SAFETY DATA SHEET

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier
Trade name or designation LAMICTAL TABLETS
of the mixture
Registration number -
Synonyms LAMICTAL TABLET 25MG * LAMICTAL TABLET 50MG * LAMICTAL TABLET 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 * LAMICTIN
TABLETS * LAMOTRIGINE, FORMULATED PRODUCT
Issue date 25-November-2015
Version number 12
Revision date 25-November-2015
1.2. Relevant identified uses of the substance or mixture and uses advised against
Identified uses Medicinal Product.

This safety data sheet is written to provide health, safety and environmental information for people
handling this formulated product in the workplace. It is not intended to provide information relevant
to medicinal use of the product. In this instance patients should consult prescribing
information/package insert/product label or consult their pharmacist or physician. For health and
safety information for individual ingredients used during manufacturing, refer to the appropriate
safety data sheet for each ingredient.
Uses advised against No other uses are advised.
1.3. Details of the supplier of the safety data sheet
GlaxoSmithKline UK
980 Great West Road
Brentford, Middlesex TW8 9GS UK
UK General Information (normal business hours): +44-20-8047-5000

Email Address: [email protected]

Website: www.gsk.com

1.4. Emergency telephone

number
TRANSPORT EMERGENCIES:
UK In-country toll call: +(44)-870-8200418
International toll call: +1 703 527 3887
available 24 hrs/7 days; multi-language response

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture

Classification according to Directive 67/548/EEC or 1999/45/EC as amended

Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Classification according to Regulation (EC) No 1272/2008 as amended
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
2.2. Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
2.3. Other hazards Caution - Pharmaceutical agent. See section 11 for additional information on health hazards.

SECTION 3: Composition/information on ingredients

3.2. Mixtures

Material name: LAMICTAL TABLETS SDS IRELAND

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General information
Chemical name % CAS-No. / EC REACH Registration No. INDEX No. Notes
No.

LAMOTRIGINE 40 - < 50 84057-84-1 - -

281-901-8
Classification: Acute Tox. 3;H301

MICROCRYSTALLINE CELLULOSE 20 - < 30 9004-34-6 - -

232-674-9
Classification: -

Polyvinylpyrrolidone 3-<5 9003-39-8 - -

-
Classification: Aquatic Chronic 3;H412

MAGNESIUM STEARATE <1 557-04-0 - -

209-150-3
Classification: -

Other components below reportable levels 30 - < 40

List of abbreviations and symbols that may be used above
M: M-factor
vPvB: very persistent and very bioaccumulative substance.
PBT: persistent, bioaccumulative and toxic substance.
#: This substance has been assigned Community workplace exposure limit(s).
Composition comments The full text for all H-statements is displayed in section 16.

SECTION 4: First aid measures

General information In the case of accident or if you feel unwell, seek medical advice immediately (show the label
where possible). Ensure that medical personnel are aware of the material(s) involved, and take
precautions to protect themselves. Pre-placement and periodic health surveillance is not usually
indicated. The final determination of the need for health surveillance should be determined by local
risk assessment.
4.1. Description of first aid measures
Inhalation Move to fresh air. If breathing is difficult, trained personnel should give oxygen. Call a physician if
symptoms develop or persist. Under normal conditions of intended use, this material is not
expected to be an inhalation hazard.
Skin contact Immediately flush skin with plenty of water. Take off contaminated clothing and wash before reuse.
Get medical attention if symptoms occur.
Eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Ingestion If swallowed, rinse mouth with water (only if the person is conscious). If ingestion of a large
amount does occur, call a poison control centre immediately. Do not induce vomiting without
advice from poison control center.
4.2. Most important symptoms The following adverse effects have been noted with therapeutic use of this material: changes in
and effects, both acute and behaviour; irritability; headache; somnolence; insomnia; dizziness; tremor; incoordination; blurred
delayed vision; nausea; vomiting; diarrhoea; back pain; fatigue; symptoms of hypersensitivity (such as skin
rash, hives, itching, and/or difficulty breathing).
4.3. Indication of any No specific antidotes are recommended. Treat according to locally accepted protocols. For
immediate medical attention additional guidance, refer to the current prescribing information or to the local poison control
and special treatment needed information centre.

