Package leaflet: Information for the patient

Sildenafil PPH, 50 mg, film-coated tablets
Sildenafil PPH, 100 mg, film-coated tablets
Sildenafilum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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.

Contents of the leaflet

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

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

Sildenafil PPH contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax blood vessels in the penis, thereby increasing blood flow into the penis during sexual stimulation. Sildenafil PPH helps achieve an erection only if the patient is sexually stimulated.
Sildenafil PPH is used in the treatment of erectile dysfunction in adult men, i.e. impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Information before using Sildenafil PPH

When not to take Sildenafil PPH

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 nitrates, because 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). If in doubt, consult a doctor or pharmacist.
If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to a dangerous decrease in blood pressure.
If the patient is taking riociguat. 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 lung pressure 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 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 eye diseases, such as retinitis pigmentosa.
If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Before starting treatment with Sildenafil PPH, consult a doctor or pharmacist if:

The patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
The patient has been diagnosed with penile anatomical deformity or Peyronie's disease.
The patient has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
The patient has peptic ulcers or bleeding disorders (such as hemophilia).
If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking Sildenafil PPH and contact a doctor immediately.

Sildenafil PPH must not be used concurrently with other oral or topical treatments for erectile dysfunction.
Sildenafil PPH must not be used together with other therapies for pulmonary arterial hypertension (PAH) containing sildenafil, or with other phosphodiesterase type 5 inhibitors (e.g. tadalafil).
Sildenafil PPH should not be taken if erectile dysfunction has not been diagnosed.
Sildenafil PPH 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 PPH.

Children and adolescents
Sildenafil PPH must not be used in individuals under 18 years of age.

Sildenafil PPH and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Sildenafil PPH may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, the doctor or pharmacist must be informed about the intake of Sildenafil PPH and the time it was taken. Sildenafil PPH must not be taken with other medicines without medical advice.
Do not take Sildenafil PPH if the patient is using nitrates, because their concomitant use may lead to a dangerous drop in 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 PPH if the patient is using medicines that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous drop in blood pressure.
If the patient is taking riociguat, inform the doctor or pharmacist.
When taking protease inhibitors used in the treatment of HIV infection, the doctor may recommend starting treatment with a lower dose (25 mg) of the medicine available on the market.
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 occurred in some patients taking Sildenafil PPH together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking Sildenafil PPH. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Sildenafil PPH. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of the medicine available on the market.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the doctor or pharmacist.

Sildenafil PPH with food, drink, and alcohol
Sildenafil PPH can be taken with or without food. However, taking Sildenafil PPH with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Sildenafil PPH, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Sildenafil PPH is not intended for use by women.

Driving and using machines
Sildenafil PPH may cause dizziness and visual disturbances. Patients should assess how they react to Sildenafil PPH before driving or operating machinery.

Sildenafil PPH contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to use Sildenafil PPH

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended starting dose is 50 mg.
Sildenafil PPH should not be taken more than once a day.
Do not take Sildenafil PPH together with other medicines containing sildenafil.
Sildenafil PPH should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
If you feel that the effect of Sildenafil PPH is too strong or too weak, consult your doctor or pharmacist.
Sildenafil PPH enables an erection to occur only in the presence of sexual stimulation.
The time it takes for Sildenafil PPH to take effect varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Sildenafil PPH, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil PPH
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 about 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 PPH are usually mild or moderate in severity and transient.

If any of the following adverse reactions occur, stop taking Sildenafil PPH 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:
- adopt a semi-sitting position and try to relax,
- do not take nitrates to relieve chest pain.
Prolonged and sometimes painful erections – occurs rarely (may occur in less than 1 in 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
Sudden decrease or loss of vision – occurs rarely
Severe skin reactions – occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
Seizures or fits – occurs 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 a 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, inflammation of the nasal mucosa (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, feeling of warmth, 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 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 the eyes or eyelids, small particles or spots in the field of vision, seeing halos around light sources, pupil dilation, abnormal discolouration of the white part of the eye, rectal bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss.

After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse reactions, cardiac disorders were present prior to taking sildenafil. It is not possible to determine whether these adverse reactions were related to the use of sildenafil.

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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Sildenafil PPH

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The label on the packaging shows "EXP" followed by the expiry date, and "Lot/LOT" followed by the batch number.
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 packaging and other information

What Sildenafil PPH contains

The active substance in Sildenafil PPH is sildenafil. Each tablet contains 50 mg or 100 mg of sildenafil (as citrate).
Other components of the medicinal product are:
Tablet core: mannitol (E421), crospovidone (type A), povidone (K30), colloidal anhydrous silica, maize 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 contents of the pack
Sildenafil PPH 50 mg: Blue, round, biconvex tablets with a diameter of 8 mm.
Sildenafil PPH 100 mg: Blue, round, biconvex tablets with a diameter of 10 mm.
Pack sizes: 1, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01