Doppelsil max

Before using the medicine, read the package leaflet carefully and review the
"Diagnostic Tool" included with the packaging. For safe use of the medicine,
please answer all questions contained in the "Diagnostic Tool".
Package leaflet: information for the patient
DoppelSil MAX, 50 mg, chewable tablets
Sildenafilum
Please read this 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 doctor or pharmacist.

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

Table of contents of the leaflet

1. What DoppelSil MAX is and what it is 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 pack and other information

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

DoppelSil MAX contains the active substance sildenafil, which belongs to a group of medicines known as phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax blood vessels in the penis, thereby increasing blood flow to this area during sexual stimulation. DoppelSil MAX helps achieve an erection only if sexual stimulation is present.
DoppelSil MAX is used in adult men (over 18 years of age) for the treatment of erectile dysfunction, defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
This medicine should not be taken if you do not have erectile dysfunction.

2. Important information before using DoppelSil MAX

Before using DoppelSil MAX, read carefully the "Diagnostic Tool" included in the packaging. To ensure safe use of the medicine, please answer all questions contained in the "Diagnostic Tool".

When not to use DoppelSil MAX:

• 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 medicines from the group of nitrates (available under various brand names):
  • nitroglycerin
  • isosorbide mononitrate
  • isosorbide dinitrate
  • pentaerythritol tetranitrate
    because concomitant use may lead to a dangerous drop in blood pressure. Inform your doctor if you are taking any of these medicines – they are often used to relieve symptoms of angina (chest pain). If in doubt, consult your doctor or pharmacist.
• If the patient is taking medicines or other agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their simultaneous 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 DoppelSil MAX have been shown to enhance the blood pressure-lowering effect of riociguat. If the patient is taking riociguat or is unsure, inform the 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, or if the doctor has advised against sexual activity.
• 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 ischemic optic neuropathy (NAION).

Warnings and precautions
It is important that during the first 6 months of using DoppelSil MAX, other serious conditions that may be causing erectile dysfunction are ruled out by consulting a doctor, such as:

• heart and blood vessel diseases
• diabetes
• hypertension
• elevated cholesterol levels

Before starting to take DoppelSil MAX, consult your doctor or pharmacist if:

• The patient has ever experienced an erection lasting longer than 4 hours, even without sexual stimulation, known as priapism. Priapism may be triggered by sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• The patient has a known 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 allows for the additional strain associated with sexual activity.
• The patient has peptic ulcer disease.
• The patient has bleeding disorders (such as hemophilia). If sudden worsening of vision or sudden vision loss occurs, stop using DoppelSil MAX and contact a doctor immediately.

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

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should consult a doctor before using DoppelSil MAX. Patients with impaired kidney or liver function should not take a dose of sildenafil higher than 25 mg.

Children and adolescents
DoppelSil MAX should not be used in individuals under 18 years of age.

DoppelSil MAX and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
DoppelSil MAX may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and you require immediate medical assistance, inform the emergency medical personnel or nurse that you have taken DoppelSil MAX and the time of ingestion.
Do not take DoppelSil MAX together with other medicines without medical advice.
Do not take DoppelSil MAX if the patient is taking nitrates, because their concomitant use may lead to a dangerous drop in blood pressure.
Always inform your doctor or pharmacist if you are taking nitrates used to treat angina (chest pain).
Do not take DoppelSil MAX if the patient is taking medicines that release nitric oxide (such as amyl nitrite), because their simultaneous use may also cause a dangerous drop in blood pressure.
Do not take DoppelSil MAX together with other medicines containing sildenafil.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If the patient is taking protease inhibitors (e.g. ritonavir) used in the treatment of HIV infection, consult the doctor before taking DoppelSil MAX. The doctor may consider initiating treatment with sildenafil, starting with a lower dose (25 mg).
If the patient is taking alpha-blockers, consult the doctor before taking DoppelSil MAX. In some patients taking alpha-blockers (e.g. doxazosin, tamsulosin, alfuzosin, terazosin, silodosin) for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a sudden drop in blood pressure upon standing or sitting quickly. Such symptoms have been reported in some patients taking DoppelSil MAX together with alpha-blockers. They are most likely to occur within 4 hours after taking DoppelSil MAX. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting DoppelSil MAX. The doctor may decide to start treatment with a lower initial dose (25 mg) of sildenafil.
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 the legs may also help. Avoid standing or sitting up quickly.
If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), consult the doctor before taking DoppelSil MAX.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the doctor or pharmacist.

