Sildenafil Polpharma

Package Leaflet: Information for the Patient

Sildenafil Polpharma, 50 mg, Chewable Tablets

Sildenafil Polpharma, 100 mg, Chewable Tablets

Sildenafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 the flow of blood to the penis during sexual arousal. Sildenafil helps to achieve an erection only if you are sexually aroused.

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 medicine does not improve or if you feel worse after taking it, you should contact your doctor.

2. Important information before taking Sildenafil Polpharma

When not to take Sildenafil Polpharma

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any of these medicines; they are often used to relieve angina (chest pain).
• If you are taking medicines or other agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as the combination may also cause a dangerous decrease in blood pressure.
• If you are 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 inhibitors (PDE5), such as Sildenafil Polpharma, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

• If you have severe heart or liver disease.
• If you have recently had a stroke or heart attack, and in cases of low blood pressure.
• If you have inherited degenerative eye diseases, such as retinitis pigmentosa.
• If you have ever had a sudden loss of vision due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before taking Sildenafil Polpharma, you should discuss it with your doctor or pharmacist if:

• you have sickle cell anemia (a condition that affects red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer);
• you have a physical deformity of the penis or Peyronie's disease;
• you have heart problems. In this case, your doctor should assess whether your heart condition allows for the extra strain associated with sexual activity;
• you have stomach ulcers or bleeding disorders (such as hemophilia).

If you experience sudden vision loss or sudden hearing loss, you should stop taking Sildenafil Polpharma and seek medical attention immediately.

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

Sildenafil Polpharma should not be used in combination with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or other phosphodiesterase type 5 inhibitors.

Sildenafil Polpharma should not be taken if you do not have erectile dysfunction.

Sildenafil Polpharma is not intended for use by women.

Special considerations for patients with kidney or liver problems

Patients with kidney or liver problems 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 individuals under 18 years of age.

Sildenafil Polpharma and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Sildenafil Polpharma chewable tablets may interact with some medicines, especially those used to treat chest pain. If your condition worsens and you need immediate medical attention, you should inform your doctor or pharmacist about taking Sildenafil Polpharma and the time of taking it. You should not take Sildenafil Polpharma with other medicines without your doctor's advice.

You should not take Sildenafil Polpharma if you are taking medicines called nitrates, as the combination may lead to a dangerous decrease in blood pressure. You should always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina (chest pain).

You should not take Sildenafil Polpharma if you are taking medicines or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as the combination may lead to a dangerous decrease in blood pressure.

If you are taking riociguat, you should inform your 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 take alpha-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 quickly or sitting down. Such symptoms occurred in some patients taking sildenafil and alpha-blockers. 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-blocker before starting Sildenafil Polpharma. The doctor may decide to use a lower initial dose of sildenafil (25 mg).

If you are taking medicines containing sacubitril with valsartan, used to treat heart failure, you should inform your doctor or pharmacist.

Sildenafil Polpharma with food, drink, and alcohol

Sildenafil Polpharma can be taken with or without food.

However, taking Sildenafil Polpharma during 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, you 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 be aware of 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 you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

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

3. How to take Sildenafil Polpharma

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

The recommended starting dose is 50 mg.

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

You should not take Sildenafil Polpharma 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 you feel that the effect of Sildenafil Polpharma is too strong or too weak, you should consult your doctor or pharmacist.

Sildenafil Polpharma allows for an erection only if you are sexually aroused. The time it takes for the medicine to start working varies from person to person, usually between half an hour and one hour. The effect may occur later if the medicine is taken after a large meal.

You should contact your doctor if, after taking Sildenafil Polpharma, you do not achieve 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 increase the efficacy of the medicine.

Do not take more tablets than prescribed by your doctor.

You should contact your doctor if you have taken more tablets than prescribed.

If you have any further questions about the use of this medicine, you should ask your 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.

If you experience any of the following side effects, stop taking Sildenafil Polpharma and seek medical attention immediately:

• Allergic reaction - occurs uncommonly(may occur in less than 1 in 100 patients). Symptoms: sudden, wheezing breath, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonly. If it occurs during or after sexual intercourse:
• you should sit half-up and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occurs rarely(may occur in less than 1 in 1,000 patients). If the erection lasts for more than 4 hours, you should seek medical attention immediately.
• Sudden vision loss or hearing loss - occurs rarely.
• Severe skin reactions - occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occurs 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,
• hot flashes (symptoms include a feeling of heat in the upper body),
• indigestion,
• visual disturbances, blurred vision,
• stuffy nose,
• dizziness.

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

• vomiting,
• skin rash,
• eye irritation, conjunctivitis,
• eye pain, flashes of light, excessive 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 compression in the throat, numbness of the lips,
• bleeding in the back of the eye,
• double vision, reduced visual acuity,
• abnormal sensations in the eye,
• eye 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, swelling inside the nose,
• feeling irritable,
• sudden hearing loss.

Rarely, after the medicine was introduced to the market, 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 side effects, heart problems existed 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 you experience any side effects, including those not listed in this leaflet, you should inform your 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, you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Polpharma

The medicine should be stored out of 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.

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 storage instructions for the medicine; it should be stored in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 situfrom 70.24 mg of sildenafil citrate.

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

• The other ingredients are: polyacrylate potassium, colloidal silica anhydrous, lactose monohydrate, povidone K-30, aspartame (E951), croscarmellose sodium, 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 contents of the pack

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