MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Donepezil hydrochloride film coated tabletsTrade Name:ARICEPTC hemical Family:MixtureIntended Use:Pharmaceutical product for the treatment of Alzheimer's disease2. HAZARDS IDENTIFICATIONA ppearance:White tabletsSignal Word:WARNINGS tatement of Hazard:Harmful if Clinical Effects:Ingestion of this MATERIAL can cause effects similar to those seen in clinical use includingcholinergic crisis, charactertized by severe nausea, vomiting, salivation, sweating, slow heartrate, low blood pressure, muscles weakness, respiratory depression, syncope and Indication of danger:HarmfulEU Hazard Symbols:EU Risk Phrases:R22 - Harmful if Hazard Classification(NOHSC):Hazardous Substance.

2 Non-Dangerous :This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 Pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 02-Sep-2010 Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322 Contact MATERIAL SAFETY data SHEETPage 1 of 7 MATERIAL SAFETY data SHEET_____3.

3 COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification%Donepezil hydrochloride120011-70-3 Not ListedT;R25Xi; stearate557-04-0209-150-3 Not Listed*Starch9005-25-8232-679-6 Not Listed*Microcrystalline cellulose9004-34-6232-674-9 Not Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Hydroxypropyl cellulose9004-64-2 Not ListedNot Listed*Lactose NF, monohydrate64044-51-5 Not ListedNot Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for the full text of the R phrases mentioned in this Section, see Section 164.

4 FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes. Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention and Effects of Exposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Combustion Products:Formation of toxic gases is possible during heating or Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:Not applicable6.

5 ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize date: 02-Sep-2010 MATERIAL Name: Donepezil hydrochloride film coated tabletsVersion: 2 of 7 MATERIAL SAFETY data SHEET_____Measures for Cleaning / Collecting:Contain the source of spill if it is safe to do so. Collect spilled MATERIAL by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal.

6 Care should be taken toavoid environmental Consideration for LargeSpills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained HANDLING AND STORAGEG eneral Handling:Minimize dust generation and accumulation. If tablets or capsules are crushed and/or broken,avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash hands and any exposed skinafter removal of PPE. Releases to the environment should be avoided.

7 Review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure or environmental releases. Potential points of process emissions of thismaterial to the atmosphere should be controlled with dust collectors, HEPA filtration systems orother equivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure OEL - TWAL istedMagnesium stearateSweden OEL - TWAsListedVersion: Threshold Limit Value (TWA)10 mg/m3 TWAACGIH Threshold Limit Value (TWA)10 mg/m3 TWAPage 3 of 7 Australia TWA10 mg/m3 Belgium OEL - TWAL istedAustralia TWA10 mg/m3 Bulgaria OEL - TWAL istedDonepezil hydrochlorideCzech Republic OEL - TWAL istedBelgium OEL - TWAG reece OEL - TWAL istedListedIreland OEL - TWAsListedRevision date: 02-Sep-2010 OSHA - Final PELS - TWAs:15 mg/m3 total5 mg/m3 Ireland OEL - TWAsListedPortugal OEL - TWAL istedSpain OEL - TWAL istedPfizer OEL TWA-8 Hr.

8 Microcrystalline celluloseLithuania OEL - TWAL istedACGIH Threshold Limit Value (TWA)10 mg/m3 TWA150 g/m3 Portugal OEL - TWAL istedMaterial Name: Donepezil hydrochloride film coated tablets MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONThe exposure limit(s) listed for solid components are only relevant if dust may be Method:Analytical method available for Donepezil Hydrochloride. Contact Pfizer Inc for Controls:Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes.

9 Keep airbornecontamination levels below the exposure limits listed above in this Exposure Controls:Refer to specific Member State legislation for requirements under Community Protective Equipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).Hands:Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing :Wear SAFETY glasses or goggles if eye contact is :Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the PHYSICAL AND CHEMICAL PROPERTIES10.

10 STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:Fine particles (such as dust and mists) may fuel Materials:As a precautionary measure, keep away from strong oxidizers11. TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)_____296 Spain OEL - TWAC olor:WhiteListedMolecular Formula:MixtureMolecular Weight:MixtureEstonia OEL - TWAL istedMaterial Name: Donepezil hydrochloride film coated tabletsFrance OEL - TWAL istedVersion: 4 of 7 Ireland OEL - TWAsListedAustralia TWAL atvia OEL - TWAL isted10 mg/m3 OSHA - Final PELS - TWAs.