SILDENAFIL 25 mg Tablets

Contents of the leaflet

1. Before taking the medicine, use the attached diagnostic tool (questionnaire)!
2. Leaflet attached to the packaging: patient information
3. Sildenafil Dr. Max, 25 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Sildenafil Dr. Max and what is it used for
5. Important information before taking Sildenafil Dr. Max
   1. When not to take Sildenafil Dr. Max
   2. Warnings and precautions
   3. Children and adolescents
   4. Sildenafil Dr. Max and other medicines
   5. Sildenafil Dr. Max with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Sildenafil Dr. Max contains sodium
6. How to take Sildenafil Dr. Max
   1. Taking a higher dose of Sildenafil Dr. Max than recommended
7. Possible side effects
   1. In case of any of the following side effects, you should stop taking Sildenafil Dr. Max and seek medical attention immediately:
   2. Other side effects:
   3. Reporting side effects
8. How to store Sildenafil Dr. Max
9. Contents of the pack and other information
   1. What Sildenafil Dr. Max contains
   2. What Sildenafil Dr. Max looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. Date of last revision of the leaflet:

Before taking the medicine, use the attached diagnostic tool (questionnaire)!

Leaflet attached to the packaging: patient information

Sildenafil Dr. Max, 25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after taking the medicine, you should contact your doctor.

Table of contents of the leaflet:

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

1. What is Sildenafil Dr. Max and what is it used for

Sildenafil Dr. Max contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Dr. Max helps achieve an erection only if there is prior sexual stimulation.

2. Important information before taking Sildenafil Dr. Max

When not to take Sildenafil Dr. Max

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. You should inform your doctor if you are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, consult your 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 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). It has been shown that PDE5 inhibitors, such as Sildenafil Dr. Max, enhance the blood pressure-lowering effect of this medicine. 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, and in cases of low blood pressure.
• If you have hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If you have ever had a loss of vision due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Sildenafil Dr. Max, you should discuss it with your 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 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 effort associated with sexual activity.
• Ulcer disease or bleeding disorders (such as hemophilia).
• If you experience sudden vision loss or sudden loss of vision, you should stop taking Sildenafil Dr. Max and seek medical attention immediately.

Sildenafil Dr. Max should not be taken at the same time as other oral or topical treatments for erectile dysfunction.

Sildenafil Dr. Max should not be taken at the same time as treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.

Sildenafil Dr. Max should not be taken if you have not been diagnosed with erectile dysfunction. Sildenafil Dr. Max is not intended for women.

Special considerations for patients with kidney or liver function disorders

Patients with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a dose of Sildenafil Dr. Max higher than 25 mg.

Children and adolescents

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

Sildenafil Dr. Max and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Sildenafil Dr. Max may interact with some medicines, especially those used to treat chest pain. If your condition worsens, requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Sildenafil Dr. Max and the time of its administration. You should not take Sildenafil Dr. Max at the same time as other medicines without a doctor's recommendation.

You should not take Sildenafil Dr. Max if you are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. You should always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina pectoris ("chest pain").

You should not take Sildenafil Dr. Max if you are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure.

If you are already taking riociguat, you should inform your 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 Dr. Max.

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 Dr. Max and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Sildenafil Dr. Max. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Sildenafil Dr. Max. The doctor may decide to use a lower initial dose (25 mg) of Sildenafil Dr. Max. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting) occur, you should first lie down or sit and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing your legs may also help. You should avoid rapid standing or sitting.

You should tell your doctor or pharmacist if you are taking medicines containing sacubitril with valsartan, used to treat heart failure.

Sildenafil Dr. Max with food, drink, and alcohol

Sildenafil Dr. Max can be taken with or without food.

Although taking Sildenafil Dr. Max during a heavy meal may prolong the time needed for the medicine to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Sildenafil Dr. Max, you should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Sildenafil Dr. Max is not intended for use by women.

Driving and using machines

Sildenafil Dr. Max may cause dizziness and visual disturbances.

Before driving vehicles or operating machinery, patients should see how they react to Sildenafil Dr. Max.

Sildenafil Dr. Max contains sodium

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

3. How to take Sildenafil Dr. Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is 25 mg. Your doctor may, after consultation, recommend a different dosing regimen.

Sildenafil Dr. Max should not be taken more than once a day.

