Tadalafil APTEO MED, 10 mg, 2 coated tablets

The active substance is tadalafil. Each tablet contains 10 mg of tadalafil. The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K-29-32, sodium citrate, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, sodium stearyl fumarate. Tablet coating: hypromellose 6 cPs, triacetin, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

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• Tadalafil APTEO MED tablets are intended for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken regardless of meals.
• The recommended dose is one 10 mg tablet taken before planned sexual activity. If you feel that the effect of Tadalafil APTEO MED is too strong or insufficient, talk to your doctor or pharmacist. After consultation, your doctor may recommend a different dosage. Tadalafil APTEO MED tablets are intended for oral administration.
• The tablet can be taken at least 30 minutes before planned sexual activity.
• Tadalafil APTEO MED may be effective for up to 36 hours after taking the tablet.
• Tadalafil APTEO MED is intended for use before planned sexual activity.
• The medicine should be used occasionally, as needed. Do not use more than once a week. Do not take more than 1 tablet.
• Tadalafil APTEO MED should not be used concomitantly with other oral or topical medications for the treatment of erectile dysfunction.
• Tadalafil APTEO MED should not be used concomitantly with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
• For 48 hours after taking Tadalafil APTEO MED, you must not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
• Tadalafil APTEO MED should not be taken if you have not been diagnosed with erectile dysfunction.
• It is important to be aware that Tadalafil APTEO MED does not work in the absence of sexual stimulation. The patient and his partner should arrange foreplay, just as they would if the patient was not taking medication for erectile dysfunction.
• Drinking alcohol may cause a temporary decrease in blood pressure. If you have taken Tadalafil APTEO MED or are planning to take it, you should not drink large amounts of alcohol (blood alcohol level of 0.08% or more), as this may increase the risk of dizziness when standing up.

When not to take Tadalafil APTEO MED:

• if you are allergic to tadalafil or any of the other ingredients of this medicine
• if you are taking any form of organic nitrates or other nitric oxide donors such as amyl nitrite. This is a group of medicines (‘nitrates’) used to treat angina pectoris (‘chest pain’). Tadalafil has been shown to enhance the effects of these medicines. If you are taking any form of nitrates or are unsure, tell your doctor;
• if your doctor has advised you to avoid sexual activity;
• if you have severe heart disease or have had a heart attack within the last 90 days;
• if you have had a stroke in the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure, or uncontrolled heart rhythm problems;
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), known as ‘eye palsy’;
• if you are 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 pressure in the lungs caused by blood clots). PDE5 inhibitors such as Tadalafil APTEO MED have been shown to enhance the blood pressure lowering effect of this medicine. If you are taking riociguat or are not sure, tell your doctor.