SECTION 5: Firefighting measures

General fire hazards No unusual fire or explosion hazards noted.
5.1. Extinguishing media
Suitable extinguishing Water. Foam. Dry chemical powder. Carbon dioxide (CO2).
media
Unsuitable extinguishing None known.
media
5.2. Special hazards arising During fire, gases hazardous to health may be formed.
from the substance or mixture
5.3. Advice for firefighters
Special protective Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
equipment for firefighters

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 Special fire fighting Move containers from fire area if you can do so without risk.
procedures
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
For non-emergency Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Keep
personnel upwind. Keep out of low areas. Wear appropriate protective equipment and clothing during
clean-up. Do not touch damaged containers or spilled material unless wearing appropriate
protective clothing. Ensure adequate ventilation. Local authorities should be advised if significant
spillages cannot be contained. For personal protection, see section 8.
For emergency responders Keep unnecessary personnel away. Use personal protection recommended in Section 8 of the
SDS.
6.2. Environmental precautions Avoid discharge into drains, water courses or onto the ground.
6.3. Methods and material for Stop the flow of material, if this is without risk. Prevent entry into waterways, sewer, basements or
containment and cleaning up confined areas. Following product recovery, flush area with water.
6.4. Reference to other For personal protection, see section 8. For waste disposal, see section 13 of the SDS.
sections

SECTION 7: Handling and storage

7.1. Precautions for safe Avoid breaking or crushing tablets. Avoid prolonged exposure. Observe good industrial hygiene
handling practices.
7.2. Conditions for safe Store in original tightly closed container. Store away from incompatible materials (see Section 10
storage, including any of the SDS).
incompatibilities
7.3. Specific end use(s) Medicinal Product.

SECTION 8: Exposure controls/personal protection

8.1. Control parameters
Occupational exposure limits
GSK
Components Type Value
LAMOTRIGINE (CAS 8 HR TWA 200 mcg/m3
84057-84-1)
OHC 2
Ireland. Occupational Exposure Limits
Components Type Value Form

MAGNESIUM STEARATE TWA 10 mg/m3

(CAS 557-04-0)
MICROCRYSTALLINE STEL 20 mg/m3 Total inhalable dust.
CELLULOSE (CAS
9004-34-6)
TWA 4 mg/m3 Respirable dust.
10 mg/m3 Total inhalable dust.
Biological limit values No biological exposure limits noted for the ingredient(s).
Recommended monitoring Follow standard monitoring procedures.
procedures
Derived no-effect level (DNEL) Not available.

Predicted no effect Not available.

concentrations (PNECs)

Exposure guidelines
8.2. Exposure controls
Appropriate engineering General ventilation normally adequate. An Exposure Control Approach (ECA) is established for
controls operations involving this material based upon the OEL/Occupational Hazard Category and the
outcome of a site- or operation-specific risk assessment.
Individual protection measures, such as personal protective equipment
General information Personal protection equipment should be chosen according to the CEN standards and in
discussion with the supplier of the personal protective equipment. Follow all local regulations if
personal protective equipment (PPE) is used in the workplace.
Eye/face protection Not normally needed. If contact is likely, safety glasses with side shields are recommended. (e.g.
EN 166).

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 Skin protection
- Hand protection Not normally needed. For prolonged or repeated skin contact use suitable protective gloves. Select
suitable chemical resistant protective gloves (EN 374) with a protective index 6 (>480min
permeation time).
- Other Not normally needed. Wear suitable protective clothing as protection against splashing or
contamination. (EN 14605 for splashes, EN ISO 13982 for dust).
Respiratory protection No personal respiratory protective equipment normally required. When workers are facing
concentrations above the exposure limit they must use appropriate certified respirators. Where
breathable aerosols/dust are formed, use suitable combination filter for gases/vapours of organic,
inorganic, acid inorganic, alkaline compounds and toxic particles (eg. EN 14387).
Thermal hazards Wear appropriate thermal protective clothing, when necessary.
Hygiene measures Always observe good personal hygiene measures, such as washing after handling the material
and before eating, drinking, and/or smoking. Routinely wash work clothing and protective
equipment to remove contaminants. For advice on suitable monitoring methods, seek guidance
from a qualified environment, health and safety professional.
Environmental exposure controls
Hazard guidance and Environmental manager must be informed of all major releases.
control recommendations

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties
Appearance
Physical state Solid.
Form Tablet.
Colour Not available.
Odour Not available.
Odour threshold Not available.
pH Not available.
Melting point/freezing point Not available.
Initial boiling point and boiling Not available.
range
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Vapour pressure Not available.
Vapour density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Not available.
Solubility (other) Not available.
Partition coefficient Not available.
(n-octanol/water)
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Explosive properties Not explosive.
Oxidising properties Not oxidising.
9.2. Other information No relevant additional information available.

