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Almus Erectile Dysfunction Relief 50 mg Film-Coated Tablets
Qualitative and quantitative composition
Each film-coated tablet contains 50 mg sildenafil (as citrate).
Excipient with known effect:
Each film-coated tablet contains 1.24 mg of lactose (as lactose monohydrate)
Posology
Use in adults
The recommended dose is one 50 mg tablet taken with water approximately one hour before sexual activity.
The maximum recommended dosing frequency is once per day. If Almus Erectile Dysfunction is taken with food, the onset of activity may be delayed compared to the fasted state.
Patients should be advised that they may need to take Almus Erectile Dysfunction a number of times on different occasions (a maximum of one 50 mg tablet per day), before they can achieve a penile erection satisfactory for sexual activity. If after several attempts on different dosing occasions patients are still not able to achieve a penile erection sufficient for satisfactory sexual activity, they should be advised to consult a doctor.
Special populations
Elderly
Dosage adjustments are not required in elderly patients (= 65 years old).
Renal impairment
No dosage adjustments are required for patients with mild to moderate renal impairment. However, since sildenafil clearance is reduced in individuals with severe renal impairment (creatinine clearance < 30 ml/min), individuals previously diagnosed with severe renal impairment must be advised to consult their doctor before taking Almus Erectile Dysfunction, since a 25 mg tablet may be more suitable for them (see section 4.4 for further information).
Hepatic impairment
Sildenafil clearance is reduced in individuals with hepatic impairment (e.g. cirrhosis). Individuals previously diagnosed with mild to moderate hepatic impairment must be advised to consult their doctor before taking Almus Erectile Dysfunction, since a 25 mg tablet may be more suitable for them (see section 4.4 for further information). The safety of sildenafil has not been studied in patients with severe hepatic impairment, and its use is therefore contraindicated (see section 4.3).
Paediatric population
Almus Erectile Dysfunction is not indicated for individuals below 18 years of age.
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