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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.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: 24/05/2010
SPC Motens Tablets 4mg

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 24/05/2010 and displayed until Current
Reasons for adding or updating:
  • 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:   01-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8

 

The following text has been deleted:

 

Muscle cramps and disturbances of mood have also been reported rarely.

 

The following text has been added:

 

Psychiatric disorders:

Depression                  rare

 

Musculoskeletal and  connective tissue disorders:

Muscle cramps            rare

 

Section 10

Date of revision updated to May 2010
Updated on 04/05/2010 and displayed until 24/05/2010
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 4.6 - 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:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4

Minor wording changes.

 

Section 4.5

Inclusion of information regarding patients (in clinical studies) with a renal transplant treated with cyclosporin; concomitant use of lacidipine and corticoids or tetracosactide; also other minor wording changes.

 

Section 4.6

Update of information.

 

Section 4.8

Update to include tachycardia, syncope and hypotension and to change stomach discomfort to abdominal discomfort.  The side effects have also been re-ordered according to frequency within each system organ class.

 

Section10

Date of revision updated to April 2010.
Updated on 04/08/2009 and displayed until 04/05/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The words PRODUCT SUMMARY have been deleted from just before the Section 1 header.

 

Section 2

The words Excipient: Lactose 255.25 mg per tablet have been added as a new second sentence.

 

The words full list of have been added to what was previously the second sentence, which now reads For full list of excipients, see 6.1.

 

Section 4.3

The hyphen sign has been deleted from the words Contra-indications and contra-indicated in this section.

 

The words In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section 4.4 Special Warnings and Precautions for Use) the use of the product is contraindicated have been added as a final paragraph in this section.

 

Section 4.4

The word special has been deleted from the header of this section which now reads Special Warnings and Precautions for Use.

 

The words This product contains 255.25 mg lactose have been added to the beginning of the last paragraph of this section.

 

Section 4.5

The letter s has been deleted from the word Interactions in the header of this section.

 

The word acid has been deleted from the fourth paragraph of this section to now read … to albumin and a1-glycoprotein.

 

Section 4.8

This section has been reworded with text deleted and new text added, including the ranking of adverse events under frequency headings.

 

Section 6.3

The hyphen sign has been deleted from between Shelf and life in the header of this section.

 

Section 6.6

This whole section (including header text) has been replaced with Special precautions for disposal and No special requirements.

 

Section 8

The text (s) has been added to the end of the section header.

 

Section 9

The word the has been added to the section header between the words of and authorisation.

 

Section 10

The word partial has been deleted from the section header.

 

The date February 2006 has been replaced with the date June 2009.
Updated on 29/09/2006 and displayed until 04/08/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   02/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 Addition of:
Patients with hepatic impairment
Lacidipine is metabolised primarily by the liver and therefore in patients with hepatic impairment, the bioavailability of MOTENS may be increased and the hypotensive effect enhanced.  These patients should be carefully monitored, and in severe cases, a dose reduction may be necessary
 
Section 4.4 Addition of:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
 
Section 4.5
Re-wording of 1st paragraph.
 
Addition of: Lacidipine is known to be metabolised by cytochrome CYP3A4 and, therefore, significant inhibitors and inducers of CYP3A4 administered concurrently may interact with the metabolism and elimination of lacidipine.
 
Section 4.7 Addition of:
MOTENS may cause dizziness.  Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
 
Section 4.9 Addition to Therapy:
Standard general measures for monitoring cardiac function and appropriate supportive and therapeutic measures should be used
Updated on 20/09/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 Addition of:
Patients with hepatic impairment
Lacidipine is metabolised primarily by the liver and therefore in patients with hepatic impairment, the bioavailability of MOTENS may be increased and the hypotensive effect enhanced.  These patients should be carefully monitored, and in severe cases, a dose reduction may be necessary
 
Section 4.4 Addition of:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
 
Section 4.5
Re-wording of 1st paragraph.
 
Addition of: Lacidipine is known to be metabolised by cytochrome CYP3A4 and, therefore, significant inhibitors and inducers of CYP3A4 administered concurrently may interact with the metabolism and elimination of lacidipine.
 
Section 4.7 Addition of:
MOTENS may cause dizziness.  Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
 
Section 4.9 Addition to Therapy:
Standard general measures for monitoring cardiac function and appropriate supportive and therapeutic measures should be used
 
Updated on 27/06/2005 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/08/2001 and displayed until 27/06/2005
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 09/08/2001 and displayed until 22/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 24/07/2001 and displayed until 09/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 07/02/2000 and displayed until 24/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 07/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  lacidipine