SECTION 10: Stability and reactivity

10.1. Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
10.2. Chemical stability Material is stable under normal conditions.

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10.3. Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
10.4. Conditions to avoid Contact with incompatible materials.
10.5. Incompatible materials Strong oxidising agents.
10.6. Hazardous None known. Irritating and/or toxic fumes and gases may be emitted upon the product's
decomposition products decomposition.

SECTION 11: Toxicological information

General information Caution - Pharmaceutical agent. Occupational exposure to the substance or mixture may cause
adverse effects.
Information on likely routes of exposure
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
Skin contact Health injuries are not known or expected under normal use.
Eye contact Health injuries are not known or expected under normal use. Direct contact with eyes may cause
temporary irritation.
Ingestion Health injuries are not known or expected under normal use. However, ingestion is not likely to be
a primary route of occupational exposure. May be harmful if swallowed.
Symptoms The following adverse effects have been noted with therapeutic use of this material: changes in
behaviour; irritability; headache; somnolence; insomnia; dizziness; tremor; incoordination; blurred
vision; nausea; vomiting; diarrhoea; back pain; fatigue; symptoms of hypersensitivity (such as skin
rash, hives, itching, and/or difficulty breathing).
11.1. Information on toxicological effects

Acute toxicity Harmful if swallowed.

Components Species Test results
LAMOTRIGINE (CAS 84057-84-1)
Acute
Oral
LD50 Mouse 269 mg/kg
Rat 185 mg/kg
Chronic
Oral
LOEL Monkey 5 mg/kg/day, 1 years
Subacute
Oral
LD Rat 50 mg/kg/day, 30 Day
LOEL Monkey 10 mg/kg/day, 30 Day Behavioural effects.
Rat 10 mg/kg/day, 30 Day Rat-specific kidney
effects.
Subchronic
Oral
LD Monkey 20 mg/kg/day, 6 months Convulsive
effects, Death.
Rat 25 mg/kg/day, 6 months
LOEL Rat 1 mg/kg/day, 6 months Rat-specific kidney
effects.
NOAEL Monkey 5 mg/kg/day, 90 Day
NOEL Monkey 10 mg/kg/day, 6 months
TD Monkey 10 mg/kg/day, 90 Day Behavioural effects.
MAGNESIUM STEARATE (CAS 557-04-0)
Acute
Oral
LD50 Rat > 2000 mg/kg
MICROCRYSTALLINE CELLULOSE (CAS 9004-34-6)
Acute
Dermal
LD50 Rabbit > 2000 mg/kg

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Components Species Test results
Oral
LD50 Rat > 2000 mg/kg
Polyvinylpyrrolidone (CAS 9003-39-8)
Acute
Oral
LD50 Rat > 5000 mg/kg

* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Health injuries are not known or expected under normal use.
Corrosivity
LAMOTRIGINE OECD 404
Result: Non-irritant
Species: Rabbit
Irritation Corrosion - Skin: P.I.I. value
LAMOTRIGINE 0
MAGNESIUM STEARATE 0
Serious eye damage/eye Direct contact with eyes may cause temporary irritation.
irritation
Eye
LAMOTRIGINE OECD 405
Result: Mild irritant
Species: Rabbit
Eye / Kay and Calandra class - Intact
LAMOTRIGINE 3
MAGNESIUM STEARATE 4
Recovery Period: 2 days
Respiratory sensitisation Not established.
Skin sensitisation Not established.
Sensitisation
LAMOTRIGINE SAR / QSAR, DEREK, Lhasa, UK
Result: negative
Germ cell mutagenicity No data available to indicate product or any components present at greater than 0.1% are
mutagenic or genotoxic.
Mutagenicity
LAMOTRIGINE <= 200 mg/kg/day Micronucleus Test
Result: negative
Species: Rat
Ames
Result: negative
BlueScreen mammalian cell mutation assay
Result: negative
GreenScreen mammalian cell mutation assay
Result: negative
In vitro cytogenetic Assay
Result: negative
L5178Y mouse lymphoma thymidine kinase locus assay
Result: negative
Carcinogenicity Carcinogenic effects are not expected as a result of occupational exposure. Not classifiable as to
carcinogenicity to humans.
LAMOTRIGINE 10 - 15 mg/kg/day
Result: negative
Species: Rat
10 - 30 mg/kg/day
Result: negative
Species: Mouse
IARC Monographs. Overall Evaluation of Carcinogenicity
Polyvinylpyrrolidone (CAS 9003-39-8) 3 Not classifiable as to carcinogenicity to humans.
Reproductive toxicity Components in this product have been shown to cause birth defects and reproductive disorders in
laboratory animals. These effects are linked only to high doses of this substance; low doses did
not produce this adverse effect.
Reproductivity
LAMOTRIGINE 12.5 - 25 mg/kg/day Embryofetal Development
Result: Maternal toxicity; adverse foetal effects
Species: Rat

