MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Spironolactone and Hydrochlorothiazide TabletsTrade Name:AldactazideChemical Family:MixtureIntended Use:Pharmaceutical product used as antihypertensive, diuretic2. HAZARDS IDENTIFICATIONA ppearance:Tan film-coated tabletsSignal Word:DANGERS tatement of Hazard:May damage fertility or the unborn of causing cause damage to: blood and blood forming organs through prolonged or Hazard Information:Short Term:Antihypertensive drug: has blood pressure-lowering propertiesLong Term:Repeat-dose studies in animals have shown a potential to cause adverse effects on blood,kidneys, reproductive Clinical Effects:Signs and symptoms might include nausea, vomiting, cramps, dizziness, headache, vertigo,low blood pressure on standing, rash, urticaria, photosensitivity, electrolyte imbalance, musclespasm, weakness, and restlessness.

2 Hypersensitivity reactions may also occur in susceptibleindividuals. Effects on blood and blood-forming organs have also occurred. May causeadverse effects on the developing Indication of danger:HarmfulToxic to reproduction: Category 1 Carcinogenic: Category 3EU Hazard Symbols:EU Risk Phrases:_____SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEV ersion: MATERIAL SAFETY data SHEETPage 1 of 11 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 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 03-Apr-2012 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Contact MATERIAL SAFETY data SHEET_____2.

3 HAZARDS IDENTIFICATIONR40 - Limited evidence of a carcinogenic effectR48/22 - Harmful: danger of serious damage to health by prolonged exposure if - May impair - May cause harm to the unborn :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 COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification%Iron oxide1309-37-1215-168-2 Not Listed* ; ;R40Xn;R48/2225 / 50 mg **Magnesium stearate557-04-0209-150-3 Not Listed*Hydrochlorothiazide58-93-5200-403 -3 Not Listed25 / 50 mg **Polyethylene glycol25322-68-3 Not ListedNot Listed*Titanium dioxide13463-67-7236-675-5 Not Listed*Corn Starch9005-25-8232-679-6 Not Listed*Calcium sulfate, dihydrate10101-41-4 Not ListedNot Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Hydroxypropyl cellulose9004-64-2 Not ListedNot Listed*FlavorNOT ASSIGNEDNot ListedNot Listed*Povidone9003-39-8 Not ListedNot Listed*Hydroxypropyl methylcelluslose9004-65-3 Not ListedNot Listed*Additional Information.

4 ** per tablet/capsule/lozenge/suppository* 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. 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 HYDROCHLOROTHIAZIDEM aterial Name: Spironolactone and HydrochlorothiazideTabletsVersion: 2 of 11 Revision date: 03-Apr-2012 MATERIAL SAFETY data SHEET_____Symptoms 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:Toxic or corrosive gases including oxides of carbon and oxides of sulfurFire 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 HANDLING AND STORAGEG eneral Handling:Minimize dust generation and accumulation.

6 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 thoroughly after to the environment should be avoided. Review and implement appropriate technicaland procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this MATERIAL to theatmosphere should be controlled with dust collectors, HEPA filtration systems or otherequivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure AND HYDROCHLOROTHIAZIDER evision date: 03-Apr-2012 MATERIAL Name: Spironolactone and HydrochlorothiazideTabletsAustria OEL - MAKs5 mg/m310 mg/m3 Version: OEL - TWA2 ppm5 mg/m3 Iron oxideDenmark OEL - mg/m3 Page 3 of 11 Estonia OEL - mg/m3 ACGIH Threshold Limit Value (TWA)5 mg/m3 Australia TWA5 mg/m3 MATERIAL SAFETY data SHEET_____8.

