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 Package 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. 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, tell your 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 you are allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If you are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. Inform your doctor if you are taking any medications from this group, which are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult a doctor or pharmacist.
• If you are taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may also lead to a dangerous decrease in blood pressure.
• If you are 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 you are taking riociguat or are unsure, inform your doctor.

If you have severe heart or liver disease.

• If you have recently had a stroke or heart attack, as well as in cases of low blood pressure.
• If you have hereditary eye diseases, such as retinitis pigmentosa.
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and Precautions

Before starting to take Sildenafil PPH, discuss it with your doctor or pharmacist in case of:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer).
• If you have anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, your doctor should assess whether your heart condition allows for the additional strain associated with sexual activity.
• Ulcers or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden vision deterioration, stop taking Sildenafil PPH and contact your doctor immediately.

Sildenafil PPH should not be used concurrently with other oral or topical treatments for erectile dysfunction.

Sildenafil PPH should not be used concurrently 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 you do not have erectile dysfunction.

Sildenafil PPH is not intended for use by women.

Special Considerations for Patients with Renal or Hepatic Impairment

Patients with renal or hepatic impairment should inform their doctor. The doctor may decide to use a lower dose of Sildenafil PPH.

Children and Adolescents

Sildenafil PPH should not be used in individuals under 18 years of age.

Sildenafil PPH and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Sildenafil PPH may interact with certain medications, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, inform your doctor or pharmacist about taking Sildenafil PPH and the time of its intake. Do not take Sildenafil PPH concurrently with other medications without a doctor's recommendation.

Do not use Sildenafil PPH if you are taking nitrate medications, as their concurrent use may lead to a dangerous decrease in blood pressure. Always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina pectoris ("chest pain").

Do not use Sildenafil PPH if you are taking medications that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure.

If you are taking riociguat, inform your doctor or pharmacist.

In the case of taking protease inhibitors used to treat HIV infections, your 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 concurrently. 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 Sildenafil PPH. The doctor may decide to use a lower initial dose (25 mg) of Sildenafil PPH available on the market.

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

Sildenafil PPH with Food, Drink, and Alcohol

Sildenafil PPH can be taken with or without food.

However, taking Sildenafil PPH during a heavy 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 benefits of Sildenafil PPH, do 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 Operating Machinery

Sildenafil PPH may cause dizziness and visual 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 advised by your doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

The recommended initial dose is 50 mg.

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

Do not take Sildenafil PPH concurrently with other medications containing sildenafil.

Sildenafil PPH should be taken approximately one hour before planned sexual activity.

Swallow the tablet whole with a glass of water.

If you feel that the effect of Sildenafil PPH is too strong or too weak, consult a doctor or pharmacist.

Sildenafil PPH enables an erection only if there is prior sexual stimulation.

The time it takes for Sildenafil PPH to work varies from person to person, usually between half an hour to one hour. The effect may occur later if the medication is taken after a heavy meal.

Consult a doctor if, after taking Sildenafil PPH, 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 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.

Do not take more tablets than prescribed by your doctor.

Consult a doctor in case of taking more tablets than recommended.

In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible Side Effects

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

In Case of the Following Side Effects, Stop Taking Sildenafil PPH and Seek Medical Help Immediately:

• •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:
• take a half-sitting position 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 1000 patients) If the erection lasts more than 4 hours, seek medical help immediately.
• 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 - 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, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tint on objects, blurred vision, visual 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 sensitivity to light, lacrimation, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, decreased sensation, vertigo of labyrinthine origin, tinnitus, dry mouth, nasal congestion, rhinitis (symptoms include runny nose, sneezing, and stuffy nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), hematuria, pain in arms or legs, epistaxis, feeling of heat, 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 a part of the brain, feeling of tightness 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, penile bleeding, presence of blood in semen, nasal dryness, nasal swelling, 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 existed before taking sildenafil. It is not possible to determine whether these side effects were related to the use of sildenafil.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell 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 medication.

5. How to Store Sildenafil PPH

Keep 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 month stated.

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. Ask your 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.

Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of the Last Revision of the Leaflet:August 2022