What Memantine Torrent contains
The active substance is memantine hydrochloride.
Pump: Each pump actuation (one downward pump) delivers 0.5 ml of solution containing 5 mg of memantine hydrochloride equivalent to 4.16 mg memantine.
Dosing Pipette: 0.5 ml contains 5 mg of memantine hydrochloride equivalent to 4.16 mg of memantine.
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ID: PL 167M |
Version: 01 |
Review Date: 20/06/13 |
Each ml of solution contains 10 mg of Memantine Hydrochoride.
The other ingredients are potassium sorbate E202, sorbitol E420 and purified water.
What Memantine Torrent looks like and contents of the pack
Memantine Torrent oral solution is presented as a clear, colourless to light yellowish solution. Memantine Torrent oral solution is available in bottles of 50 ml, 100 ml or 10 x 50 ml.
A pump or dosing pipette is provided. The dosing pipette is printed in 0.5 ml graduations. Not all pack sizes may be marketed.
In het register ingeschreven onder nummer
RVG 112063
Marketing Authorisation Holder and Manufacturer
Vergunninghouder
Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Duitsland
Fabrikanten
Torrent Pharma GmbH
Südwestpark 50
90449 Nürnberg
Duitsland
Chanelle Medical
Loughrea, Co. Galway
Ierland
Heumann Pharma GmgH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Duitsland
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court, County Oak Way, Crawley,
West Sussex, RH11 7XA
Verenigd Koninkrijk
This medicinal product is authorised in the Member States of the EEA under the following names:
Netherlands: Memantin Torrent 10 mg/ml, drank
Germany: Memantin Heumann 10 mg/ml, Lösung zum Einnehmen Greece: Memantine Torrent 10 mg/ml, πόσιμου διαλύματος Lithuania: Memantine Torrent 10 mg/ml, geriamasis tirpalas Romania: Memantina Torrent 10 mg/ml, soluţie orală
United Kingdom: Memantine hydrochloride Torrent 10 mg/ml oral solution
|
ID: PL 167M |
Version: 01 |
Review Date: 20/06/13 |
This leaflet was last revised in juli 2013
Instruction for proper use of the pump
The solution must not be poured or pumped directly into the mouth from the bottle or pump. Measure the dose onto a spoon or into a glass of water, using the pump.
Take the screw cap off the bottle:
The cap must be turned anticlockwise, unscrewed completely and removed (fig. 1).
Mounting the dosing pump on the bottle:
Take the dosing pump out of the plastic bag (fig. 2) and place it on top of the bottle. Slide the plastic dip tube carefully into the bottle. Hold the dosing pump onto the neck of the bottle and screw it clockwise until it fits firmly (fig. 3). The dosing pump is only screwed on once when starting the use, and should never be unscrewed.
ID: PL 167M 01 Review Date: 20/06/13
How the dosing pump works:
The dosing pump head has two positions and is easy to turn: -anticlockwise to unlock and
-clockwise to lock.
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 unlock, turn the pump head in the direction of the arrow until it cannot be turned any further (about one eighth of a turn, 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 heads 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 (fig 6.)
Correct use of the dosing pump:
Hold a glass with a little water or a spoon below the nozzle. Push down the dosing pump head in a firm but calm and steady manner-not too slowly (fig. 7, fig. 8).
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ID: PL 167M |
Version: 01 |
Review Date: 20/06/13 |
The dosing pump head can then be released and is ready for the next pump compression. The dosing pump must only be used with the Memantine Torrent solution in the bottle provided, not for other substances or containers. If the pump does not function properly, consult your doctor or pharmacist. Lock the dosing pump after using Memantine Torrent.
Instruction for proper use of the dosing pipette
Remove the cap from the bottle by turning it anti-clockwise. (fig. 1)
Insert the pipette into the bottle. While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or milligrams you need to give. (fig 2)
Holding the bottom ring, remove the entire pipette from the bottle.
The solution must not be pipetted into the mouth directly from the bottle but should be dosed onto a spoon or into a glass of water using the pipette.(fig 3)
