NEXIUM TABLETS PH3464

SAFETY DATA SHEET

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

Product identifier

NEXIUM TABLETS
Details of the supplier of : ASTRAZENECA PTY LTD Emergency Telephone
the safety data sheet PO Box 131 +44 (0) 1235 239 670
Alma Road, North Ryde
NSW 2113
AUSTRALIA
+61 2 9978 3500

SafetyDataSheets.AlderleyPark@astrazeneca.com

Alternative Names
Esomeprazole gastro-resistant tablets

CAS No. : Not applicable.

Use : Symptomatic treatment of gastro-oesophageal reflux disease (GERD)

2. HAZARDS IDENTIFICATION

Classification of the substance or mixture

Classification UN GHS

Hazard class Category Hazard statements

Skin sensitisation 1 H317

Chronic aquatic toxicity 3 H412
# Refer to Section 16 'Other
Information'

Label elements

Signal word
Warning

Hazard statements

H317 : May cause an allergic skin reaction.

H412 : Harmful to aquatic life with long lasting effects.

Precautionary statements

P261 Avoid breathing dust.

P273 Avoid release to the environment.

P280 Wear protective gloves.

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P302 + P352 : IF ON SKIN: Wash with plenty of soap and water.

P333 + P313 : If skin irritation or rash occurs: Get medical advice/ attention.

P501 : Dispose of contents/ container to an approved incineration plant.

Other hazards
May cause irritation to skin, eyes and respiratory system. May form explosible dust-air mixture if dispersed.

3. COMPOSITION/INFORMATION ON INGREDIENTS

Mixture:
Component % CAS No.

Esomeprazole Magnesium
5 -8 217087-09-7
Trihydrate
# Category #
Hazard class Hazard statements

Acute toxicity 4 H302

Skin sensitisation 1 H317
Acute aquatic toxicity 3 H402
Chronic aquatic toxicity 2 H411

Component % CAS No.

Celluloses 70 - 71 -
# Category #
Hazard class Hazard statements

- - -
# Refer to Section 16 'Other Information'

4. FIRST-AID MEASURES

Description of first aid measures

Inhalation : Remove patient from exposure. Obtain medical attention if ill effects occur.
Skin Contact : Wash skin with soap and water.
Eye Contact : Irrigate with eyewash solution or clean water, holding the eyelids apart, for at least 10
minutes. Obtain medical attention if ill effects remain.
Ingestion : Wash out mouth with water and give 200-300ml of water to drink. Obtain medical attention
if ill effects occur. Do NOT induce vomiting as a First-Aid measure.

Most important symptoms and effects, both acute and delayed

Refer to sections 2 and 11

Indication of any immediate medical attention and special treatment needed

Symptomatic treatment and supportive therapy as indicated.For further information consult the prescribing
information.

5. FIRE-FIGHTING MEASURES

Extinguishing Media (suitable) : water spray, foam, dry powder or CO2.

Extinguishing Media (unsuitable) : Avoid high pressure media which could cause the formation of
a potentially explosible dust-air mixture.

Special hazards arising from the : If involved in a fire, it may burn and emit noxious and toxic
substance or mixture fumes.

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Special protective actions for fire-fighters : A self contained breathing apparatus and suitable protective
clothing should be worn in fire conditions. Prevent fire
extinguishing water from contaminating surface water or the
ground water system.

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective : Ensure suitable personal protection during removal of spillages.
equipment and emergency procedures See Section 8. Avoid dispersal of dust in the air.

Environmental Precautions : Prevent entry into drains. Collect spillage.

Methods and material for containment and : Avoid dust generation. Transfer spilled tablets to a suitable
cleaning up container for disposal. Wash the spillage area with water. Avoid
release to the environment. See section 13.

7. HANDLING AND STORAGE

Precautions for safe handling : Avoid contact with skin and eyes. Wear protective gloves. See
Section 8. Minimize dust generation and accumulation. The
product may form flammable dust clouds in air, if dust from
crushed tablets is allowed to accumulate.
Conditions for safe storage, including any : Keep container tightly closed. Protect from light.
incompatibilities

Storage temperature : < 30 °C

Specific end use(s) : Not applicable, refer to Section 1

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Control parameters

Occupational Exposure Limit Value

Components Value Control parameters Comments

Esomeprazole Magnesium 0,1 mg/m3 LTEL 8hr TWA COM, HYG
Trihydrate
Cellulose (Total Inhalable Dust) 10 mg/m3 LTEL 8hr TWA WEL
Cellulose (Total Inhalable Dust) 20 mg/m3 STEL 15min WEL
Cellulose (Respirable Dust) 4 mg/m3 LTEL 8hr TWA WEL
Exposure Controls
The specific controls will depend on local circumstances and should be based on the risk assessment.
Appropriate controls to reduce exposure may include engineering controls, for example ventilation, procedural
controls and the use of personal protection equipment.
Prevent entry into drains.See Section 6 for environmental precautions.
Occupational exposure controls
Decisions about whether the use of personal protective equipment (PPE) is appropriate as part of the control
strategy should be based on the workplace risk assessment and should take account of local legislative
requirements for selection and use. There are multiple factors that will affect the specific requirements such as
amount and concentration of the material, duration of exposure, frequency of exposure, external environmental
conditions, the task, the user etc.
The information below should not be used in isolation and should be considered in the context of the workplace
risk assessment on a case by case basis.

