Micardis Plus tablets

Boehringer Ing. Pharma GmbH & Co. KG

Revision date : 2024-08-29

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GHS08 GHS07
Health risk rating 5
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

215-185-5/1310-73-2

Name of the chemical

sodium hydroxide

Concentration

>=0,5-<1 >=5% 2-<5% 0,5-<2% 0,5-<2%

General Information

Version

6.0

Revision date

2024-08-29

Product name

Micardis Plus tablets

1.2.1 Relevant identified uses

Pharmaceutical

1.2.2. Uses advised against

Safety Data Sheet only for the professional user on use

Emergency telephone

+498007790900, +1 703-527-3887, +49800 1817059

Icons in SDS

GHS07 GHS08 M004 M009 M010 M011 M017 M059

Company Information

company name

Boehringer Ing. Pharma GmbH & Co. KG

e-mail address of the competent person responsible for the Safety Data Sheet

EHS-Services@Boehringer-Ingelheim.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H315, H319, H350, H361d, H373, H412

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Signal word

Danger

Hazard statements

H315 Causes skin irritation. H319 Causes serious eye irritation. H350 May cause cancer. H361d Suspected of damaging the unborn child. H373 May cause damage to organs (Stomach, Kidney) through prolonged or repeated exposure. H412 Harmful to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Hazardous Ingredients

Telmisartan hydrochlorothiazide

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

ECOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu- lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

TOXICOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher. This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) The pharmacological effect of the medicament has to be considered (see package leaflet).

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Skin irritation, Category 2 H315: Causes skin irritation. Eye irritation, Category 2 H319: Causes serious eye irritation. Carcinogenicity, Category 1A H350: May cause cancer. Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2, Stomach, Kidney longed or repeated exposure. Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef- egory 3 fects.

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