SDS Number 4223 Approved/Revised 14-Dec-2006 Version 10
TAGAMET TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material TAGAMET TABLETS
TAGAMET TILTABS 200 MG * TAGAMET TABLETS 200 MG * TAGAMET
Synonyms
TABLETS 300 MG * TAGAMET TABLETS 400 MG * TAGAMET TABLETS 600
MG * TAGAMET TABLETS 800 MG * NOVAMET TABLETS * CIMETAG
TABLETS * STOMEDINE TABLETS * NDC NO. 0108-5013-20 * CIMETIDINE,
FORMULATED PRODUCT
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
2. COMPOSITION / INFORMATION ON INGREDIENTS
Percentage
Ingredients CAS RN
CIMETIDINE 70 to 88
51481-61-9
NON-HAZARDOUS INGREDIENTS 12 to 30
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Pharmaceutical agent. Exposure might occur via ingestion; skin;
eyes.
Respiratory allergen.
May produce allergic skin reactions.
Possible effects of overexposure in the workplace include: symptoms of
hypersensitivity (such as skin rash, hives, itching, and difficulty breathing);
abnormal nervous system sensations.
Handling this product in its final form presents minimal risk from
occupational exposure. Health effects information is based on hazards of
components.
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Environment No environmental hazards have been identified for this material.
4. FIRST-AID MEASURES
Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the exposed subject is unconscious or semi-conscious. Wash
out the mouth with water. If the exposed subject is fully conscious, give
plenty of water to drink. Obtain medical attention.
Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Medical treatment in cases of overexposure should be treated as an
overdose of cimetidine. In allergic individuals, exposure to this material may
require treatment for initial or delayed allergic symptoms and signs. This
may include immediate and/or delayed treatment of anaphylactic reactions.
Treat according to locally accepted protocols. For additional guidance, refer
to the current prescribing information or to the local poison control
information centre.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product. Ocular
Caused or Aggravated
symptoms may be indicative of allergic reaction. Pulmonary symptoms may
by Exposure
indicate allergic reaction or asthma.
Health Surveillance The need for pre-placement and periodic health surveillance must be
determined by risk assessment. Following assessment, if the risk of
Procedures
exposure is considered significant then exposed individuals should receive
health surveillance focused on detecting respiratory symptoms and
including respiratory function testing.
In the event of overexposure, individuals should receive post exposure
health surveillance focused on detecting respiratory conditions and other
allergy symptoms.
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion Not expected for the product, although the packaging is combustible.
Hazards
Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon
dioxide extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed. For larger
amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
flammable vapours might be evolved from fires involving this product and
associated packaging, self contained breathing apparatus and full protective
equipment are recommended for firefighters. If possible, contain and collect
firefighting water for later disposal.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
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SDS Number 4223 Approved/Revised 14-Dec-2006 Version 10
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Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product. Detergent solutions can be used for clean-up and
Procedures
decontamination operations.
7. HANDLING AND STORAGE
HANDLING
General Requirements Avoid breaking or crushing tablets.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
CIMETIDINE
INGREDIENT
2
GSK Occupational
Hazard Category
SKIN SENSITISER, RESPIRATORY
GSK Occupational 500 mcg/m3 (8 HR TWA)
SENSITISER
Exposure Limit
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material based upon the OEL/Occupational Hazard Category
and the outcome of a site- or operation-specific risk assessment. Refer to
the Exposure Control Matrix for more information about how ECA's are
assigned and how to interpret them.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields or cover goggles if eye
contact is possible.
Respirators If respiratory protective equipment (RPE) is used, the type of RPE will
depend upon air concentrations present, required protection factor as well
as hazards, physical properties and warning properties of substances
present.
Other Equipment or Wear appropriate clothing to avoid skin contact. An eye wash station should
be available.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Light green.
Colour
Tablet.
Physical Form
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity Adverse effects might occur following inhalation.
Skin Effects Minor irritation might occur following direct contact.
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Eye Effects Minor irritation might occur following direct contact with eyes.
Sensitisation Allergic skin reactions might occur following dermal exposure. Respiratory
sensitisation (allergic) reactions might occur following exposure.
Assessment based upon information from human exposure.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Carcinogenicity Not expected to produce cancer in humans under occupational exposure
conditions. No components are listed as carcinogens by GSK, IARC, NTP
or US OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions.
Pharmacological Effects This preparation contains ingredient(s) with the following activity: a
histamine antagonist (H2 sub-type).
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and no environmental effects have been identified. Local regulations
and procedures should be consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided
below.
ECOTOXICITY
Aquatic
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 1000 mg/L, 3 Hours, Residential sludge
Microtox Microtox is a general toxicity test which utilizes a sensitive marine photo
bacteria as the test species. This material contains an active
pharmaceutical ingredient that is not toxic to these microorganisms.
EC50: 351 mg/L, 15 Minutes
Algal This material contains an active pharmaceutical ingredient that is not toxic
to algae.
IC50: > 105 mg/L, 72 Hours, Selenastrum
capricornutum, green algae, Measured
NOEL: 105 mg/L, 72 Hours, Selenastrum capricornutum,
green algae, Measured
* Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphnids.
EC50: 760 mg/L, 48 Hours, Daphnia pulex, Static test
NOEL: 230 mg/L, 48 Hours, Daphnia pulex, Static test
Fish This material contains an active pharmaceutical ingredient that is not toxic
to fish.
Adult Lepomis macrochirus, bluegill sunfish
EC50: > 1000 mg/L, 96 Hours, Static test
Adult Lepomis macrochirus, bluegill sunfish
NOEL: 1000 mg/L, 96 Hours, Static test
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
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Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into air from water.
Henry's Law Constant < 1.00E-11 atm m^3/mol, Calculated
Adsorption This material contains an active pharmaceutical ingredient that is likely to
adsorb to soil or sediment. It may persist in soil or sediment if released
directly to the environment.
This material contains an active pharmaceutical ingredient that is likely to
adsorb to sludges and other biomass. It may persist in sludges or other
biomass if released directly to the environment.
Soil Sediment Sorption 3.03 to 3.62, Measured
(log Koc):
Sludge Biomass 2.75 to 3.35 Estimated
Distribution Coefficient
(log Kd):
Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically stable in water. Hydrolysis is unlikely to be a
significant depletion mechanism.
Half-Life, Neutral: > 1 Months, Measured, Deionized Water
Photolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water when exposed to light. Aqueous
photolysis may be a significant depletion mechanism.
Half-Life, Aqueous: 2 to 200 Hours, Measured, Lake water
UV/Visible Spectrum: 216 nm at pH 7
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment. It is not expected to persist in the environment.
Aerobic - Inherent
Percent Degradation: 50 %, 3 days, Batch activated sludge (BAS),
Activated sludge
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
Bioconcentration Factor: 1 Estimated
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only
authorised persons trained and competent in accordance with appropriate national and international
regulatory requirements may prepare dangerous goods for transport.
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UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US
or European ground transport purposes.
15. REGULATORY INFORMATION
The information included below is an overview of the major regulatory requirements. It should not be
considered to be an exhaustive summary. Local regulations should be consulted for additional requirements.
EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal
product, cosmetic product or medical device.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 14-Dec-2006 SDS Version Number 10
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION US Environmental (EPA) Requirements
The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate
as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the
responsibility of the user to determine the applicability of this information and the suitability of the material
or product for any particular purpose.
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