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A.Menarini Pharma U.K. S.R.L.
Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
Telephone: +44 (0) 1628 856400
Fax: +44 (0) 1628 856402
Medical Information Direct Line: 0800 085 8678
Medical Information e-mail: menarini@medinformation.co.uk
Out of Hours contact: menarini@medinformation.co.uk

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: 20/05/2011
SPC Nebilet 5mg 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 20/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   18-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of baclofen and amifostine in section 4.5 Interactions (under combinations to be used with caution), together with minor changes to the wording of sections 2, 3 and 6.1.

Updated on 06/11/2007 and displayed until 20/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 4.8 Undesirable effects - update information on immune system disorders
Updated on 13/08/2007 and displayed until 06/11/2007
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   03/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
3. Pharmaceutical form – statement added: The tablets can be divided into equal quarters.
4.3 Contra-indications – pregnancy and lactation deleted.
4.4 Special warnings and precautions - statement added regarding lactose.
4.6 Pregnancy and lactation - pregnancy and lactation statements updated.
4.8 - Undesirable effects – use in hypertension - very rare side-effects added - syncope, angioneurotic oedema, psoriasis aggravated.
Updated on 07/02/2006 and displayed until 13/08/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.1 - Therapeutic Indications
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 28/09/2004 and displayed until 07/02/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/05/2002 and displayed until 28/09/2004
Reasons for adding or updating:
  • New SPC for new product
Updated on 15/05/2002 and displayed until 16/05/2002
Reasons for adding or updating:
  • New SPC for new product
Updated on 14/05/2002 and displayed until 15/05/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  nebivolol hydrochloride