Menup

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Package leaflet: information for the patient

MenUp, 25 mg, 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 a 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 the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet:

1. What MenUp is and what it is used for
2. Important information before taking MenUp
3. How to take MenUp
4. Possible side effects
5. How to store MenUp
6. Contents of the package and other information

1. What MenUp is and what it is used for

MenUp 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.
MenUp helps achieve an erection only if sexual stimulation is present beforehand.
MenUp is used in the treatment of erectile dysfunction in adult men, i.e. impotence. This refers to the inability to achieve or maintain an erection of the penis sufficient for sexual intercourse.

2. Important information before using MenUp

When not to use MenUp

• 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. Inform your doctor if you are taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult your doctor or pharmacist.
• If the patient is taking drugs that release nitric oxide (such as amyl nitrite, so-called poppers), because 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 MenUp have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, inform the 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 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, discuss with your 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 a 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 ulcer disease or bleeding disorders (such as hemophilia).
• If sudden vision loss or sudden decrease in vision occurs, stop using MenUp and contact a doctor immediately.

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

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

MenUp and other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
MenUp may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and immediate medical attention is required, inform the doctor, pharmacist, or nurse that you have taken MenUp and when it was taken. Do not take MenUp together with other medicines without medical advice.
Do not take MenUp if the patient is taking nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina (chest pain).
Do not take MenUp if the patient is taking drugs 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 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 the lowest dose (25 mg) of MenUp.
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 up. Such symptoms have occurred in some patients taking MenUp together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking MenUp. To reduce the possibility of such symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting MenUp. The doctor may decide to use a lower starting dose (25 mg) of MenUp.
If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit and wait for symptoms to subside. Drinking water, breathing fresh air, tensing abdominal muscles, and crossing legs may also help. Avoid rapid standing or sitting up.
If the patient is taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), inform the doctor or pharmacist.

MenUp with food, drink, and alcohol
MenUp can be taken with or without food. However, taking MenUp with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of MenUp, avoid consuming large amounts of alcohol before taking the medicine.

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

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

MenUp contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor 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

This medicine should always be taken exactly as described in the patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25 mg. Your doctor may recommend a different dosage regimen after consultation.
MenUp must not be taken more than once a day.
Do not take MenUp coated tablets at the same time as Viagra tablets or other medicines containing sildenafil.
MenUp 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 MenUp is too strong or too weak, consult your doctor or pharmacist.
MenUp enables an erection to occur only in the presence of sexual stimulation. The time it takes for
MenUp to take effect varies between patients, usually between half an hour and one hour. The effect may
be delayed if the medicine is taken after a heavy meal.
Contact your doctor if, after taking MenUp, an erection does not occur or if the duration of erection is
insufficient for sexual intercourse.
Taking more MenUp than recommended
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 indicated in the patient information leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further questions about 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 the use of MenUp are usually mild to moderate in intensity and transient.
If any of the following adverse effects occur, stop taking MenUp 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 intercourse:
  • 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 decrease 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 effects:
Very common (may affect more than 1 in 10 patients):

• Headache.

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

• Nausea,
• Sudden flushing of the face,
• Hot flushes (symptoms include a feeling of warmth in the upper body),
• Indigestion,
• Visual disturbances (seeing coloured halos, light sensitivity, blurred vision or reduced visual acuity),
• Nasal congestion,
• Dizziness.

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

• Vomiting,
• Skin rash,
• Eye irritation,
• Conjunctival hyperaemia,
• Eye pain,
• Seeing flashes of light,
• Bright vision,
• Light sensitivity,
• Eye tearing,
• 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 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 affect up to 1 in 1000 patients):

• Fainting,
• Stroke,
• Myocardial infarction (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 or eyelids,
• Small particles or spots in the visual field,
• Seeing halos around light sources,
• Pupil dilation,
• Abnormal eye sclera pigmentation,
• Penile bleeding,
• Blood in semen,
• Dry nose,
• Nasal swelling,
• Feeling of irritability,
• Sudden hearing loss.

After sildenafil-containing medicines were introduced into clinical use, rare cases of unstable angina (heart disease) and sudden death have been reported. Importantly, in most, but not all, men who experienced these adverse effects, pre-existing cardiac disorders were present before taking sildenafil-containing medicines. It is not possible to determine whether these adverse effects were related to the use of MenUp.

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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store MenUp

Keep this medicine out of 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 and the outer carton 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine MenUp contains

• The active substance in MenUp is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• Other components of the medicine are:
  Tablet core: microcrystalline cellulose 102, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate.
  Film-coat OPADRY II 32K205007 blue: hypromellose 15 mPa⸳s, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine (E 132), aluminium lake.

What MenUp looks like and contents of the pack
MenUp coated tablets are blue, round, 7 mm in diameter, biconvex, with the number "25" marked on one side.
PVC/PVDC/Aluminium blisters in cardboard boxes containing 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Silesian Pharma Sp. z o.o.
ul. Szopienicka 77
40-431 Katowice
tel: (32) 20 80 600

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice