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ISOTRETINOIN 10MG SOFT CAPSULES

Active substance(s): ISOTRETINOIN

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Transcript
LABELLING

15

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON

1.

NAME OF THE MEDICINAL PRODUCT

Isotretinoin 10 mg Soft Capsules
Isotretinoin

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each soft capsule contains 10 mg of isotretinoin

3.

LIST OF EXCIPIENTS

Also contains soya-bean oil, refined. See leaflet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

Capsule, soft
20 capsules
28 capsules
30 capsules
50 capsules
56 capsules
60 capsules
84 capsules
90 capsules
100 capsules
112 capsules
120 capsules
168 capsules
180 capsules

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Oral
Read the package leaflet before 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.

16

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

Warning for Female Patients
Isotretinoin will damage an unborn baby. You must not take Isotretinoin if you are pregnant or there is
any possibility that you could be pregnant. You must use effective birth control for one month before
treatment, during treatment and for one month after treatment ends.

8.

EXPIRY DATE

EXP {MM/YYYY}

9.

SPECIAL STORAGE CONDITIONS

Do not store above 25°C. Store in the original package and keep the blister in the outer carton in order
to protect from light.

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

[To be completed nationally]

12.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

13.

BATCH NUMBER

Lot nº

14.

GENERAL CLASSIFICATION FOR SUPPLY

[To be completed nationally]

15.

INSTRUCTIONS ON USE

As directed by a doctor

16.

INFORMATION IN BRAILLE

[To be completed nationally]
17

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS

1.

NAME OF THE MEDICINAL PRODUCT

Isotretinoin 10 mg Soft Capsules
Isotretinoin

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally]

3.

EXPIRY DATE

EXP {MM/YYYY}

4.

BATCH NUMBER

Lot nº

5.

OTHER

Warning for female patients: Isotretinoin will damage an unborn baby. You must not take
Isotretinoin if you are pregnant or there is any possibility that you could be pregnant. You must use
effective birth control for one month before treatment and for one month after treatment ends

18

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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