Manufactured by:GLS PHARMA LIMITEDPlot No.10, Phase-I IDA, Jeedimetla,Hyderabad-500 055, Telangana State, India.

Keep medicine out of reach of children.

Each Film coated Tablet contains:

Capecitabine IP 500mg

Excipients q.s.

Colours: Iron Oxide of Red &

Titanium Dioxide IP

Dosage: As directed by an Oncologist.

Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protected from moisture.

Warning: Cytotoxic agent: To be sold by retail on the prescription of an Oncologist / Cancer Hospital / Institution only.

Please refer accompanying package insert for detailed dosage, directions for use and precautions.

Mfg. Lic. No.: 22/RR/TS/2015/F/G

Batch No.:

Mfg. Date:

Exp. Date:

M.R.P. Rs.:(Inclusive of all taxes)

Un varnisharea

1 x 10 Tablets

Capecitabine Tablets IP 500mg

™

Corp. Office: R-4, Main Road,

Khirki Village, Malviya Nagar,

New Delhi - 110 017.

www.glspharma.com

Manufactured by:

Plot No.10, Phase-I, IDA, Jeedimetla, Hyderabad - 500 055, Telangana State, India.

GLS PHARMA LIMITED

Dose Modification guidelines: Patients should be carefully monitored for toxicity. Toxicity due to Capecitabine administration may be managed by symptomatic treatment, dose interruptions and adjustment of Capecitabine dose. Once dose has been reduced it should not be increased at a later time.

Adjustment of Starting Dose in Special Populations: Hepatic Impairment: In patient with mild to moderate hepatic dysfunction due to liver metastases, no starting dose adjustment is necessary; however, patients should be carefully monitored. Patients with severe hepatic dysfunction have not been studied.

Renal Important: Insufficient data are available in patients with renal impairment to provide a dosage recommendation.

G e r i a t r i c p o p u l a t i o n : T h e e l d e r l y m a y b e pharmacodynamically more sensitive to the toxic effects of 5-Fu and therefore, physician should exercise caution in monitoring the effects of Capecitabine in the elderly. Insufficient data are available to provide a dosage recommendation.

STORAGEStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protected from moisture.

SHELF LIFE24 months

HOW SUPPLIEDTMCAPGET 150

Capecitabine Tablets IP 150 mgBlister pack of 10 tablets.

TMCAPGET 500Capecitabine Tablets IP 500 mgBlister pack of 10 tablets.

concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.

Diarrhea: Capecitabine can induce diarrhea, sometimes severe. Necrotizing enterocolitis has been reported with Capecitabine usage.

Pregnancy: Capecitabine may cause fetal harm when given to a pregnant woman. If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Capecitabine.

DRUG INTERACTIONS

Antacid: Aluminum hydroxide- and magnesium hydroxide-containing antacid cause a small increase in plasma concentration of Capecitabine and one metabolite (5'-DFCR).

Coumarin Anticoagulants: Patients taking coumarinderivative anticoagulants concomitantly with Capecitabine should be monitored regularly for alterations in their coagulation parameters.

Phenytoin: The level of phenytoin should be carefully monitored in patients taking Capecitabine and phenytoin dose may need to be reduced.

Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by Leucovorin.

SIDE EFFECTSAdverse effects occurring in >/5% of patients taking Capecitabine are as follows.

Gastrointestinal: Diarrhea, nausea, vomiting, stomatitis, abdominal pain, constipation and dyspepsia.

Skin and subcutaneous: Hand-and-foot Syndrome, dermatitis and nail disorder.

General: Fatigue, pyrexia, pain in limb

Neurological: Paresthesia, headache, dizziness and insomnia.

Metabolism: Anorexia and dehydration

Eye: Eye irritation

Musculoskeletal: Myalgia

C a r d i o v a s c u l a r : E d e m a , b l o o d , n e u t r o p e n i a , thrombocytopenia, anemia, lymphopenia

Hepatobiliary: Hyperbillirubinemia

OVER DOSAGE

The anticipated manifestations of acute overdose are nausea, vomiting, diarrhea, gastrointestinal irritation and bleeding, and bone marrow depression. It should be managed with supportive medical interventions aimed at correcting the presenting clinical manifestations. Although no clinical experience has been reported, dialysis may be of benefit in reducing circulating concentrations of 5-DFUR, a low-molecular weight metabolite of the parent compound.

