Package leaflet: Information for the patient

MenUp Max, 100 mg, film-coated tablets
Sildenafilum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What MenUp Max is and what it is used for
What you need to know before taking MenUp Max
How to take MenUp Max
Possible side effects
How to store MenUp Max
Contents of the pack and other information

1. What MenUp Max is and what it is used for

MenUp 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 into the penis during sexual stimulation. MenUp Max helps achieve an erection only if you are sexually stimulated. MenUp Max 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 MenUp Max

When not to use MenUp 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 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). In case of 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 reduction 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 MenUp Max have been shown to enhance the blood pressure-lowering effect of riociguat. 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 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-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with MenUp Max, discuss this with a doctor, pharmacist, or nurse if:

The patient has sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
The patient has 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 worsening of vision or sudden vision loss occurs, the patient should stop taking MenUp Max and contact a doctor immediately.

MenUp Max should not be used concomitantly with other oral or topical treatments for erectile dysfunction.
MenUp Max should not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
MenUp Max should not be taken if erectile dysfunction has not been diagnosed.
MenUp 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. The doctor may decide to prescribe a lower dose of MenUp Max.

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

MenUp Max and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
MenUp 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, inform the doctor, pharmacist, or nurse that MenUp Max was taken and when it was taken. Do not take MenUp Max together with other medicines without medical advice.
Do not take MenUp Max if the patient is using nitrates, because their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (chest pain).
Do not take MenUp Max if the patient is using medicines that release nitric oxide (such as amyl nitrite), because their simultaneous use may also cause a dangerous decrease 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 MenUp 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 and alpha-blockers simultaneously. These symptoms are most likely to occur within 4 hours after taking MenUp Max. To reduce the likelihood of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting MenUp Max. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of sildenafil.
If the patient is taking medications containing sacubitril with valsartan (used in the treatment of heart failure), they should inform their doctor or pharmacist.

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

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

Driving and operating machinery
MenUp Max may cause dizziness and visual disturbances. Patients should be aware of how they react to MenUp Max before driving or operating machinery.

MenUp Max contains lactose and sodium
Patients with known intolerance to certain sugars should seek medical advice before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use MenUp Max

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist. The recommended starting dose is 50 mg.
MenUp Max must not be used more than once per day.
Do not take MenUp Max coated tablets in combination with Viagra tablets or
other medicinal products containing sildenafil.
MenUp Max should be taken approximately one hour before planned sexual activity.
The tablet should be swallowed whole with a glass of water.
If you feel that the effect of MenUp Max is too strong or too weak, consult a
doctor or pharmacist.
MenUp Max enables an erection only when accompanied by sexual stimulation.
The time required for MenUp Max to take 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.
Contact your doctor if, after taking MenUp Max, an erection does not occur, or
if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of MenUp Max
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 your doctor.
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, pharmacist, or nurse.

4. Possible adverse reactions

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

Allergic reaction (hypersensitivity) – 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 – occur rarely (may occur in 1 in 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.

Sudden worsening or loss of vision – occurs rarely

Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area or around the eyes, fever.
Seizures or convulsions – occur rarely

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

Headache.

Common (may occur in 1 in 10 patients):

Nausea
Sudden flushing of the face
Hot flushes (symptoms include a feeling of warmth in the upper body)
Indigestion
Seeing coloured halos, blurred vision, visual disturbances
Stuffy nose
Dizziness.

Uncommon (may occur in 1 in 100 patients):

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
Ringing in the ears
Nausea
Dryness in the mouth
Blocked or stuffy 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 feet
Nosebleeds
Feeling of warmth
Feeling of fatigue.

Rare (may occur in 1 in 1000 patients):

Fainting
Stroke
Heart attack
Irregular heartbeat
Transient reduction in blood flow to part of the brain
Throat tightness
Numbness of the lips
Bleeding into the back of the eye
Double vision
Decreased visual acuity
Abnormal sensations inside the eye
Swelling of the eyes or eyelids
Small specks or dots in the field of vision
Seeing halos around light sources
Pupil dilation
Abnormal discoloration of the sclera
Rectal bleeding
Blood in semen
Dry nose
Nasal swelling
Irritability
Sudden weakness or hearing loss.

Since the medicine was introduced to the market, 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 disorders were present before taking MenUp Max. It is not possible to determine whether these adverse reactions were related to the use of MenUp Max.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 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 MenUp Max

Keep the medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use the medicine after the expiry date stated on the blister and cardboard packaging
following EXP:. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Menup Max contains

The active substance in Menup Max is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
The other ingredients are:
Tablet core: microcrystalline cellulose 102, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
Coating OPADRY II 32K205007 blue: hypromellose 15 mPa⸳s, monohydrate lactose, titanium dioxide (E 171), triacetin, indigo carmine (E 132), aluminium lake of indigo carmine.

What Menup Max looks like and contents of the pack
Menup Max coated tablets are blue, elongated, measuring 16.5 mm/6.5 mm,
biconvex on both sides, with the number "100" printed on one side.
Packs contain 2, 4 or 8 tablets in PVC/PVDC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Silesian Pharma Sp. z o.o.
Szopienicka Street 77
40-431 Katowice
tel: (32) 20 80 600
Manufacturer
Adamed Pharma S.A.
Józefa Piłsudskiego Marshal Street 5
95-200 Pabianice