7 EXPOSURE CONTROLS / PERSONAL PROTECTION_____SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEI reland OEL - TWAs5 mg/m310 mg/m34 mg/m3 ACGIH Threshold Limit Value (TWA)10 mg/m3 Lithuania OEL - TWA5 mg/m3 Finland OEL - TWAS weden OEL - TWAs5 mg/m3 Lithuania OEL - mg/m3 Hydrochlorothiazide5 mg/m3 Pfizer OEL TWA-8 Hr:250 g/m3 OSHA - Final PELS - TWAs:Polyethylene glycol10 mg/m3 Austria OEL - MAKs1000 mg/m3 Germany - TRGS 900 - TWAs1000 mg/m3 Poland OEL - TWA5 mg/m3 Germany (DFG) - MAK1000 mg/m3 inhalable fractionFrance OEL - TWAS lovakia OEL - TWA1000 mg/m35 mg/m3 Slovenia OEL - TWA1000 mg/m3 Portugal OEL - TWA5 mg/m3 Titanium dioxideRevision date: 03-Apr-2012 ACGIH Threshold Limit Value (TWA)10 mg/m3 Romania OEL - TWAA ustralia TWA10 mg/m35 mg/m3 Austria OEL - MAKs5 mg/m3 Belgium OEL - TWA10 mg/m3 Slovakia OEL - mg/m3 Bulgaria OEL - mg/m3 Greece OEL - TWA10 mg/m3 Denmark OEL - TWA6 mg/m3 Estonia OEL - TWA5 mg/m3 Spain OEL - TWA5 mg/m3 France OEL - TWA10 mg/m3 MATERIAL Name: Spironolactone and HydrochlorothiazideTabletsGreece OEL - TWA10 mg/m35 mg/m3 Sweden OEL - TWAsIreland OEL - TWAs10 mg/m34 mg/m3 Latvia OEL - TWA10 mg/m3 Hungary OEL - TWAL ithuania OEL - TWA5 mg/m3 Spironolactone6 mg/m3 OSHA - Final PELS - TWAs:15 mg/m3 Version: OEL - mg/m3 Pfizer OEL TWA-8 Hr:90 g/m3, SkinPage 4 of 11 Magnesium stearate MATERIAL SAFETY data SHEET_____8.

8 EXPOSURE CONTROLS / PERSONAL PROTECTIONA nalytical Method:Analytical method available for Spironolactone. Contact Pfizer Inc for further Controls:General room ventilation is adequate unless the process generates dust, mist or controls should be used as the primary means to control exposures. Keepairborne contamination 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.

9 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 PROPERTIES_____SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEACGIH Threshold Limit Value (TWA)10 mg/m3 ACGIH Threshold Limit Value (TWA)10 mg/m3 Germany (DFG) - mg/m3 respirable fraction4 mg/m3 inhalable fraction10 mg/m3 Ireland OEL - TWAs10 mg/m34 mg/m3 Portugal OEL - TWA10 mg/m3 Australia TWA10 mg/m3 Belgium OEL - TWA10 mg/m3 Romania OEL - TWA10 mg/m3 Bulgaria OEL - mg/m3 Revision date: 03-Apr-2012 Czech Republic OEL - mg/m3 Greece OEL - TWA10 mg/m35 mg/m3 Spain OEL - TWA10 mg/m3 Ireland OEL - TWAs10 mg/m34 mg/m3 MATERIAL Name: Spironolactone and HydrochlorothiazideTabletsOSHA - Final PELS - TWAs:15 mg/m3 Sweden OEL - TWAsPhysical State:Film-coated tabletsPortugal OEL - TWAC olor:Tan10 mg/m3 Molecular Formula:Mixture5 mg/m3 Molecular Weight:MixtureVersion: OEL - TWA4 mg/m3 Page 5 of 11 Spain OEL - TWA10 mg/m3 Corn StarchCalcium sulfate, dihydratePortugal OEL - TWA MATERIAL SAFETY data SHEET_____10.

10 STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:None knownIncompatible 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)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)_____SPIRONOLACTONE AND HYDROCHLOROTHIAZIDES pironolactoneRat Oral LD 50 2750 mg/kgPovidoneMouse Oral LD 50 2830 mg/kgRat Intravenous LD 50 990 mg/kgRat Oral LD50 100 g/kgDog Intravenous LD 50 250 mg/kgRat Oral LD 50 4121 mg/kgHydroxypropyl methylcellusloseMagnesium stearateRat Oral LD50 > 10,000 mg/kgRevision date: 03-Apr-2012 Rat Oral LD50 > 2000 mg/kgMouse Oral LD 50 >1000 mg/kgSpironolactoneRat Inhalation LC50 > 2000 mg/m3 MATERIAL Name.