| Section 2 – Qualitative and Quantitative Composition
The following text has been added between the first and second sentences:
Excipients:
Each 20 mg tablet contains 84 mg sorbitol (E420)
Each 40 mg tablet contains 169 mg sorbitol (E240)
Each 80 mg tablet contains 338 mg sorbitol (E240)
Section 3 – Pharmaceutical Form
The text “50H” has moved position in the 20 mg details of this section. The word “symbol” has been replaced with the word “logo”.
The text “51H” has moved position in the 40 mg details of this section. The word “symbol” has been replaced with the word “logo”.
The text “52H” has moved position in the 80 mg details of this section. The word “symbol” has been replaced with the word “logo”.
Section 4.1 – Therapeutic Indications
The words “in adults” have been added to the end of the first sentence in this section.
Section 4.2 Posology and Method of Administration
The word “Adults” has been deleted as a sub-header within this section.
The words “…, the dose of” have been added after the text “In cases where the target blood pressure is not achieved,” to the second sentence of this section.
The text “Telmisartan may be taken with or without food” has been added as the last sentence of the first paragraph.
The “Renal impairment” paragraph has been amended in its entirety and a new paragraph entitled “Hepatic impairment” created.
The text “… for elderly patients” has been added to the sentence under the “Elderly” sub-header.
The sub-header text “Children and adolescents” has been replaced with the words “Paediatric patients”.
Section 4.4 – Special Warnings and Precautions for Use
The sub-header text “Renal impairment and kidney transplant” has been amended to “Renal impairment and kidney transplantion”.
Two occasions of the word “a” have been deleted from this paragraph and the word “transplant” in the last sentence has been amended to “transplantion”.
A new paragraph beginning “Dual blockade of the rennin-angiotension-aldosterone system:” has been added as a second paragraph to the “Intravascular hypovolaemia” sub-header.
In the “Hyperkalaemia” sub-header, the following words have been added:
“are” between the words “… hyperkalaemia” and “salt”.
“NSAIDS” between the words “… drugs (” and “including”.
“immunosuppressives” which replaces the word “immunosuppressor” between the words “…, heparin” and “… (cyclosporin …”.
In the “Sorbitol” sub-header the following paragraph has been deleted:
“A recommended daily dose of Micardis 20 mg tablets contains 84.5 mg sorbitol …” and replaced with paragraphs as follows:
First one starting with the text “This medicinal product contains sorbitol (E420)…”
Second one entitled “Ethnic differences”.
In the “Other” sub-header, the following first paragraph has been deleted:
“As observed for angiotensin converting enzyme inhibitors, …”
Section 4.5 – Interaction with other Medicinal Products and other Forms of Interaction:
The following text has been deleted as the second paragraph “Medicinal products or therapeutic class of medicinal products that may provoke hyperkalaemia:” and a new paragraph commencing with the text “As with other medicinal products acting on the rennin-angiotension-aldosterone system, …” inserted.
A new third paragraph commencing with the text “The occurrence of hyperkalaemia depends on associated risk factors.” has been inserted, replacing the previous paragraph commencing with the text “The occurrence of hyperkalaemia depends on associated risk factors.”.
The text “Angiotension II receptor antagonists such as telmisartan, …” has been added to the “Potassium sparing diuretics or potassium supplements” sub-header.
The words “including telmisartan” have been added to the “Lithium” sub-header.
The word “…, rarely” has been deleted from the “Lithium” sub-header.
The “Non-steroidal anti-inflammatory medicinal products” sub-header text has been amended in its entirety.
The words “to be taken into account” have been deleted from the second paragraph of the “Other antihypertensive agents” sub-header.
Section 4.6 – Pregnancy and Lactation:
The text “and 4.4” has been added to the sub-header “Pregnancy (see section 4.3)”.
Section 4.7 – Effects on Ability to Drive and Use Machines
The words “borne in mind” have been replaced with “taken into account” in the second sentence of this section.
Section 4.8 – Undesirable Effects
The text “…, not known (cannot be estimated from the available data).” have been added to the end of the adverse reactions rankings/frequency paragraph.
The entire text regarding different types of disorders following the words “Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness” has been reworded.
Section 4.9 – Overdose
This entire section has been reworded and new text inserted.
Section 5.1 – Pharmacodynamic Properties
This entire section has been reworded and new text inserted, with the exception of paragraphs commencing with the following words:
“Upon abrupt cessation of treatment with telmisartan, …”
“The incidence of dry cough was significantly lower in patients treated with telmisartan …”
“Beneficial effects of telmisartan on mortality and cardiovascular …”
Section 5.2 – Pharmacokinetic Properties
The sub-header “Linearity/non-linearity” has been added between paragraphs 1 and 2 of this section.
The paragraph commencing “Gender differences in plasma concentrations were observed, …” has been deleted from the “Distribution” sub-header.
The words “of the parent compound” have been added to the first sentence of the “Metabolism” sub-header.
The word “the” has been added between the words “extent,” and “area” in the “Elimination” sub-header.
A new sub-header and corresponding text entitled “Gender effects” has been added to the “Special Populations” header.
The words “in young and” and “patients” have been deleted from the “Elderly patients” sub-header and replaced with “between the” and “and those younger than 65 years”.
The text “In mild to moderate and severe renal impairment patients” has been amended to “In patients with mild to moderate and severe renal impairment” in the “Patients with renal impairment” sub-header.
The word “patients” has replaced the word “subjects” in the last sentence of the “Patients with renal impairment” sub-header.
Section 5.3 – Preclinical Safety Data
The word “receptor” has been added between the words “II” and “antagonists” in the last sentences of the first and second paragraphs of this section.
The words “a”, “such as” and “and” have been added to the third paragraph of this section between the words “of” and “teratogenic”, “offspring” and “lower” and “opening,” and “higher”.
Section 6.1 – List of Excipients
The order of the words used for each excipient has been re-arranged e.g.. “Povidone (K25), meglumine, sodium” has become “Povidone (K25)”.
Section 6.4 – Special Precautions for Storage
The following text has been added as the first sentence of this section:
“This medicinal product does not require any special storage conditions”.
Section 6.5 – Nature and Contents of Container
This section has been re-worded with various deletions and additions including additional text being inserted regarding headers entitled “20 mg” and “40 and 80 mg”.
Section 9 – Date of First Authorisation/Renewal of the Authorisation
The date of last renewal text has been amended from “16 December 2003” to “19 November 2008”.
Section 10 – Date of Revision of the Text
The date has been revised from “3rd July 2008” to “19th November 2008”.
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