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UCB Pharma Limited
208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

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: 12/12/2008
SPC Oily Phenol Injection BP (UCB Pharma Ltd)

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 12/12/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 updated to include the following:

It should not be used over large areas, since sufficient amounts may be absorbed to give rise to toxic symptoms.  Oily  Phenol Injection, BP is also contraindicated in neonates and children.
Updated on 27/06/2008 and displayed until 12/12/2008
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 4.9 - Overdose
Date of revision of text on the SPC:   20-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.3 -  Contraindicated in patients who are hypersensitive to phenol, nuts and in particular almond oil or any component of the product.

 
4.4 - Addition of special warnings:

For submucosal injection only.  Not for intrathecal use.  Complications of therapy can include local ulceration and sterile abscess formation.  These complications may be serious following a misplaced injection (eg prostatic abscess).  Care in choosing the correct site of injection is mandatory.

4.8 Addition of undesirable effects:

General disorders and administration site conditions:

Pyrexia

Pain

Discomfort

Ulcer

 

Immune system disorders:

Hypersensitivity

 

Nervous system disorders:

Dizziness

 

Hepatobiliary disorders:

Hepatitis

 

Infections and infestations:

Abscess

Prostatic abscess

Necrotizing fasciitis

Retroperitoneal sepsis

 

Renal and urinary disorders:

Dysuria

Urinary incontinence

 

Reproductive system and breast disorders:

Impotence

4.9 - Addition of contraindication in pregnancy and not recommended if breastfeeding.
Updated on 15/09/2005 and displayed until 27/06/2008
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 15/08/2001 and displayed until 15/09/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 13/08/2001 and displayed until 15/08/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  phenol