Animal studies and extensive human experience to date yield no evidence of reproductive toxicity.

6. Pharmaceutical particulars
6.1 List of excipients
Tablet core:

powdered cellulose

pregelatinised starch

sodium starch glycolate (Type A)

maize starch

magnesium stearate

Film-coating:

hypromellose

lactose monohydrate

titanium dioxide (E171)
macrogol 6000
yellow iron oxide (E172)
propylene glycol
talc
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years in paper/PET/aluminium-PVC blister packs
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Tramadol hydrochloride/Paracetamol tablets are packed in paper/PET/aluminium-PVC blisters.
Box of 2 tablets, of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets
Not all packaging sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Grünenthal Ltd
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex UB11 1BD
United Kingdom
8. Marketing authorisation number(s)
PL 21727/0039
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 25 September 2003
Date of last renewal: 22/06/2007
10. Date of revision of the text
12/06/2017