Amdipharm Plc

Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF
Telephone: +44 (0)870 777 7675
Fax: +44 (0)870 777 7875
Medical Information Direct Line: +44 (0)1268 823 049
Medical Information e-mail: medinfo@amdipharm.com
Medical Information Fax: +44 (0)1268 535 287

Summary of Product Characteristics last updated on the eMC: 25/09/2009
SPC Cyclimorph 10 Injection

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 25/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



The bolded information below has been added or changed:

 

            4.8       Undesirable Effects

As Cyclimorph Injection contains morphine and cyclizine, the type and frequency of adverse effects associated with such compounds may be expected.

 

Adverse reactions attributable to morphine include respiratory depression, raised intra-cranial pressure, orthostatic hypotension, drowsiness, confusion, dysphoria, restlessness, miosis, constipation, nausea, vomiting, skin reactions (e.g. urticaria) biliary tract and renal spasm, vertigo and difficulty with micturition.

 

Adverse reactions attributable to cyclizine include urticaria, drug rash, drowsiness/sedation, [1]headache, dryness of the mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia, auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded. 

 

Other Central Nervous System effects which have been reported rarely include dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, twitching, muscle spasms, convulsions, disorientation, dizziness, decreased consciousness transient speech disorders, hypertension and paraesthesia.

 

Rare reports of cholestatic hepatitis and hypersensitivity reactions, including anaphylaxis, angioedema, allergic skin reactions and bronchospasm have been reported in association with cyclizine.  There have also been a few reports of fixed drug eruption (rash), apnoea, generalised chorea, hypersensitivity hepatitis, hepatic dysfunction and agranulocytosis.

 

Anaphylaxis has been reported following intravenous administration of cyclizine co-administered in the same syringe as propanidid.

 

Anaphylactic shock is a rare adverse reaction to morphine.

 

A case of hyperactivity following intravenous administration of morphine during induction of anaesthesia has been reported.

 

A case of morphine-induced thrombocytopenia has been reported.

 

Morphine has a depressant effect on gonadal hormone secretion which can result in a reduction of testosterone leading to regression of secondary sexual characteristics in men on long-term therapy.

 

[2]Injection site reactions including vein tracking, erythema, pain and thrombophlebitis have been reported rarely.

 

Cyclimorph IV injection has demonstrated significant incidence of single cough or paroxysm of coughing immediately after its administration.

 

 

 

 

Updated on 28/06/2006 and displayed until 25/09/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Note: Strikethrough text has been removed, red text is new/additional text

4.5 Interaction with other medicinal products and other forms of interaction

 

The analgesic effect of opioids tends to be enhanced by co-administration of dexamphetamine dexamfetamine, hydroxyzine, and some phenothiazines although respiratory depression may also be enhanced by the latter combination.

10. DATE OF REVISION OF THE TEXT
 
October 2004 June 2006
Updated on 27/09/2005 and displayed until 28/06/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2004 and displayed until 27/09/2005
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

 
   cyclizine
   morphine tartrate