Last Updated on eMC 26-09-2016 View medicine  | Leo Laboratories Limited 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 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 to section 4.6 - Fertility, 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:12-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SmPC updated in line with the Company Core Data Sheet (CCDS) and the QRD template
Section 2 - Excipients with known effect added.
Section 3 - Description added.
Section 4.2 - No change to actual posology.
Section 4.3 - Updated in line with CCDS; some rewording and clarification of existing text.
Section 4.4 - Updated in line with CCDS; excipient warnings added and some rewording and clarification of existing text.
Section 4.5 - Updated in line with CCDS; some rewording and additional examples
Section 4.6 - Updated in line with CCDS; some rewording; additional statements:
- Anticoagulant treatment of pregnant women requires specialist involvement.
- Heparin does not cross the placenta and can be used during all trimesters of pregnancy if clinically needed.
- The decision to use heparin in pregnancy should be taken after evaluation of the risk/benefit in any particular circumstance.
- Reduced bone density has been reported with prolonged heparin treatment during pregnancy.
Section 4.8 - Updated in line with CCDS; addition of statement re reporting of adverse reactions.
Section 4.9 - Reworded:
Haemorrhage is the main complication of overdose.
As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages.
Serious bleeding may require the administration of the antidote protamine sulphate. Patients should be carefully monitored.
Section 5.1 - Pharmacotherapeutic group and ATC code added.
Section 6.3 - Addition of statement re use after first opening.
Section 6.4 - Cross reference to Section 6.3 re storage conditions after first opening.
Section 6.6 - Section reworded.
Section 10 - Date of revision amended to 'September 2016'

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:23-10-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7: Change in the address of the Marketing Authorisation Holder to Horizon, Honey Lane, Hurley, Maidenhead, Berkshire SL6 6RJ, UK 

Reasons for adding or updating:

  • Removal of one or more presentations from joint SPC following discontinuation

Date of revision of text on the SPC:01-06-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Deletion of reference to Heparin (Mucous) Injection 25,000 Units/ml (PL 00043/0039R), as this product is now discontinued.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC:14-06-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.1 Therapeutic indications
Addition of:
'For the prevention of clotting in the extracorporeal circuit during haemodialysis.'

4.2 Posology and method of administration
Addition of:
'For the treatment or prevention of thrombo-embolic disorders.'
'Prevention of clotting during haemodialysis:
An initial bolus dose should be given, followed by a continuous intravenous infusion.
Adults:
Initially: 1,000 - 5,000 IU.
Maintenance:  1,000 - 2,000 IU per hour, adjusted to maintain clotting time > 40 minutes.'

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • 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 to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-04-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2 (posology) statement added in pregnancy section concerning benzyl alcohol.
Section 4.3 (Contraindications) updated to add uncontrolled severe hypertension, acute or subacute septic endocarditis, injuries and operations on the ears, abortus imminens, epidural anaesthesia, premature babies and neonates.

Section 4.4 (Warnings & Precautions) updated to add patients with increased risk of bleeding complications, hypertension, drugs affecting platelet function, intramuscular injection, lumbar puncture and thrombocytopenia. Warnings added concerning benzyl alcohol and parahydroxybenzoates.

Section 4.5 (Interactions) updated list of drugs affecting platelet function or coagulation system.

Section 4.6 (Pregnancy & Lactation) updated - heparin should be used with caution in pregnant women and only if benefits outweigh risks. Precaution required due to uteroplacental haemorrhage, especially at time of delivery. Contraindicated in women with abortus imminens. Information added on benzyl alcohol and use of this formulation in pregnancy.

Section 4.8 (undesirable effects)- section completely re-written and frequencies added.

Section 4.9 (overdose) - first paragraph re-written to reflect minor or severe haemorrhage.

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects