Acidex Oral Suspension, Sodium Alginate 500mg, Sodium Bicarbonate 267mg, Calcium Carbonate 160mg/10ml

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Доступна с:

Pinewood Laboratories Ltd

код АТС:

B05CB; B05CB04

ИНН (Международная Имя):

Sodium alginate; Sodium bicarbonate; Calcium carbonate

дозировка:

500mg+267mg+160 milligram/ 10 millilitre

Фармацевтическая форма:

Oral suspension

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

Salt solutions; sodium bicarbonate

Статус Авторизация:

Marketed

Дата Авторизация:

1998-06-26

тонкая брошюра

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACIDEX ORAL SUSPENSION
SODIUM ALGINATE 500 MG
SODIUM BICARBONATE 267 MG
CALCIUM CARBONATE 160 MG/10 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your doctor or 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 a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET:
1.
What Acidex is and what it is used for
2.
What you need to know before you take Acidex
3.
How to take Acidex
4.
Possible side effects
5.
How to store Acidex
6.
Contents of the pack and other information
1.
WHAT ACIDEX IS AND WHAT IT IS USED FOR
Acidex belongs to a group of medicines called ‘reflux
suppressants’.
This product forms a protective layer that floats on top of the
stomach contents. This layer
prevents reflux and keeps the stomach contents away from the lining of
the food pipe to
relieve the symptoms of heartburn and indigestion.
Acidex is used for the treatment of symptoms of gastro-oesophageal
reflux such as acid
regurgitation, heartburn and indigestion (related to reflux), for
example, following meals,
or during pregnancy or in patients with symptoms related to reflux
oesophagitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACIDEX
DO NOT TAKE ACIDEX:

If you are allergic to sodium alginate, sodium bicarbonate or calcium
carbonate or
any of the other of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH ACIDEX IF YOU:

are on a sodium restricted diet
CONSULT YOUR DOCTOR IF YOU ARE OVER 40 YEARS AND HAVE NEVER SUFFERED
WITH HEARTBURN
AND ACID INDIGESTION BEFORE.
IF SYMPTOMS PERSIST AFTER 7 DAYS CONSULT YOU

Характеристики продукта

Health Products Regulatory Authority
11 November 2021
CRN00CND3
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acidex Oral Suspension, Sodium Alginate 500mg, Sodium Bicarbonate
267mg, Calcium Carbonate 160mg/10ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains:
Sodium Alginate
500 mg
Sodium Bicarbonate
267 mg
Calcium Carbonate
160 mg
Excipients with known effect
Each 10 ml dose contains 143 mg sodium, 15.0 mg ethyl
parahydroxybenzoate (E214), 5.50 mg propyl parahydroxybenzoate
(E216) and 2.5 mg butyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
Aniseed flavoured pink suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of gastric reflux, reflux oesophagitis, hiatus
hernia, heartburn (including heartburn of pregnancy) and
similar gastric distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN OVER 12 YEARS: 10-20 ml (Two to four 5 ml
spoonfuls) after meals and at bedtime. The maximum daily
dose is 80 ml.
CHILDREN UNDER 12 YEARS: Should only be given on medical advice.
_ _
CHILDREN 6 – 12 YEARS: 5-10 ml (One to two 5 ml spoonfuls) after
meals and at bedtime. The maximum daily dose is 40 ml.
CHILDREN UNDER 6 YEARS OF AGE: Not recommended.
SPECIAL PATIENT GROUPS
Elderly: No dosage modification is required in this age group.
Hepatic Impairment: No modifications necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (see section 4.4).
METHOD OF ADMINISTRATION
For oral administration.
Health Products Regulatory Authority
11 November 2021
CRN00CND3
Page 2 of 4
DURATION OF TREATMENT
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1, including ethyl parahydroxybenzoate
(E214), propyl parahydroxybenzoate (E216) and butyl
parahydroxybenzoate (see section 4.4).
4.4 SPECIAL WARNINGS A