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 Reproductivity
LAMOTRIGINE 20 mg/kg/day Fertility
Result: Parental toxicity, no adverse effects on fertility.
Species: Rat
5 - 20 mg/kg/day Pre- and Post-natal development
Result: Maternal toxicity; adverse foetal effects
Species: Rat
5 - 30 mg/kg/day Embryofetal Development
Result: Maternal toxicity; Foetal NOAEL
Species: Rabbit
6.25 mg/kg/day Embryofetal Development
Result: Maternal toxicity; Foetal NOAEL
Species: Rat
Breast feeding, Possible transient drug-induced effects in
breast-fed infants.
Species: Human
Specific target organ toxicity - Not assigned.
single exposure
Specific target organ toxicity - Not assigned.
repeated exposure
Aspiration hazard Not likely, due to the form of the product.
Mixture versus substance No information available.
information
Other information Caution - Pharmaceutical agent. Occupational exposure to the substance or mixture may cause
adverse effects.

SECTION 12: Ecological information

12.1. Toxicity Contains a substance which causes risk of hazardous effects to the environment.
Components Species Test results
LAMOTRIGINE (CAS 84057-84-1)
Aquatic
Acute
Activated Sludge IC50 Residential sludge > 1000 mg/l, 3 hours
Respiration
Algae EC50 Green algae (Selenastrum 39.7 mg/l, 72 hours
capricornutum)
Crustacea EC50 Water flea (Daphnia magna) 56 mg/l, 48 hours
NOEC Water flea (Daphnia magna) 30 mg/l, 48 hours
Fish LC50 Rainbow trout (Adult Oncorhyncus 85 mg/l, 96 hours
mykiss)
NOEC Rainbow trout (Adult Oncorhyncus 60 mg/l, 96 hours
mykiss)
Microtox MIC Aspergillus flavus > 185 mg/l
Azotobacter chroococcum > 185 mg/l
Nostoc sp. > 185 mg/l
Other MIC Pseudomonas acidovorans > 185 mg/l
Chronic
Algae NOEC Green algae (Selenastrum 7.5 mg/l, 72 hours
capricornutum)
Crustacea LOEC Ceriodaphnia dubia > 10 mg/l, 7 days
NOEC Ceriodaphnia dubia 10 mg/l, 7 days
MAGNESIUM STEARATE (CAS 557-04-0)
Aquatic
Acute
Fish EC50 Orange-red killfish (Adult Oryzias 130 mg/l, 96 hours
latipes)
Polyvinylpyrrolidone (CAS 9003-39-8)
Acute
IC50 Activated sludge > 1000 mg/l, 3 hours Static test

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Components Species Test results
Aquatic
Acute
Crustacea EC50 Water flea (Daphnia magna) 84 mg/l, 48 hours Static test
NOEC Water flea (Daphnia magna) 32 mg/l, 48 hours Static test