DOSAGE AND ADMINISTRATION

The recommended dose of Capecitabine is 2500 mg/m2 administered orally daily with food for 2 weeks followed by a 1-week rest period given as 3 week cycles. The Capecitabine

daily dose should be given orally in two divided doses (approximately 12 hours apart) at the end of a meal. Capecitabine tablets should be swallowed with water. The following table displays the total daily dose by body surface area and the number of tablets to be taken at each dose

* National Cancer Institute of Canada Common Toxicity Criteria were used except for the Hand-and-Foot Syndrome.

Recommended Dose Modifications

Toxicity NCCIC Grades*

During a Course ofTherapy

Dose Adjustment for NextCycle (%of starting dose)

Grade 1

Grade 2

Grade 3

Grade 4

st- 1 appearance

st- 1 appearance

st- 1 appearance

nd- 2 appearance

nd- 2 appearance

rd- 3 appearance

rd- 3 appearance

th- 4 appearance

Maintain dose level

Interrupt until resolved tograde 0-1

Interrupt until resolved tograde 0-1

Interrupt until resolved tograde 0-1

Interrupt until resolved tograde 0-1

Interrupt until resolved tograde 0-1

Discontinue treatmentpermanently

Discontinue treatmentpermanently

Discontinue permanentlyor if physician deems it tobe in the patient’s besti n t e r e s t t o c o n t i n u e ,interrupt until resolved tograde 0-1

Maintain dose level

100%

75%

75%

50%

50%

50%

Capecitabine Dose Calculation According to Body Surface Area

*Total Daily dose divided by 2 to allow equal morning and evening doses.

Dose level 225 mg/m2/day

Surface Area(m2)

Total Daily*Dose (mg)

150 mg 500 mg

</=1.24

1.25-1.36

1.37-1.51

1.52-1.64

1.65-1.76

1.65-1.76

1.92-2.04

2.05-2.17

>/=2.18

3000

3300

3600

4000

4300

4600

5000

5300

5600

3

3

3

4

4

4

5

5

5

0

1

2

0

1

2

0

1

2

Number of tablets to be taken at eachdose (morning and evening)

Manufactured by:

CELON LABORATORIES LTD.,# 2, ALEAP Industrial Estate, Gajularamaram,R.R. District - 500 072, A.P., INDIA.

Marketed by:GLS PHARMA LIMITED206, Skylark Building,60, Nehru Place,New Delhi - 110019www.glspharma.com

Capecitabine is a f luoropyrimidine Carbamate withantineoplastic activity. It is an orally administered systemic prodrug of 5’ -deoxy-5-fluorourdine (5; DRUG), which is converted to 5- Fluorouracil (5-FU) in vivo.

Relicape-500TM

Relicape-500TM

Keep medicine out of reach of children.

Each Film coated Tablets contains:

Capecitabine IP 500mg

Excipients q.s.

Colour: Iron Oxide of Red & Titanium

Dioxide IPDosage: As directed by an Oncologist.

Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Storage: Store at a temperature not exceeding 30°C.

Warning: Cytotoxic agent: To be sold by retail on the prescription of an Oncologist / Cancer Hospital / Institution only.

Please refer accompanying package insert for detailed dosage, directions for use and precautions.

Relicape-500

TM

Relic

ape-500

TM

jsyhdsi&‡00Relicape-500

TM

3 x 10 Tablets Rx

Capecitabine

Tablets IP 500mg

Mfg. Lic. No.: 22/RR/TS/2015/F/G Un varnisharea

(mRiknu frfFk)

(volku frfFk)

(?kku la[;k)Batch No.:

Mfg. Date:

Exp. Date:

M.R.P. Rs.:

vf/kdre [kqnjk ewY; (lHkh djksa lfgr)(Inclusive of all taxes) (Per 10 Tablets)

Manufactured by:

Plot No.: 10, Phase-I, IDA, Jeedimetla,

Hyderabad - 500 055, Telangana State, India.

GLS PHARMA LIMITED

Marketed by:

ISO 9001:2008 Certified Company

Survey No.: 112/1/1, Plot No.: 2472,

At: Po-Uruli Devachi, Pune - 412 308.

Caution: It is dangerous to take this preparation except under medical supervision.

