Although taking DoppelSil MAX during a heavy meal may prolong the time needed for the medicine to start working.

Do not take DoppelSil MAX with grapefruit juice, as it may affect the medicine's action.

The ability to achieve an erection may be temporarily impaired after consuming alcohol.

To maximize the therapeutic benefits of DoppelSil MAX, do not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

DoppelSil MAX is not intended for use in women.

Driving and using machines

DoppelSil MAX may cause dizziness and vision disturbances.

Before driving or operating machinery, you should be aware of how you react to DoppelSil MAX.

DoppelSil MAX contains aspartame and lactose

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria.

This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take DoppelSil MAX

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

If you have previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg.

Otherwise, DoppelSil MAX in a dose of 50 mg should only be taken if you did not experience the desired effect (i.e., did not achieve an erection sufficient for sexual intercourse) after taking sildenafil in a dose of 25 mg.

If taking a lower dose of sildenafil (25 mg) allowed you to achieve an erection sufficient for sexual intercourse, do not take a dose of 50 mg.

Do not take DoppelSil MAX more than once a day.

Do not take this medicine with other medicines containing sildenafil.

Take DoppelSil MAX about an hour before planned sexual activity.

Chew the tablet whole and then swallow it.

If you feel that the effect of DoppelSil MAX is too strong or too weak, consult your doctor or pharmacist.

DoppelSil MAX allows you to achieve an erection only if there is prior sexual stimulation.

The time it takes for DoppelSil MAX 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.

Consult your doctor if, after taking DoppelSil MAX, you do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of DoppelSil MAX than recommended

You 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.

Do not take more tablets than indicated in the patient leaflet.

Consult your doctor if you have taken more tablets than recommended.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, DoppelSil MAX can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of DoppelSil MAX are usually mild or moderate and short-lived.

If you experience any of the following side effects, stop taking DoppelSil MAX and seek medical attention immediately:

• An allergic reaction - occurs uncommonly(may affect up to 1 in 100 people). Symptoms: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonly. If it occurs during or after sexual intercourse:
• take a semi-sitting position and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may affect up to 1 in 1000 people). If an erection lasts more than 4 hours, seek medical attention immediately.
• Sudden vision loss or blindness - occurs rarely.
• Severe skin reactions - occurs rarely. Symptoms 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 affect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, sudden flushing, hot flushes (symptoms include a feeling of heat in the upper body), indigestion, colored vision, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, flashes of light, increased light sensitivity, photophobia, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, stuffy or runny nose, sinusitis (symptoms include a runny nose, sneezing, and a stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in the urine, pain in the arms or legs, nosebleeds, feeling hot or tired.

Rare(may affect up to 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 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 visual field, seeing halos around light sources, dilated pupils, abnormal discoloration of the white of the eye, bleeding from the penis, blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss.

After the introduction of sildenafil-containing medicines to the market, rare cases of unstable angina (heart disease) and sudden death have been reported.

It is essential to note that in most, but not all, men who experienced these side effects, heart disease was present before taking the sildenafil-containing medicine.

It is not possible to determine whether these side effects were related to the use of DoppelSil MAX.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist.

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: 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, you can help gather more information on the safety of the medicine.

5. How to store DoppelSil MAX

Keep the medicine out of sight and reach of children.

There are no special storage temperature recommendations for the medicine.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton and blister after: EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the packaging and other information

What DoppelSil MAX contains

• The active substance of the medicine is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• Other ingredients are: polyacrylate potassium, colloidal silicon dioxide, lactose monohydrate, povidone K-30, aspartame (E 951), croscarmellose sodium, peppermint flavor, magnesium stearate, potassium hydroxide (to adjust pH) or hydrochloric acid (to adjust pH).

What DoppelSil MAX looks like and contents of the packaging

White, triangular, biconvex tablets, with the inscription "50" on one side.

DoppelSil MAX is available in PVC/PCTFE/Aluminum blisters, containing 1, 2, or 4 chewable tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Doppelherz Pharma GmbH

Schleswiger Strasse 74

24941 Flensburg

Germany

Manufacturer

Genepharm S.A.

18th km Marathonos Avenue

153 51 Pallini Attiki

Greece

To obtain more detailed information, contact the local representative of the marketing authorization holder:

Queisser Pharma Poland Sp. z o.o.

ul. Domaniewska 39

02-672 Warsaw

Poland

tel. +48 22 487 52 54

Date of last revision of the leaflet: