Tolucombi 80mg25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrochlorothiazide; Telmisartan

Available from:

Consilient Health Ltd

ATC code:

C09DA07

INN (International Name):

Hydrochlorothiazide; Telmisartan

Dosage:

25mg ; 80mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5391512452650

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOLUCOMBI 40 MG/12.5 MG TABLETS
TOLUCOMBI 80 MG/12.5 MG TABLETS
TOLUCOMBI 80 MG/25 MG TABLETS
telmisartan/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tolucombi is and what it is used for
2.
What you need to know before you take Tolucombi
3.
How to take Tolucombi
4.
Possible side effects
5.
How to store Tolucombi
6.
Contents of the pack and other information
1.
WHAT TOLUCOMBI IS AND WHAT IT IS USED FOR
Tolucombi is a combination of two active substances, telmisartan and
hydrochlorothiazide in one
tablet. Both of these substances help to control high blood pressure.
-
Telmisartan belongs to a group of medicines called angiotensin II
receptor antagonists.
Angiotensin II is a substance produced in your body which causes your
blood vessels to narrow
thus increasing your blood pressure. Telmisartan blocks the effect of
angiotensin II so that the
blood vessels relax, and your blood pressure is lowered.
-
Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics, which cause your
urine output to increase, leading to a lowering of your blood
pressure.
High blood pressure, if not treated, can damage blood vessels in
several organs, which could lead
sometimes to heart attack, heart or kidney failure, stroke, or
blindness. There are usually no symptoms
of high blood pressure before damage occurs. Thus it is important to
regularly measure blood pressure
to verify if it is within the normal range.
TOLUCOMBI (40 MG/12.5 MG

Summary of Product characteristics

OBJECT 1
TOLUCOMBI 80 MG/25 MG TABLETS
Summary of Product Characteristics Updated 20-May-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Tolucombi 80 mg/25 mg tablets
2. 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.
3. Pharmaceutical form
Tablet.
80 mg/25 mg tablets: 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.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension.
Tolucombi fixed dose combination (80 mg telmisartan/25 mg
hydrochlorothiazide) is indicated in adults
whose blood pressure is not adequately controlled on Tolucombi 80
mg/12.5 mg (80 mg telmisartan/12.5
mg hydrochlorothiazide) or adults who have been previously stabilised
on telmisartan and
hydrochlorothiazide given separately.
4.2 Posology and method of administration
Posology
Tolucombi should be taken in patients whose blood pressure is not
adequately controlled by telmisartan
alone. Individual dose titration with each of the two components is
recommended before changing to the
fixed dose combination. When clinically appropriate, direct change
from monotherapy to the fixed
combination may be considered.
- Tolucombi 80 mg/25 mg may be administered once daily in patients
whose blood pressure is not
adequately controlled by Tolucombi 80 mg/12.5 mg or in patients who
have been previously stabilised on
telmisartan and hydrochlorothiazide given separately.
Tolucombi is also available at the dose strengths 40 mg/12.5 mg and 80
mg/12.5 mg.
_Special populations:_
Patients with renal impairment
Periodic monitoring of renal function is advised (see section 4.4).
Patients with hepatic impairment
In patients with mild to moderate hepatic impairment the posology
should not exceed Tolucombi