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
1.0
Revision date
2025-04-02
Product name
Twynsta tablets 40/10 mg
Product Synonyms
Pritor/Amlodipine tablets 40/10 mg, Micardis® Duo tablets 40/10 mg, Micardis® Amlo tablets 40/10 mg
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
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, H318, H361d, H411
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. H318 Causes serious eye damage. H361d Suspected of damaging the unborn child. H411 Toxic to aquatic life with long lasting effects.
Prevention
P201 Obtain special instructions before use. 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
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rins- ing. Immediately call a POISON CENTER/ doctor. P391 Collect spillage.
Hazardous Ingredients
Telmisartan Amlodipine Besylate
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. Serious eye damage, Category 1 H318: Causes serious eye damage. Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Long-term (chronic) aquatic hazard, Cat- H411: Toxic to aquatic life with long lasting effects. egory 2
