Menup forte

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Package leaflet: Information for the patient

MenUp Forte, 50 mg, coated tablets
Sildenafilum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or further information is needed, please consult a pharmacist.
• If any adverse reactions occur, 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, medical advice should be sought.

Table of contents of the leaflet:

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

MenUp Forte 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, thereby increasing blood flow to the penis during sexual stimulation.
MenUp Forte helps achieve an erection only if sexual stimulation occurs first.
MenUp Forte is used to treat erectile dysfunction in adult men, defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using MenUp Forte

When not to use 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, because 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 drugs 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 blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as MenUp Forte 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 (NAION).

Warnings and precautions
Before starting to take MenUp Forte, discuss with a doctor or pharmacist if:

• The patient has sickle cell anaemia (an abnormality of red blood cells), leukaemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with 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 haemophilia).
• If sudden vision deterioration or sudden vision loss occurs, the patient should stop taking MenUp Forte and contact a doctor immediately.

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

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

MenUp Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
MenUp Forte may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, inform the doctor, pharmacist, or nurse about taking MenUp Forte and the time of its administration. Do not take MenUp Forte together with other medicines without medical advice.
Do not use MenUp Forte 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 use MenUp Forte if the patient is taking drugs that release nitric oxide (such as amyl nitrite), because their concomitant use may also cause dangerous lowering of blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
If the patient is taking protease inhibitors used in the treatment of HIV infection, consult a doctor before taking this medicine; in such cases, starting treatment with a lower dose of sildenafil (25 mg) is recommended.
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 when standing up or sitting down quickly. Such symptoms have been reported in some patients taking MenUp Forte together with alpha-blockers. These symptoms are most likely to occur within 4 hours after taking MenUp Forte. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting MenUp Forte. The doctor may decide to start with a lower initial dose of sildenafil (25 mg). If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Avoid standing up or sitting down quickly.
If the patient is taking ketoconazole (an antifungal medicine), erythromycin (an antibiotic), or cimetidine (a medicine for heartburn), they should consult a doctor before taking MenUp Forte.
If the patient is taking medicines containing sacubitril with valsartan (used in the treatment of 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. However, taking MenUp Forte 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 effect of MenUp Forte, significant amounts of alcohol should not be consumed before taking the medicine.

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

Driving and using machines
MenUp Forte may cause dizziness and visual disturbances. Patients should determine 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 certain sugars, they 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 Forte

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, MenUp Forte at a dose of 50 mg should only be used if the patient did not achieve the desired effect (i.e. an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg.
If treatment with a lower dose of sildenafil (25 mg) has already enabled an erection sufficient for sexual intercourse, the 50 mg dose should not be used.
MenUp Forte must not be taken more than once a day.
Do not take MenUp Forte coated tablets at the same time as Viagra tablets or other medicines containing sildenafil.
MenUp Forte should be taken approximately one hour before planned sexual activity.
Swallow the tablet whole with a glass of water.
If the effect of MenUp Forte seems too strong or too weak, consult a doctor or pharmacist.
MenUp Forte enables an erection only in the presence of sexual stimulation.
The time it takes for MenUp Forte 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 a doctor if, after taking MenUp Forte, an erection does not occur or if the duration of the erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of MenUp Forte
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 leaflet.
Contact a doctor if more tablets have been taken than recommended.
If there are any further doubts regarding 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 will experience them.
Adverse reactions reported with the use of MenUp Forte are usually mild
or moderately severe and transient.
If any of the following adverse reactions occur, you should
stop taking MenUp Forte and seek immediate medical help:

• Allergic (hypersensitivity) reaction – occurs uncommonly (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 uncommonly. If they occur during or after sexual intercourse:
  • sit half-upright and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occur rarely (may occur in 1 out of 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 peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – occur rarely.

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

• Headache.

Common (may affect 1 in 10 people):

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

Uncommon (may affect 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
• Ringing in the ears
• Dryness in the mouth
• Blocked or stuffy sinuses
• Nasal mucositis (symptoms include runny nose, sneezing and blocked nose)
• 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 1 in 1000 people):

• 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
• Reduced visual acuity
• Abnormal sensations inside the eye
• Swelling of the eyes or eyelids
• Small spots or particles in the field of vision
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the sclera
• Bleeding from the penis
• Blood in semen
• Dry nose
• Swelling inside the nose
• Irritability
• Sudden hearing loss or deafness.

After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that in most, but not all, men who experienced these adverse reactions, heart problems were already present before taking MenUp Forte. It is not possible to determine whether these adverse reactions were related to the use of MenUp Forte.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, please 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: 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 to provide more information on the safety of the medicine.

5. How to store Menup Forte

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for 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 should 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 pack and other information

What MenUp Forte contains

• The active substance in MenUp Forte is sildenafil. Each tablet contains 50 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 Forte looks like and contents of the pack
MenUp Forte 50 mg is blue, round tablets, 10 mm in diameter, biconvex, with the number "50" printed on one side.
Packs: PVC/PVDC/Aluminium blisters in cardboard cartons containing 2 or 4 tablets.
Not all pack sizes may be marketed.

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

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