Boehringer Ingelheim Limited

Section 3 Pharmaceutical Form

Size of tablets details (in mm) have been added to this section.

Section 4.2 Posology and Method of Administration

The text … once daily with liquid, with or without food has been deleted from the first sentence of the first paragraph of this section.

A new sub-heading entitled Special populations has been added to this section.

The previous sub-heading entitled Children has been updated to now read Paediatric population.  This sub-heading paragraph has had both text added to and removed from it.

New sub-headings and corresponding text entitled Method of administration and Precautions to be taken before handling or administering the medicinal product have been added to this section.

Section 4.4 Special Warnings and Precautions for Use

The text … ,including hydrochlorothiazide has been added to the end of the fourth to last sentence of this section.

Section 4.6 Fertility, Pregnancy and Lactation

The header of this section has been amended from Pregnancy and Lactation to Fertility, Pregnancy and Lactation.

The sub-heading Lactation has been deleted and replaced with Breastfeeding.

A new final sub-heading and corresponding text entitled Fertility has been added to this section.

Section 4.8 Undesirable Effects

A new first sub-heading (a. Summary of the safety profile) and corresponding text has been added to this section.

A new second sub-heading (b. Tabulated summary of adverse reactions) has been added to this section.

The following frequency grouping details within the section b. sub-heading have been amended, with text being deleted from and added to: Infections and infestations, Immune system disorders, Metabolism and nutrition disorders, Gastrointestinal disorders, Hepatobiliary disorders and Skin and subcutaneous tissue disorders.

Points 1 and 2 at the end of the frequency grouping details have been added.

All of the frequency grouping details within the Telmisartan sub-heading have had both text added to and deleted from.  All Not knowns have been replaced with either Uncommon or Rare.

Point 3 at the end of the frequency grouping details has been added.

The typographical error Sialoadenitis has been corrected to Sialadenitis in the Infections and infestations frequency grouping of the Hydrochlorothiazide sub-heading.

The word Aplastic has been moved to now come before the word Anaemia in the Blood and lymphatic system disorders grouping of the Hydrochlorothiazide sub-heading.

A new sub-heading (c. Description of selected adverse reactions) and corresponding text (points 1 and 2) has been added to this section.

Section 5.3 Preclinical Safety Data

A new last but one paragraph has been added to this section i.e. regarding no evidence of a teratogenic effect.

Section 10 Date of Revision of the Text

The date has been updated from 27 April 2010 to 02 May 2011.

Section 4.4 Special Warnings and Precautions for Use

A new seventh paragraph has been added to this section i.e. the one commencing with the text:

Dual blockade of the rennin-angiotension-aldosterone system:

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

A new final paragraph has been added to the Non-steroidal anti-inflammatory medicinal products section i.e. the one commencing with the text:

In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold …

Section 4.8 Undesirable Effects

The text:

, drug ineffective

has been deleted from the Not known sentence of the General disorders and administration site conditions section under the Telmisartan heading in this section i.e. the text now reads:

Not known: Asthenia

Section 6.5 Nature and Contents of Container

The text:

, 30 x 1 or 90 x 1

has been added to the Pack sizes paragraph of this section.

Section 10 Date of Revision of the Text

The date has been updated from 29^th May 2009 to 27^th April 2010.

The following text has been added as a second paragraph to this section:

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.

MicardisPlus 80 mg/25 mg Tablets changes

Section 4.3 Contraindications

The third bullet point of this section has been amended from Second and third trimester of pregnancy and lactation (see sections 4.4 and 4.6) to Second and third trimesters of pregnancy (see sections 4.4 and 4.6).

Section 4.4 Special Warnings and Precautions for Use

The hyphen between anti and hypertensive in the second sentence of this section has been deleted i.e. the text now becomes antihypertensive.

Section 4.6 Pregnancy and Lactation

The text Pregnancy: has been added as a header above the first boxed paragraph.

The text Pregnancy (see section 4.3): has been deleted as a header from the second paragraph of this section.

The hyphen between anti and hypertensive in the third sentence of the third paragraph of this section has been deleted i.e. the text now becomes antihypertensive.

The words Exposure to … have been added to the beginning of the fourth paragraph of this section. 

