Sildenafil dr. max

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Package leaflet: information for the patient

Sildenafil Dr. Max, 50 mg, film-coated tablets
Sildenafilum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if you feel worse, contact your doctor.

Table of contents of the leaflet:

1. What Sildenafil Dr. Max is and what it is 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 Sildenafil Dr. Max is and what it is 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 blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil Dr. Max helps achieve an erection only if sexual stimulation is present.
Sildenafil Dr. Max is used to treat erectile dysfunction in adult men, i.e. impotence defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before using Sildenafil Dr. Max

When not to use 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 concomitant use may lead to a dangerous drop 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"), as their concomitant use may also lead to a dangerous drop 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 Dr. Max, 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 ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with Sildenafil Dr. Max, discuss with a doctor or pharmacist if:

• The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with penile anatomical deformation 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 vision deterioration or sudden vision loss occurs, the patient should stop taking Sildenafil Dr. Max and contact a doctor immediately.

Sildenafil Dr. Max should not be used together with other oral or topical treatments for erectile dysfunction.
Sildenafil Dr. Max should not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Sildenafil Dr. Max should not be taken if erectile dysfunction has not been diagnosed. Sildenafil Dr. Max 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. Patients with impaired kidney or liver function should not take a dose of Sildenafil Dr. Max higher than 25 mg.

Children and adolescents
Sildenafil Dr. Max should not be used in individuals under 18 years of age.

Sildenafil Dr. Max and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Sildenafil Dr. Max may interact with certain medicines, particularly those used to treat chest pain. If the patient's health deteriorates and immediate medical attention is required, inform the doctor, pharmacist, or nurse that Sildenafil Dr. Max has been taken and when it was taken. Do not take Sildenafil Dr. Max together with other medicines without medical advice.
Do not take Sildenafil Dr. Max if the patient is using nitrates, as 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 Dr. Max if the patient is using medicines that release nitric oxide (such as amyl nitrite), as their concomitant use may also cause a dangerous drop 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 Dr. Max.
In some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have been reported in some patients taking Sildenafil Dr. Max together with alpha-blockers. They are most likely to occur within 4 hours after taking Sildenafil Dr. Max. To reduce the possibility of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Sildenafil Dr. Max. The doctor may decide to start with a lower initial dose (25 mg) of Sildenafil Dr. Max. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Avoid rapid standing or sitting.
Inform the doctor or pharmacist if the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Sildenafil Dr. Max with food, drink, and alcohol
Sildenafil Dr. Max can be taken with or without food. However, taking Sildenafil Dr. Max with a high-fat meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of Sildenafil Dr. Max, significant alcohol intake should be avoided before taking the medicine.

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

Driving and operating machinery
Sildenafil Dr. Max may cause dizziness and visual disturbances. Patients should understand how they react to Sildenafil Dr. Max before driving or operating machinery.

Sildenafil Dr. Max contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use 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 in doubt, consult a doctor or pharmacist.
If the patient has previously taken medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Sildenafil Dr. Max 50 mg should only be used if the patient did not achieve the desired effect (i.e. did not obtain an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg.
If treatment with a lower dose of sildenafil (25 mg) has enabled an erection sufficient for sexual intercourse, a dose of 50 mg should not be used.
Sildenafil Dr. Max must not be taken more than once a day.
Do not take Sildenafil Dr. Max coated tablets together with other medicines containing sildenafil (e.g. Viagra).
Sildenafil Dr. Max should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Dr. Max is too strong or too weak, consult your doctor or pharmacist.
Sildenafil Dr. Max enables an erection only in the presence of sexual stimulation. The time to onset of effect of Sildenafil Dr. Max 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 Dr. Max, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Sildenafil Dr. Max
Adverse reactions 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 indicated in the patient leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects reported with Sildenafil Dr. Max are usually mild or moderate in intensity and short-lived.
If any of the following adverse effects occur, stop taking Sildenafil Dr. Max and seek immediate medical help:

• 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 chest pain occurs during or after sexual activity:
  • 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 1 in 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 – occurs rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on the genitals and around the eyes, fever.
• Seizures or fits – occurs rarely

Other adverse effects:
Very common (may affect more than 1 in 10 people):

• Headache

Common (may affect up to 1 in 10 people):

• Nausea
• Sudden flushing
• Hot flushes (sensation of heat in the upper body)
• Indigestion
• Vision disturbances (seeing coloured tinge, blurred vision, visual disturbances)
• Stuffy nose
• Dizziness

Uncommon (may affect up to 1 in 100 people):

• Vomiting
• Skin rash
• Eye irritation
• Eye redness
• Eye pain
• Seeing flashes of light
• Bright vision
• Light sensitivity
• Palpitations
• Rapid heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Drowsiness
• Reduced sense of touch
• Dizziness
• Tinnitus
• Dryness in the mouth
• Blocked or stuffy sinuses
• Nasal mucositis (symptoms include: runny nose, sneezing, and blocked nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptom is heartburn)
• Blood in urine
• Pain in arms or legs
• Nosebleeds
• Sensation of warmth
• Feeling of fatigue

Rare (may affect up to 1 in 1,000 people):

• Fainting
• Stroke
• Heart attack
• Irregular heartbeat
• Transient reduction in blood flow to part of the brain
• Sensation of tightness in the throat
• 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 eye sclera
• Bleeding from the penis
• Blood in semen
• Dry nose
• Nasal swelling
• Irritability
• Sudden weakness or hearing loss.

Since sildenafil-containing medicines have been marketed, 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 effects, pre-existing heart conditions were present before taking sildenafil-containing medicines. It is not possible to determine whether these adverse effects were related to the use of Sildenafil Dr. Max.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sildenafil Dr. Max

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
following EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect the
environment.

6. Contents of the pack and other information

What Sildenafil Dr. Max contains

• The active substance in Sildenafil Dr. Max is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• Other components of the medicine are:

Tablet core: microcrystalline cellulose (type 112), calcium hydrogen phosphate, sodium croscarmellose,
magnesium stearate.
Tablet coating Opadry II blue, 85F505164: polyvinyl alcohol - partially hydrolysed,
titanium dioxide (E 171), polyethylene glycol 3350, talc, indigo carmine (E 132), aluminium lake (11-14%),
indigo carmine (E 132), aluminium lake (3-5%).
Tablet coating Opadry clear 02K19253: hypromellose 5cp (2910), triacetin.

What Sildenafil Dr. Max looks like and contents of the pack
Round, biconvex, film-coated blue tablets, 9.0 mm in diameter, embossed with "50" on one side and "H" and "J" on the other side with a breakline. The tablet can be divided into equal doses.
Sildenafil Dr. Max is available in packs containing blisters made of PVC/Aluminium or PVC/PVDC/Aluminium with 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2139/2
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
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic