Package leaflet: Information for the patient

Sildenafil Polpharma, 50 mg, chewable tablets
Sildenafil Polpharma, 100 mg, chewable tablets
Sildenafil
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Sildenafil Polpharma is and what it is used for
Important information before taking Sildenafil Polpharma
How to take Sildenafil Polpharma
Possible side effects
How to store Sildenafil Polpharma
Contents of the pack and other information

1. What Sildenafil Polpharma is and what it is used for

Sildenafil Polpharma contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Sildenafil works by helping to relax blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Sildenafil helps achieve an erection only if sexual stimulation is present.
Sildenafil Polpharma is used to treat erectile dysfunction in adult men, i.e. impotence. This is the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
Sildenafil Polpharma should not be used by patients who do not have erectile dysfunction.
Sildenafil Polpharma is not a medicine intended for use by women.
If there is no improvement after using the medicine, or if the patient feels worse, medical advice should be sought.

2. Important information before taking Sildenafil Polpharma

When not to take Sildenafil Polpharma

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 containing nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if they are taking any medicines from this group; these medicines 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"), as their concomitant use may also cause dangerous lowering of blood pressure.
If the patient is taking riociguat (e.g. Adempas). 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 phosphodiesterase type 5 (PDE5) inhibitors, such as Sildenafil Polpharma, 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.
If the patient has inherited degenerative retinal disorders, such as retinitis pigmentosa.
If the patient has ever experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil Polpharma, the patient should discuss with their doctor or pharmacist if they have:

Sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow);
Anatomical deformation of the penis or Peyronie's disease;
Heart problems. In such cases, the doctor should assess whether the patient's cardiac condition can tolerate the additional strain associated with sexual activity;
Peptic ulcer disease or bleeding disorders (such as hemophilia).

If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking Sildenafil Polpharma and contact a doctor immediately.
Sildenafil Polpharma should not be used together with other oral or topical treatments for erectile dysfunction.
Sildenafil Polpharma should not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other phosphodiesterase type 5 inhibitors.
Sildenafil Polpharma should not be taken if erectile dysfunction has not been diagnosed.
Sildenafil Polpharma is not a medicine intended for women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of Sildenafil Polpharma.

Children and adolescents
Sildenafil Polpharma should not be used in individuals under 18 years of age.

Sildenafil Polpharma and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take.
Sildenafil Polpharma chewable tablets may interact with certain medicines, especially those used to treat chest pain. In case of worsening health requiring immediate medical attention, the patient should inform the doctor or pharmacist about having taken Sildenafil Polpharma and the time of administration. Sildenafil Polpharma should not be taken with other medicines unless advised by a doctor.
Do not take Sildenafil Polpharma if the patient is taking nitrate-containing medicines, as their concomitant use may lead to dangerous lowering of blood pressure. Always inform the doctor or pharmacist if the patient is taking nitrates, which are used to treat angina (chest pain).
Do not take Sildenafil Polpharma if the patient is taking medicines or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant use may lead to dangerous lowering of blood pressure.
If the patient is taking riociguat, they should inform their doctor or pharmacist.
In patients taking protease inhibitors used in the treatment of HIV infection, initiation of treatment with the lowest dose of sildenafil (25 mg) is recommended.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have been reported in some patients taking sildenafil together with alpha-blockers. These are most likely to occur within 4 hours after taking Sildenafil Polpharma. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Sildenafil Polpharma. The doctor may decide to start with a lower initial dose of sildenafil (25 mg).
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, they should inform their doctor or pharmacist.

Sildenafil Polpharma with food, drink, and alcohol
Sildenafil Polpharma may be taken with or without food. However, taking Sildenafil Polpharma with a heavy meal may delay the time it takes for the medicine to start working.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Sildenafil Polpharma, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Sildenafil Polpharma is not intended for use in women.

Driving and operating machinery
Sildenafil Polpharma may cause dizziness and visual disturbances. Patients should assess how they react to the medicine before driving or operating machinery.

Sildenafil Polpharma contains aspartame, lactose, and sodium
The medicine contains 4.30 mg of aspartame in each Sildenafil Polpharma 50 mg tablet and 8.60 mg in each Sildenafil Polpharma 100 mg tablet.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Sildenafil Polpharma chewable tablets contain lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free."

