Last Updated on eMC 05-02-2016 View medicine  | Wockhardt UK Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:29-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

ADR statement -4.8

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:04-03-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 amended to include information regarding maintenance during unstable angina and acute peripheral arterial occlusion

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:18-09-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of information relating to "heparin resistance" in sections 4.2 & 4.4. 

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change of Marketing Authorisation Holder
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC:07-09-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.3: text added –

 

Because of the special hazard of post-operative haemorrhage heparin is contra-indicated during surgery of the brain, spinal cord and eye, in procedures at sites where there is a risk of bleeding, in patients that have had recent surgery, and in patients undergoing lumbar puncture or regional anaesthetic block.

 

 

Section 4.4: text amended:

 

The risk of bleeding is increased with severe renal impairment and in the elderly (particularly elderly women) over 60 years of age.

 

 

Section 4.5 – text amended

 

Interaction with other medicinal products and other forms of interactions

           

            Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and other NSAIDs, dextran solutions, dipyridamole, or any other drug which may interfere with coagulation, should be used with care.  Increased risk of haemorrhage with ketorolac (avoid concomitant use even with low-dose heparin).

 

            Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with oral anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase, dipyridamole, dextran solutions, or. Aany other drug which may interfere with coagulation.

           

Cephalosporins:  Some cephalosporins, e.g. cefaclor, cefixime and ceftriaxone, can affect the coagulation process and may therefore increase the risk of haemorrhage when used concurrently with heparin.

 

ACE inhibitors:  Hyperkalaemia may occur

 with concomitant use ACE inhibitors

           

 Nitrates:  Reduced activity of heparin has been reported with simultaneous intravenous glyceryl trinitrate infusion.

          

Probenecid: May increase the anticoagulant effects of heparin.

 

 Tobacco smoke:  Nicotine may partially  counteract the anticoagulant effect of heparin.  Increased heparin dosage may be required in  smokers.

 

            Interference with diagnostic tests may be  associated with pseudo-hypocalcaemia (in

            haemodialysis patients), artefactual increases in total thyroxine and triiodothyronine,

             simulated metabolic acidosis and inhibition of the chromogenic lysate assay for

            endotoxin.  Heparin may interfere with the determination of aminoglycosides by   immunoassays.     

 

Section 4.8 – text added:

Adrenal insufficiency secondary to adrenal haemorrhage has been associated with heparin (rarely).

 

Section 6.2 – text added:

 

The following drugs are incompatible with heparin;

                       

                        Alteplase, amikacin sulphate,   amiodarone hydrochloride, ampicillin sodium, aprotinin, benzylpenicillin  potassium or sodium, cefalotin sodium,   chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium  besilate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam, doxorubicin hydrochloride, droperidol, erythromycin lactobionate, gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone sodium succinate, kanamycin sulphate, labetolol hydrochloride, meticillin sodium, methotrimeprazine, netilmicin sulphate, nicardipine hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride, polymyxin B sulphate,

                         promethazine hydrochloride, streptomycin sulphate, tobramycin sulphate, triflupromazine hydrochloride, vancomycin hydrochloride and vinblastine

                         sulphate. 

                         

             


Section 7 - 'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'

Section 8 - PL 04543/0210 amended to PL 29831/0106

Section 9 & 10 amended

Reasons for adding or updating:

  • Change to section 1 - trade name
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-04-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1: product debranded, name amended

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

  • Change to section 3 - pharmaceutical form

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation