Campral EC *

  • Company:

    Merck
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 11 December 2020

File name

Campral EC 333mg - Ireland - SPC - Current - TW 2607469_1607697763.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Statement regarding excipient's added in section 4.4.

Our reference: TW 2607469

Updated on 11 December 2020

File name

Campral Ireland PIL - TW 2607469 - Dec 2020_1607697468.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Information on sodium content added in section 2

Our reference: TW 2607469

Updated on 03 January 2019

File name

Campral PIL - Brexit Transfer - TW1735731_1546529019.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 29 August 2018

File name

Campral EC 333mg tablets_ SmPC- TW1735731 clean_1535539345.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 July 2018

File name

Campral PIL - TW1325532-1344150.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 02 July 2018

File name

Campral EC 333mg tablets_ SmPC- TW1325532-1344150 (clean).docx

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 May 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

There are several administrative changes (QRD version 9 updates) including adverse event wording in section 4.8

Updated on 07 May 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 May 2015

File name

PIL_15327_807.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 May 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 28 April 2014

Reasons for updating

  • Change of distributor details

Updated on 11 January 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 24 October 2012

Reasons for 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.3 Contraindications

in patients with a known hypersensitivity to acamprosate or to any of the excipients
in lactating women (see section 4.6)
in cases of renal insufficiency (serum creatinine >120 micromol/L)

 

4.4 Special warnings and precautions for use

The safety and efficacy of Campral has not been established in patients younger than 18 years or older than 65 years. Campral is therefore not recommended for use in these populations.

The safety and efficacy of Campral has not been established in patients with severe liver insufficiency (Childs-Pugh Classification C).

Because the interrelationship between alcohol dependence, depression and suicidality is well-recognised and complex, it is recommended that alcohol-dependent patients, including those treated with acamprosate, be monitored for such symptoms.

Abuse and dependence

 

Non-clinical studies suggest that acamprosate has little or no abuse potential. No evidence of dependence on acamprosate was found in any clinical study thus demonstrating that acamprosate has no significant dependence potential.

4.5 Interaction with other medicinal products and other forms of interaction

 

The concomitant intake of alcohol and Campral EC does not affect the pharmacokinetics of either alcohol or

acamprosate.

Administering Campral EC with food diminishes the bioavailability of the drug compared with its administration in the fasting state.

No change in the frequency of clinical and/or biological adverse reactions has been shown when acamprosate is used concomitantly with disulfiram, oxazepam, tetrabamate or meprobamate.

In clinical trials, acamprosate has been safely administered in combination with antidepressants, anxiolytics, hypnotics and sedatives, and non-opioid analgesics.

 

4.6 Pregnancy and lactation

Pregnancy

There are no adequate data from the use of Campral in pregnant women. Animal studies do not indicate any

evidence of foetotoxicity or tetragenicity. Campral must therefore only be used during pregnancy after a careful

benefit/risk assessment, when the patient cannot abstain from drinking alcohol without being treated with Campral and when there is consequently a risk of foetotoxicity or teratogenicity due to alcohol.

Lactation

It is known that Campral is excreted in the milk of lactating animals. It is not known whether acamprosate is excreted in human milk. There are no adequate data from the use of acamprosate in infants. Campral must therefore not be used in breastfeeding women.

If a breastfeeding woman cannot abstain from drinking alcohol without being treated with acamprosate, a decisionmust be made whether to discontinue nursing or to discontinue Campral, taking into account the importance of the medicinal product to the woman.

Fertility

In animal studies, no adverse effects on fertility were observed. Whether or not acamprosate affects the fertility inhumans is unknown.

 

4.7 Effects on ability to drive and use machines

Campral EC

has no influence on the ability to drive and use machines.


 

4.8 Undesirable effects

According to information collected during clinical trials and spontaneous reports since marketing authorisation, thefollowing adverse reactions may occur under treatment with Campral.

The following definitions apply to the frequency terminology used hereafter: very common (

1/10), common (1/100, < 1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data)

 

Gastrointestinal disorders:

Very common: Diarrhoea
Common: Abdominal pain, nausea, vomiting,
flatulence

 

Skin and subcutaneous tissue disorders:

Common: Pruritus, maculo-papular rash
Not known: Vesiculo-bullous eruptions

 

Immune system disorders:

Very rare: Hypersensitivity reactions including urticaria, angiooedema or anaphylactic reactions.

 

Reproductive system and breast disorders:

Common: Frigidity or impotence.

 

Psychiatric disorders:

Common: Decreased libido
Uncommon: Increased libido

 

4.9 Overdose

Acute overdose is usually mild. In the reported cases, the only symptom, which can be reasonably related to overdose is diarrhoea. No case of hypercalcaemia has ever been reported.

Treatment of overdose is directed to symptoms.

 

 


 

 

Updated on 10 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 November 2010

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 9 - Date of Renewal

9.      Date of First Authorisation/Renewal of Authorisation

 

         Date of first authorisation: 16 February 1996

         Date of last renewal: 05 November 2010

Updated on 21 May 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1) Change to section 4.4 of the SPC:

A general recommendation is added to section 4.4 of the SPC concerning the monitoring of alcohol-dependent patients for symptoms of suicidality.

2) Change to section 4.8 of the SPC:

Hypersensitivity reactions are added to section 4.8 of the SPC. The opportunity was also taken to re-write this section, listing the side effects by MedDRA frequency as recommended in the SPC guideline.
 
Details as follows:
 

4.4 Special Warnings and Precautions for Use

 

Campral EC does not constitute treatment for the withdrawal period.

The prescription of the product should be initiated under the direct supervision of a consultant or a clinician experienced in the field, working in a hospital based clinic or an alcohol treatment unit. General practitioners with an interest in treating alcohol dependent patients are allowed to initiate and/or pursue Campral treatment.

 

Because the interrelationship between alcohol dependence, depression and suicidality is well-recognised and complex, it is recommended that alcohol-dependent patients, including those treated with acamprosate, be monitored for such symptoms.
 
 

4.8 Undesirable Effects


The following definitions apply to the frequency terminology used hereafter: very common (
³ 1/10), common (³ 1/100, < 1/10), uncommon (³ 1/1,000, < 1/100), rare (³ 1/10,000, < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data)


Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.


Gastrointestinal disorders:

Very common: Diarrhoea

Common: Abdominal pain, nausea, vomiting


Skin and subcutaneous tissue disorders:

Common: Pruritus, maculo-papular rash

Rare: Bullous skin reactions


Immune system disorders:

Very rare: Hypersensitivity reactions including urticaria, angio-oedema or anaphylactic reactions.


Reproductive system and breast disorders:

Common: Frigidity or impotence.


Psychiatric disorders:

Common: Decreased libido

Uncommon: Increased libido 

Updated on 26 April 2006

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)