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Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

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: 09/04/2010
SPC Morphine Sulphate 15mg/ml Injection BP

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 09/04/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   17-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1 - addition of full pharmaceutical form to product name
Updated on 16/09/2008 and displayed until 09/04/2010
Reasons for adding or updating:
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Sep-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - 'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'

Section 8 - PL 04543/0411 amended to PL 29831/0145

Section 9 & 10 amended
Updated on 21/09/2006 and displayed until 16/09/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   11/2004
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2  

Addition of text regarding the following:

·          Reduced dosage in hepatic impairment

·          Reduced dosage in moderate to severe renal impairment

·          Reduced dosage in debilitated patients.

·          Cross-reference to other concomitant illnesses/conditions in section 4.4

 

Section 4.3     

Deletion:

·          Acute abdomen

 

Additions:

·          Risk of paralytic ileus

·          Diarrhoea

 

Supplementary/amended information:

·          Acute respiratory depression

·          Obstructive airways disease (to be covered under section 4.4)

·          Convulsive disorder (move to section 4.4)

·          Interaction with MAOI (move to section 4.5)

·          Head Injury

·          Biliary colic (cross reference to biliary tract disorders in section 4.4)

 

Section 4.4

Deletions:

·          Myasthenia gravis

·          Biliary colic

 

Additions:

·          Convulsive disorders (moved from section 4.3)

·          Urethral stricture

·          Palliative care

·          Cross-referencing to section 4.2 (elderly, hepatic, renal)

 

Amendments/Supplementary:

·          Asthma and decreased respiratory reserve

·          Biliary tract disorders

·          History of drug abuse and dependence

 

 

Section 4.5     

Deletions:

·          Cisapride (no longer on UK market)

·          Cimetidine

·          Anaesthetics and hypotensives

 

Additions:

·          Antidiarrhoeals and antiperistaltic agents (increased risk of severe constipation)

 

Amended/supplementary information:

·          Antipsychotics

·          MAOIs (severe CNS excitation or depression with pethidine, similar interaction possible with other opioids – moved from section 4.3)

·          Ciprofloxacin

 

Section 4.6

Additional of the following text

·          Gastric stasis may increase the mother’s risk of inhalation pneumonia

 

Section 4.8

Deletions:

·          Muscle rigidity

·          Effects more common in ambulatory patients & in those without severe pain

·          Raised intracranial pressure

 

Additions:

·          Tachycardia

·          Dizziness

·          Headache

·          Rash

·          Visual disturbances

·          Sexual – decrease in libido or potency

·          Respiratory depression

 

Supplementary/amended information:

·          Hypothermia (moved to Overdose)

·          Restlessness (moved to Overdose)

·          Confusion/mental clouding

·          Mood changes – dysphoria

·          Urinary retention & tolerance to urinary effects

 

Section 4.9

Amendment of overdose symptoms:

·          Principle overdose symptoms listed first (coma, pinpoint pupils, respiratory depression)

 

Addition of overdose symptoms:

·          Bradycardia, severe dizziness, severe drowsiness, severe restlessness or nervousness, hallucinations, convulsions (especially in infants and children)

 

Deletion of overdose symptoms:

·          Nausea, vomiting, tremor, miosis, dysphoria (not identified in standard texts as key overdose symptoms)

 

Amendment of overdose treatment:

·          Use of naloxone

 

Section 6.2

Deletion:

·          Chlorpromazine hydrochloride injection

 

Addition:

·          Doxorubicin

·          Fluorouracil

·          Consult specialised references for compatibility information
Updated on 29/09/2003 and displayed until 21/09/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  morphine sulphate