TOLUCOMBI 80 mg/25 mg Tablet Ref.[28078] Active ingredients: Hydrochlorothiazide Telmisartan

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Tolucombi 80 mg/25 mg tablets.

Pharmaceutical Form

Tablet.

White to yellowish white on one side and yellow marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.

Qualitative and quantitative composition

Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.

Excipient(s) with known effect:

Each tablet contains 114 mg of lactose (as monohydrate) and 294.08 mg sorbitol (E420).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Hydrochlorothiazide

Hydrochlorothiazide is a diuretic with antihypertensive properties. It acts by inhibiting the renal tubular re-absorption of sodium and chloride ions, which are excreted with an accompanying volume of water. Potassium excretion is also promoted.
Telmisartan

Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist. Telmisartan selectively binds the AT1 receptor. The binding is long-lasting.
List of Excipients

Hydroxypropylcellulose
Lactose monohydrate
Magnesium stearate
Mannitol
Meglumine
Povidone (K30)
Silica, colloidal anhydrous
Sodium hydroxide (E524)
Sodium stearyl fumarate
Sorbitol (E420)
Yellow ferric oxide (E172)

Pack sizes and marketing

Blisters (OPA/Al/PVC foil//Al foil): 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1 and 100 × 1 tablet in a box.

Blisters (OPA/Al/PE foil with desiccant//Al foil): 14 × 1 and 98 × 1 tablet in a box. 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

EU/1/13/821/021
EU/1/13/821/022
EU/1/13/821/023
EU/1/13/821/024
EU/1/13/821/025
EU/1/13/821/026
EU/1/13/821/027
EU/1/13/821/028
EU/1/13/821/029
EU/1/13/821/030
EU/1/13/821/033

Date of first authorisation: 13 March 2013
Date of latest renewal: 8 January 2018

Drugs

Drug Countries
TOLUCOMBI Austria, Germany, Estonia, Spain, Finland, Ireland, Italy, Lithuania, Poland, Romania, Singapore, United Kingdom
 
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