* Estimates for product may be based on additional component data not shown.
12.2. Persistence and
degradability
Photolysis
Half-life (Photolysis-atmospheric)
MAGNESIUM STEARATE 17 Hours Estimated
UV/visible spectrum wavelength
LAMOTRIGINE 300 nm Measured, pH >6
MAGNESIUM STEARATE 210 nm
Hydrolysis
Half-life (Hydrolysis-neutral)
LAMOTRIGINE > 1 years Measured
Biodegradability
Percent degradation (Aerobic biodegradation-inherent)
LAMOTRIGINE 0 %, 14 days Modified Zahn-Wellens, Activated sludge
MAGNESIUM STEARATE 77 %, 28 days BOD
Polyvinylpyrrolidone 0 %, 28 days Modified MITI test, Activated sludge
Percent degradation (Aerobic biodegradation-ready)
LAMOTRIGINE 0 %, 28 days Modified Sturm test.
MAGNESIUM STEARATE 95 %, 22 days Sturm test
Percent degradation (Aerobic biodegradation-soil)
MAGNESIUM STEARATE 50 %, 13 days
12.3. Bioaccumulative potential
Partition coefficient
n-octanol/water (log Kow)
LAMOTRIGINE 1.4 (Measured).
Bioconcentration factor (BCF)
MAGNESIUM STEARATE > 9999 Estimated
12.4. Mobility in soil
Adsorption
Sludge/biomass distribution coefficient - log Kd
LAMOTRIGINE 1.15 Measured, pH 7
Soil/sediment sorption - log Koc
MAGNESIUM STEARATE 5.86 Estimated
Mobility in general
Volatility
Henry's law
LAMOTRIGINE 0 atm m^3/mol, 25 C Estimated
Distribution
Octanol/water distribution coefficient log DOW
LAMOTRIGINE 1.4, pH 7
1.4, pH 9
12.5. Results of PBT Not available.
and vPvB
assessment
12.6. Other adverse effects Not available.

SECTION 13: Disposal considerations

13.1. Waste treatment methods
Residual waste Dispose of in accordance with local regulations. Empty containers or liners may retain some
product residues. This material and its container must be disposed of in a safe manner (see:
Disposal instructions). Avoid discharge into water courses or onto the ground.
Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.
Since emptied containers may retain product residue, follow label warnings even after container is
emptied.

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EU waste code The Waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Disposal methods/information Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Do not
discharge into drains, water courses or onto the ground. Dispose in accordance with all applicable
regulations.
Special precautions Dispose in accordance with all applicable regulations.

SECTION 14: Transport information

ADR
Not regulated as dangerous goods.
IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.
Not available.
14.7. Transport in bulk MARPOL Annex II applies to liquids used in a ship's operation that pose a threat to the marine
according to Annex II of environment. These materials may not be transported in bulk.
MARPOL73/78 and the IBC Code

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulations
Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I and II, as amended
Not listed.
Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex I, Part 1 as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex I, Part 2 as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex I, Part 3 as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex V as amended
Not listed.
Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry, as amended
Not listed.
Regulation (EC) No. 1907/2006, REACH Article 59(10) Candidate List as currently published by ECHA
Not listed.
Authorisations
Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorization, as amended
Not listed.
Restrictions on use
Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended
Not listed.
Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at
work, as amended
Not listed.
Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are
breastfeeding, as amended
Not listed.
Other EU regulations
Directive 2012/18/EU on major accident hazards involving dangerous substances
Not listed.
Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at
work, as amended
Not listed.
Directive 94/33/EC on the protection of young people at work, as amended
Not listed.
Other regulations The product is classified and labelled in accordance with EC directives or respective national laws.
This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006.

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National regulations Young people under 18 years old are not allowed to work with this product according to EU
Directive 94/33/EC on the protection of young people at work. Follow national regulation for work
with chemical agents.
15.2. Chemical safety No Chemical Safety Assessment has been carried out.
assessment

SECTION 16: Other information

List of abbreviations Not available.
References GSK Hazard Determination
Information on evaluation The classification for health and environmental hazards is derived by a combination of calculation
method leading to the methods and test data, if available.
classification of mixture
Full text of any H-statements
not written out in full under
Sections 2 to 15 H301 Toxic if swallowed.
H412 Harmful to aquatic life with long lasting effects.
Revision information Product and Company Identification: Product and Company Identification
Composition / Information on Ingredients: Undisclosed Ingredient Statement
Physical & Chemical Properties:
Ecological Information: Reports
Transport information:
Regulatory Information: United States
Material Attributes & Uses; Experimental Data: Material Uses
Training information Follow training instructions when handling this material.
Disclaimer 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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