Summary of Product Characteristics
last updated on the eMC:
07/01/2009
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 07/01/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.3 - Contraindications
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 16-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 3 - description of the tablets has been removed
Section 4.3 - section has been re-formatted, contraindication in pregnancy and lactation has been removed
Section 4.6 - following wording has been removed;
Pregnancy - Amaryl is contra-indicated durign pregnancy. The use of insulin is required under such circumstances. Patients who wondeir pregnany should inform their physician
Lactation - Because sulphonylurea-derivatives lik glimepiride pass into the breast milk, Amaryl must nto be taken by breat feeding women
The following wording has been added;
Pregnancy
Risk related to the diabetes
Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities and perinatal mortality. So the blood glucose level must be closely monitored during pregnancy in order to avoid the teratogenic risk. The use of insulin is required under such circumstances. Patients who consider pregnancy should inform their physician.
Risk related to glimepiride
There are no adequate data from the use of glimepiride in pregnant women. Animal studies have shown reproductive toxicity which likely was related to the pharmacologic action (hypoglycaemia) of glimepiride (see section 5.3). Consequently, glimepiride should not be used during the whole pregnancy. In case of treatment by glimepiride, if the patient plans to become pregnant or if a pregnancy is discovered, the treatment should be switched as soon as possible to insulin therapy.
Lactation
The excretion in human milk is unknown. Glimepiride is excreted in rat milk. As other sulfonylureas are excreted in human milk and because there is a risk of hypoglycaemia in nursing infants, breast-feeding is advised against during treatment with glimepiride.
Section 4.7 - following sentence has been added - No studies on the effects on the ability to drive and use machines have been performed.
Section 6.1 - (type A) has been added to the sodium starch glycollate
Section 7 - address of the marketing authorsation holder has been changed.
|
|
Updated on 15/08/2008 and displayed until 07/01/2009
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
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
|
| Date of revision of text on the SPC: 16-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Changes to sections 4.2, 5.1, 5.2
To reflect paediatric experience with the product in patients with type II diabetes
Change to section 4.5
Relating to an interaction with clarithromycin
|
|
Updated on 19/03/2008 and displayed until 15/08/2008
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 6. 4 - Special Precautions for Storage
|
| Date of revision of text on the SPC: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Added
4.4 Special warnings and special precautions for use
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to hemolytic anaemia. Since glimepiride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Amaryl contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Changed
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original package.
|
|
Updated on 18/09/2007 and displayed until 19/03/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 (Market Authorisation Holder): change to sanofi-aventis
|
|
Updated on 08/08/2006 and displayed until 18/09/2007
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 01/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to excipients list lactose now reads lactose monohydrate. Storage precautions now include a statement to store in the original container.
|
|
Updated on 14/04/2005 and displayed until 08/08/2006
|
Reasons for adding or updating:
|
-
Change to section 3 - pharmaceutical form
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 4 - Special Precautions for Storage
|
|
Updated on 22/04/2002 and displayed until 14/04/2005
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
|
|
Updated on 23/08/2001 and displayed until 22/04/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 16/10/2000 and displayed until 23/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 10/07/2000 and displayed until 16/10/2000
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 10/07/2000
|
Reasons for adding or updating:
|
|
|
|