Sildenafil Pph

Package Leaflet: Information for the Patient

Sildenafil PPH, 50 mg, Film-Coated Tablets

Sildenafil PPH, 100 mg, Film-Coated Tablets

Sildenafil

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Sildenafil PPH contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medication works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil PPH helps achieve an erection only if there is prior sexual stimulation. Sildenafil PPH is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Sildenafil PPH

When not to take Sildenafil PPH

• If the patient is allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If the patient is taking 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 medications from this group, which are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubts, consult a doctor or pharmacist.
• If the patient is taking medications that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their simultaneous use may also lead to a dangerous decrease in blood pressure.
• If the patient is taking riociguat. This medication 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 PPH, enhance the blood pressure-lowering effect of this medication. If the patient is taking riociguat or is unsure, they should inform their doctor.

If the patient has severe heart or liver disease, recently had a stroke or heart attack, or has low blood pressure, they should not take Sildenafil PPH.

• If the patient has severe heart disease or liver disease.
• If the patient has recently had a stroke or heart attack, or has low blood pressure.
• If the patient has inherited eye diseases, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Sildenafil PPH, 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).
• 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 effort associated with sexual activity.
• Ulcer disease or blood clotting disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden vision deterioration, they should stop taking Sildenafil PPH and immediately consult their doctor.

Sildenafil PPH should not be taken simultaneously with other oral or topical treatments for erectile dysfunction. Sildenafil PPH should not be taken simultaneously with other methods of treating pulmonary arterial hypertension (PAH) using sildenafil or other phosphodiesterase type 5 (PDE5) inhibitors (e.g., tadalafil). Sildenafil PPH should not be taken if the patient does not have erectile dysfunction. Sildenafil PPH is not intended for women. Special considerations for patients with kidney or liver function disordersPatients with kidney or liver function disorders should inform their doctor. The doctor may decide to use a lower dose of Sildenafil PPH.

Children and adolescents

Sildenafil PPH should not be taken by persons under 18 years of age.

Sildenafil PPH and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. Sildenafil PPH may interact with some medications, 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 PPH and the time of its administration. The patient should not take Sildenafil PPH simultaneously with other medications without their doctor's recommendation. The patient should not take Sildenafil PPH if they are taking nitrate medications, 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 take Sildenafil PPH if they are taking medications that release nitric oxide (such as amyl nitrite), as their simultaneous use may also lead to a dangerous decrease in blood pressure. If the patient is taking riociguat, they should inform their doctor or pharmacist. When taking protease inhibitors used to treat HIV infections, the doctor may recommend starting treatment with a lower dose (25 mg) of Sildenafil PPH available on the market. In some patients 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 during rapid standing or sitting. Such symptoms occurred in some patients taking Sildenafil PPH and alpha-adrenergic blockers simultaneously. Their occurrence is most likely within 4 hours after taking Sildenafil PPH. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Sildenafil PPH. The doctor may decide to use a lower initial dose of Sildenafil PPH (25 mg) available on the market. If the patient is taking medications containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Sildenafil PPH with food, drinks, and alcohol

Sildenafil PPH can be taken with or without food. However, taking Sildenafil PPH during a large meal may prolong the time it takes for the medication to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic effects of Sildenafil PPH, the patient should not consume significant amounts of alcohol before taking the medication.

Pregnancy, breastfeeding, and fertility

Sildenafil PPH is not intended for use by women.

Driving and using machines

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

Sildenafil PPH contains sodium

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

3. How to take Sildenafil PPH

This medication should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The recommended initial dose is 50 mg. Sildenafil PPH should not be taken more than once a day.The patient should not take Sildenafil PPH simultaneously with other medications containing sildenafil. Sildenafil PPH should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water. If the patient feels that the effect of Sildenafil PPH is too strong or too weak, they should consult their doctor or pharmacist. Sildenafil PPH enables an erection only if there is prior sexual stimulation. The time it takes for Sildenafil PPH to start working varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medication is taken after a large meal. The patient should consult their doctor if they do not achieve an erection after taking Sildenafil PPH or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Sildenafil PPH 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 effectiveness of the medication. The patient should not take more tablets than prescribed by their doctor.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 medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Sildenafil PPH can cause side effects, although not everybody gets them. The side effects reported in connection with the use of Sildenafil PPH are usually mild or moderate and short-term.

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

• •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 uncommonlyIf 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 - occurs rarely(may occur in less than 1 in 1000 patients) If the erection lasts for more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or deterioration - occurs rarely
• •Severe skin reactions - occurs rarelySymptoms may include severe skin peeling and swelling, 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 of the face, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tint on objects, blurred vision, vision disturbances, stuffy nose, dizziness.
Uncommon(may occur in less than 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, increased light perception, sensitivity to light, tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, decreased sensation, vertigo of labyrinthine origin, tinnitus, 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, pain in arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.
Rare(may occur in less than 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to a part of the brain, feeling of compression in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased 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, pupil dilation, abnormal discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritability, and sudden hearing loss or hearing impairment. After the medication 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 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 sildenafil.

Reporting side effects

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

5. How to store Sildenafil PPH

Store the medication out of sight and reach of children. There are no special precautions for storing the medication. Do not use this medication after the expiry date stated on the packaging. The expiry date refers to 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. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil PPH contains

• The active substance of Sildenafil PPH is sildenafil. Each tablet contains 50 mg or 100 mg of sildenafil (in the form of citrate).
• Other ingredients of the medication are:
• Core: mannitol (E421), crospovidone (type A), povidone (K30), colloidal anhydrous silica, corn starch, magnesium stearate, sodium lauryl sulfate.
• Coating: hypromellose (viscosity 15 mPa.s), macrogol 6000, titanium dioxide (E171), talc, indigo carmine lake (E132).

What Sildenafil PPH looks like and what the pack contains

Sildenafil PPH 50 mg: The tablets are blue, round, biconvex, with a diameter of 8 mm. Sildenafil PPH 100 mg: The tablets are blue, round, biconvex, with a diameter of 10 mm. The packaging contains 1, 4, 8, or 12 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A. Pharmaceutical Works ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01 Date of the last update of the leaflet:August 2022