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Alli (Orlistat GSK) (orlistat) – Labelling - A08AB01

Updated on site: 05-Oct-2017

Medication nameAlli (Orlistat GSK)
ATC CodeA08AB01
Substanceorlistat
ManufacturerGlaxo Group Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON SLEEVE, 42, 60, 84, 90 or 120 CAPSULES

1.NAME OF THE MEDICINAL PRODUCT

alli 60 mg hard capsules Orlistat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 60 mg orlistat.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

This pack includes:

1 bottle containing 42 hard capsules

1 bottle containing 60 hard capsules

1 bottle containing 84 hard capsules

1 bottle containing 90 hard capsules

1 bottle containing 120 hard capsules

1 carry case

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Glaxo Group Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/07/401/007-011

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.

15.INSTRUCTIONS ON USE

For adults with a BMI of 28 or above

Weight loss aid

Can help you lose more weight than dieting alone.

alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight (BMI 28 or above) adults, aged 18 or over.

alli is clinically proven to help you lose more weight than dieting alone. The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed. This fat passes out of your body and may cause changes to your bowel movements. Eat lower-fat meals to help manage these effects.

To see if your BMI is 28 or above, find your height on the chart. If you weigh less than the weight shown for your height, your BMI is below 28 - do not use alli.

Height

Weight

 

Height

Weight

 

 

 

 

 

1.50 m

63 kg

4' 10''

9 st 8 lbs

1.55 m

67.25 kg

 

5' 0''

10 st 3 lbs

1.60 m

71.75 kg

 

5' 2''

10 st 13 lbs

1.65 m

76.25 kg

 

5' 4''

11 st 9 lbs

1.70 m

81 kg

 

5' 6''

12 st 5 lbs

1.75 m

85.75 kg

 

5' 8''

13 st 2 lbs

1.80 m

90.75 kg

 

5' 10''

13 st 13 lbs

1.85 m

95.75 kg

 

6' 0''

14 st 10 lbs

1.90 m

101 kg

 

6' 2''

15 st 8 lbs

Being overweight increases your risk of developing several serious health problems such as diabetes and heart disease. You should see your doctor for a check-up.

Do not use

if you are under 18 years old.

if you are pregnant or breast-feeding.

if you are taking ciclosporin.

if you are taking warfarin or any other medicines used to thin the blood.

if you are allergic to orlistat or any of the ingredients.

if you have cholestasis (condition where the flow of bile from the liver is blocked).

if you have problems absorbing food (chronic malabsorption syndrome).

Talk to your doctor before taking alli

if you are taking amiodarone for heart rhythm problems.

if you are taking a medicine for diabetes.

if you are taking a medicine for epilepsy.

if you have kidney disease.

if you are taking a thyroid medicine (levothyroxine).

if you are taking medicines for HIV.

if you are taking medicines for depression, psychiatric disorders or anxiousness

Talk to your doctor or pharmacist when taking alli

if you are taking a medicine for high blood pressure.

if you are taking a medicine for high cholesterol. How to use

take one capsule whole with water, three times a day with each main meal containing fat.

do not take more than three capsules a day.

you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.

you should not take alli for more than six months.

<www.xxx.xxx>

16.INFORMATION IN BRAILLE

alli 60 mg hard capsules

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER CARTON SLEEVE, 42, 60, 84, 90 or 120 CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

alli 60 mg hard capsules Orlistat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 60 mg orlistat.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

This pack includes:

1 bottle containing 42 hard capsules

1 bottle containing 60 hard capsules

1 bottle containing 84 hard capsules

1 bottle containing 90 hard capsules

1 bottle containing 120 hard capsules

1 carry case

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Glaxo Group Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/401/007-011

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.

15. INSTRUCTIONS ON USE

Weight loss aid

Can help you lose more weight than dieting alone.

alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight adults, aged 18 or over.

alli is clinically proven to help you lose more weight than dieting alone. The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed. This fat passes out of your body and may cause changes to your bowel movements. Eat lower-fat meals to help manage these effects.

How to use

take one capsule whole with water, three times a day with each main meal containing fat.

do not take more than three capsules a day.

you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.

you should not take alli for more than six months.

For further information about the alli weight loss programme visit <www.xxx.xxx>.

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL, 42, 60, 84, 90 or 120 CAPSULES

1. NAME OF THE MEDICINAL PRODUCT

alli 60 mg hard capsules Orlistat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 60 mg orlistat.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

42 hard capsules

60 hard capsules

84 hard capsules

90 hard capsules

120 hard capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Glaxo Group Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/401/007-011

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.

15. INSTRUCTIONS ON USE

Weight loss aid

Adults, aged 18 or over, who are overweight.

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARRY CASE (SHUTTLE)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

alli 60 mg hard capsules Orlistat

Oral use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

4.BATCH NUMBER

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Holds 3 capsules.

6.OTHER

Read the package leaflet before use.

Do not store above 25°C.

Discard any capsules stored in this case for more than one month.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON SLEEVE, 42, 60, 84, 90 or 120 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

alli 27 mg chewable tablets Orlistat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each chewable tablet contains 27 mg orlistat.

