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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 14/01/2011
SPC DHC Continus prolonged release tablets 60mg, 90mg and 120 mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.4
"The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy.  When a patient no longer requires therapy with dihydrocodeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal." has been added.

"Dihydrocodeine has an abuse profile similar to other agonist opioids.  DHC CONTINUS tablets may be sought and abused by people with latent or manifest addiction disorders.  The product should be used with particular care in patients with a history of alcohol and drug abuse." has been added.  

  "Dihyrocodeine has a recognised abuse and addiction similar to other opioids.  Tolerance to analsgesic effects may develop upon repeated administration" has been deleted.

Section 4.6 "There are no or limited amount of data from the use of dihydrocodeine in pregnant women. Dihydrocodeine should not be used during pregnancy and labour due to the risk of neonatal respiratory depression. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression. Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with dihydrocodeine." has been added.

"Animal studies are insufficient with respect to reproductive toxicity.  DHC CONTINUS tablets are not recommended during pregnancy (see section 4.8) and in women of childbearing potential not using contraception.  There is little published evidence on safey in human pregnancy but dihyrocodeine has been used for many years without apparent ill effects". has been deleted.

Section 4.8 has been rewritten.

Section 4.9
Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea , "which may in severe cases result in a fatal outcome." has been added.

Section 5.1
Pharmacotherapeutic group: Natural opium alkaloids

ATC code: N02A A08  has been added

Central Nervous System

The principal actions of therapeutic value of dihydrocodeine are analgesia and an antitussive effect (depression of the cough reflex by direct effect on the cough centre in the medulla). Antitussive effects may occur with doses lower than those usually required for analgesia.

 Dihydrocodeine may produce respiratory depression by direct action on brain stem respiratory centres.

 Gastrointestinal Tract and Other Smooth Muscle

Dihydrocodeine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.  Digestion of food in the small intestine is delayed and propulsive contractions are decreased.  Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm resulting in constipation. has been added.
Updated on 03/12/2007 and displayed until 14/01/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Change to revision date, now reads February 2007
Updated on 15/03/2007 and displayed until 03/12/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/03/2007 and displayed until 15/03/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 risk benefit statement added
Section4.8 regulat prolonged use is known to lead to addiction and tolerance added. painkiller and headaches statement added
Updated on 04/05/2006 and displayed until 02/03/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   27/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4  Constipation and obstructive bowel disorders added to the list for administering with caution to patients wiath a history of.
 
Updated on 29/06/2005 and displayed until 04/05/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 15/02/2002 and displayed until 29/06/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 14/08/2001 and displayed until 15/02/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 28/09/2000 and displayed until 14/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 28/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  dihydrocodeine tartrate