Sildenafil Polpharma

Leaflet attached to the packaging: patient information

Sildenafil Polpharma, 50 mg, chewable tablets

Sildenafil Polpharma, 100 mg, chewable tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

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

Sildenafil Polpharma is used to treat erectile dysfunction in adult men, which is the inability to achieve or maintain an erection sufficient for sexual intercourse.

Sildenafil Polpharma should not be used by patients who do not have erectile dysfunction.

Sildenafil Polpharma is not intended for use by women.

If the patient does not experience improvement after taking the medicine or feels worse, they should contact their doctor.

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 simultaneous 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, so-called "poppers"), as their simultaneous use may also cause a dangerous decrease in blood pressure.
• If the patient is taking riociguat (e.g. Adempas). 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 phosphodiesterase type 5 inhibitors (PDE5), 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, and in cases of low blood pressure.
• If the patient has hereditary degenerative changes in the retina, such as retinitis pigmentosa.
• If the patient has ever had a loss of vision due to non-inflammatory ischemic optic neuropathy.

Warnings and precautions

Before starting to take Sildenafil Polpharma, the patient should discuss it with their doctor or pharmacist in the following cases:

• sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer);
• penile deformity or Peyronie's disease;
• heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional effort associated with sexual activity;
• stomach ulcers or bleeding disorders (such as hemophilia).

If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Sildenafil Polpharma and seek medical help immediately.

Sildenafil Polpharma should not be used simultaneously with other oral or topical treatments for erectile dysfunction.

Sildenafil Polpharma should not be used simultaneously with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other phosphodiesterase type 5 inhibitors.

Sildenafil Polpharma should not be taken if the patient does not have erectile dysfunction.

Sildenafil Polpharma is not intended for use by women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. The doctor may decide to use a lower dose of Sildenafil Polpharma.

Children and adolescents

Sildenafil Polpharma should not be used in people 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 or have recently taken, as well as any medicines they plan to take.

Sildenafil Polpharma chewable tablets may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, they should inform their doctor or pharmacist about taking Sildenafil Polpharma and the time of taking it. The patient should not take Sildenafil Polpharma simultaneously with other medicines without their doctor's recommendation.

The patient should not use Sildenafil Polpharma if they are taking medicines from the nitrate group, as their simultaneous 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 use Sildenafil Polpharma if they are taking medicines or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their simultaneous use may lead to a dangerous decrease in blood pressure.

If the patient is taking riociguat, they should inform their doctor or pharmacist.

In the case of taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with the lowest dose of sildenafil (25 mg).

In some patients who are taking alpha-adrenergic blockers 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 occurred in some patients taking sildenafil and alpha-adrenergic blockers simultaneously. Their occurrence is most likely within 4 hours of taking Sildenafil Polpharma. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Sildenafil Polpharma. The doctor may decide to use a lower initial dose of sildenafil (25 mg).

If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Sildenafil Polpharma with food, drink, and alcohol

Sildenafil Polpharma can be taken with or without food.

However, taking Sildenafil Polpharma while eating a large meal may prolong the time it takes for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Sildenafil Polpharma, the patient should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Polpharma is not intended for use by women.

Driving and using machines

Sildenafil Polpharma may cause dizziness and visual disturbances.

Before driving or operating machinery, patients should see how they react to Sildenafil Polpharma.

Sildenafil Polpharma contains aspartame, lactose, and sodium

The medicine contains 4.30 mg of aspartame in each 50 mg Sildenafil Polpharma tablet and 8.60 mg in each 100 mg Sildenafil Polpharma tablet.

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.

Sildenafil Polpharma chewable tablets contain lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Sildenafil Polpharma

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The recommended initial dose is 50 mg.

Sildenafil Polpharma should not be taken more than once a day.

The patient should not take Sildenafil Polpharma simultaneously with other medicines containing sildenafil.

Sildenafil Polpharma should be taken about an hour before planned sexual activity.

The tablet should be chewed completely and then swallowed.

If the patient feels that the effect of Sildenafil Polpharma is too strong or too weak, they should consult their doctor or pharmacist.

Sildenafil Polpharma allows for an erection only if there is prior sexual stimulation. The time it takes for Sildenafil Polpharma to work 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 large meal.

The patient should contact their doctor if, after taking Sildenafil Polpharma, they do not experience an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil Polpharma 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 mean increased efficacy of the medicine.

The patient should not take more tablets than prescribed by their doctor.

The patient should contact their doctor if they have taken more tablets than prescribed.

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Polpharma can cause side effects, although not everybody gets them.

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

In the event of any of the following side effects, the patient should stop taking Sildenafil Polpharma and seek medical help immediately:

• Allergic reaction - occurs uncommonly(may occur in less than 1 in 100 patients). Symptoms: sudden, wheezing breathing, 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,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in less than 1 in 1,000 patients). If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• 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 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,
• flushing (symptoms include a feeling of heat in the upper body),
• indigestion,
• visual disturbances, blurred vision, changes in vision,
• stuffy nose,
• dizziness.

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

• vomiting,
• skin rash,
• eye irritation, conjunctivitis,
• eye pain, seeing flashes of light, increased light perception,
• light sensitivity, tearing,
• palpitations, rapid heartbeat,
• high blood pressure, low blood pressure,
• muscle pain,
• drowsiness,
• reduced sense of touch,
• vertigo, ringing in the ears,
• dry mouth,
• stuffy or congested sinuses,
• nasal inflammation (symptoms include runny nose, sneezing, and stuffy nose),
• upper abdominal pain,
• gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine,
• arm or leg pain,
• nosebleeds,
• feeling hot and feeling tired.

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,
• feeling of pressure in the throat, numbness of the lips,
• bleeding in the back of the eye,
• double vision, decreased visual acuity,
• abnormal sensations in the eye,
• eye swelling or eyelid swelling,
• small particles or spots in the field of vision, seeing halos around light sources,
• pupil dilation,
• abnormal discoloration of the white of the eye,
• penile bleeding, presence of blood in semen,
• dry nose, nasal congestion,
• feeling irritable,
• sudden hearing loss.

Rarely, after the medicine was introduced to the market, there were reports of unstable angina (heart disease) and sudden death. It is important to note that in most, but not all, men who experienced these side effects, heart function disorders occurred before taking sildenafil. It is not possible to determine whether these side effects were related to the use of the medicine containing sildenafil.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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.: +48 22 49 21 301

Fax: +48 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, it is possible to gather more information on the safety of the medicine.

5. How to store Sildenafil Polpharma

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the packaging and blister. The expiry date stated on the packaging is the last day of the specified month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

There are no special instructions for storing the medicine at a certain temperature; the medicine should be stored in its original packaging to protect it from light.

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. Contents of the packaging and other information

What Sildenafil Polpharma contains

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

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

• The other ingredients are: potassium polacrylate, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E951), sodium croscarmellose, peppermint flavor (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 what the packaging contains

Sildenafil Polpharma 50 mg: White, triangular, biconvex tablets, with the inscription "50" on one side.

Sildenafil Polpharma 100 mg: White, triangular, biconvex tablets, with the inscription "100" on one side.

Sildenafil Polpharma is available in blisters of 1, 2, 4, 8, or 12 chewable tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

Genepharm S.A.

18th km Marathon Avenue

15351 Pallini Attiki

Greece

Date of last revision of the leaflet:July 2022