Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Tolucombi 40 mg/12.5 mg tablets.
Tolucombi 80 mg/12.5 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Tolucombi 40 mg/12.5 mg tablets: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 15 mm x 7 mm. Tolucombi 80 mg/12.5 mg tablets White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm. |
Tolucombi 40 mg/12.5 mg tablets:
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Tolucombi 80 mg/12.5 mg tablets:
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Excipient(s) with known effect:
Each 40 mg/12.5 mg tablet contains 57 mg of lactose (as monohydrate) and 147.04 mg sorbitol (E420).
Each 80 mg/12.5 mg 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 |
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.
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Tolucombi 40 mg/12.5 mg tablets:
EU/1/13/821/001
EU/1/13/821/002
EU/1/13/821/003
EU/1/13/821/004
EU/1/13/821/005
EU/1/13/821/006
EU/1/13/821/007
EU/1/13/821/008
EU/1/13/821/009
EU/1/13/821/010
EU/1/13/821/031
Tolucombi 80 mg/12.5 mg tablets:
EU/1/13/821/011
EU/1/13/821/012
EU/1/13/821/013
EU/1/13/821/014
EU/1/13/821/015
EU/1/13/821/016
EU/1/13/821/017
EU/1/13/821/018
EU/1/13/821/019
EU/1/13/821/020
EU/1/13/821/032
Date of first authorisation: 13 March 2013
Date of latest renewal: 8 January 2018
| Drug | Countries | |
|---|---|---|
| TOLUCOMBI | Austria, Germany, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Poland, Romania, Singapore, United Kingdom |
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