Maxigra

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Maxigra is and what it is used for
2. What you need to know before taking Maxigra
3. How to take Maxigra
4. Possible side effects
5. How to store Maxigra
6. Contents of the pack and other information

1. What Maxigra is and what it is used for

Maxigra contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Maxigra works by helping the blood vessels in the penis to relax, thereby increasing blood flow to the penis during sexual stimulation. Maxigra helps achieve an erection only if you are sexually stimulated.
Maxigra is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using Maxigra

When not to use Maxigra

• 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, because their concomitant use with Maxigra 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 simultaneous 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 arterial 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). Phosphodiesterase type 5 (PDE5) inhibitors, such as Maxigra, 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 inherited eye diseases, 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 to take Maxigra, the patient should discuss this with a doctor or pharmacist if:

• They have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
• They have been diagnosed with anatomical deformity of the penis or Peyronie's disease.
• They have heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
• They have peptic ulcer disease or bleeding disorders (such as hemophilia).

If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking Maxigra and contact a doctor immediately.
Maxigra must not be used together with other oral or topical treatments for erectile dysfunction.
Maxigra must not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other phosphodiesterase type 5 inhibitors (e.g. tadalafil).
This medicine should not be taken if erectile dysfunction has not been diagnosed.
Maxigra is not a medicine intended for use in women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of Maxigra.

Children and adolescents
Maxigra must not be used in individuals under 18 years of age.

Maxigra and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Maxigra may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, they must inform the doctor that they took Maxigra and when it was taken.
Do not take Maxigra together with other medicines unless advised by a doctor.
Do not take Maxigra if the patient is taking nitrates, because their concomitant use may lead to a dangerous decrease in blood pressure.
Always inform the doctor or pharmacist if the patient is taking nitrates used to treat angina (chest pain).
Do not take Maxigra if the patient is taking medicines that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause a dangerous drop in blood pressure.
If the patient is 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 the medicine available on the market.
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 been reported in some patients taking Maxigra together with alpha-blockers. These are most likely to occur within 4 hours after taking Maxigra. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Maxigra. The doctor may decide to start with a lower initial dose (25 mg) of the medicine available on the market.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the doctor or pharmacist.

Maxigra with food, drink, and alcohol
Maxigra may be taken with or without food. However, taking Maxigra 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 Maxigra, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Maxigra is not intended for use in women.

Driving and operating machinery
Maxigra may cause dizziness and visual disturbances. Patients should assess how they react to Maxigra before driving or operating machinery.

Maxigra contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Maxigra

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended starting dose is 50 mg.
Maxigra must not be taken more than once a day.
Maxigra must not be taken at the same time as other medicines containing sildenafil.
Maxigra 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 Maxigra seems too strong or too weak, consult a doctor or pharmacist.
Maxigra enables an erection to be achieved only in the presence of sexual stimulation. The time
after which Maxigra takes effect 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.
Consult a doctor if, after taking Maxigra, an erection does not occur or if the duration of
erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Maxigra
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 the doctor.
Consult a doctor if more tablets have been taken than recommended.
If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported with the use of Maxigra are usually mild or
moderate in intensity and transient.
If any of the following adverse reactions occur, stop taking Maxigra and seek immediate medical help:

• Allergic reaction – uncommon (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 – uncommon. If it 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 – rare (may occur in 1 out of 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – rare.
• Severe skin reactions – rare. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – rare.

Other adverse reactions:
Very common (may occur in more than 1 out of 10 patients):

• headache.

Common (may occur in 1 out of 10 patients):

• nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of warmth in the upper body), indigestion,
• colored vision, blurred vision, visual disturbances,
• stuffy nose, dizziness.

Uncommon (may occur in 1 out of 100 patients):

• vomiting, skin rash,
• eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes,
• palpitations, rapid heartbeat, hypertension, hypotension,
• muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus,
• dry mouth, stuffy or blocked sinuses, nasal mucositis (symptoms include runny nose, sneezing and nasal congestion),
• upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine, pain in hands or legs, nosebleeds, feeling of warmth and feeling of fatigue.

Rare (may occur in 1 out of 1000 patients):

• fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain,
• throat tightness, lip numbness,
• bleeding in the back of the eye, double vision,
• decreased visual acuity, abnormal sensations inside 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 white of the eye,
• rectal bleeding, blood in semen, dry nose, nasal swelling,
• irritability and sudden weakness or hearing loss.

After marketing of the medicine, cases of unstable angina (heart disease) and sudden death have been rarely reported.
It is important to note that in most, but not all, men who experienced these adverse reactions, heart problems were present before taking sildenafil. It is not possible to determine whether these adverse reactions were related to the use of sildenafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +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 to provide more information on the safety of this medicine.

5. How to store Maxigra

Keep this medicine out of the 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 packaging following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Maxigra contains

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
• The other ingredients are:
• Tablet core: mannitol (E421), crospovidone (type A), povidone (K30), colloidal anhydrous silica, maize starch, magnesium stearate, sodium lauryl sulfate.
• Coating: hypromellose, polyethylene glycol 6000, titanium dioxide, talc, indigo carmine lake (E132).

What Maxigra looks like and contents of the pack
The coated tablets are round, biconvex, and blue in colour.
The pack contains 1, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01