MATERIAL SAFETY DATA SHEET - Pfizer: One of …

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: AVIGRA (Sildenafil Citrate) TabletsTrade Name:Viagra Synonyms:Sildenafil citrate tabletsChemical Family:MixtureIntended Use:Pharmaceutical product used for male erectile dysfunction2. HAZARDS IDENTIFICATIONA ppearance:Blue film-coated tabletsStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:Active ingredient may be harmful if swallowed. May cause eye irritation (based oncomponents) .Long Term:Animal studies indicate that this MATERIAL may cause adverse effects on the Clinical Effects:Adverse effects most commonly reported in clinical use include difficult digestion (dyspepsia),nose bleed, headache, flushing, insomnia, abnormal redness of skin (erythema), difficultybreathing, muscle pain, fever, gastrointestinal irritation, tingling/itching (paresthesia), transientchanges in light perception and color vision, effects on hearing, and effects on 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 List EU Classification%Sildenafil citrate171599-83-0 Not ListedXn;R2223_____PZ01668 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 Emergency telephone number:1-877-777-3180 Revision date: 06-Dec-2011 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Contact MATERIAL SAFETY data SHEET_____3.

3 COMPOSITION/INFORMATION ON INGREDIENTSM icrocrystalline cellulose9004-34-6232-674-9 Not Listed*Titanium dioxide13463-67-7236-675-5 Not Listed*Magnesium stearate557-04-0209-150-3 Not Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%FD & C Blue No. 2, Aluminum lake16521-38-3240-589-3 Not Listed*Lactose Monohydrate64044-51-5 Not ListedNot Listed*Triacetin102-76-1203-051-9 Not Listed*Calcium phosphate dibasic, anhydrous7757-93-9231-826-1 Not Listed*Croscarmellose sodium74811-65-7 Not ListedNot Listed*Hydroxypropyl methylcelluslose9004-65-3 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:Immediately flush eyes with water for at least 15 minutes. If irritation occurs or persists, getmedical Contact:Wash skin with soap and water. Remove contaminated clothing and shoes. If irritation occursor persists, get medical attention. This MATERIAL may not be completely removed byconventional laundering. Consult professional laundry service. Do not home :Get medical attention immediately. Do not induce vomiting unless directed by medicalpersonnel. Never give anything by mouth to an unconscious :Remove to fresh air. If not breathing, give artificial respiration. Get medical 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:Fine particles (such as dust and mists) may fuel Information: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: 06-Dec-2011 MATERIAL Name: AVIGRA (Sildenafil Citrate) TabletsVersion: 2 of 8 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. Care should be taken toavoid environmental Consideration for LargeSpills:Non-essential personnel should be evacuated from affected area.

6 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 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 controls.

7 Refer to Section 12 - Ecological Information, for information on potentialeffects on the Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure OEL - TWA10 mg/m3 Sildenafil citrateIreland OEL - TWAs10 mg/m34 mg/m3 Version: OEL - TWA2 mg/m3 pfizer OEL TWA-8 Hr:350 g/m3 OSHA - Final PELS - TWAs:15 mg/m3 Page 3 of 8 Portugal OEL - TWA10 mg/m3 Microcrystalline celluloseRomania OEL - TWA10 mg/m3 Calcium phosphate dibasic, anhydrousSpain OEL - TWA10 mg/m3 Titanium dioxideACGIH Threshold Limit Value (TWA)10 mg/m3 ACGIH Threshold Limit Value (TWA)10 mg/m3 Revision date: 06-Dec-2011 Australia TWA10 mg/m3 Australia TWAA ustria OEL - MAKs5 mg/m310 mg/m3 Belgium OEL - TWA10 mg/m3 Latvia OEL - TWAB ulgaria OEL - mg/m3 Belgium OEL - TWA10 mg/m3 Denmark OEL - TWA6 mg/m310 mg/m3 Estonia OEL - TWA10 mg/m3 MATERIAL Name: AVIGRA (Sildenafil Citrate) Tablets MATERIAL SAFETY data SHEET_____8.

8 EXPOSURE CONTROLS / PERSONAL PROTECTIONA nalytical Method:Analytical method available for Sildenafil. 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).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.

9 STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:None knownIncompatible Materials:As a precautionary measure, keep away from strong oxidizers_____PZ01668 OSHA - Final PELS - TWAs:15 mg/m3 Poland OEL - mg/m3 France OEL - TWA10 mg/m3 Portugal OEL - TWA10 mg/m3 Revision date: 06-Dec-2011 Romania OEL - TWA10 mg/m3 Spain OEL - TWA10 mg/m3 Greece OEL - TWA10 mg/m35 mg/m3 Physical State:TabletColor:BlueSweden OEL - TWAs5 mg/m3 Molecular Formula:MixtureMaterial Name: AVIGRA (Sildenafil Citrate) TabletsMolecular Weight:MixtureMagnesium stearateIreland OEL - TWAsACGIH Threshold Limit Value (TWA)10 mg/m310 mg/m34 mg/m3 Version: OEL - TWA5 mg/m3 Page 4 of 8 Sweden OEL - TWAs5 mg/m3 Latvia OEL - TWA10 mg/m3 Estonia OEL - TWAL ithuania OEL - TWA5 mg/m35 mg/m3 MATERIAL SAFETY data SHEET_____11.

10 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)Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))_____PZ01668 Sildenafil citrateTriacetinRat Oral LD50 > 5000 mg/kgRat Oral LD 50 3000 mg/kgRat Oral LDmin.