Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

RISPERDAL Film-coated tablets:

Tablet core
Lactose monohydrate
Maize starch
Microcrystalline cellulose
Hypromellose 2910 15 mPa.s
Magnesium stearate
Colloidal anhydrous silica
Sodium lauryl sulfate
Film-coating
RISPERDAL 1 mg
Hypromellose 2910 5 mPa.s
Propylene glycol

RISPERDAL 2 mg
Hypromellose 2910 5 mPa.s
Titanium dioxide
Talc
Propylene glycol
Orange yellow S aluminium lake (sunset yellow)

RISPERDAL 3 mg
Hypromellose 2910 5 mPa.s
Titanium dioxide
Talc
Propylene glycol
Quinoline yellow

RISPERDAL 4 mg
Hypromellose 2910 5 mPa.s
Titanium dioxide
Talc
Propylene glycol
Quinoline yellow
Indigotindisulphonate aluminium lake

RISPERDAL 1 mg/ml Oral solution:
Tartaric acid
Benzoic acid
Sodium hydroxide
Purified water

6.2 Incompatibilities
RISPERDAL tablets not applicable
RISPERDAL oral solution: incompatible with most types of tea including black tea.

6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
Oral solution: Shelf life after first opening: 3 months.


6.4 Special precautions for storage
RISPERDAL tablets store below 30°C.
RISPERDAL oral solution store below 30°C and do not freeze.
Keep out of reach and sight of children.


6.5   Nature and contents of container
Tablets:
PVC-PE-PVDC/Al blister consisting of aluminium foil.

RISPERDAL 1, 2, 3 and 4 mg tablets are individually packaged in a blister card containing 10 tablets.
Blisters are packed in a cardboard box (2 blisters per box).
Oral solution:

RISPERDAL Oral Solution is provided in 30 ml amber glass bottles with plastic (polypropylene) child resistant and tamper-evident cap.
A dosing pipette is also provided.
The pipette supplied with the 30 ml bottle is graduated in milligrams and milliliters with a minimum volume of 0.25 ml and a maximum volume of 3 ml. Graduation marks in 0.25 ml (equals 0.25 mg oral solution) increments up to 3 ml (equals 3mg oral solution) are printed on this pipette.

6.6   Special precautions for disposal and other handling

No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6.7 Instructions for Use/Handling
Oral Solution

Fig. 1: The bottle comes with a child- resistant cap, and should be opened as follows: − Push the plastic screw cap down while turning it counter clockwise.
− Remove the unscrewed cap.



Fig. 2: 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 milliliters or milligrams you need to give.



Fig. 3: Holding the bottom ring, remove the entire pipette from the bottle. Empty the pipette into any non- alcoholic drink, except for tea, by sliding the upper ring down.
Close the bottle. Rinse the pipette with some water.



7.    REGISTRATION HOLDER

J-C Health Care Ltd., Kibbutz Shefayim 6099000, Israel.