Capecitabine Dose Calculation According to Body Surface Area.2

Dose level 2500 mg/m day Number of tablets to betaken at each Dose(morning and evening)

Surface Area(re)Total Daily Dose (mg)

150 mg 500 mg

</=1.24

1.25-1.36

1.37-1.51

1.52-1.64

1.65-1.76

1.65-1.76

1.92-2.04

2.05-2.17

>/=2.18

3000

3300

3600

4000

4300

4600

5000

5300

5600

3

3

3

4

4

4

5

5

5

0

1

2

0

1

2

0

1

2

* Total Daily Dose divided by 2 to allow equal morning and evening doses.

For the use of Registered Medical Practitioner or a Hospital or a Laboratory only

Capecitabine Tablets IP 150mg & 500mgRELICAPE -150 & 500

TM

Rx only

COMPOSITION

Capecitabine Tablets IP 150mgEach film coated Tablets contains:Capecitabine IP 150mgExcipients q.s.Colours: Iron Oxide of Red & Titanium Dioxide IP

TMRELICAPE -150

Capecitabine Tablets IP 500mgEach film coated Tablets contains:Capecitabine IP 500mgExcipients q.s.Colours: Iron Oxide of Red & Titanium Dioxide IP

TMRELICAPE -500

Storage: Store at a temperature not exceeding 30°C.

Presentation:

TMRELICAPE -150 Blister pack of 10 Tablets.

TMRELICAPE -500 Blister pack of 10 Tablets.

SHELF LIFE

24 Months

22500 mg/m

Manufactured by:

Plot No.: 10, Phase-I, IDA, Jeedimetla, Hyderabad - 500 055, Telangana State, India.

GLS PHARMA LIMITEDMarketed by:

ISO 9001:2008 Certified Company

Survey No.: 112/1/1, Plot No.: 2472,At: Po-Uruli Devachi, Pune - 412 308.

RELICAPETM

RELICAPETM

Toxicity NCIC Grades*

During a Course of Therapy

Dose Adjustmentfor Next Cycle

(% of starting dose)

Grade 1

Grade 2

Maintain dose level Maintain Dose Level

*1st appearence Interrupt until resolved to grade 0-1

Interrupt until resolved to grade 0-1

Interrupt until resolved to grade 0-1

Discontinue treatment

permanently

Interrupt until resolved to grade 0-1

Interrupt until resolved to grade 0-1

Discontinue treatment

permanently

Grade 3

Grade 4

100%

75%

50%

50%

75%

50%Discontinue permanently or

If physician deems it to be in the

patient best interest to continue, interrupt

until resolved to grade 0-1

*3rd appearence

*2nd appearence

*4th appearence

*1st appearence

*2nd appearence

*3rd appearence

*1st appearence

*National Cancer Institute of Canada Common Toxicity Criteria were used except for the Hand-and-Foot Syndrome.

RELICAPETM

RELICAPETM

Adjustment of Starting Dose in Special Populations:

ARTWORK DETAILS

9. Design / Style: Leaflet

2. Product: Capget 150/500 (Capecitabine Tablets IP 150/500mg)

3. Country/Market: Domestic

5. No. of Colours: 01

7. Specifications: 60 GSM Map litho paper

8. Dimensions: mm 150 x 165

11. Artwork has been made: 100 %

13. Artwork No.: AW/CPT/A,B/01-00

4. Pack: NA

6. Pantone Shade No.: Pantone Black C

10. Print proof to represent full printing area with Station Numbers: NA

12. Item Code No.: NA

14. Revision No: 00

1. Product Code: NA

Approved By:

Prepared by

PD

Checked by

QA

Checked by

PDN

Authorized by

Head QA

Checked by

QC

16. Change Control No.: NA

15. Reason for change: NA

ARTWORK DETAILS

4. Component: Pack Insert

2. Generic Name: Capecitabine Tablets IP 150mg/500mg

3. Country/Market: Domestic- T.P. (Relic Biotecnology Pvt. Ltd.)

7. No. of Colours: 01

5. Dimensions: 150 x 165mm

9. Specification: 60 GSM Map litho Paper

10. Artwork has been made: 100 %

11. Artwork No.: AW/CPT/A,B/03-00

8. Pantone Shade No.: Pantone Black C

12. Revision No: 00

1. Product Name: Relicape 150/500

14. Change Control No.: NA

13. Reason for change: NA

Approved By:

Prepared by: PD

Sign/Date

Checked by: QC

Sign/Date

Checked by: QA

Sign/Date

Checked by: PDN

Sign/Date

Authorized by: Head QA

Sign/Date