Losec Control 20 mg gastro-resistant tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Omeprazole

제공처:

Bayer Limited

ATC 코드:

A02BC; A02BC01

INN (International Name):

Omeprazole

복용량:

20 milligram(s)

약제 형태:

Gastro-resistant tablet

처방전 유형:

Product not subject to medical prescription

치료 영역:

Proton pump inhibitors; omeprazole

승인 상태:

Marketed

승인 날짜:

2011-12-21

환자 정보 전단

Losec Control
, IE/H/0655/001/IA/008/G, BCH23019
1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSEC CONTROL 20 MG GASTRO-RESISTANT TABLETS
Omeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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
- You must talk to your doctor if you do not feel better or if you
feel worse after 14 days.
WHAT IS IN THIS LEAFLET
:
1. What Losec Control is and what it is used for
2. What you need to know before you take Losec Control
3. How to take Losec Control
4. Possible side effects
5. How to store Losec Control
6. Contents of the pack and other information
1.
WHAT LOSEC CONTROL IS AND WHAT IT IS USED FOR
Losec Control gastro-resistant tablets contains the active substance
omeprazole. It belongs to a group of
medicines called ‘proton pump inhibitors’. They work by reducing
the amount of acid that your stomach
produces.
Losec Control is used in adults for the short-term treatment of reflux
symptoms (for example heartburn and
acid regurgitation).
Reflux is the backflow of acid from the stomach into the gullet
“foodpipe”, which may become inflamed and
painful. This may cause you symptoms such as a painful burning
sensation in the chest rising up to the throat
(heartburn) and a sour taste in the mouth (acid regurgitation).
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSEC CONTROL
DO NOT TAKE LOSEC CONTROL
- if you are allergic to omeprazole or any of the other ingredients of
Losec Control (listed in section 6).
- if you are allergic to medicines containing other proton pump
inhibitors (e.g. pantopraz

제품 특성 요약

Health Products Regulatory Authority
31 March 2023
CRN00DH73
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losec Control 20 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 20.6 mg omeprazole magnesium
equivalent to 20 mg omeprazole.
Excipients with known effect:
Each gastro-resistant tablet contains 19–20 mg sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Pink, oblong, biconvex, film-coated tablets engraved with
on one side and 20 mg on the other side, containing enteric
coated pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losec Control gastro-resistant tablets is indicated for the treatment
of reflux symptoms (e.g. heartburn, acid regurgitation) in
adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology in adults
The recommended dose is 20 mg once daily for 14 days.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of symptoms.
The majority of patients achieve complete relief of heartburn within 7
days. Once complete relief of symptoms has occurred,
treatment should be discontinued.
Special populations
_Impaired renal function_
Dose adjustment is not needed in patients with impaired renal function
(see section 5.2).
_Impaired hepatic function_
Patients with impaired hepatic function should be advised by a doctor
before taking Losec Control (see section 5.2).
_Elderly (> 65 years old)_
Dose adjustment is not needed in the elderly (see section 5.2).
Method of administration
It is recommended to take Losec Control tablets in the morning,
preferably on an empty stomach, swallowed whole with half a
glass of water. The tablets must not be chewed or crushed.
_For patients with swallowing difficulties_
Break the tablet and disperse it in a spoonful of non-carbonated water
- if so wished, mix with some fruit juices or applesauce.
The dispersion should be taken immediately (or within 30 minutes). The
dispersion sho