Sildenafil walmark

Package leaflet: information for the patient

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

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms appear identical.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

Sildenafil Walmark 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 to the penis during sexual stimulation.
Sildenafil Walmark helps achieve an erection only if sexual stimulation occurs beforehand.
Sildenafil Walmark is used to treat erectile dysfunction in adult men, that is,
impotence defined as the inability to obtain or maintain a penile erection sufficient
for sexual intercourse.

2. Important information before using Sildenafil Walmark

When not to use Sildenafil Walmark

• 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, as 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 drugs 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 blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as Sildenafil Walmark, have been shown to 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 hereditary degenerative retinal disorders, such as retinitis pigmentosa.

• If the patient has ever experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions

Before starting treatment with Sildenafil Walmark, discuss this with a doctor, pharmacist, or nurse if:

• The patient has sickle cell anaemia (an abnormality of red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has a known anatomical deformation of the penis or Peyronie's disease.
• The patient has heart problems. In such cases, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity.
• The patient has peptic ulcer disease or bleeding disorders (such as haemophilia).
• If sudden decrease in vision or sudden vision loss occurs, the patient should stop taking Sildenafil Walmark and contact a doctor immediately.

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

Sildenafil Walmark should not be used concomitantly with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.

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

Sildenafil Walmark is not a medicine intended for use in women.

Special considerations for patients with kidney or liver impairment

Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe 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 medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. Sildenafil Walmark 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, pharmacist, or nurse should be informed that Sildenafil Walmark was taken and when it was taken. Do not take Sildenafil Walmark with other medicines unless directed by a doctor.

Do not use Sildenafil Walmark if the patient is taking nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates, which are commonly used to treat angina (chest pain).

Do not use Sildenafil Walmark if the patient is taking drugs that release nitric oxide, such as amyl nitrite (so-called poppers), because their concomitant use may also cause a dangerous decrease in blood pressure.

If the patient is already taking riociguat, inform the doctor or pharmacist.

When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with a lower dose (25 mg) of sildenafil.

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 and alpha-blockers concomitantly. These symptoms are most likely to occur within 4 hours after taking Sildenafil Walmark. To reduce the likelihood of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Sildenafil Walmark. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.

If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit down and wait for symptoms to subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.

Sildenafil Walmark with food, drink, and alcohol

Sildenafil Walmark can be taken with or without food. However, taking Sildenafil Walmark with a heavy meal may prolong the time required for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Sildenafil Walmark, significant amounts of alcohol should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Walmark is not intended for use in women.

Driving and operating machinery

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

3. How to use Sildenafil Walmark

This medicine should always be taken as prescribed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. The recommended starting dose is 50 mg.
Sildenafil Walmark must 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 effect of Sildenafil Walmark seems too strong or too weak, consult a doctor or pharmacist.
Sildenafil Walmark enables an erection only in the presence of sexual stimulation.
The time it takes for Sildenafil Walmark to take effect varies between individuals, but is usually
between half an hour and one hour. The effect may occur later if the medicine is taken
after a heavy meal.
Consult a doctor if, after taking Sildenafil Walmark, an erection does not occur or if the duration
of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Walmark
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 a doctor.
Contact a doctor if more tablets have been taken than recommended.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions reported with Sildenafil Walmark are usually mild or moderate in intensity and transient.
If any of the following serious adverse reactions occur, stop taking Sildenafil Walmark immediately and seek medical help at once:

• Allergic reaction – occurs uncommonly (may occur in 1 out of 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 half-sitting position and try to relax,
• do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 1,000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – occurs rarely
• Severe skin reactions – occur 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 – occur rarely

Other adverse reactions:
Very commonly (may affect more than 1 in 10 patients): headache.
Commonly (may affect 1 in 10 patients): nausea, sudden flushing, hot flushes (symptoms include feeling of warmth in the upper body), indigestion, coloured vision, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommonly (may affect 1 in 100 patients): vomiting, skin rash, eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, eye tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth, blocked or stuffy sinuses, nasal mucositis (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, feeling of fatigue.
Rarely (may affect 1 in 1,000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of throat tightness, numbness of the lips, 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 discoloration of the white part of the eye, rectal bleeding, blood in semen, dry nose, swelling inside the nose, feeling of irritation, sudden hearing loss or decreased hearing.

After the medicine 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 adverse reactions, heart problems were already present before taking sildenafil-containing medicines. It is not possible to determine whether these adverse reactions were related to the use of Sildenafil Walmark.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sildenafil Walmark

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 blister and carton after "EXP:". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Walmark contains

• The active substance in Sildenafil Walmark is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
• The other ingredients are:
  Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
  Tablet coating: Opadry II blue 85F505164 (polyvinyl alcohol - partially hydrolysed, titanium dioxide (E 171), macrogol, talc, indigo carmine, lac (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, biconvex, with the imprint "100" on one side and "H" and "J" with a score line on the other side.
The tablets are packed in PVC/Aluminium blisters containing 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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