DHC Continus prolonged release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIHYDROCODEINE TARTRATE

Available from:

Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom

ATC code:

N02AA08

INN (International Name):

DIHYDROCODEINE TARTRATE 60 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

DIHYDROCODEINE TARTRATE 60 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Withdrawn

Authorization date:

2007-02-22

Patient Information leaflet

2640-7
_DHC_
_®_
 _CONTINUS_
_®_
 60 MG, 90 MG AND 120 MG 
PROLONGED-RELEASE TABLETS
Dihydrocodeine tartrate
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE.
•  Keep this leaflet. You may need to read it
again.
•  If you have any further questions, ask your
doctor or pharmacist.
•  This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
•  If any of the side effects become serious,
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What _DHC_ _CONTINUS_ tablets are and what
they are used for
2. Before you take _DHC_ _CONTINUS_ tablets
3. How to take _DHC_ _CONTINUS_ tablets
4. Possible side effects
5. How to store _DHC_ _CONTINUS_ tablets
6. Further information
1.  WHAT _DHC_ _CONTINUS_ TABLETS ARE AND 
WHAT THEY ARE USED FOR
These tablets have been prescribed for you
to relieve severe pain over a period of 12
hours. They contain the active ingredient
dihydrocodeine which belongs to a group
of medicines called strong analgesics or
‘painkillers’.
2.  BEFORE YOU TAKE _DHC_ _CONTINUS_ TABLETS
DO NOT TAKE _DHC_ _CONTINUS_ TABLETS IF YOU:
•  are allergic (hypersensitive) to
dihydrocodeine or any of the other
ingredients of the tablets (see section 6
‘Further Information’);
•  have breathing problems, such as obstructive
airways disease or respiratory depression.
Your doctor will have told you if you have
these conditions. Symptoms may include
breathlessness, coughing or breathing more
slowly or weakly than expected;
•  are having an asthma attack;
•  have a condition where the small bowel
(part of your gut) does not work properly
(paralytic ileus);
•  have a severe headache or feel sick due to
a head injury or increased pressure in your
skull (for instance due to brain disease).
This is because the tablets may make these
symptoms worse or hide t

Summary of Product characteristics

Page 1 of 6 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

DHC CONTINUS prolonged release tablets 60 mg. 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Dihydrocodeine Tartrate 60 mg. 
3 PHARMACEUTICAL 
FORM 

Prolonged release tablet. 
White capsule-shaped tablet marked DHC 60. 
4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 

For the relief of severe pain in cancer and other
chronic conditions. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adults and children over 12 years: One or two tablets 12-hourly. 
Elderly: Dosage should be reduced. 
Children 12 years or under: Not recommended. 

Method of administration 
Oral. 
4.3 CONTRAINDICATIONS 

Hypersensitivity to dihydrocodeine
or any of the tablet constituents; respiratory depression; 
obstructive airways disease; paralytic ileus; head injury; raised
intracranial pressure; acute 
alcoholism. As dihydrocodeine may cause the release of
histamine, it should not be given 
during an asthma attack and should be given with caution
to asthmatics. 

Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency 
or glucose-galactose malabsorption should not take
this medicine. 

Page 2 of 6 
4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Dosage should be reduced
in the elderly, in hypothyroidism, chronic hepatic disease and 
renal insufficiency.   

Dihydrocodeine should be administered with caution to patients
with a history of opioid 
abuse, biliary tract disorders, prostatic
hypertrophy, pancreatitis, constipation, obstructive 
bowel disorder and severe cor
pulmonale. Dihydrocodeine has a recognised abuse and 
addiction profile similar to other opioids. Tolerance
to analgesic effects may develop upon 
repeated administration. 

The risk-benefit of continued use should be assessed
regularly by the