Doppelsil

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, 25 mg, chewable tablets

Sildenafil

It is essential to carefully read the contents of the leaflet 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 advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient does not improve or feels worse after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

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

1. What is DoppelSil and what is it used for

DoppelSil 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 arousal. DoppelSil helps achieve an erection only if the patient is sexually aroused. DoppelSil 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. The medicine should not be taken if the patient does not have erectile dysfunction.

2. Important information before taking DoppelSil

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

When not to take DoppelSil:

• 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 (which are available under different trade names):
• nitroglycerin
• isosorbide mononitrate
• isosorbide dinitrate
• pentaerythritol tetranitrate, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medicines or other agents that release nitric oxide (such as amyl nitrite, also known as "poppers"), as their concurrent use may also lead to a dangerous decrease in blood pressure.
• If the patient is 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 DoppelSil, 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, and their doctor has advised them to avoid sexual activity.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever had a sudden 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, the patient should discuss the following with their doctor or pharmacist:

• If the patient has ever had an erection lasting more than 4 hours, even without sexual arousal, known as 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).
• If the patient has anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• Peptic ulcer disease.
• Bleeding disorders (such as hemophilia). If sudden vision loss or sudden blindness occurs, the patient should stop taking DoppelSil and immediately consult their doctor.

DoppelSil should not be taken with other oral or topical treatments for erectile dysfunction. DoppelSil should not be taken with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other PDE5 inhibitors (e.g., tadalafil). DoppelSil should not be taken if the patient does not have erectile dysfunction. DoppelSil 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. Patients with kidney or liver function disorders should not take a dose of sildenafil higher than 25 mg.

Children and adolescents

DoppelSil should not be taken by individuals under the age of 18.

DoppelSil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. DoppelSil may interact with some medicines, especially those used to treat chest pain. In case of worsening health, requiring immediate medical attention, the patient should inform the doctor, paramedic, or nurse about taking DoppelSil and the time of its administration.The patient should not take DoppelSil with other medicines without their doctor's advice. The patient should not take DoppelSil if they are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor or pharmacist if they are taking nitrates, which are used to treat angina pectoris ("chest pain"). The patient should not take DoppelSil if they are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure. The patient should not take DoppelSil with other medicines containing sildenafil. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking medicines from the protease inhibitor group, used to treat HIV infections, the patient should consult their doctor before taking DoppelSil. 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, caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking DoppelSil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking DoppelSil. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting DoppelSil. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling of impending faint), the patient should 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. The patient should avoid standing up or sitting down quickly. If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

DoppelSil with food, drink, or alcohol

DoppelSil can be taken with or without food. Although taking DoppelSil during a heavy meal may prolong the time it takes for the medicine to start working. The patient should not take DoppelSil 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, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

DoppelSil is not intended for use in women.

Driving and using machines

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

DoppelSil 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 elimination. If the patient has previously been diagnosed with an intolerance to some sugars, they should consult their doctor before taking DoppelSil.

3. How to take DoppelSil

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose is 25 mg (1 DoppelSil tablet) once a day. The doctor may advise a different dosage after consultation.

Do not take DoppelSil more than once a day.

The patient should not take DoppelSil with other medicines containing sildenafil. DoppelSil should be taken about an hour before planned sexual activity. The tablet should be chewed and then swallowed. If the patient feels that the effect of DoppelSil is too strong or too weak, they should consult their doctor or pharmacist. DoppelSil allows for an erection only if the patient is sexually aroused. The time it takes for DoppelSil to start working varies from patient to patient, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a heavy meal. The patient should consult their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking DoppelSil.

Taking a higher dose of DoppelSil 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 medicine's effectiveness. The patient should not take more tablets than indicated in the patient leaflet.The patient should consult their doctor if they have taken more tablets than recommended. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of any of the following side effects, the patient should stop taking DoppelSil and seek immediate medical attention:

• 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:
• the patient should sit half-up and try to relax,
• they should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may affect up to 1 in 1,000 people). If an erection lasts more than 4 hours, the patient should seek immediate medical attention.
• Sudden vision loss or blindness - occur rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur 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, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensitivity to touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy nose, sinusitis (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 hot, and feeling tired.
Rare(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, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, reduced 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, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden hearing loss or loss of hearing.
Rarely, after the introduction of sildenafil-containing medicines to the market, 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.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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, more information can be collected on the safety of the medicine.

5. How to store DoppelSil

The medicine should be stored out of sight and reach of children. There are no special recommendations for the storage temperature of the medicine. The medicine should be stored in its original packaging to protect it from light. The patient should 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. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What DoppelSil contains

• The active substance of DoppelSil is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients are: potassium polacrylate, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, peppermint flavor, magnesium stearate, potassium hydroxide (to adjust pH) or concentrated hydrochloric acid (to adjust pH).

What DoppelSil looks like and contents of the pack

White, triangular, biconvex tablets, with the inscription "25" on one side. DoppelSil is available in PVC/PCTFE/Aluminum blisters containing 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, the patient should 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: