SDS Number 110563 Approved/Revised 09-Mar-2006 Version 9
LAMICTAL TABLETS
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material LAMICTAL TABLETS
LAMICTAL TABLET 25MG * LAMICTAL TABLET 50MG * LAMICTAL TABLET
Synonyms
100MG * LAMICTAL TABLET 150MG * LAMICTAL TABLET 200MG *
LAMICTAL VALPROATE STARTER PACK 25MG * LAMICTAL
MONOTHERAPY STARTER PACK 25MG * LAMICTAL NON-VALPROATE
STARTER PACK 50MG * LAMICTAL COMPRIMES * LAMICTAL
COMPRIMIDOS * NDC NO 0173-0526-00 * NDC NO 0173-0527-00 * NDC NO
0173-0633-02 * NDC NO 0173-0642-55 * NDC NO 0173-0643-60 * NDC NO
0173-0644-60 * NDC NO 0173-0594-01 * NDC NO 0173-0594-02 * NDC NO
0173-0633-10 * LAMOTRIGINE, 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
LAMOTRIGINE 31 to 50
84057-84-1
NON-HAZARDOUS INGREDIENTS 50.0 to 69.0
Unassigned
3. HAZARDS IDENTIFICATION
Expected to be non-combustible.
Fire and Explosion
Health Caution - Pharmaceutical agent.
Exposure might occur via eyes; skin; ingestion.
May produce allergic skin reactions.
Health effects information is based on hazards of components.
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SDS Number 110563 Approved/Revised 09-Mar-2006 Version 9
LAMICTAL TABLETS
Material
Environment Harmful to aquatic organisms. May cause long-term adverse effects in the
aquatic environment.
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 a sodium channel antagonist. 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 This material may cause or aggravate allergy to phenothiazines.
Caused or Aggravated
by Exposure
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,
Procedures
corrosive or 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.
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.
Procedures
7. HANDLING AND STORAGE
HANDLING
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SDS Number 110563 Approved/Revised 09-Mar-2006 Version 9
LAMICTAL TABLETS
Material
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
LAMOTRIGINE
INGREDIENT
2
GSK Occupational
Hazard Category
GSK Occupational 200 mcg/m3 (8 HR TWA)
Exposure Limit
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
Other Equipment or Wear appropriate clothing to avoid skin contact. Wash hands and arms
thoroughly after handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
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 Adverse effects might occur following ingestion.
Inhalation Toxicity No studies have been conducted.
Skin Effects Irritation is not expected following direct contact.
* Eye Effects Minor irritation might occur following direct contact with eyes.
Target Organ Effects Adverse effects might occur in the following organ(s) following
overexposure: central nervous system; red blood cells.
Sensitisation Allergic skin reactions might occur following repeated contact with this
material in susceptible individuals.
Genetic Toxicity Not expected to be genotoxic, based on effects of individual components.
Carcinogenicity 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 sodium
channel antagonist.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This product contains an active ingredient that has been tested and which
may be harmful if released directly to the environment. Consult the MSDS
of the active ingredient for specific information about potential
environmental effects. Appropriate precautions should be taken to limit
release of this mixture to the environment. Local regulations and
procedures should be consulted prior to environmental release.
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SDS Number 110563 Approved/Revised 09-Mar-2006 Version 9
LAMICTAL TABLETS
Material
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, Activated sludge
Microbial Growth This material contains an active pharmaceutical ingredient that is not toxic
to these microorganisms.
Inhibition
Minimum Inhibition > 185 mg/l, , Aspergillus flavus
Concentration: > 185 mg/l, , Azotobacter chroococcum
> 185 mg/l, , Chaetomium globosum
> 185 mg/l, , Nostoc sp.
> 185 mg/l, , Pseudomonas acidovorans
Algal This mixture contains an active pharmaceutical ingredient that is harmful to
algae.
IC50: 39.7 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
NOEL: 7.5 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
Daphnid This mixture contains an active pharmaceutical ingredient that is harmful to
daphnids.
EC50: 56 mg/l, 48 Hours, Daphnia magna, Static test
NOEL: 30 mg/l, 48 Hours, Daphnia magna, Static test
Fish This mixture contains an active pharmaceutical ingredient that is harmful to
fish.
Adult Oncorhyncus mykiss, rainbow trout
EC50: 85 mg/l, 96 Hours, Static test
Adult Oncorhyncus mykiss, rainbow trout
NOEL: 60 mg/l, 96 Hours, Static test
MOBILITY
Solubility This mixture contains an active pharmaceutical ingredient that for
environmental fate predictions has limited solubility in water.
Adsorption This mixture contains an active pharmaceutical ingredient that is not likely
to adsorb to soil or sediment if released directly to the environment. This
mixture contains an active pharmaceutical ingredient that is not likely to
adsorb to sludge or biomass if released directly to the environment.
Sludge Biomass 1.15 Measured Measured at pH 7
Distribution Coefficient
(log Kd):
Partitioning This mixture 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 Years, Measured
Photolysis This mixture contains an active pharmaceutical ingredient that is likely to
undergo photodegradation.
UV/Visible Spectrum: 300 nm at pH > 6, Measured
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SDS Number 110563 Approved/Revised 09-Mar-2006 Version 9
LAMICTAL TABLETS
Material
Biodegradation This mixture contains an active pharmaceutical ingredient that is not readily
nor inherently biodegradable (as defined by 1993 OECD Testing
Guidelines) and may persist in the environment.
Aerobic - Ready
Percent Degradation: 0 %, 28 days, Modified Sturm test.
Aerobic - Inherent
Percent Degradation: 0 %, 14 days, Modified Zahn-Wellens, Activated
sludge
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
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.
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 09-Mar-2006 SDS Version Number 9
SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
DISPOSAL CONSIDERATIONS Regulatory Requirements
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
REGULATORY INFORMATION US Environmental (EPA) Requirements
TOXICOLOGY INFORMATION Eye Effects
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SDS Number 110563 Approved/Revised 09-Mar-2006 Version 9
LAMICTAL TABLETS
Material
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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