Doppelsil

Before using the medicine, carefully read the package leaflet and review the "Diagnostic Tool"
provided with the packaging. To ensure safe use of the medicine, please answer all questions
contained in the "Diagnostic Tool".
Package leaflet: information for the patient
DoppelSil, 25 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 this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please 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.

Contents of the leaflet

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

1. What DoppelSil is and what it is used for

DoppelSil 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 the penis during sexual stimulation. DoppelSil helps achieve an erection only if sexual stimulation is present. DoppelSil is used in adult men (over 18 years of age) for the treatment of erectile dysfunction, i.e. impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.
This medicine should not be taken if erectile dysfunction is not present.

2. Important information before using DoppelSil

Before using DoppelSil, read carefully the
"Diagnostic Tool" included in the package. To use the medicine safely,
please answer all questions contained in the "Diagnostic Tool".
When not to use 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 medicines from the group of nitrates (available under various brand names):
  • glyceryl trinitrate
  • isosorbide mononitrate
  • isosorbide dinitrate
  • pentaerythritol tetranitrate
    because their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if taking any of these medicines – they are often used to relieve symptoms of angina (chest pain). In case of doubt, consult a 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 concomitant 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). PDE5 inhibitors such as DoppelSil 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 and the doctor has advised avoiding 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 ischaemic optic neuropathy (NAION).

Warnings and precautions
It is important that during the first 6 months of using DoppelSil, consultation with a doctor excludes
other serious diseases that may be causing erectile dysfunction, such as:

• cardiovascular diseases
• diabetes
• hypertension
• elevated cholesterol levels

Before starting DoppelSil, discuss with a 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 caused by sickle cell anaemia (an abnormality of red blood cells), leukaemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• The patient has been diagnosed with anatomical penile deformity or Peyronie's disease.
• The patient has heart problems. In this case, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
• Peptic ulcer disease.
• Coagulation disorders (such as haemophilia).
  If sudden worsening of vision or sudden vision loss occurs, discontinue use of DoppelSil and contact a doctor immediately.

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

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

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

DoppelSil and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
DoppelSil may interact with certain medicines, especially those used to treat chest pain.
If your health deteriorates and you require immediate medical assistance, inform the healthcare provider, paramedic, or nurse that you have taken DoppelSil and the time of ingestion.
Do not take DoppelSil with other medicines without a doctor's recommendation.
Do not take DoppelSil if the patient is taking nitrates, because their concomitant use may lead to a dangerous decrease in blood pressure.
Always inform your doctor or pharmacist if you are taking nitrates used to treat angina (chest pain).
Do not take DoppelSil if the patient is taking medicines that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous decrease in blood pressure.
Do not take DoppelSil together with other medicines containing sildenafil.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If taking protease inhibitors used in the treatment of HIV infection, consult a doctor before taking DoppelSil.
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 drop in blood pressure upon rapid standing or sitting.
Such symptoms have occurred in some patients taking DoppelSil together with alpha-blockers. They are most likely to occur within 4 hours after taking DoppelSil. To reduce the possibility of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting DoppelSil. 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. Avoid rapid standing or sitting.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the doctor or pharmacist.

DoppelSil with food, drink, and alcohol
DoppelSil can be taken with or without food. However, taking DoppelSil with a heavy meal may delay the onset of the medicine's effect. Do 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 alcohol consumption. To maximize the therapeutic effect of DoppelSil, significant amounts of alcohol should not be consumed before taking the medicine.

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

Driving and operating machinery
DoppelSil may cause dizziness and visual disturbances. Patients should determine 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 improper excretion.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking DoppelSil.

3. How to use DoppelSil

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is 25 mg (1 DoppelSil tablet) once daily. A doctor may recommend a different dosing regimen after consultation.
Do not take DoppelSil more than once a day.
Do not take DoppelSil together with other medicines containing sildenafil.
DoppelSil should be taken approximately one hour before planned sexual activity.
The tablet should be chewed completely and then swallowed.
If the effect of DoppelSil appears too strong or too weak, consult a doctor or pharmacist.
DoppelSil enables an erection only when accompanied by sexual stimulation. The time it takes for DoppelSil to take 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.
Contact a doctor if, after taking DoppelSil, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of DoppelSil
Adverse effects may occur more frequently and 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 information leaflet.
Contact a doctor if more tablets have been taken than recommended.
If there are 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 will experience them.
Adverse reactions reported with the use of DoppelSil are usually mild or
moderate in intensity and transient.
If any of the following adverse reactions occur, discontinue taking DoppelSil and seek immediate medical assistance:

• 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 longer 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, on the genital organs and around the eyes, fever.
• Seizures or convulsions – occur rarely.

Other adverse reactions:
Very common (may affect more than 1 in 10 patients): headache.
Common (may affect 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of warmth in the upper body), indigestion, vision with coloured tinge, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon (may affect 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 mucositis (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 fatigue.
Rare (may affect 1 in 1000 patients): 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 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 discolouration of the sclera, rectal bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden weakness or hearing loss.

Since sildenafil-containing medicines have been marketed, 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 reactions, cardiac disorders were present prior to taking sildenafil-containing medicines.
It is not possible to determine whether these adverse reactions were related to the use of DoppelSil.

Reporting of adverse reactions
If any adverse effects occur, including any 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 directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store DoppelSil

Keep this medicine out of sight and reach of children.
There are no special storage temperature requirements for this 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 pack 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. Such measures help protect the environment.

6. Contents of the pack and other information

What DoppelSil contains

• The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients are: potassium polyacrylate, anhydrous colloidal silicon dioxide, lactose monohydrate, povidone K-30, aspartame (E 951), sodium croscarmellose, mint flavour, magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid, concentrated (for pH adjustment).

What DoppelSil looks like and contents of the pack
White, triangular, biconvex tablets with the imprint "25" on one side.
DoppelSil is available in PVC/PCTFE/Aluminium blisters containing 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