3. LIST OF EXCIPIENTS

Contains lactose and sucrose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

This pack includes:

1 bottle containing 42 chewable tablets

1 bottle containing 60 chewable tablets

1 bottle containing 84 chewable tablets

1 bottle containing 90 chewable tablets

1 bottle containing 120 chewable tablets

1 carry case

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Glaxo Group Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/401/012-016

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.

15. INSTRUCTIONS ON USE

For adults with a BMI of 28 or above

Weight loss aid.

Can help you lose more weight than dieting alone.

Chew one tablet three times a day.

alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight (BMI 28 or above) adults, aged 18 or over.

alli is clinically proven to help you lose more weight than dieting alone. The tablets work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed. This fat passes out of your body and may cause changes to your bowel movements. Eat lower-fat meals to help manage these effects.

To see if your BMI is 28 or above, find your height on the chart. If you weigh less than the weight shown for your height, your BMI is below 28 - do not use alli.

Height

Weight

 

Height

Weight

 

 

 

 

 

 

1.50 m

63 kg

' 10 ''

9 st 8 lbs

1.55 m

67.25 kg

 

' 0 ''

10 st 3 lbs

1.60 m

71.75 kg

 

' 2 ''

10 st 13 lbs

1.65 m

76.25 kg

 

' 4 ''

11 st 9 lbs

1.70 m

81 kg

 

' 6 ''

12 st 5 lbs

1.75 m

85.75 kg

 

' 8 ''

13 st 2 lbs

1.80 m

90.75 kg

 

' 10 ''

13 st 13 lbs

1.85 m

95.75 kg

 

' 0 ''

14 st 10 lbs

1.90 m

101 kg

 

' 2 ''

15 st 8 lbs

Being overweight increases your risk of developing several serious health problems such as diabetes and heart disease. You should see your doctor for a check-up.

Do not use

-if you are under 18 years old.

-if you are pregnant or breast-feeding.

-if you are taking ciclosporin.

-if you are taking warfarin or any other medicines used to thin the blood.

-if you are allergic to orlistat or any of the ingredients.

-if you have cholestasis (condition where the flow of bile from the liver is blocked).

-if you have problems absorbing food (chronic malabsorption syndrome).

Talk to your doctor before taking alli

-if you are taking amiodarone for heart rhythm problems.

-if you are taking a medicine for diabetes.

-if you are taking a medicine for epilepsy.

-if you have kidney disease.

-if you are taking a thyroid medicine (levothyroxine).

-if you are taking medicines for HIV.

Talk to your doctor or pharmacist when taking alli

-if you are taking a medicine for high blood pressure.

-if you are taking a medicine for high cholesterol. How to use

-chew one tablet, three times a day with each main meal containing fat.

-only take one tablet at a time.

-do not take more than three tablets a day.

-you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.

-you should not take alli for more than six months.

<www.xxx.xxx>

16. INFORMATION IN BRAILLE

alli 27 mg chewable tablets

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER CARTON SLEEVE, 42, 60, 84, 90 or 120 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

alli 27 mg chewable tablets Orlistat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each chewable tablet contains 27 mg orlistat.

3. LIST OF EXCIPIENTS

Contains lactose and sucrose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

This pack includes:

1 bottle containing 42 chewable tablets

1 bottle containing 60 chewable tablets

1 bottle containing 84 chewable tablets

1 bottle containing 90 chewable tablets

1 bottle containing 120 chewable tablets

1 carry case

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Glaxo Group Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/401/012-016

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.

15. INSTRUCTIONS ON USE

Weight loss aid

Can help you lose more weight than dieting alone.

Chew one tablet three times a day.

alli is used for weight loss alongside reduced calorie, lower-fat meals in overweight adults, aged 18 or over.

alli is clinically proven to help you lose more weight than dieting alone. The tablets work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed. This fat passes out of your body and may cause changes to your bowel movements. Eat lower-fat meals to help manage these effects.

How to use

-chew one tablet, three times a day with each main meal containing fat.

-only take one tablet at a time.

-do not take more than three tablets a day.

-you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.

-you should not take alli for more than six months.

For further information about the alli weight loss programme visit <www.xxx.xxx>.

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL, 42, 60, 84, 90 or 120 TABLETS

1. NAME OF THE MEDICINAL PRODUCT

alli 27 mg chewable tablets Orlistat

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each chewable tablet contains 27 mg orlistat.

3. LIST OF EXCIPIENTS

Contains lactose and sucrose.

4. PHARMACEUTICAL FORM AND CONTENTS

42 chewable tablets

60 chewable tablets

84 chewable tablets

90 chewable tablets

120 chewable tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

Keep the container tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Glaxo Group Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/07/401/012-016

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product not subject to medical prescription.

15. INSTRUCTIONS ON USE

Weight loss aid

Adults, aged 18 or over, who are overweight.

16. INFORMATION IN BRAILLE

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

CARRY CASE (SHUTTLE)

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

alli 27 mg chewable tablets Orlistat

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. BATCH NUMBER

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

Holds 3 tablets.

6. OTHER

Read the package leaflet before use.

Do not store above 25°C.

Discard any tablets stored in this case for more than one month.

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