3. How to take Sildenafil Polpharma

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
Sildenafil Polpharma must not be taken more than once a day.
Do not take Sildenafil Polpharma together with other medicines containing
sildenafil.
Sildenafil Polpharma should be taken approximately one hour before planned sexual activity.
The tablet should be chewed completely and then swallowed.
If you feel that the effect of Sildenafil Polpharma is too strong or too weak,
consult your doctor or pharmacist.
Sildenafil Polpharma enables an erection to be achieved only in the presence of
sexual stimulation. The time it takes for Sildenafil Polpharma to take effect varies between individuals, usually ranging from half an hour to one hour. The effect may occur later if
the medicine is taken after a heavy meal.
Consult your doctor if, after taking Sildenafil Polpharma, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Polpharma
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 prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding the use of this medicine, consult your
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 Sildenafil Polpharma are usually mild to moderate in intensity and transient.
If any of the following adverse reactions occur, stop taking Sildenafil Polpharma and seek
immediate medical help:

Allergic reaction – occurs uncommonly (may occur in less than 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:
- sit in a half-upright position and try to relax,
- do not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – occur rarely (may occur in less than 1 in 1,000 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, genital organs and around the eyes, fever.
Seizures or fits – occur rarely.

Other adverse reactions:
Very common (may occur in more than 1 in 10 patients):

headache.

Common (may occur in less than 1 in 10 patients):

nausea,
sudden flushing of the face,
hot flushes (symptoms include feeling of warmth in the upper body),
indigestion,
coloured vision, blurred vision, visual disturbances,
stuffy nose,
dizziness.

Uncommon (may occur in less than 1 in 100 patients):

vomiting,
skin rash,
eye irritation, eye redness,
eye pain, seeing flashes of light, bright vision,
light sensitivity, watery eyes,
palpitations, rapid heartbeat,
hypertension, hypotension,
muscle pain,
drowsiness,
reduced sense of touch,
vertigo, tinnitus,
dry mouth,
blocked or stuffy sinuses,
rhinitis (symptoms include runny nose, sneezing and blocked nose),
upper abdominal pain,
gastroesophageal reflux disease (symptoms include heartburn),
blood in urine,
pain in arms or legs,
nosebleeds,
feeling of warmth and feeling of fatigue.

Rare (may occur in less than 1 in 1,000 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 eyes or eyelids,
small specks or spots in the field of vision, seeing halos around light sources,
pupil dilation,
abnormal discoloration of the white part of the eye,
bleeding from the penis, blood in semen,
dry nose, nasal swelling,
feeling irritable,
sudden weakening or loss of hearing.

After the medicine was placed on the market, 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, heart problems were present before taking sildenafil. It is not possible to determine whether these adverse reactions were related to the use of sildenafil-containing medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 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 provide more information on the safety of this medicine.

5. How to store Sildenafil Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
There are no special storage temperature requirements; store in the original packaging to protect from light.
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 Sildenafil Polpharma contains

The active substance is sildenafil. Sildenafil Polpharma 50 mg: Each orodispersible and chewable tablet contains 50 mg of sildenafil formed in situ from 70.24 mg of sildenafil citrate.

Sildenafil Polpharma 100 mg: Each orodispersible and chewable tablet contains 100 mg of sildenafil
formed in situ from 140.48 mg of sildenafil citrate.

Other components are: potassium polyacrylate, colloidal anhydrous silica, lactose monohydrate, povidone K-30, aspartame (E951), sodium croscarmellose, peppermint flavour (maltodextrin, modified corn starch (E1450) and peppermint oil), magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

What Sildenafil Polpharma looks like and contents of the pack
Sildenafil Polpharma 50 mg: White, triangular, biconvex tablets, embossed with the number "50" on one side.
Sildenafil Polpharma 100 mg: White, triangular, biconvex tablets, embossed with the number "100" on one side.
Sildenafil Polpharma is available in blisters containing 1, 2, 4, 8 or 12 orodispersible and chewable tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Genepharm S.A.
18th km Marathon Avenue
15351 Pallini Attiki
Greece