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Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Telephone: +44 (0)1707 366 000
Fax: +44 (0)1707 338 297
WWW: http://www.rocheuk.com
Medical Information Direct Line: +44 (0)800 032 7298
Medical Information e-mail: roche@professionalinformation.co.uk
Customer Care direct line: +44 (0)800 731 5711
Medical Information Fax: +44 (0)1748 828801

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: 17/05/2011
SPC Madopar Hard Capsules

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 17/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   15-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Underlined text has been added:

 

6.1       List of Excipients

 

Capsule contents:

Microcrystalline cellulose (E460)

Povidone K90 (E1201)

Talc (E553b)

Magnesium stearate (E572)

Mannitol (E421)

 

Capsule shell:

Gelatin

Indigo carmine (E132)

Titanium dioxide (E171)

Iron oxide (E172)

 

Printing Ink:

Black iron oxide (E172)

 
Updated on 11/04/2011 and displayed until 17/05/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   20-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 29/04/2009 and displayed until 11/04/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   20-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following underlined text has been added to section 4.8:

Laboratory abnormalities:

-        Transient rises in SGOT, SGPT and alkaline phosphatase values have been noted.

-        Increase of gamma-Glutamyltransferase has been reported.

-        Serum uric acid and blood urea nitrogen levels are occasionally increased.
Updated on 17/09/2007 and displayed until 29/04/2009
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Underlined text has been added, text with strike through deleted

 

4.9       Overdose symptoms, emergency procedures, antidotes

Symptoms and signs

Symptoms and signs of overdosage are qualitatively similar to the side-effects of Madopar in therapeutic doses but may be of greater severitymagnitude.

 

Overdose may lead to cardiovascular side effects (e.g. cardiac arrhythmias), psychiatric disturbances (e.g. confusion and insomnia), gastro-intestinal effects (e.g. nausea and vomiting) and abnormal involuntary movements (see section 4.8)

 

Treatment

Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular patients may require symptomatic treatment for cardiovascular effects (e.g. antiarrhythmics) or central nervous system effects (e.g. respiratory stimulants, neuroleptics).

 

Treatment should include gastric lavage, general supportive measures, intravenous fluids and the maintenance of an adequate airway.

 

Electrocardiographic monitoring should be instituted and the patient carefully observed for the possible development of arrhythmias.  If necessary, anti-arrhythmic therapy should be given and other symptoms treated as they arise.

 
Updated on 24/08/2007 and displayed until 17/09/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Underlined text has been added, text with strike through deleted:

 

4.4              Special warnings and precautions for use

 

Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists and/or levodopa for Parkinson’s disease.  Madopar is not a dopamine agonist, however caution is advised as Madopar is a dopaminergic drug.

 

4.8              Undesirable effects

 

-          Patients treated with dopamine agonists and/or levodopa for treatment of Parkinson’s disease, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose of treatment discontinuation.  Madopar is not a dopamine agonist, however there is the possibility that these adverse effects may occur as Madopar is a dopaminergic drug.

 
Updated on 22/05/2006 and displayed until 24/08/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   31/01/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1
Any reference to 62.5mg, 125mg and 250mg has been changed to read 50mg/12.5, 100mg/25mg and 200mg/50mg.
 
Section 2
Previous text:

Each 62.5 capsule contains 50.0mg Levodopa and 14.25mg Benserazide hydrochloride (equivalent to 12.5mg of the base).

Each 125 capsule contains 100mg Levodopa and 28.5mg Benserazide hydrochloride (equivalent to 25mg of the base).
Each 250 capsule contains 200mg Levodopa and 57mg Benserazide hydrochloride (equivalent to 50mg of the base).

New text:

 Madopar 50 mg/12.5 mg: Each capsule contains 50.0mg Levodopa and 12.5mg Benserazide  (as benserazide hydrochloride).

 

Madopar 100 mg/25 mg: Each capsule contains 100.0 mg Levodopa and 25 mg Benserazide (as benserazide hydrochloride).

 

Madopar 200 mg/50 mg: Each capsule contains 200.0 mg Levodopa and 50 mg Benserazide (as benserazide hydrochloride).

 

For excipients, see section 6.1

 

Section 4.2:
Any reference to 62.5mg, 125mg and 250mg has been changed to read 50mg/12.5, 100mg/25mg and 200mg/50mg.
 
Section 6.1:
"E" numbers added to excipients.
 
Section 6.4:
Added - Store in original package.
Reference to "container" changed to "bottle"
 
Section 9:
Date of renewal changed
 
Section 10:
Date of revision changed
 

 
Updated on 08/03/2006 and displayed until 22/05/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/03/2003 and displayed until 08/03/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Updated on 24/10/2001 and displayed until 06/03/2003
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 17/08/2001 and displayed until 24/10/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  levodopa
  benserazide hydrochloride