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Lundbeck Limited
Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG
Telephone: +44 (0)1908 649 966
Fax: +44 (0)1908 647 888
WWW: http://www.lundbeck.co.uk
Medical Information Direct Line: +44 (0)1908 638 972
Medical Information e-mail: ukmedicalinformation@lundbeck.com
Customer Care direct line: +44 (0)1908 638 935

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: 23/05/2011
SPC Cipralex 5, 10 and 20 mg film-coated tablets and 20 mg/ml oral drops, 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 23/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.5 has been revised. 
  • 5mg, 10mg, 20mg Tablets - to register an alternative High Density Polyethylene (HDPE) tablet container (not marketed)
  • 20mg Drops - Deletion of the hospital pack size (5 x 15ml), which was not marketed.

The date of revision is updated to 19 April 2011.
Updated on 04/04/2011 and displayed until 23/05/2011
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Date of revision of text on the SPC:   12-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The change is due to removal of one of the strengths of Cipralex drops.

Cipralex drops 10mg/ml will not be available after 31st March 2011.  However, Cipralex drops 20mg/ml will continue to be available.

The joint SmPC here has therefore been revised to reflect this.
Updated on 02/12/2010 and displayed until 04/04/2011
Reasons for adding or updating:
  • 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:   12-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4
The paragraph on epilepsy has been re-worded:
"Escitalopram should be discontinued if a patient  develops seizures for the first time, or if there is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy). SSRIs should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored."
In the paragraph on hyponatraemia, the following sentence has been re-worded:
"Caution should be exercised in patients at risk, such as the elderly, or patients with cirrhosis, or if used in combination with other medications which may cause hyponatraemia."

Section 4.5 para on haemorrhage, the following sentence has been added: "Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase bleeding-tendency (see section 4.4)."

Section 4.8 the table of adverse events as been reformatted.  The following information has been added. " In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 msec at the 10 mg/day dose and 10.7 msec at the 30 mg/day dose."
Updated on 13/08/2010 and displayed until 02/12/2010
Reasons for adding or updating:
  • SPC Retired pending re-submission
  • 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:   15-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6 Pregnancy and lactation

 

Addition of: Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).  The observed risk was approximately 5 cases per 1000 pregnancies.  In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.

 

Section 4.8 Undesirable effects

 

Addition of:  Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.  The mechanism leading to this risk is unknown.
Updated on 10/06/2010 and displayed until 13/08/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   09-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 02/07/2009 and displayed until 10/06/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  escitalopram oxalate