Olfen max

INFORMATION ON OUTER PACKAGING
CARDBOARD BOX

1. NAME OF THE MEDICINAL PRODUCT

Olfen MAX
Diclofenacum natricum
(in the form of Diclofenacum diethylammonium)
gel, 20 mg/g

2. ACTIVE SUBSTANCE CONTENT

1 gram of gel contains 23.2 mg of diethylammonium diclofenac, equivalent to 20 mg of sodium diclofenac.

3. LIST OF EXCIPIENTS

Excipients:
carbomer, coco-caprylocapronate, cetostearyl polyglycol ether, liquid paraffin, diethanolamine,
isopropyl alcohol, propylene glycol (E 1520), oleic acid (E 570), butylhydroxytoluene (E 321),
fragrance (containing benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool), purified water.
More information is available in the package leaflet.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENTS

Gel
30 g GTIN number: 5 9 0 9 9 9 1 4 4 0 6 5 7
50 g GTIN number: 5 9 0 9 9 9 1 4 4 0 6 2 6
60 g GTIN number: 5 9 0 9 9 9 1 4 4 0 6 4 0
100 g GTIN number: 5 9 0 9 9 9 1 4 4 0 6 6 4
150 g GTIN number: 5 9 0 9 9 9 1 4 4 0 6 3 3
180 g GTIN number: 5 9 0 9 9 9 1 4 4 0 6 7 1

5. METHOD AND ROUTE OF ADMINISTRATION

For topical application to the skin.
Read the instruction leaflet carefully before use.

6. WARNINGS ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date (EXP)

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.
Store in the original packaging to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVING FROM IT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
{Logo of the marketing authorisation holder}

12. MARKETING AUTHORISATION NUMBER

Authorisation number: 26078

13. LOT NUMBER

Lot number (Lot)

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

For adults and adolescents aged 14 years and above
Adults:
Olfen MAX is intended for local, symptomatic treatment of pain and inflammatory conditions, such as:

• soft tissue injuries, including traumatic inflammation of tendons, ligaments, muscles and joints, resulting from, for example, sprains, dislocations and contusions (sports injuries);
• acute muscle pain (e.g. in the back area).

Adolescents aged 14 years and above:
Olfen MAX is intended for short-term, local, symptomatic treatment of acute pain, inflammation and swelling associated with soft tissue injuries, such as traumatic inflammation of tendons, ligaments, muscles and joints caused by sprains, dislocations or contusions (sports injuries).
Dosage instructions are provided in the patient information leaflet.

16. INFORMATION PROVIDED IN BRAILLE

Olfen MAX 20 mg/g gel

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.
MINIMUM INFORMATION TO BE PRINTED ON PRIMARY PACKAGING
TUBE

1. NAME OF THE MEDICINAL PRODUCT

Olfen MAX
Diclofenacum natricum
(in the form of Diclofenacum diethylammonium)
gel, 20 mg/g

2. COMPOSITION OF THE ACTIVE SUBSTANCE

1 gram of gel contains 23.2 mg of diethylammonium diclofenac, equivalent to 20 mg of sodium diclofenac.

3. LIST OF EXCIPIENTS

Excipients:
carbomer, cocoyl caprylocaprate, cetostearyl alcohol polyglycol ether, liquid paraffin, diethanolamine,
isopropyl alcohol, propylene glycol (E 1520), oleic acid (E 570), butylated hydroxytoluene (E 321),
fragrance (containing benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool), purified water.
More information is available in the package leaflet.

4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS

Gel
30 g
50 g
60 g
100 g
150 g
180 g

5. METHOD AND ROUTE OF ADMINISTRATION

For topical application to the skin.
Read the instructions in the leaflet before using the medicine.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep this medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date (EXP)

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.
Store in the original packaging to protect from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH MEDICINAL PRODUCT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
{Logo of the marketing authorisation holder}

12. MARKETING AUTHORISATION NUMBER

Authorisation number: 26078

13. LOT NUMBER

Lot number

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.

15. INSTRUCTIONS FOR USE

For adults and adolescents aged 14 years and older.
Adults:
Olfen Max is intended for local, symptomatic treatment of pain and inflammation in conditions such as:

• soft tissue injuries, including traumatic inflammation of tendons, ligaments, muscles and joints caused, for example, by sprains, dislocations and contusions (sports injuries);
• acute muscle pain (e.g. in the back area).

Adolescents aged 14 years and older:
Olfen Max is intended for short-term, local symptomatic treatment of acute pain, inflammation and swelling associated with soft tissue injuries, such as traumatic inflammation of tendons, ligaments, muscles and joints caused by sprains, dislocations or contusions (e.g. sports injuries).
Dosage instructions are provided in the patient leaflet.

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

Not applicable.

17. UNIQUE IDENTIFIER – 2D CODE

Not applicable.

18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA

Not applicable.