Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Potassium sorbate
Sorbitol 70% (non-crystallising)
Purified water

6.2     Incompatibilities
Not applicable.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials .
Once opened, the contents of the bottle should be used within 3 months.
6.4     Special precautions for storage

The bottle with the mounted pump may only be kept and transported in a vertical position.

Do not store above 30ºC.
6.5     Nature and contents of container

50 g in brown glass bottles (class II) and 100 g in brown glass bottles (class III).

Not all pack sizes may be marketed.
6.6     Special precautions for disposal and other handling

No special requirements.
Prior to first use the dosing pump has to be screwed on the bottle. For removing the screw cap from the bottle the cap must be turned anticlockwise and unscrewed completely (fig.1).



Mounting the dosing pump on the bottle:


The dosing pump has to be removed from the plastic bag (fig. 2) and placed on top of the bottle, sliding the plastic dip 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 (fig 3). For the intended use the dosing pump is only screwed on once when starting the use, and should never be unscrewed.



Use of the dosing pump for dispensing:

The dosing pump head has two positions and is easy to turn – anticlockwise (unlocked position) and clockwise (locked position). The dosing pump head should not be pushed down while in the locked position. The solution may only be dispensed in the unlocked position. To do this, the dosing pump head has to be turned in the direction of the arrow about one eighth of a turn, until a resistance is felt (fig. 4) 


The dosing pump is then ready for use.

Preparing the dosing pump:
When used for the first time, the dosing pump does not dispense the correct amount of oral solution. Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely five times in succession (fig.
5).



The solution thus dispensed is discarded. The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; fig. 6).



Correct use of the dosing pump:

The bottle should be placed on a flat, horizontal surface, for example a table top, and only use it in a vertical position. A glass with a little water or a spoon should be held below the nozzle and the dosing pump head has to be pushed down in a firm but calm and steady manner (not too slowly) right down to the stop (fig. 7, fig. 8).



The dosing pump head can then be released and is ready for the next pump actuation.

The dosing pump may only be used with the memantine hydrochloride solution in the bottle provided, not for other substances or containers. If the pump does not function as described during intended use and according to instruction, the patient should consult the treating physician or a pharmacist. The dosing pump should be locked after use.