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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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: 19/04/2012
SPC Dozic 5mg/5ml Oral Solution

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 19/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • 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:   07-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.6 (Fertility, pregnancy and lactation) Warning regarding the use of antipsychotics during pregnancy and risk of abnormal muscle movements and/or withdrawal symptom in newborns.
In section 4.8 (Undesirable effects) A section for pregnancy, puerperium and perinatal conditions has been added and accounts for neonatal drug withdrawal syndrome.
In section 10 (Date of revision of the text) Updated to 07-Feb-2012
Updated on 07/05/2010 and displayed until 19/04/2012
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:   27-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.4 (Special Warnings and Precautions for Use) text to include a warning for venous thromboembolism has been inserted. A paragraph covering increased mortality in elderly people with dementia has been added. A sentence stating that chlorpromazine is not licensed for the treatment of dementia-related behavioural disturbances has been added.

In section 4.8 (Undesirable Effects) venous thromboemolism including cases of pulmonary embolism and deep vein thrombosis have been included.

In section 10 (Date of (Partial) Revision of the Text) the date has been updated to 27/01/2010.
Updated on 12/05/2008 and displayed until 07/05/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   08-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arrangement
Updated on 29/04/2008 and displayed until 12/05/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arrangement
Updated on 10/09/2007 and displayed until 29/04/2008
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 to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Section 4.3: Added contraindication of clinically sugnificant cardiac disorders, QTc interval prolongation, history of ventricular arrhythmia, Torsade de Pointes, uncorrected hypokalaemia, use of other QT prolonging drugs.

Section 4.4: Caution in patients with cardiovascular diseae or family history of QT prolongation added. Added risk of cerebrovascular adverse events in patients with dementia

Section 4.5: Added: Carbemazepine, phenobarbital, rifampicin, drugs that prolong QT interval, amiodarone, fluoxetine, fluvoxamine, quinidine, buspirone, drugs causing electrolyte imbalance.

Section 4.8: Included ECG changes, prolongation of QT interval, ventricular arrhythmias, VT, VF, Torsades de pointes, cardiac arrest, sudden unexplained death.
Updated on 26/09/2002 and displayed until 10/09/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  haloperidol