Posology : מינונים

4.2 Posology and method of administration

Posology

Use in adults
The recommended dose is 2 mL (4 actuations), equivalent to 50 mg of sildenafil taken as needed, approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 4 mL (8 actuations), equivalent to 100 mg, or decreased to 1 mL (2 actuations), equivalent to 25 mg of sildenafil. The maximum recommended dose is 4 mL (8 actuations), equivalent to 100 mg of sildenafil. The maximum recommended dosing frequency is once per day. If Sildazen is taken with food, the onset of its pharmacological activity may be delayed compared to the fasted state (see section 5.2).

Quantity of suspension
Number of actuations                      delivered                Quantity of sildenafil                 2                               1 mL                             25 mg
4                               2 mL                             50 mg
8                               4 mL                            100 mg Each actuation delivers 0.5 mL of product which contains 12.5 mg of sildenafil.


Special populations
Elderly
Dosage adjustments are not required in elderly patients (patients aged 65 years or older).

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Renal impairment
The dosage recommendations described under “Use in adults” are applicable to patients with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min).

Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose (two actuations) should be considered for these patients.
Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg.

Hepatic impairment
Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose (two actuations) should be considered for these patients. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg.

Paediatric population
Sildazen is not indicated for children and adolescents below 18 years of age.

Use in patients taking other medicinal products
With the exception of ritonavir, for which co-administration with sildenafil is not advised (see section 4.4), a starting dose of 1 mL (2 actuations) equivalent to 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).

In order to minimise the potential for developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil administration. In addition, initiation of sildenafil treatment at a dose of 1 mL (2 actuations) equivalent to 25 mg should be considered (see sections 4.4 and 4.5).

Method of administration

For oral administration.
Not to be administered nasally or cutaneously (locally applied).


INSTRUCTIONS FOR USE
1. Shake the bottle vigorously approximately 20 seconds to ensure that no drug precipitate is observed in the bottle before each use. See figure 1.

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2. The child-resistant screw cap should be removed by pushing it down firmly and turning it anticlockwise. See figure 2.



3. The dosage pump has to be placed on top of the bottle sliding the plastic tube carefully into the bottle. Then the dosing pump needs to be held onto the neck of the bottle and screwed clockwise until it is firmly attached. See figure 3.

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4. Twist the dosage pump into open position. See Figure 4.



5. Before every use (including first-time use): Activate the pump three times to prepare (prime) the dosage pump, discard any product released during this activation into an absorbent material.
The pump is now ready to be used and each metered spray delivers an average of 12.5 mg of sildenafil.
A failure in this priming process may lead to a lower dose when used.

Discard the bottle when the drug level is below the red line.

6. Tilt your head back a little. Place the pump in your mouth. Press the dosage pump as many times as required, according to the dose prescribed by your doctor and apply the suspension on the tongue and swallow the suspension immediately with saliva. Avoid direct contact between the end of the dosage pump and inside the mouth and tongue. See figure 5.

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7. Twist the dosage pump to closed position (Figure 6) and remove the pump after dripping it against the internal walls of the bottle by unscrewing anticlockwise (Figure 7).



8. The child resistant screw cup should be put back on the bottle to close it immediately after each use (Figura 8).

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9. Wash completely the dosage pump with water, ensuring no product or water remains in the pump by activating the pump several times into an absorbent material. Allow it to dry thoroughly before the next use. See figure 9 and figure 10.



Store this medicine out of the sight and reach of children.

NOTE FOR PATIENTS – With these instructions for use requiring repriming before each dose and washing the dosing pump, the bottle will contain a final average deliverable volume of 20 ml of the oral suspension.