The word exposure has been deleted from between the words therapy and during in the fourth paragraph of this section.

The word also has been deleted from the last sentence of the fourth paragraph of this section i.e. text now becomes (See section 5.3).

The word also has been deleted from the last sentence of the fifth paragraph of this section i.e. text now becomes … observed for hypotension (see sections 4.3 and 4.4).

The first paragraph of the Lactation paragraph of this section has been deleted and completely replaced with new text i.e. paragraph now commences Because no information is available regarding the use of Micardis during breast-feeding …

Section 10 Date of Revision of the Text

The date has been updated from 27^th January 2009 to 18^th March 2009.

MicardisPlus 80/25 mg Tablets changes

Section 2 Qualitative and Quantitative Composition

The text (E420) has been added to the end of the second sentence in this section i.e. after the word sorbitol.

Section 3 Pharmaceutical Form

The text H9 has had single speech marks added i.e. to become ‘H9’.

Section 4.4 Special Warnings and Precautions for Use

In the Renal impairment and kidney transplantation section, the text … with a recent kidney transplant has been amended to … with recent kidney transplantation. 

In the Metabolic and endocrine effects second paragraph the text Increase in cholesterol and triglyceride levels have been … has been amended to An increase in cholesterol and triglyceride levels has been …

In the Ethic differences section, the text As with all other angiotensin antagonists telmisartan is … has been amended to As with all other angiotensin II receptor antagonists, telmisartan is …

In the General section the second occurrence of the word hypersensitivity in the first paragraph has been replaced with the word allergy.

A new paragraph in the General section has been added i.e. last paragraph now commences with the text Cases of photosensitivity reactions have been reported …

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

On two occasions in the Non-steroidal anti-inflammatory medicinal products section, the word receptor has been added between the text angiotensin II and antagonists.

Section 4.7 Effects on Ability to Drive and Use Machines

In the second sentence of this section, the words … operating machinery it must be borne in mind that … have been replaced with the words … operating machinery it should be taken into account that …

Section 4.8 Undesirable Effects

Details of the side effects and their frequencies have been updated in this section.

Section 4.9 Overdose

In the first paragraph the text No data are … has been replaced by the text There is limited information …

In the first paragraph the text Telmisartan is not removed by haemodialysis (that was previously the second sentence) has been deleted.

The Symptoms paragraph has been amended from:

Symptoms: The most likely manifestations of telmisartan overdose are expected to be hypotension and tachycardia; bradycardia might also occur. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products. 

to:

Symptoms: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products. 

The text Telmisartan is not removed by haemodialysis has been added as the first sentence in the Treatment paragraph.

Section 5.1 Pharmacodynamic Properties

The word receptor has been added between the text Angiotensin II and antagonists.

Section 10 Date of Revision of the Text

The date has been updated from 4^th July 2008 to 27^th January 2009.

MicardisPlus 80/25 mg Tablets changes

Section 4.3 – Contraindications:

The third bullet point has been amended to include reference to sections 4.4 and 4.6 as opposed to just section 4.6.

The word “trimesters” in the third bullet point has been replaced with the word “trimester”.

Section 4.4 – Special warnings and precautions for use:

A new paragraph under the heading “Pregnancy” has been added to the beginning of this section.

Section 4.6 – Pregnancy and lactation:

All paragraphs with the exception of the ones regarding “Thiazides crossing the placental barrier” and “Lactation” have been deleted. 

Paragraphs regarding the use of angiotensin II receptor antagonists, angiotensin II receptor antagonists, angiotensin II receptor antagonist therapy exposure during second and third trimesters and exposure to angiotensin II receptor antagonists occurring from the second trimester of pregnancy have been added.  The paragraph regarding the use of angiotensin II receptor antagonises (first one) has been boxed as well.

Section 8 – Marketing authorisation numbers:

Various text has been removed to leave just the following text:

EU/1/02/213/017-023

Section 9 – Date of first authorisation/renewal of the authorisation:

The date 27^th March 2008 has been deleted.  The following text has been added:

“Date of first authorisation: 19 April 2002

Date of last renewal: 19 April 2007”

Section 10 – Date of revision of the text:

The date has been revised to 4^th July 2008.