SILDENAFIL 50 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, 50 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, the patient should stop taking Sildenafil Dr. Max and seek immediate medical attention:
   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, 50 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 a 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 contact a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient does not improve after taking the medicine or feels worse, they should contact their 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 (PDE5) inhibitors. 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 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 concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is 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 the patient is taking riociguat. This medicine 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 Dr. Max, 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, 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-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before taking Sildenafil Dr. Max, the patient should discuss it with their 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 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 effort associated with sexual activity.
• Ulcers or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden vision deterioration, they should stop taking Sildenafil Dr. Max and immediately contact their doctor.

Sildenafil Dr. Max should not be taken concurrently with other oral or topical treatments for erectile dysfunction.

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

Sildenafil Dr. Max should not be taken if the patient has not been diagnosed with erectile dysfunction. Sildenafil Dr. Max is not intended for women.

Special considerations for patients with renal or hepatic impairment

Patients with renal or hepatic impairment should inform their doctor. Patients with renal or hepatic impairment should not take a dose of Sildenafil Dr. Max higher than 25 mg.

Children and adolescents

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

Sildenafil Dr. Max and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Sildenafil Dr. Max may interact with some medicines, 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 Dr. Max and the time of its administration. The patient should not take Sildenafil Dr. Max concurrently with other medicines without their doctor's recommendation.

The patient should not take Sildenafil Dr. Max if they are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure.

The patient should always inform their doctor or pharmacist if they are taking nitrates, which are used to treat angina pectoris ("chest pain").

The patient should not take Sildenafil Dr. Max if they are taking medicines that release nitric oxide (such as amyl nitrite), 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 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 when standing up or sitting down quickly. Such symptoms occurred in some patients taking Sildenafil Dr. Max and alpha-adrenergic blockers concurrently. 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 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 occur (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 standing up or sitting down quickly.

The patient should tell their doctor or pharmacist if they 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 while eating a large 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, the patient 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 or operating machinery, patients should be aware of 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 it 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 a doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

If the patient has previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Sildenafil Dr. Max in a dose of 50 mg should only be taken if the patient did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., they did not achieve an erection sufficient for intercourse).

If taking a lower dose of sildenafil (25 mg) allowed the patient to achieve an erection enabling them to have sexual intercourse, they should not take a dose of 50 mg.

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

The patient should not take Sildenafil Dr. Max concurrently with other medicines containing sildenafil (e.g., Viagra).

Sildenafil Dr. Max 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 Dr. Max is too strong or too weak, they should consult their doctor or pharmacist.

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

The patient should contact their doctor if they do not achieve an erection after taking Sildenafil Dr. Max or if the duration of the erection is not sufficient for 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 increase the efficacy of the medicine.

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

The patient should contact their doctor in case of taking more tablets than recommended.

If the patient has any further doubts about the use of this medicine, they should consult their 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-lived.

In case of any of the following side effects, the patient should stop taking Sildenafil Dr. Max 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 uncommonly. If 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 - occur rarely(may occur in 1 in 1,000 patients). If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or deterioration - occur 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
• Hot flushes (a feeling of heat in the upper body)
• Indigestion
• Visual disturbances (seeing a colored glow, 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
• Eye discharge
• Pounding heart
• Fast heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Drowsiness
• Decreased sensitivity to touch
• Dizziness
• Ringing in the ears
• Dry mouth
• Stuffy or runny nose
• Sinusitis
• Upper abdominal pain
• Gastroesophageal reflux disease (symptom: 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
• Transient reduction in 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
• Decreased visual acuity
• Abnormal sensations in the eye
• Eye or eyelid swelling
• Small particles or spots in the visual field
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the whites of the eyes
• Bleeding from the penis
• Blood in semen
• Nose dryness
• Nasal congestion
• Feeling irritable
• Sudden 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 essential to note that in most, but not all, men who experienced these side effects, heart problems existed 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, it is possible to 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 precautions for storing the medicine.

The patient should 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 50 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 croscarmellose, 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, 9.0 mm in diameter, with "50" embossed on one side and "H" and "J" on the other side with a dividing line. The tablet can be divided into equal doses.

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