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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 23/02/2012
SPC Telfast 120mg film-coated tablets

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 23/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   17-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Type IB C.1.z to update the SPC.
Updated on 14/01/2011 and displayed until 23/02/2012
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:   16-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 of 120mg and 180mg SPC’s re-worded to:

 

In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:

 

Nervous system disorders

Common (≥1/100 to <1/10): headache, drowsiness, dizziness

 

Gastrointestinal disorders

Common (≥1/100 to <1/10): nausea

 

General disorders and administration site conditions

Uncommon (≥1/1,000 to <1/100): fatigue

 

In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not be estimated from available data):

 

Immune system disorders

hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis 

 

Psychiatric disorders

insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)

 

Cardiac disorders

tachycardia, palpitations

 

Gastrointestinal disorders

diarrhoea

 

Skin and subcutaneous tissue disorders

rash, urticaria, pruritus


Section 10 updated to 16th december 2010
Updated on 06/01/2009 and displayed until 14/01/2011
Reasons for adding or updating:
  • Joint SPC superseded by SPCs for individual presentations
Date of revision of text on the SPC:   20-Feb-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
JOint SPC for 120mg and 180mg split into individual SPCs
Updated on 24/09/2007 and displayed until 06/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special warnings and precautions for use): Warning added regarding use in patients with history of or ongoing cardiovascular disease:
 

'Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class, have been associated with the adverse events, tachycardia and palpitations (see section 4.8).' 

 
Section 7 (Marketing Authorisation Hoder): Change in MA Holder's details
Updated on 17/09/2004 and displayed until 24/09/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 5.3 - Preclinical Safety Data
Updated on 06/08/2004 and displayed until 17/09/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/06/2004 and displayed until 06/08/2004
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Updated on 26/09/2002 and displayed until 08/06/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 23/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  fexofenadine hydrochloride