Tadalafil Mensil 10 mg, 4 coated tablets, Hasco-Lek

Tadalafil Mensil 10 mg is a medication for erectile dysfunction in adult men. It is available as light blue, film-coated tablets for oral administration.

Each tablet contains 10 mg of tadalafil.

Erectile dysfunction is the inability to achieve or maintain an erection suitable for sexual intercourse.

Tadalafil (the active ingredient in Tadalafil Mensil) belongs to the group of phosphodiesterase type 5 (PDE5) inhibitors. It works by relaxing smooth muscle and increasing blood flow to the tissues of the penis, which leads to improved erections. It does not work without sexual stimulation and does not help patients who do not have erectile dysfunction.

The tablet should be taken 30 minutes before planned sexual activity.

Tadalafil Mensil may remain effective for up to 36 hours after taking the tablet.

Indications:

Treatment of erectile dysfunction in adult men.

Composition:

• 1 tablet contains: active substance: tadalafil 10 mg
• Other ingredients: tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate
• Opadry II Blue 85F30605 coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350 and 4000, talc, indigo carmine, aluminum lake (E132).

Action:

Helps dilate the blood vessels in the penis (after sexual stimulation), improving erections.

How to use: 

• Always use this medicine exactly as described in the patient information leaflet or as directed by your doctor, pharmacist, or nurse. If you have any questions, ask your doctor, pharmacist, or nurse. Adult men: the recommended dose is 1 tablet taken at least 30 minutes before planned sexual activity
• Your doctor may recommend a different dosage after consultation
• Tadafil Mensil is intended for oral administration
• Swallow the tablet whole with a small amount of water
• This medication may be effective for up to 36 hours after taking the tablet
• It is intended for use as needed, no more than once a week
• Do not take more than 1 tablet. If you take more than the recommended dose, inform your doctor.

Contraindications:

• Allergy to tadalafil or any of the other ingredients of this medication
• Taking organic nitrates in any form or other nitric oxide donors
• Avoiding sexual activity as directed by your doctor
• Severe heart disease or a myocardial infarction within the last 90 days
• Stroke within the last 6 months
• Low blood pressure or uncontrolled high blood pressure or uncontrolled heart rhythm disturbances
• Have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy
• Taking riociguat.

Side Effects:

Like all medicines, this medicine can cause side effects, although not everyone gets them. These effects are usually mild or moderate. If you experience any of the side effects listed below, stop taking the medicine and see a doctor immediately:

• allergic reactions, including rashes (seen in 1 to 10 in 1,000 patients - uncommon)
• chest pain - do not use nitrates, but seek immediate medical attention (seen uncommonly)
• priapism, a prolonged and possibly painful erection after taking the medicine (seen in up to 1 in 1,000 patients - rare). If you experience such an erection and it lasts continuously for more than 4 hours, contact your doctor immediately
• sudden vision loss (rare).

Other reported side effects:

• Common (seen in 1 to 10 in 100 patients): headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion, and indigestion.
• Uncommon (seen in 1 to 10 in 1,000 patients): dizziness, abdominal pain, nausea, vomiting, acid reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, pounding heartbeat, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired
• Rare (seen in 1 to 10 in 10,000 patients): fainting, seizures and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the skin), penile bleeding, presence of blood in semen, and increased sweating
• Heart attack and stroke have been reported rarely in men taking tadalafil. Most of these men had heart problems before starting tadalafil.
• There have been rare reports of partial, temporary, or permanent decrease or loss of vision in one or both eyes
• Several additional side effects have been reported rarely in men taking tadalafil, but these were not observed in clinical trials. These include: migraine, facial swelling, serious allergic reactions that cause swelling of the face and throat, severe skin rashes, eye problems, irregular heartbeat, angina, and sudden cardiac death
• Side effects: Dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Interactions:

Before taking this medicine, use the questionnaire included in the package insert. If you are not sure, tell your doctor or pharmacist about all medicines you are taking, have recently taken, or are planning to take.

Do not take Tadalafil Mensil if you are taking nitrates.

Tadalafil Mensil may affect the way some medicines work, or other medicines may affect the way Tadalafil Mensil works. Tell your doctor or pharmacist if you are taking the following medicines:

• alpha-adrenergic blockers (used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia)
• other medicines used to treat high blood pressure
• riociguat
• 5-alpha-reductase inhibitors (used to treat symptoms of benign prostatic hyperplasia)
• such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (anticonvulsants)
• rifampicin, erythromycin, clarithromycin (antibiotics), or itraconazole (antifungal)
• other medicines used to treat erectile dysfunction.

Some patients taking blood pressure-lowering medications may experience a drop in blood pressure, especially when standing or sitting up quickly. If you experience symptoms of low blood pressure (dizziness, lightheadedness, feeling faint), you should first lie down or sit until the symptoms subside. Drinking water, getting some fresh air, tensing your abdominal muscles, or crossing your legs may also help. Avoid standing up or sitting up quickly.

Use with food, drink, and alcohol

• Alcohol consumption may affect your ability to get an erection and may cause a temporary decrease in blood pressure. If you have taken or are planning to take this medication, you should avoid drinking large amounts of alcohol, as this may increase the risk of dizziness when standing up
• Grapefruit juice may affect the effectiveness of this medication, so exercise caution when consuming it.

Warnings and Precautions:

• Before taking this medicine, please use the questionnaire included in the package. If you have any questions, talk to your doctor or pharmacist
• Inform your doctor if you have heart problems
• Tadalafil Mensul should not be used concurrently with other oral or topical medications used to treat erectile dysfunction
• This medicine should not be used concurrently with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors
• Do not take sildenafil-containing medications used to treat erectile dysfunction or pulmonary hypertension for 48 hours after taking this medicine
• Do not take this medicine if you have no history of erectile dysfunction
• Alcohol consumption may affect your ability to get an erection and may cause a temporary decrease in blood pressure. If you have taken or are planning to take this medicine, avoid drinking large amounts of alcohol, as this may increase the risk of dizziness when standing up

Before taking this medicine, tell your doctor if you have any of the following conditions:

• sickle cell anemia (an abnormal shape of red blood cells)
• multiple myeloma (a cancer of the bone marrow)
• leukemia (a cancer of the blood cells)
• any deformity of the penis
• severe liver disease
• severe kidney disease.

If you experience sudden decrease or loss of vision, stop taking this medicine and contact your doctor immediately.

Decrease or sudden hearing loss has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience decrease or sudden hearing loss, stop taking this medicine and contact your doctor immediately.

This medicine is not intended for use in women.

Pregnancy, breast-feeding, and fertility

• Reduced sperm count has been observed in some men while taking this medicine. This is unlikely to lead to infertility
• This medicine is not intended for use in women.

Use in children and adolescents

• This medicine is not intended for use in children and adolescents under 18 years of age.

This medicine contains lactose and sodium.

• If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine
• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free.

Storage:

• Keep this medicine out of the sight and reach of children
• There are no special storage requirements.

Presentation: 4 film-coated tablets