Revision No.: 00. Section 1. Identification Identification of the product Product Name: Budesonide Capsules. Formula: C 25 H 34 O 6 Chemical Name:

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1 EMERGENCY OVERVIEW Each Budesonide Capsules intended for oral administration contains Budesonide and excipients generally considered to be non- toxic and non-hazardous in small quantities and under conditions of normal occupational exposure. Section 1. Identification Identification of the product Product Name: Budesonide Capsules Formula: C 25 H 34 O 6 Chemical Name: (RS)-11β, 16α, 17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde Manufacturer / supplier identification Company: Cadila Healthcare Ltd., Matoda, India Address: Cadila Healthcare Limited, Plot No- 1A/1 & 2, Pharmez Special Economic Zone, Sarkhej- Bavla N.H. No. 8A, Near Village Matoda, Tal. Sanand, Dist. Ahmedabad , India Contact for information: Tel: Fax: Emergency Telephone No. Tel:

2 Recommended use / Therapeutic Category Restriction on Use / Contraindications: Section 2. Hazard(s) Identification Dose and Administration Adverse Effects Over Dose Effect Budesonide capsules (enteric coated) are corticosteroid indicated for: Treatment of mild to moderate active Crohn s disease involving the ileum and/or the ascending colon Maintenance of clinical remission of mild to moderate Crohn s disease involving the ileum and/or the ascending colon for up to 3 months in adults. Budesonide capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred Newly Diagnosed GBM: 75 mg/m 2 for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m2 once daily for Days 1 to 5 of a 28-day cycle of temozolomide for 6 cycles. (2.1) Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m 2 once daily for 5 consecutive days per 28-day treatment The following clinically significant adverse reactions are described elsewhere in labeling: Hypercorticism and adrenal axis suppression Symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids Increased risk of infection Other corticosteroid effects Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy. If corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism and adrenal axis suppression may occur. For chronic overdosage in the case of severe disease requiring continuous steroid therapy, the dosage may be reduced temporarily. Single oral doses of 200 and 400 mg/kg were lethal in female and male mice, respectively. The signs of acute toxicity were

3 Contraindications Pregnancy Comments Pregnancy Category decreased motor activity, piloerection and generalized edema. Budesonide capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations [see Clinical Considerations]. In animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and rabbits at these dose levels [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage of the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. D

4 Section 3. Composition / information on ingredients Component Exposure Limit CAS No. Principle Component: Budesonide Not Found Inactive Ingredients: Sugar spheres Not Found (sucrose); (starch). Ethylcellulose Aqueous Dispersion Not Found (Aquacoat ECD) Acetyltributyl citrate Not Found Polysorbate 80 (Tween 80) Not Found Methacrylic acid copoly. Not Found Dispersion (Typec) (EUDRAGIT L30D-55) Triethyl citrate (Morflex) Not Found NA Talc Not Found NA Simethicone Emulsion 30% Not Found NA Section 4. First -aid measures General After inhalation: Move to fresh air in case of accidental inhalation. assure fresh air breathing. If there are signs of intoxication, irritation, dizziness or nausea seek medical attention After skin contact: After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing. After eye contact: Rinse with water while holding the eyes wide open. Contact lenses should be removed.

5 Overdose Treatment Section 5. Fire -fighting measures Specific hazards arising from the chemical Special protective equipment and precautions for firefighters After swallowing: Rinse mouth out with water Information for doctor: Most important symptoms and effects, both acute and delayed- No further relevant information available. Indication of any immediate medical attention and special treatment needed- No further relevant information available. Limited data are available related to overdosage in humans. If symptomatic hypotension occurs, initiate supportive treatment. Extinguishing media Suitable extinguishing agents: Use extinguishing media appropriate for surrounding fire. Extinguishing blanket. Carbon dioxide. Dry powder Special hazards arising from the substance or mixture Stable under normal conditions. Advice for firefighters Small amounts: Use normal individual fire protective equipment. Large amounts: Not Protective equipment: Hand protection : Gloves Skin and body protection : Lab coat Respiratory protection : Quarter mask (DIN EN 140) No additional information available Use normal individual fire protective equipment General fire hazards No unusual fire or explosion hazards noted Section 6. Accidental Release Measures Personal precautions, protective Avoid raising dust. Wear suitable protective clothing, gloves equipment and emergency and eye or face protection. procedures Environmental precautions: No additional information available Methods and material for containment and cleaning up: Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.

6 Section 7. Handling and Storage Storage: Section 8. Exposure controls / personal protection Large Spill: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system. Store at 20 C to 25 C (68 F to 77 F) [See USP Controlled Room Temperature]. Keep container tightly closed. Precautions for safe handling: Keep it dry & in a cool, well ventilated place away from heat. Store in original container Information about fire - and explosion protection: No special measures required. Respiratory Protection Quarter mask (DIN EN 140) Skin protection Eye/face protection Protective Clothing Biological limit values Exposure guidelines Thermal hazards For prolonged or repeated skin contact use suitable protective gloves. If contact is likely, safety glasses with side shields are recommended. Protective clothing is not normally necessary, however it is good practice to use apron. No biological exposure limits noted for the ingredient(s). General ventilation normally adequate. Wear appropriate thermal protective clothing, when necessary.

7 General hygiene considerations Keep away from foodstuffs, beverages and feed. Wash hands before breaks and at the end of work. 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. Engineering controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Section 9. Physical and chemical properties Appearance Description of Budesonide Capsules 3 mg : White to offwhite, free flowing pellets, filled in size l hard gelatin capsules having opaque light orange colored cap printed with"720" in black ink and opaque white Solubility Not available. Odour Not available. Boiling point Not available. Melting Point Not available. Evaporation rate Not available. Vapour density Not available. Reactivity in water Not available. Vapour pressure Not available. % Volatile by volume Not available. Specific gravity Not available. Section 10. Stability and Reactivity Conditions to avoid Stable Contact with incompatible materials. Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport. Chemical stability

8 Material is stable under normal conditions. Hazardous reactions Decomposition products No dangerous reaction known under conditions of normal use. When heated to decomposition, emits dangerous fumes. Incompatible materials Strong Oxidizing agent Section 11. Toxicological information General Ingestion Handling of formulated product is not expected to cause any toxicological affects. The data pertains to the ingredient in formulations, rather than this specie formulation. Health injuries are not known or expected under normal use. Expected to be a low ingestion hazard. However, ingestion is not likely to be a primary route of occupational exposure. Other Symptoms related to the Not available physical, chemical and Toxicological characteristics Information on toxicological effects Acute toxicity Acute oral toxicity (LD50): 3200 mg/kg [Rat]. Further information Not available Section 12. Ecological information Poorly soluble in water. No data available on ecotoxicity. Section 13. Disposal Consideration Dispose the waste in accordance with all applicable Federal, State and local laws. Section 14. Transport Information The product is not hazardous when shipping via air (IATA), ground (DOT), or sea (IMDG). In accordance with ADR / RID / IMDG / IATA / ADN Section 15. Regulatory Information Generic Medicine. Under Approval by USFDA & the ANDA Number is

9 Section 16. Other information None Date of issue: 10/05/17 Supersedes edition: New Edition The information contained herein is based on the state of our knowledge. It characterizes the product with regard to the appropriate safety precautions. It does not represent a guarantee of the properties of the product.