Cholestagel 625 mg film-coated tablets
Last Updated on eMC 13-Jun-2017 View document | SANOFI Contact details
Versions
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 13-Jun-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC: 05-Apr-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
|
Type IB “EMEA/H/C/000512/IB/0037: To update section 4.2 of the SmPC to include the following information ‘The tablet should be swallowed whole and not broken, crushed or chewed’ as requested in the LEG 031.1. The Package Leaflet is updated accordingly. Furthermore the PI is brought in-line with the latest QRD template version. The MAH also took this opportunity to update the contact details of the local representative in Greece, Spain, Cyprus and Hungary. |
Updated on 12-Mar-2015 and displayed until 13-Jun-2017
Reasons for adding or updating:
- 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 10 - Date of revision of the text
Date of revision of text on the SPC: 18-Dec-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.5 updated to include potential drug interactions of colesevelam with olmesartan, metformin, glimepiride and glipizide.Section 4.8 updated to include intestinal obstruction as an adverse reaction.
Updated on 19-Oct-2012 and displayed until 12-Mar-2015
Reasons for adding or updating:
- Change to section 1 -Name of the Medicinal product
- Removal of Black Triangle
Date of revision of text on the SPC: 21-Feb-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The Black Triangle has been removed from the product.Updated on 13-Apr-2012 and displayed until 19-Oct-2012
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 4.8 - Undesirable Effects
- Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC: 21-Feb-2012
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.8 has been updated to include abdominal distention, dysphagia and pancreatitis as adverse events associated with Cholestagel.Sections 2, 4.3, 4.6 and 9 have been updated in line with version 8 of the QRD template.
Updated on 13-Apr-2010 and displayed until 13-Apr-2012
Reasons for adding or updating:
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic Properties
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 23-Mar-2010
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Changes to:
Section 4.1 - Therapeutic Indications - Addition of paragraph 3 regarding Cholestagel used in combination with ezetimibe with or without a statin, in adult patients with primary hypercholesterolaemia including familial hypercholesterolaemia.
Section 4.2 - Posology and method of administration – Addition to information regarding the combination with a statin with or without ezetimibe. Clarification in paragraph 4 regarding concomitant medication. Change to text in Paediatric population information.
Section 4.5 - Interaction with other medicinal products and other forms of interaction – Changes to paragraph 1 regarding concomitant medication. Paragraph 10 – Alteration to final sentence. Addition of paragraph 14 – Ursodeoxycholic acid.
Section 4.8 - Undesirable effects – additional information in last paragraph.
Section 5.1 - Pharmacodynamic properties – Addition of paragraphs 5, 7, 8 and 9. Deletion of paragraph 11.
Section 10 – Date of revision of the text
Updated on 24-Apr-2009 and displayed until 13-Apr-2010
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- 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 5.1 - Pharmacodynamic Properties
- Change to section 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
- Improved Electronic Presentation
Date of revision of text on the SPC: 30-Mar-2009
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Changes to sections 4.2, 4.4, 4.5, 4.8, 5.1 and 5.3 were as a result of a comprehensive QRD review by EMEA. Text has been removed from sections 4.2 and 4.8.
Updated on 03-Feb-2009 and displayed until 24-Apr-2009
Reasons for adding or updating:
- 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
Date of revision of text on the SPC: 01-Dec-2008
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
In Section 4.4 (Special warnings and special precautions for use) Addition of Ciclosporin interaction
In Section 4.5 ( Interaction with other medicinal products and other forms of interaction) includes addition of an interaction study
Updated on 06-Aug-2008 and displayed until 03-Feb-2009
Reasons for adding or updating:
- Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC: 01-Jul-2008
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
"In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone. The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group (65 patients). Reductions were also seen for non‑HDL‑C, Total‑C and Apo B. A small 5%, non‑significant increase in triglycerides was noted. The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known"
Updated on 04-Aug-2008 and displayed until 06-Aug-2008
Reasons for adding or updating:
- Change to section 5.1 - Pharmacodynamic Properties
- SPC Retired pending re-submission
Date of revision of text on the SPC: 01-Jul-2008
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
-
In section 5.1 (pharmacodynamic properties) the following paragraph has been added
"In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone. The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group (65 patients). Reductions were also seen for non‑HDL‑C, Total‑C and Apo B. A small 5%, non‑significant increase in triglycerides was noted. The effects of combination of fenofibrate and Cholestagel on the risks of myopathy or hepatotoxicity are not known"
Updated on 16-Jul-2008 and displayed until 04-Aug-2008
Reasons for adding or updating:
- 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 4.2 - Posology and method of administration
Date of revision of text on the SPC: 19-Jun-2008
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
In Section 4.2 (Posology and method of administration) , Cholestagel should be administered at least four hours after the concomitant medication in order to minimize the risk of reduced absorption of the concomitant medication has been added, removing cholestagel should be administered one hour before.
In Section 4.4 (Special warnings and special precautions for use), Cholestagel can affect the bioavailability of the combined oral contraceptive pill when administered simultaneously. It is important to ensure that Cholestagel is administered at least 4 hours after the combined oral contraceptive pill to minimise the risk of any interaction has been added.
In Section 4.5 (Interaction with other medicinal products and other forms of interaction) the following paragraphs have been added;
Interaction studies have only been performed in adults.
There have been very rare reports of reduced phenytoin levels in patients who have received Cholestagel administered with phenytoin.
Levothyroxine
In an interaction study in healthy volunteers, Cholestagel reduced the AUC and Cmax of levothyroxine when administered either concomitantly or after 1 hour. No interaction was observed when Cholestagel was administered at least four hours after levothyroxine.
Combined oral contraceptive pill
In an interaction study in healthy volunteers, Cholestagel reduced the Cmax of norethindrone as well as the AUC and Cmax of ethinylestradiol when administered simultaneously with the combined oral contraceptive pill. This interaction was also observed when Cholestagel was administered one hour after the combined oral contraceptive pill. However no interaction was observed when Cholestagel was administered four hours after the combined oral contraceptive pill.
Antidiabetic agents
Co-administration of Cholestagel and glyburide (also known as glibenclamide) caused a decrease in the AUC0-inf and Cmax of glyburide by 32% and 47%, respectively. No interaction was observed when Cholestagel was administered four hours after glyburide.
Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown. No interaction was observed when Cholestagel was administered one hour after repaglinide.
No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
The Following paragraph has been removed.
The effect of thyroid replacement therapy should be monitored, since other bile acid sequestrants have been shown to reduce absorption of thyroxine. Specific clinical interaction studies with colesevelam and thyroid replacement therapy have not been performed. A reduced contraceptive effect cannot be excluded when colesevelam is administered to women taking oral contraceptives, as bile sequestrants have been shown to reduce the T1/2 of ethinylestradiol and the effect of colesevelam on ethinylestradiol pharmacokinetics has not been studied.
Updated on 24-Oct-2007 and displayed until 16-Jul-2008
Reasons for adding or updating:
- New SPC for new product
SANOFI
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
+44 (0)1483 535 432
+44 (0)1483 505 515
+44 (0)845 372 7101
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