Menup Forte

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Leaflet attached to the packaging: patient information

MenUp Forte, 50 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient does not improve after taking the medicine or feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

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

2. Important information before taking MenUp Forte

When not to take MenUp Forte

• 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 simultaneous intake may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"),

as their simultaneous intake may also lead to a dangerous decrease in blood pressure.

• If the patient is taking riociguat. This medicine is 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). It has been shown that PDE5 inhibitors, such as MenUp Forte, 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 experienced a stroke or heart attack, as well as in cases of low blood pressure.
• If the patient has hereditary degenerative changes in the retina, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take MenUp Forte, the patient should discuss it with their doctor or pharmacist in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer).
• If the patient has anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional effort associated with sexual activity.
• Peptic ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden vision impairment, they should stop taking MenUp Forte and immediately consult their doctor.

MenUp Forte should not be taken simultaneously with other oral or topical treatments for erectile dysfunction. MenUp Forte should not be taken simultaneously with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. MenUp Forte should not be taken if the patient has not been diagnosed with erectile dysfunction. MenUp Forte is not intended for women. Special considerations for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. Patients with renal or hepatic impairment should not take a dose of sildenafil higher than 25 mg.

Children and adolescents

MenUp Forte should not be taken by persons under 18 years of age.

MenUp Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. MenUp Forte may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking MenUp Forte and the time of intake. The patient should not take MenUp Forte simultaneously with other medicines without their doctor's recommendation. The patient should not take MenUp Forte if they are taking nitrates, as their simultaneous intake may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor or pharmacist if they are taking nitrates, which are used to treat angina pectoris ("chest pain"). The patient should not take MenUp Forte if they are taking medicines that release nitric oxide (such as amyl nitrite), as their simultaneous intake may also lead to a dangerous decrease in blood pressure. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking protease inhibitors used to treat HIV infections, the patient should consult their doctor before taking this medicine; in such cases, it is recommended to start treatment with a lower dose of sildenafil (25 mg). In some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up quickly or sitting down. Such symptoms have occurred in some patients taking MenUp Forte and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking MenUp Forte. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take MenUp Forte. The doctor may decide to use a lower initial dose of sildenafil (25 mg). If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint) occur, the patient should first lie down or sit down and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up quickly or sitting down. If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), they should consult their doctor before taking MenUp Forte. If the patient is taking medicines containing sacubitril with valsartan (used to treat heart failure), they should inform their doctor or pharmacist.

MenUp Forte with food, drink, and alcohol

MenUp Forte can be taken with or without food. Although taking MenUp Forte during a large meal may prolong the time needed for the medicine to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of MenUp Forte, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

MenUp Forte is not intended for use by women.

Driving and using machines

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

MenUp Forte contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take MenUp Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If the patient has previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, MenUp Forte in a dose of 50 mg should only be taken if the patient did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., they did not achieve an erection sufficient for sexual intercourse). If taking a lower dose of sildenafil (25 mg) allowed the patient to achieve an erection sufficient for sexual intercourse, they should not take a dose of 50 mg. MenUp Forte should not be taken more than once a day.The patient should not take MenUp Forte tablets simultaneously with Viagra tablets or other medicines containing sildenafil. MenUp Forte should be taken about an hour before planned sexual activity. The tablet should be swallowed whole, with a glass of water. If the patient feels that the effect of MenUp Forte is too strong or too weak, they should consult their doctor or pharmacist. MenUp Forte allows for an erection only if the patient is sexually stimulated. The time after which the effect of MenUp Forte occurs varies from patient to patient, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large meal. The patient should consult their doctor if they do not achieve an erection after taking MenUp Forte or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of MenUp Forte than recommended

The patient may experience more frequent side effects, and they may be more severe. Taking a dose higher than 100 mg does not increase the effectiveness of the medicine. The patient should not take more tablets than indicated in the patient leaflet.The patient should consult their doctor if they have taken more tablets than recommended. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, MenUp Forte can cause side effects, although not everybody gets them. Side effects reported in connection with the use of MenUp Forte are usually mild or moderate and short-lived.

In case of the following side effects, the patient should stop taking MenUp Forte and immediately seek medical attention:

• 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 uncommonlyIf it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in 1 in 1000 patients). If an erection lasts more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or vision impairment - occur rarely.
• Severe skin reactions - occur rarely.Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely.

Other side effects: Very common (may occur in more than 1 in 10 patients):

• Headache.

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

• Nausea
• Sudden flushing
• Hot flashes (symptoms include a feeling of heat in the upper body)
• Indigestion
• Visual disturbances, blurred vision, changes in vision
• Stuffy nose
• Dizziness.

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

• Vomiting
• Rash
• Irritation of the eye
• Conjunctivitis
• Eye pain
• Seeing flashes of light
• Increased sensitivity to light
• Eye irritation
• Tearing
• Pounding heart
• Fast heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Somnolence
• Decreased sensation of touch
• Dizziness
• Ringing in the ears
• Dry mouth
• Stuffy or congested sinuses
• Rhinitis (symptoms include runny nose, sneezing, and stuffy nose)
• Pain in the upper abdomen
• Gastroesophageal reflux disease (symptoms include heartburn)
• Blood in urine
• Pain in arms or legs
• Nosebleeds
• Feeling of heat
• Feeling of fatigue.

Rare(may occur in up to 1 in 1000 patients):

• Fainting
• Stroke
• Heart attack
• Irregular heartbeat
• Transient reduction in blood flow to part of the brain
• Feeling of tightness in the throat
• Numbness of the lips
• Bleeding in the back of the eye
• Double vision
• Decreased visual acuity
• Abnormal sensations in 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 white of the eye
• Bleeding from the penis
• Blood in semen
• Dry nose
• Swelling inside the nose
• Feeling of irritability
• Sudden hearing loss or decrease.

After the medicine was placed on 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 side effects, heart problems existed before taking MenUp Forte. It is not possible to determine whether these side effects were related to the use of MenUp Forte.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store MenUp Forte

The medicine should be stored out of sight and reach of children. There are no special recommendations for storing the medicine. The patient should not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What MenUp Forte contains

• The active substance of MenUp Forte is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are: Tablet core: microcrystalline cellulose 102, calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate. OPADRY II 32K205007 blue coating: hypromellose 15 mPa⸳s, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine (E 132), aluminum lake.

What MenUp Forte looks like and contents of the pack

MenUp Forte 50 mg is a blue, round, biconvex film-coated tablet, 10 mm in diameter, with the number "50" engraved on one side. PVC/PVDC/Aluminum blisters in a carton pack containing 2 or 4 tablets. Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the leaflet: