MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Procardia XL (Nifedipine) tabletsTrade Name:Procardia; Procardia XLChemical Family:MixtureIntended Use:Pharmaceutical product for the treatment of high blood pressure (hypertension), angina2. HAZARDS IDENTIFICATIONA ppearance:Round, biconvex, rose-pink film coated tabletsAdditional Hazard Information:Short Term:Dust may cause irritation . May be harmful if swallowed. Individuals sensitive to this chemicalor other materials in its chemical class may develop allergic reactions. Exposure to sunlightfollowing contact may result in skin reactions. Antihypertensive drug: has blood pressure-lowering propertiesKnown Clinical Effects:Ingestion of this MATERIAL may cause effects similar to those seen in clinical use includinghypotension (low blood pressure), dizziness, headache and Indication of danger:Not classifiedAustralian Hazard Classification(NOHSC):Non-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 product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all needs may vary depending upon the potential for exposure in your COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS ListClassification%Nifedipine21829-25-42 44-598-3Xn;R2211 Ferric oxide red1309-37-1215-168-2 Not Listed*Magnesium stearate557-04-0209-150-3 Not Listed*IngredientCAS NumberEU EINECS/ELINCS ListClassification%_____173 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 04-Jan-2010 Emergency telephone number:ChemSafe (24 hours).

3 +44 (0)208 762 8322 Contact MATERIAL SAFETY data SHEETPage 1 of 8 Pfizer 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 MATERIAL SAFETY data SHEET_____Cellulose Acetate9004-70-0 Not listedNot Listed*Opadry YS-5-7017 NOT ASSIGNEDNot listedNot Listed*Polyethylene oxide NF25322-68-3 Not listedNot Listed*Polyethylene glycol25322-68-3 Not listedNot Listed*Hydroxypropyl methylcelluslose9004-65-3 Not listedNot Listed*Sodium chloride7647-14-5231-598-3 Not 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. FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes.

4 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:Emits toxic fumes of carbon monoxide, carbon dioxide, and nitrogen 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 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. 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 2 of 8 Revision date: 04-Jan-2010 MATERIAL Name: Procardia XL (Nifedipine) tabletsVersion: MATERIAL SAFETY data SHEET_____7.

6 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. 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 at room temperature in properly labeled containers. Keep away from heat, sparks Temperature:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure Threshold Limit Value (TWA)1 mg/m3 TWA5 mg/m3 TWAF rance OEL - TWAL istedPage 3 of 8 Germany (DFG) - mg/m3 MAKG reece OEL - TWAL istedAustralia TWA1 mg/m35 mg/m3 Hungary OEL - TWAL istedNifedipineIreland OEL - TWAsListedAustria OEL - MAKsLithuania OEL - TWAL istedListedOSHA - Final PELS - TWAs:10 mg/m3 Revision date: 04-Jan-2010 Poland OEL - TWAL istedBelgium OEL - TWAL istedPortugal OEL - TWAL istedRomania OEL - TWAL istedPfizer OEL TWA-8 Hr.

7 Spain OEL - TWAL istedBulgaria OEL - TWAL istedSweden OEL - TWAsListed300 g/m3 Polyethylene oxide NFCzech Republic OEL - TWAA ustria OEL - MAKsListedListedMaterial Name: Procardia XL (Nifedipine) tabletsGermany - TRGS 900 - TWAs1000 mg/m3 Germany (DFG) - MAK1000 mg/m3 MAKD enmark OEL - TWAL istedSlovenia OEL - TWAL istedFerric oxide redPolyethylene glycolAustria OEL - MAKsListedEstonia OEL - TWAL istedVersion: OEL - TWAL isted MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONA nalytical Method:Analytical method available for Nifedipine. Contact Pfizer Inc for further 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. 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).

8 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 PROPERTIESP olymerization:Will not occur10. STABILITY AND REACTIVITYS tability: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 oxidizers_____173 Ireland OEL - TWAsListedGermany (DFG) - MAK1000 mg/m3 MAKL ithuania OEL - TWAL istedRevision date: 04-Jan-2010 Portugal OEL - TWAL istedSpain OEL - TWAL istedSlovenia OEL - TWAL istedPhysical State:TabletColor:Rose-pinkSweden OEL - TWAsMolecular Formula:MixtureListedMolecular Weight:MixtureMaterial Name: Procardia XL (Nifedipine) tabletsSodium chlorideMagnesium stearateLatvia OEL - TWAL istedVersion.

9 4 of 8 Lithuania OEL - TWAL istedACGIH Threshold Limit Value (TWA)10 mg/m3 TWAG ermany - TRGS 900 - TWAsAustralia TWA10 mg/m31000 mg/m3 Belgium OEL - TWAL isted MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the / Sensitization: (Study Type, Species, Severity)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Subchronic intravenous and oral toxicity studies revealed no drug-related effects in general behavior, clinical laboratory tests, grossnecropsy, or histopathology in any of the dog and rat studies.

10 Oral doses administered demonstrated nifedipine to be without significanttoxic effects at doses up to 100 - 125 mg/ & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))_____173 Mouse Oral LD50 454 mg/kgSkin Irritation Rabbit MildRat Oral LD50 > 10,000 mg/kgPolyethylene oxide NFRat Oral LD50 1022 mg/kgMaterial Name: Procardia XL (Nifedipine) tabletsEye Irritation Rabbit MildSkin Irritation Rabbit MildMouse IV LD50 mg/kgSodium chlorideMagnesium stearateEye Irritation Rabbit ModerateRat IV LD50 mg/kgVersion: Irritation Rabbit MildPage 5 of 8 Sodium chlorideNifedipineRat Oral LD50 > 2000 mg/kg13 Week(s) Rat Oral 100 mg/kg/day NOAEL No effects at maximum doseRat Oral LD50 3000 mg/kg13 Week(s) Dog Oral 50 mg/kg/day NOAEL No effects at maximum dose4 Week(s) Dog Oral 125 mg/kg/day NOAEL No effects at maximum doseMouse Oral LD50 4000 mg/kg4 Week(s) Dog Intravenous mg/kg/day NOAEL No effects at maximum doseRat Inhalation LC50 > 2000 mg/m31 Year(s) Dog Oral 100 mg/kg/day NOAEL No effects at maximum doseHydroxypropyl methylcellusloseNifedipinePolyethylene glycolRevision date.