BEVACOMB 5/80 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VALSARTAN, AMLODIPINE BESILATE

Available from:

Teva B.V.

INN (International Name):

VALSARTAN, AMLODIPINE BESILATE

Dosage:

5/80 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

2017-03-10

Patient Information leaflet

PRODUCT:
1
7-4-17
WA
INDESIGN CS6
Body: Univers 55 Roman/
65 Bold/ 55 Oblique 9pts
Subhead: Univers 65 Bld 11pts
Header: Univers 65 Bld 13pts
48793
AMLODIPINE/VALSARTAN (BEVACOMB)
5MG/80MG, 5MG/160MG,
10MG/160MG FC TABS ALL (DUPNITSA)
TEI
7-4-17
190 x 380mm
WA
Leafl et
CUTTER GUIDE
PMS PROCESS BLACK
PMS GREEN
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Y
Y
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SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered.
The only exceptions to this are: bleeds, chokes, spreads or other
adjustments required for print reproduction
purposes only. If you have any diffi culties please contact the Teva
Artwork Team. We must receive a copy of the 3rd Party Vendors Proof
before fi nal approval can be made.
BEVACOMB 5 MG/80 MG
FILM-COATED TABLETS
BEVACOMB 5 MG/160 MG
FILM-COATED TABLETS
BEVACOMB 10 MG/160 MG
FILM-COATED TABLETS
AMLODIPINE/VALSARTAN
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leafl et. 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 leafl et. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT BEVACOMB IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEVACOMB
3. HOW TO TAKE BEVACOMB
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BEVACOMB
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT BEVACOMB IS AND WHAT IT IS USED
FOR
Bevacomb tablets contain two substances called
amlodipine and valsartan. Both of these substances
help to control high blood pressure.
•
Amlodipine belongs to a group of substances called
“calcium channel blockers”. Amlodipine stops
calcium from moving into the blood vessel wall
which stops the blood vessels from tightening.
•
Valsartan belongs

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bevacomb 5 mg/80mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate) and 80 mg of valsartan.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, 8mm round, biconvex, film-coated tablet, imprinted with
“I” on one side and “LD” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Bevacomb is indicated in adults whose blood pressure is not adequately
controlled on amlodipine or valsartan
monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Bevacomb is one tablet per day.
Bevacomb 5 mg/80 mg may be administered in patients whose blood
pressure is not adequately controlled with
amlodipine 5 mg or valsartan 80 mg alone.
Bevacomb can be used with or without food.
Individual dose titration with the components (i.e. amlodipine and
valsartan) is recommended before changing to the
fixed dose combination. When clinically appropriate, direct change
from monotherapy to the fixed-dose combination
may be considered.
For convenience, patients receiving valsartan and amlodipine from
separate tablets/capsules may be switched to
Bevacomb containing the same component doses.
_Renal impairment_
There are no available clinical data in severely renally impaired
patients. No dosage adjustment is required for patients
with mild to moderate renal impairment. Monitoring of potassium levels
and creatinine is advised in moderate renal
impairment.
_Hepatic impairment_
Bevacomb is contraindicated in patients with severe hepatic impairment
(see section 4.3).
Caution should be exercised when administering Bevacomb to patients
with hepatic impairment or biliary obstructive
disorders (see section 4.4). In patients with mild to moderate hepatic
impairment without cholestasis, the maximum
recommended dose is 80 mg valsartan. Amlodipine dosage recommendati