ASPIRIN KRKA 75 mg Gastro-resistant tablet Ref.[116530] Active ingredients: Acetylsalicylic acid

Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Aspirin Krka 75 mg gastro-resistant tablets.

Pharmaceutical Form
Gastro-resistant tablet. Pink, round biconvex film-coated tablets with a diameter of about 7.2 mm.

Qualitative and quantitative composition

Each gastro-resistant tablet contains 75 mg acetylsalicylic acid.

Excipients with known effect:

Lactose monohydrate 45 mg per tablet.

Sunset yellow (E110) 0.0006 mg per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient
Acetylsalicylic acid
Acetylsalicylic acid combines significant advantages such as strong anti-pyretic, analgesic and anti-inflammatory action, that is the measure of comparison with all the newer NSAIDs.

List of Excipients
Tablet core: Lactose monohydrate Cellulose, microcrystalline Silica, colloidal anhydrous Potato starch Film-coating: Talc Triacetin Methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30% Sodium laurilsulfate* Polysorbate 80* Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Carmine (E120) Sunset yellow aluminium lake (E110) ^* It may contain sodium laurilsulfate and polysorbate 80.

Pack sizes and marketing

Blister (PVC/Aluminium).

Pack sizes:

Blisters: 28, 30, 50, 56, 60, 84, 90 and 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/070/001

Date of first authorisation: 10^th March 2017
Date of last renewal: 19^th December 2021

Drugs

Drug	Countries
ASPIRIN	Germany, Finland, Nigeria, Poland, United Kingdom

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