Meptid 200 mg Film-Coated Tablets
*Company:
Almirall LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 July 2020
File name
ie-spc-meptidtabs-Jul20.pdf
Reasons for updating
- 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 - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated with opioid warning as per UK CHM recommendation.
Updated on 27 July 2020
File name
ie-pl-meptidtabs-Jul20.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 2: Updated with Opioid Warning and potential for addiction.
Section 4 - Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?”). Plus drug withdrawal adivice.
Updated on 21 January 2020
File name
ie-spc-meptidtabs-jul19.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of revision: July 2019
Updated on 20 January 2020
File name
uk-ie-pl-meptidtabs-June2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Reordering of adverse effects according to SmPC frequencies.
Updated on 22 September 2017
File name
PIL_14311_240.pdf
Reasons for updating
- New PIL for new product
Updated on 22 September 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 August 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 August 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 March 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 11 March 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correction of Sunset Yellow content to 1.47 mg.
Section 6.1
Change of excipients of tablet coating - removal of Opaspray
Updated on 17 March 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- section 1 for the tablet updated to include the full pharmaceutical form
· section 4.3 updated to strengthen the safety statements already under sections 4.4 and 4.5 namely contraindicating use during an asthma attacks and for patients on MAOIs and for 14 days after stopping MAOIs
· section 4.4 updated by deleting the cautionary statement regarding MAOIs as this is now under section 4.3
· section 4.5 updated with minor rewording
· section 4.8 updated by ranking undesirable events under headings of frequency using the following convention: very common (≥ 1/10); common (≥1/100 to ≤1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data). This was purely a formatting request by the IMB; where within section 4.8, it was written that these were the "most commonly reported adverse reactions", these AEs were slotted under the tabular heading very common and those detailed as uncommon were slotted under the uncommon tabular heading under the relevant system organ class; "occassional reports" were re-classified as very rare reports.
section 7 updated with change of name of MAH from "Laboratorios Almirall SA" to Almirall SA
Updated on 16 March 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to appearance of the medicine
Updated on 30 June 2009
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 18 June 2009
Reasons for updating
- New PIL for new product