Manseldem 30/500mg Film-coated Tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: myHealthbox

Werkstoffen:

Codeine Phosphate Hemihydrate/Paracetamol

Beschikbaar vanaf:

Actavis Group PTC ehf

ATC-code:

N02AA59

INN (Algemene Internationale Benaming):

Codeine Phosphate Hemihydrate/Paracetamol

Dosering:

30/500mg

farmaceutische vorm:

Film-coated tablets

Toedieningsweg:

Oral use

Eenheden in pakket:

8, 10, 16, 20, 24, 30, 40, 50 and 100 film-coated tablets

Prescription-type:

POM - Prescription Only Medicine

Geproduceerd door:

Balkanpharma-Dupnitsa AD

Therapeutische categorie:

Codeine, combinations excl. Psycholeptics

therapeutische indicaties:

For the relief of moderate to severe pain in adults and children above 12 years. Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).

Autorisatie-status:

Authorised

Autorisatie datum:

2015-05-13

Bijsluiter

ACTAVIS LOGO 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

MANSELDEM 30/500MG FILM-COATED TABLETS 

Codeine phosphate hemihydrate/paracetamol 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU. 
- 
Keep this leaflet. You may need to read it again 
- 
If you have further questions, ask your doctor or pharmacist 
- 
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even 
if their signs of illness are the same as yours. 
- 
If you get any side effects, talk to
your doctor or pharmacist.

This includes any possible side effects 
not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 
1. 
What Manseldem is and what it is used for 
2. 
What you need to know before you take Manseldem 
3. 
How to take Manseldem 
4. 
Possible side effects 
5. 
How to store Manseldem 
6. 
Contents of the pack and other information 

1. 
WHAT MANSELDEM IS AND WHAT IT IS USED FOR 

The name of your medicine is Manseldem. 
Manseldem contains two different analgesics
(painkillers) called paracetamol and codeine (as codeine 
phosphate hemihydrate). Codeine belongs to a group
of medicines called opioid analgesics which act to 
relieve pain.  
Manseldem can be used in children over 12 years of age for the
short-term relief of moderate or severe 
pain that is not relieved by other painkillers such
as paracetamol or ibuprofen alone. 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MANSELDEM 

DO NOT TAKE MANSELDEM: 
- 
if you are
allergic to codeine, paracetamol or any of the other ingredients of this medicine (listed in 
Section 6). Signs of an allergic reaction include a rash and
breathing problems. There can also be 
swelling of the legs, arms, face, throat or

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Manseldem 30/500mg Film-coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 30mg Codeine Phosphate Hemihydrate
and 500mg 
Paracetamol  

Excipient with known effect: Each film-coated tablet contains
2.93mg lecithin soya 
(E322). 

For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet 

Manseldem Film-coated tablets are white, oval,
8.5 x 17mm, biconvex tablets, 
marked ’5 3’ on one side with a score line
on the other side. 

The score line is only to facilitate breaking for ease
of swallowing and not to divide 
into equal doses. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
For the relief of moderate to severe
pain in adults and children above 12 years. 

Codeine is indicated in patients older than 12 years of age for
the treatment of acute 
moderate pain which is not considered to be relieved by other
analgesics such as 
paracetamol or ibuprofen (alone). 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 

The duration of treatment should be limited to 3 days and if no
effective pain relief is 
achieved the patients/carers should be advised to seek the views
of a physician. 

_Adults over 18 years:_One or two tablets not more
frequently than every 4 hours, up to 
a maximum of 8 tablets in any 24 hour period. 
_Maximum daily dose: _
• 
The maximum daily dose of Paracetamol must not exceed 4000 mg. 
• 
Maximum single dose is 1000 mg (2 tablets). 

_Elderly:_ As adults, however a reduced dose may be required. See
warnings. 

_Renal insufficiency _
In case of renal insufficiency the dose should be reduced: 
Glomerulal filtration 
Dose 
10 – 50 ml/min 
One Manseldem 30 mg / 500 mg 
tablet every 6 hours 
< 10 ml/min 
One Manseldem 30 mg / 500