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Abbott Healthcare Products Limited
Solvay Healthcare, Mansbridge Road, West End, Southampton, SO18 3JD
Telephone: +44 (0)2380 467 000
Fax: +44 (0)2380 465 350
Medical Information e-mail: medinfo.shl@abbott.com
Customer Care direct line: +44 (0)1753 650 099
Medical Information Fax: +44 (0)2380 465 350

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: 17/02/2012
SPC Tarka 180mg/2 mg modified-release 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 17/02/2012 and displayed until Current
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
Date of revision of text on the SPC:   13-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special warnings and special precautions for use

Intestinal angioedema

Intestinal angioedema has also been reported in patients treated with ACE inhibitors. This should be considered in patients on Tarka presenting with abdominal pain (with or without nausea or vomiting).

Section 4.5 Interaction with other medicinal products and other forms of interaction

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (P-gp). Verapamil is known to inhibit CYP3A and P-gp. When verapamil and colchicine are administered together, inhibition of P-gp and/or CYP3A by verapamil may lead to increased exposure to colchicine. Combined use is not recommended.

is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (P-gp). Verapamil is known to inhibit CYP3A and P-gp. When verapamil and colchicine are administered together, inhibition of P-gp and/or CYP3A by verapamil may lead to increased exposure to colchicine. Combined use is not recommended.

Section 4.8 Undesirable effects

Additional of Stevens-Johnson syndrome with a not known frequency

In addition, further clarification has been added to Section 4.5 on the pharmacokinetic interactions with verapamil and Section 4.8 on adverse events seen with ACE inhibitors and phenylalkylamine calcium-channel blockers.
Updated on 11/11/2010 and displayed until 17/02/2012
Reasons for adding or updating:
  • 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 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Sections 4.5, 4.6 and 4.8 have been updated with new safey information and in alignment with class labelling.

Section 6.5 has been updated to include the term modified-release in the product name.

Section 7 has been updated to reflect the new address of the MAH
Updated on 30/11/2009 and displayed until 11/11/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   25-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 1 - A black triangle has been added to the name of the medicinal product in line with the MHRA Black Triangle list
Updated on 07/04/2009 and displayed until 30/11/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
There are several changes but we do not have a consolidated SPC with track changes.  This is an MRP product and therefore represents the European SPC.  It has been updated to reflect relevant EU guidelines on ACE Inhibitors. 

Changes are to section:
1
2
4.3, 4.4, 4.5, 4.6, 4.7 4.8 4.9
5.1, 5.2, 5.3
6.1
10  
Updated on 21/11/2006 and displayed until 07/04/2009
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 03/03/2006 and displayed until 21/11/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
Updated on 01/03/2006 and displayed until 03/03/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 21/02/2006 and displayed until 01/03/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 18/12/2002 and displayed until 21/02/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 02/10/2002 and displayed until 18/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 28/08/2001 and displayed until 02/10/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 21/08/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  trandolapril
  verapamil hydrochloride