DoppelSil MAX with food, drink, or alcohol
DoppelSil MAX can be taken with or without food. However, taking DoppelSil MAX with a heavy meal may delay the onset of its effect. 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 alcohol consumption. To maximize the therapeutic effect of DoppelSil MAX, avoid consuming large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility
DoppelSil MAX is not intended for use by women.

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

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 improper excretion.
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use DoppelSil MAX

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.
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, DoppelSil MAX 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 25 mg.
If taking a lower dose of sildenafil (25 mg) enabled the patient to achieve an erection sufficient for sexual intercourse, the 50 mg dose should not be used.
Do not take DoppelSil MAX more than once a day.
Do not take this medicine together with other medicines containing sildenafil.
DoppelSil MAX should be taken approximately one hour before planned sexual activity.
The tablet should be chewed completely and then swallowed.
If the effect of DoppelSil MAX seems too strong or too weak, consult a doctor or pharmacist.
DoppelSil MAX enables an erection only in the presence of sexual stimulation.
The time until DoppelSil MAX takes effect 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.
Consult a doctor if no erection occurs after taking DoppelSil MAX, or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of DoppelSil MAX
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 have been taken than recommended.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

• 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 uncommonly. If chest pain occurs during or after sexual intercourse:
  • adopt a semi-sitting position and try to relax,
  • do not take nitrates to relieve chest pain.
  • Prolonged and sometimes painful erections – occur rarely (may occur in 1 in 1000 patients). If an erection lasts more than 4 hours, contact a doctor immediately.
  • Sudden worsening or loss of vision – occurs rarely.
  • Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
  • Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may occur in more than 1 in 10 patients): headache.
Common (may occur in 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include feeling of warmth in the upper body), indigestion, vision with coloured tinge, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, eye congestion, 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, tinnitus, dry mouth, blocked or stuffy sinuses, nasal mucosal inflammation (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 and feeling of fatigue.
Rare (may occur in 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, throat tightness, lip numbness, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small particles or spots in the visual field, seeing halos around light sources, pupil dilation, abnormal discoloration of the sclera, rectal bleeding, blood in semen, dry nose, nasal swelling, irritability and sudden weakness or hearing loss.

Since the introduction of sildenafil-containing medicines, 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 adverse events, pre-existing cardiac disorders were present before taking sildenafil-containing medicines.
It is not possible to determine whether these adverse reactions were related to the use of DoppelSil MAX.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 DoppelSil MAX

Keep this medicine out of sight and reach of children.
There are no special requirements regarding storage temperature.
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 stated month.
Medicines must 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 pack and other information

What DoppelSil MAX contains

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (in the form of sildenafil citrate).
• The other ingredients are: potassium polyacrylate, anhydrous colloidal silicon dioxide, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, peppermint flavor, magnesium stearate, potassium hydroxide (for pH adjustment) or concentrated hydrochloric acid (for pH adjustment).

What DoppelSil MAX looks like and contents of the pack
White, triangular, biconvex tablets with the imprint "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 Authorisation Holder
Doppelherz Pharma GmbH
Schleswiger Strasse 74
24941 Flensburg
Germany

Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
153 51 Pallini Attiki
Greece

For further information, please contact the local representative of the Marketing Authorisation Holder:
Queisser Pharma Poland Sp. z o.o.
ul. Domaniewska 39
02-672 Warsaw
Poland
tel. +48 22 487 52 54