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Merck Serono

Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Telephone: +44 (0)208 818 7200
Fax: +44 (0)208 818 7267
Medical Information Direct Line: +44 (0)208 818 7373
Medical Information e-mail: medinfo.uk@merckserono.net
Medical Information Fax: +44 (0)208 818 7274

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Summary of Product Characteristics last updated on the eMC: 03/02/2012
SPC Slo-Phyllin 60mg, 125mg, 250mg, 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 03/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Jan-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Changes are marked in red.

3. Pharmaceutical Form

Prolonged release capsule

Slo-Phyllin 60mg

 

Hard gelatin capsules with opaque white body and clear colourless cap, printed radially in black with Slo-phyllin 60 on one half and Lipha on the other, and containing white-grey to light yellow pellets.

 

Slo-Phyllin 125mg

Hard gelatin capsules with opaque brown body and clear colourless cap, printed radially in black with Slo-phyllin 125 on one half and Lipha on the other, and containing white-grey to light yellow pellets.

Slo-Phyllin 250mg

 

Hard gelatin capsules with opaque purple body and clear colourless cap, printed radially in black with Slo-phyllin 250 on one half and Lipha on the other, and containing white-grey to light yellow pellets.

 

10. Date of (Partial) Revision of the Text

 

31 January 2012

Updated on 25/01/2010 and displayed until 03/02/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Sep-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 7: MA Holder

From

Rona Laboratories Ltd

To

Merck Serono Ltd

Change to section 8: MA Numbers

From

Slo-Phyllin 60mg capsules    PL 0161/0021

Slo-Phyllin 125mg capsules  PL 0161/0019
Slo-Phyllin 250mg capsules  PL 0161/0020

To

Slo-Phyllin 60mg capsules    PL 11648/0079

Slo-Phyllin 125mg capsules  PL 11648/0080

Slo-Phyllin 250mg capsules  PL 11648/0081

Change to section 10: Date of revision of text to reflect date of approval of change of ownership application

From
30 May 2008
To
25 September 2009

Updated on 09/06/2008 and displayed until 25/01/2010
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   28-May-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 4.9 Overdose

4.9    Overdose

 

Over 3 g could be serious in an adult (40 mg/kg in a child). The fatal dose may be as little as 4.5 g in an adult (60 mg/kg in a child), but is generally higher.

 

Symptoms

Warning: Serious features may develop as long as 12 hours after overdosage with sustained release formulations.

 

Alimentary features: Nausea, vomiting (which is often severe), epigastric pain and haematemesis. Consider pancreatitis if abdominal pain persists.

 

Neurological features: Restlessness, hypertonia, exaggerated limb reflexes and convulsions. Coma may develop in very severe cases.

 

Cardiovascular features: Sinus tachycardia is common. Ectopic beats and supraventricular and ventricular tachycardia may follow.

 

Metabolic features: Hypokalaemia due to shift of potassium from plasma into cells is common, can develop rapidly and may be severe. Hyperglycaemia, hypomagnesaemia and metabolic acidosis may also occur. Rhabdomyolysis may also occur.

 

 

Management

Activated charcoal or gastric lavage should be considered if a significant overdose has been ingested within 1-2 hours. Repeated doses of activated charcoal given by mouth can enhance theophylline elimination. Measure the plasma potassium concentration urgently, repeat frequently and correct hypokalaemia. BEWARE! If large amounts of potassium have been given, serious hyperkalaemia may develop during recovery. If plasma potassium is low then the plasma magnesium concentration should be measured as soon as possible.

 

In the treatment of ventricular arrhythmias, proconvulsant antiarrhythmic agents such as lignocaine (lidocaine) should be avoided because of the risk of causing or exacerbating seizures.

 

Measure the plasma theophylline concentration regularly when severe poisoning is suspected, until concentrations are falling. Vomiting should be treated with an antiemetic such as metoclopramide or ondansetron.

 

Tachycardia with an adequate cardiac output is best left untreated. Beta-blockers may be given in extreme cases but not if the patient is asthmatic. Control isolated convulsions with intravenous diazepam. Exclude hypokalaemia as a cause.

Updated on 04/06/2008 and displayed until 09/06/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   28-May-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to the Address of the Marketing Authorisation Holder - section 7

Address is now:

Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Updated on 14/01/2008 and displayed until 04/06/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   01/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 6.1

e
xcipients

 

         The following statement has been added:
 
         Printing ink: black iron oxide (E172), shellac glaze, propylene glycol.
Updated on 04/04/2003 and displayed until 14/01/2008
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 28/06/2001 and displayed until 04/04/2003
Reasons for adding or updating:
  • No reasons supplied
Updated on 14/08/2000 and displayed until 28/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 21/07/2000 and displayed until 14/08/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/07/2000 and displayed until 21/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   theophylline