The recommended personal protective equipment (PPE) is based on preventing the potential adverse health
effects from exposure to the active pharmaceutical ingredient (API). The risk of exposure to the API in the
formulation/product needs to be taken into consideration.

Respiratory protection
Use a negative pressure air purifying respirator (half face mask) with filter class P3 if the risk assessment
does not support the selection of other protection.

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Skin protection
Use impervious clothing to protect against direct contact with the product if the risk assessment does not
support the selection of other protection. Use impervious protective gloves to protect against direct
contact with the product. If the product is dissolved or wetted use a glove material that is resistant to the
solvent/liquid.

Eye protection
Use safety glasses to protect against direct contact with the product if the risk assessment does not
support the selection of other protection.

9. PHYSICAL AND CHEMICAL PROPERTIES

Information on basic physical and chemical properties

Form : coated tablets

Colour : 20 mg-light pink, 40 mg-pink

Other information

No other data available

10. STABILITY AND REACTIVITY

Reactivity : No known reactivity hazard under normal conditions.

Chemical stability : Stable under normal conditions.

Possibility of hazardous reactions : None known.

Conditions to avoid : No conditions producing hazardous situations known.

Incompatible materials : Acids , decomposes

Hazardous decomposition : No hazardous decomposition products are known.

products

11. TOXICOLOGICAL INFORMATION

The following health hazard assessment is based on a consideration of the composition of this product.

Inhalation : May cause effects as described under single exposure.(STOT)

Skin Contact : May cause skin irritation.

Eye Contact : May cause eye irritation.

May cause conjunctivitis.

Ingestion : Low acute oral toxicity.

Specific Target Organ Toxicity : Single exposure

(STOT) Exposure routes: Oral, Inhalation
May cause nausea and vomiting., Rare cases of hypersensitivity (including
allergic reactions) and CNS-effects (including dizziness and muscle jerks)
have been reported in patients.

Exposure routes: Inhalation

Dust may be irritant to the respiratory tract.

Repeated exposure
Exposure routes: Oral
Target Organs: Stomach
Repeated exposure may produce adverse effects., These effects are
derived from studies in animals.
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Common side effects reported from patients include headache,

gastrointestinal disorders, sinusitis and respiratory infection., May cause
effects as described under single exposure.(STOT)

Sensitisation : May cause an allergic skin reaction.

Omeprazole:
It is an extreme skin sensitiser in animal tests.
Many cases of occupational skin sensitisation have been reported.

Carcinogenicity : The substance is not considered to be carcinogenic.

Mutagenicity : The substance is not considered to be genotoxic.

Reproductive toxicity : There is no evidence of a teratogenic potential or any other adverse

effects on reproductive function.

12. ECOLOGICAL INFORMATION

Harmful to aquatic life with long lasting effects. No information on this formulation. The following information
refers to Omeprazole sodium :

Toxicity : ErC50 green algae 72 H > 76 mg/l

(OECD 201)
EbC50 green algae 72 H 30 mg/l
(OECD 201)
No observed effect concentration (growth rate) green algae 72 H 1,8
mg/l
(OECD 201)
EC50 Daphnia magna 48 H > 100 mg/l
(OECD 202)
NOEC Daphnia magna 21 d 10 mg/l
(OECD 211)
LC50 Zebra Fish 96 H 42 mg/l
(OECD 203)
NOEC fathead minnow 32 d 1 mg/l
(OECD 210)

Effect on Effluent : There is no evidence of inhibition to the aerobic treatment process at a

Treatment concentration of 100 mg/l.

Persistence and degradability : Not rapidly degradable. Biodegradability < 60% (OECD 301C)

Bioaccumulative potential : The substance has low potential for bioaccumulation.

Mobility in soil : No information available.

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Other adverse effects : No information available.

13. DISPOSAL CONSIDERATIONS

Waste treatment methods : Disposal should be in accordance with local, state or national legislation.
Waste, even small quantities, should never be poured down drains, sewers or
water courses. Normal disposal is via incineration operated by an accredited
disposal contractor.

Contaminated Packaging : Empty container will retain product residue. Observe all hazard precautions.

14. TRANSPORT INFORMATION

NOT RESTRICTED FOR TRANSPORT

15. REGULATORY INFORMATION

In order to comply with legal duties it is necessary to consult local and national legislation.

16. OTHER INFORMATION

Hazard statements H302 : Harmful if swallowed.

H317 : May cause an allergic skin reaction.
H402 : Harmful to aquatic life.
H411 : Toxic to aquatic life with long lasting effects.

The following sections contain revisions or new statements :

Minor changes:, 8

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GLOSSARY
COM : In-house occupational exposure limit
LTEL : Long-term exposure limit (8 hour TWA (time-weighted average))
STEL : Short-term exposure limit (15-minute TWA (time-weighted average))
TLV : Threshold Limit Value (ACGIH)
TLV-C : Threshold Limit Value - Ceiling limit (ACGIH)
HYG : An in-house analytical method for occupational exposure monitoring is available
Sk : Can be absorbed through skin, thus contributing to systemic effects
Sen : Capable of causing respiratory sensitisation

This Glossary is applicable to Substances for which Hazardous Ingredients/Occupational Exposure Limits are
assigned.

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