Manseldem 60-1000mg Film-coated Tablets

국가: 영국

언어: 영어

출처: myHealthbox

유효 성분:

Codeine Phosphate Hemihydrate/Paracetamol

제공처:

Actavis Group PTC ehf

ATC 코드:

N02AA59

INN (국제 이름):

Codeine Phosphate Hemihydrate/Paracetamol

복용량:

60/1000mg

약제 형태:

Film-coated tablets

관리 경로:

Oral use

패키지 단위:

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

처방전 유형:

POM - Prescription Only Medicine

Manufactured by:

Balkanpharma-Dupnitsa AD

치료 그룹:

Codeine, combinations excl. Psycholeptics

치료 징후:

For the relief of moderate to severe pain in adults and adolescents 16 years and older. Codeine is indicated in patients 16 years and older for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen

승인 상태:

Authorised

승인 날짜:

2015-05-13

환자 정보 전단

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 16 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 tongue
•  if you are allergic to soya or peanut
•  if you have severe asthma attacks or severe breathing problems
•  if you have recently had a head injury
•  if you have severe liver problems
•  if you have been told by your doctor that you have increased 
pressure in your head. Signs of this include: headaches, being 
sick (vomiting) an

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Manseldem 60/1000mg Film-coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 60mg Codeine Phosphate Hemihydrate
and 1000mg 
Paracetamol  

Excipient with known effect: Each film-coated tablet contains
5.85mg lecithin soya 
(E322). 

For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Film-coated tablets 

Manseldem Film-coated tablets are white, oval, 10.7
x 21.4mm, biconvex tablets, 
marked ’10 6’ on one side with a score line on the other
side and side scores. 

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 adolescents 16 years and older. 

Codeine is indicated in patients 16 years and older 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. 

This presentation is reserved for use in adults and
in adolescents over 50kg of body 
weight aged 16 years and above. 

_Adults over 18 years: _One tablet not more frequently than
every 4 hours, up to a 
maximum of 4 tablets in any 24 hour period. 
_ _
_Adolescents over 50kg of body weight aged 16 years and above: _
One tablet not more frequently than every 6 hours, up to a
maximum of 4 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 (