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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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 Loniten Tablets 2.5 mg, 5 mg and 10mg

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 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updates to sections 4.1 (Therapeutic indications); 4.2 (Posology and method of administration); 4.3(Contraindications); 4.4 (Special warnings and precautions); 4.5 (Interactions); 4.6 (Pregnancy and lactation); 4.8 (Undesirable effects) ; 4.9 (Overdose) ; 10 (Revision date )
Updated on 30/08/2011 and displayed until 17/02/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 – Admin only change
Section 4.6 – Update to pregnancy, lactation and fertility section
Section 4.7 – Re-wording of section
Section 4.8 – In section 4.8 Undesirable effects,
Section 4.4 Special Warnings and Precautions for Use.
Section 5.3 – Preclinical safety data
Updated on 12/02/2010 and displayed until 30/08/2011
Reasons for adding or updating:
  • 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 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3 Contraindications – addition of hypersensitivity

Section 4.4 Special Warnings – addition of fluid and electrolyte balance, angina pectoris, thrombocytopenia, pericardial effusion, galactose intolerance warning.

Section 4.5 Interactions – addition of guanethidine

Section 4.6 Pregnancy – information updated

Section 5.1 Pharmacodynamic properties – Addition of ATC code
Updated on 22/01/2008 and displayed until 12/02/2010
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
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2 (posology and method of administration) BAN to INN change - Chlorthalidone to Chlortalidone and Frusemide to Furosemide

 

4.4 (Special warnings) BAN to INN change  – bethanidine to betanidine

 

4.5 (Interactions) BAN to INN change  – bethanidine to betanidine
Updated on 16/07/2007 and displayed until 22/01/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 MA Holder address amended from Milton Keynes to Sandwich
Updated on 28/09/2004 and displayed until 16/07/2007
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Updated on 25/09/2002 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 24/08/2001 and displayed until 25/09/2002
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 23/08/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/07/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 18/08/2000 and displayed until 18/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 25/05/2000 and displayed until 18/08/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 25/05/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  minoxidil