Sildenafil dr. max

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Package leaflet: Information for the patient

Sildenafil Dr. Max, 25 mg, film-coated tablets
Sildenafilum
Please read this leaflet carefully before using the 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
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects 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, you should contact your doctor.

Table of contents:

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 known as 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 the patient is sexually stimulated.
Sildenafil Dr. Max is used to treat erectile dysfunction in adult men, i.e. impotence defined as the inability to achieve or maintain a penile 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 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 medicines 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 lung pressure 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.

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 anatomical deformity of the penis 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 ulcer disease or bleeding disorders (such as hemophilia).
• Sudden worsening of vision or sudden vision loss occurs—the patient should stop taking Sildenafil Dr. Max and contact a doctor immediately.

Sildenafil Dr. Max must not be used together with other oral or topical treatments for erectile dysfunction.
Sildenafil Dr. Max must not be used together with arterial pulmonary 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 kidney or liver 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 must not be used in individuals under 18 years of age.

Sildenafil Dr. Max and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Sildenafil Dr. Max 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 must be informed about the intake of Sildenafil Dr. Max and the time 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 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.
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 Dr. Max together with alpha-blockers. These symptoms 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 regimen of their alpha-blocker before starting Sildenafil Dr. Max. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Sildenafil Dr. Max. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling of impending fainting), the patient should lie down or sit 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.
Tell 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 heavy 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 consumption should be avoided before taking the medicine.

Pregnancy, breastfeeding and fertility
Sildenafil Dr. Max is not intended for use in 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
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it 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 your doctor or pharmacist. If in 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 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 to be achieved only in the presence of sexual stimulation. The time to onset of effect varies between patients, but usually ranges 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 more than the recommended dose of Sildenafil Dr. Max
Side effects may occur more frequently and may be more severe.
Taking a dose higher than 00 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 concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• Allergic reaction – occurs not commonly (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 not commonly. If chest pain occurs during or after sexual intercourse:
  • 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 out of 1,000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening 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 – occur rarely

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

• Headache

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

• Nausea
• Sudden flushing of the face
• Hot flushes (a sensation of warmth in the upper body)
• Indigestion
• Vision disturbances (seeing coloured halos, light sensitivity, blurred vision, visual disturbances)
• Stuffy nose
• Dizziness

Not common (may affect up to 1 in 100 people):

• Vomiting
• Skin rash
• Eye irritation
• Eye congestion
• Eye pain
• Seeing flashes of light
• Bright vision
• Light sensitivity
• Watery eyes
• Palpitations
• Rapid heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Drowsiness
• Reduced sense of touch
• Dizziness
• Tinnitus (ringing in the ears)
• Dryness of the mouth
• Blocked or stuffy sinuses
• Rhinitis (symptoms include runny nose, sneezing and blocked nose)
• Pain in the upper abdomen
• Gastroesophageal reflux disease (symptom is heartburn)
• Blood in urine
• Pain in hands or legs
• Nosebleeds
• Feeling 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 specks or spots in the field of vision
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the eye sclera
• Bleeding from the penis
• Presence of blood in semen
• Dry nose
• Swelling inside the nose
• Feeling of irritability
• Sudden weakness or loss of hearing

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 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 Dr. Max.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 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 Dr. Max

Keep this medicine out of sight and reach of children.
There are no special storage instructions 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 indicated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Sildenafil Dr. Max contains

• The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• Other ingredients 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), macrogol 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, 7.2 mm in diameter, embossed with "HJ" on one side and "25" on the other. The tablet has a break line to facilitate breaking for easier swallowing; this does not indicate division into equal doses.
Sildenafil Dr. Max is available in packs containing blisters made of PVC/Aluminium or PVC/PVDC/Aluminium with 2, 4 or 8 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