SILDENAFIL 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Sildenafil Walmark, 100 mg, Film-Coated Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Sildenafil Walmark and what is it used for
4. Important information before taking Sildenafil Walmark
   1. When not to take Sildenafil Walmark
   2. Warnings and precautions
   3. Children and adolescents
   4. Sildenafil Walmark and other medications
   5. Sildenafil Walmark with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to take Sildenafil Walmark
   1. Taking a higher dose of Sildenafil Walmark than recommended
6. Possible side effects
   1. In case of any of the following serious side effects, the patient should stop taking Sildenafil Walmark and seek immediate medical attention:
   2. Other side effects:
   3. Reporting side effects
7. How to store Sildenafil Walmark
8. Contents of the pack and other information
   1. What Sildenafil Walmark contains
   2. What Sildenafil Walmark looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer and importer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Sildenafil Walmark, 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, pharmacist, or nurse.
• 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 any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

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

Sildenafil Walmark 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 Walmark helps achieve an erection only if there is prior sexual stimulation.

Sildenafil Walmark 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 Walmark

When not to take Sildenafil Walmark

• 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 concurrent 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 - these medications are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking medications 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 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 PDE5 inhibitors, such as Sildenafil Walmark, 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 recently experienced a stroke or heart attack, as well as in cases of low blood pressure.

• If the patient has severe heart or liver disease.
• If the patient has recently experienced a stroke or heart attack, as well as in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, 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 to take Sildenafil Walmark, the patient should discuss it with their doctor, pharmacist, or nurse 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 strain associated with sexual activity.
• Ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Sildenafil Walmark and immediately consult their doctor.

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

Sildenafil Walmark should not be used concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Sildenafil Walmark should not be taken if the patient has not been diagnosed with erectile dysfunction.

Sildenafil Walmark 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 Walmark.

Children and adolescents

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

Sildenafil Walmark 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 Walmark may interact with certain medications, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Sildenafil Walmark and the time of intake. The patient should not take Sildenafil Walmark concurrently with other medications without their doctor's recommendation.

The patient should not use Sildenafil Walmark if they are taking medications from the nitrate group, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are often used to treat angina pectoris ("chest pain").

The patient should not use Sildenafil Walmark if they are taking medications 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 the patient is already 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 a lower dose (25 mg) of sildenafil.

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

In case of symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint), the patient should first lie down or sit and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid rapid standing or sitting.

Sildenafil Walmark with food, drink, and alcohol

Sildenafil Walmark can be taken with or without food.

Although taking Sildenafil Walmark during a heavy meal may prolong the time needed 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 Walmark, the patient should not consume significant amounts of alcohol before taking the medication.

Pregnancy, breastfeeding, and fertility

Sildenafil Walmark is not intended for use by women.

Driving and using machines

Sildenafil Walmark may cause dizziness and visual disturbances.

Before driving or operating machinery, patients should be aware of how they react to Sildenafil Walmark.

3. How to take Sildenafil Walmark

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 Walmark should not be taken more than once a day.

Sildenafil Walmark should be taken approximately one 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 Walmark is too strong or too weak, they should consult their doctor or pharmacist.

Sildenafil Walmark enables an erection only if there is prior sexual stimulation. The time it takes for Sildenafil Walmark to work 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 heavy meal.

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

Taking a higher dose of Sildenafil Walmark 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 in case of taking more tablets than recommended.

In case of any further doubts about the use of this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Sildenafil Walmark can cause side effects, although not everybody gets them.

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

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

• Allergic reaction - occurs uncommonly(may occur in 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 1 in 1,000 patients) If the erection lasts more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or vision impairment - 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 up to 1 in 10 patients): nausea, sudden flushing, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, seeing a blue tinge, blurred vision, visual disturbances, stuffy nose, dizziness.

Uncommon(may occur in up to 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, seeing flashes of light, increased sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal congestion (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 hot, feeling tired.

Rare(may occur in up to 1 in 1,000 patients): fainting, stroke, heart attack, irregular heartbeat, temporary reduction of blood flow to part of the brain, feeling of tightness in the throat, numbness of the lips, bleeding in the back of the eye, double vision, reduced sharpness of vision, 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, dilated pupils, discoloration of the white of the eye, bleeding from the penis, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, sudden loss of hearing.

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 the medication containing sildenafil. It is not possible to determine whether these side effects were related to the use of Sildenafil Walmark.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C,

02-222 Warsaw,

phone: 22 49-21-301,

fax: 22 49-21-309,

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medication.

5. How to store Sildenafil Walmark

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 blister pack and carton after "EXP:". The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture.

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 Walmark contains

• The active substance of Sildenafil Walmark is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medication are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
• Tablet coating: Opadry II blue 85F505164 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, indigo carmine, lake (E 132)), Opadry clear 02K19253 (hypromellose 5cp (2910), triacetin)

What Sildenafil Walmark looks like and contents of the pack

Sildenafil Walmark 100 mg is a blue, round, film-coated tablet, convex on both sides, with an embossing of "100" on one side and "H" and "J" with a break line on the other side.

The tablets are packaged in PVC/Aluminum blisters of 4 or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer and importer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Date of last revision of the leaflet: