Sevikar 20mg/5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Olmesartan medoxomil; Amlodipine besilate

Available from:

Daiichi Sankyo UK Ltd

ATC code:

C09DB02

INN (International Name):

Olmesartan medoxomil; Amlodipine besilate

Dosage:

20mg ; 5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5015494200053

Patient Information leaflet

0
1.3.1.3 TEXT PROPOSED FOR THE PACKAGE LEAFLET
SEVIKAR 20 MG/5 MG
SEVIKAR 40 MG/5 MG
SEVIKAR 40 MG/10 MG
FILM-COATED TABLETS
VARIATION APPLICATION NL/H/1113/001-003/IB/031
ATTACHED PLEASE FIND:
- APPROVED UK PACKAGE LEAFLET - END OF PROCEDURE – CLEAN VERSION
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEVIKAR 20 MG/5 MG
SEVIKAR 40 MG/5 MG
SEVIKAR 40 MG/10 MG
FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE
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 Sevikar is and what it is used for
2.
What you need to know before you take Sevikar
3.
How to take Sevikar
4.
Possible side effects
5.
How to store Sevikar
6.
Contents of the pack and other information
1.
WHAT SEVIKAR IS AND WHAT IT IS USED FOR
Sevikar contains two substances called olmesartan medoxomil and
amlodipine (as amlodipine
besilate). Both of these substances help to control high blood
pressure.

Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II
receptor antagonists” which lower blood pressure by relaxing the
blood vessels.

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 thereby also reducing blood pressure.
The actions of both these substances contribute to stopping the
tightening of blood vessels, so
that blood vessels relax and blood pressure decreases.
Sevikar is used for the treatment of high blood pressure in patients
whose blood pressur

Summary of Product characteristics

OBJECT 1
SEVIKAR 20 MG/5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Oct-2017 | Daiichi
Sankyo UK Limited
1. Name of the medicinal product
Sevikar 20 mg/5 mg film-coated tablets
Sevikar 40 mg/5 mg film-coated tablets
Sevikar 40 mg/10 mg film-coated tablets
2. Qualitative and quantitative composition
Sevikar 20 mg/5 mg film-coated tablets:
Each film-coated tablet of Sevikar contains 20 mg of olmesartan
medoxomil and 5 mg of amlodipine (as
amlodipine besilate).
Sevikar 40 mg/5 mg film-coated tablets:
Each film-coated tablet of Sevikar contains 40 mg of olmesartan
medoxomil and 5 mg of amlodipine (as
amlodipine besilate).
Sevikar 40 mg/10 mg film-coated tablets:
Each film-coated tablet of Sevikar contains 40 mg of olmesartan
medoxomil and 10 mg of amlodipine (as
amlodipine besilate).
Excipients with known effect
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Sevikar 20 mg/5 mg film-coated tablets:
White, round, film-coated tablet of 6 mm with C73 debossed on one
side.
Sevikar 40 mg/5 mg film-coated tablets:
Cream, round, film-coated tablet of 8 mm with C75 debossed on one
side.
Sevikar 40 mg/10 mg film-coated tablets:
Brownish-red, round, film-coated tablet of 8 mm with C77 debossed on
one side
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension.
Sevikar is indicated in adult patients whose blood pressure is not
adequately controlled on olmesartan
medoxomil or amlodipine monotherapy (see section 4.2 and section 5.1).
4.2 Posology and method of administration
Posology
Adults
The recommended dosage of Sevikar is 1 tablet per day.
Sevikar 20 mg/5 mg may be administered in patients whose blood
pressure is not adequately controlled
by 20 mg olmesartan medoxomil or 5 mg amlodipine alone.
Sevikar 40 mg/5 mg may be administered in patients whose blood
pressure is not adequately controlled
by Sevikar 20 mg/5 mg.
Sevikar 40 mg/10 mg may be administered in patients whose blood
pressure is not adequately controlled
by Sevik