Campral EC
*Company:
MerckStatus:
No Recent UpdateLegal 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
Updated on 11 December 2020
File name
Campral EC 333mg - Ireland - SPC - Current - TW 2607469.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.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.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.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
- New SPC for new product
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
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
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:
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.
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)