You should not take Sildenafil Dr. Max at the same time as other medicines containing sildenafil (e.g., Viagra).

Sildenafil Dr. Max should be taken about an hour before planned sexual activity. The tablet should be swallowed whole with a glass of water.

If you feel that the effect of Sildenafil Dr. Max is too strong or too weak, you should consult your doctor or pharmacist.

Sildenafil Dr. Max allows for an erection only if there is prior sexual stimulation. The time after which the effect of Sildenafil Dr. Max occurs varies from patient to patient, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.

You should contact your doctor if, after taking Sildenafil Dr. Max, 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 Dr. Max 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 mean an increase in the efficacy of the medicine.

You should not take more tablets than indicated in the patient leaflet.

You should contact your doctor in case of taking more tablets than recommended.

In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafil Dr. Max can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of Sildenafil Dr. Max are usually mild or moderate and short-term.

In case of any of the following side effects, you should stop taking Sildenafil Dr. Max and seek medical attention immediately:

• 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 uncommonly. If they occur during or after sexual intercourse:
• you should take a half-sitting position and try to relax,
• do not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1,000 patients). If an erection lasts more than 4 hours, you should seek medical attention immediately.
• Sudden vision loss or vision loss - occurs rarely
• Severe skin reactions - occur rarely. Symptoms 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 up to 1 in 10 patients):

• Nausea
• Sudden flushing of the face
• Flushing (a feeling of heat in the upper part of the body)
• Indigestion
• Visual disturbances (seeing a colored glow, sensitivity to light, blurred vision, visual disturbances)
• Stuffy nose
• Dizziness

Uncommon(may occur in up to 1 in 100 patients):

• Vomiting
• Skin rash
• Eye irritation
• Conjunctival hyperemia
• Eye pain
• Seeing flashes of light
• Increased light perception
• Light sensitivity
• Eye watering
• Palpitations
• Rapid heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Somnolence
• Decreased tactile sensitivity
• Dizziness
• Tinnitus
• Dry mouth
• Stuffy or congested sinuses
• Rhinitis (symptoms are: runny nose, sneezing, and stuffy nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptom is: heartburn)
• Hematuria
• Pain in arms or legs
• Nosebleeds
• Feeling of heat
• Feeling of fatigue

Rare(may occur in up to 1 in 1,000 patients):

• Fainting
• Stroke
• Heart attack
• Irregular heartbeat
• Transient reduction in blood flow to part of the brain
• Feeling of constriction in the throat
• Numbness of the lips
• Bleeding in the back of the eye
• Double vision
• Decreased visual acuity
• Abnormal sensations in the eye
• Eye or eyelid edema
• Small particles or dots in the visual field
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the whites of the eyes
• Penile bleeding
• Presence of blood in semen
• Nasal dryness
• Nasal congestion
• Feeling of irritability
• Sudden hearing loss or hearing loss.

After the introduction of sildenafil-containing medicines to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important that in most, but not all, men who experienced these side effects, heart function disorders occurred before taking the sildenafil-containing medicine. It is not possible to determine whether these side effects were related to the use of Sildenafil Dr. Max.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 gather more information on the safety of the medicine.

5. How to store Sildenafil Dr. Max

The medicine should be stored out of sight and reach of children.

There are no special recommendations for storing the medicine.

Do not use this medicine 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.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sildenafil Dr. Max contains

• The active substance of Sildenafil Dr. Max is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are:

Core of the tablet: microcrystalline cellulose (type 112), calcium hydrogen phosphate, sodium carmellose, magnesium stearate.

Coating of the tablet Opadry II blue, 85F505164: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine (E 132), aluminum lake (11-14%), indigo carmine (E 132), aluminum lake (3-5%).

Coating of the tablet Opadry clear 02K19253: hypromellose 5cp (2910), triacetin.

What Sildenafil Dr. Max looks like and contents of the pack

Round, biconvex, blue film-coated tablets, 7.2 mm in diameter, with "HJ" embossed on one side and "25" on the other side. The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses.

Sildenafil Dr. Max is available in packs containing blisters of PVC/Aluminum or PVC/PVDC/Aluminum, each containing 2, 4, or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Dr. Max Pharma s.r.o.

Na Florenci 2116/15

Nové Město

110 00 Prague 1

Czech Republic

tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.

Průmyslová 961/16

747 23 Bolatice

Czech Republic

Date of last revision of the leaflet: