Rennie Deflatine Chewable Tablets Calcium Carbonate 680mg Magnesium Carbonate 80mg Simeticone 25mg

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Calcium carbonate; Magnesium carbonate; Simeticone

Доступно од:

Bayer Limited

АТЦ код:

A02AA01; A02AC01; A02AX; A03AX13

INN (Међународно име):

Calcium carbonate; Magnesium carbonate; Simeticone

Дозирање:

680 mg/80 mg/25 milligram(s)

Фармацеутски облик:

Chewable tablet

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

magnesium carbonate; calcium carbonate; Antacids, other combinations; silicones

Статус ауторизације:

Marketed

Датум одобрења:

1994-05-16

Информативни летак

BCH22005
Package leaflet: Information for the user
Rennie
®
Deflatine
680mg/ 80mg/ 25mg CHEWABLE TABLETS
Calcium carbonate, magnesium Carbonate and simeticone
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 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 contact a doctor if you do not feel better or if you feel
worse after 7
days.
IN THIS LEAFLET
1.
WHAT RENNIE
® DEFLATINE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE
® DEFLATINE
3.
HOW TO TAKE RENNIE
® DEFLATINE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE RENNIE
® DEFLATINE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT RENNIE
® DEFLATINE IS AND WHAT IT IS USED FOR
RENNIE
® DEFLATINE relieves the PAIN AND DISCOMFORT OF BLOATING, FLATULENCE,
AND TRAPPED
WIND. EACH TABLET IS FORMULATED WITH SIMETICONE, A HIGHLY EFFECTIVE
ANTI-FOAMING AGENT
THAT CAUSES THE TRAPPED AIR BUBBLES TO COMBINE AND DISPERSE, HELPING
TO ELIMINATE
THE SYMPTOMS DISCREETLY AND WITHOUT EMBARRASSMENT. RENNIE DEFLATINE
ALSO CONTAINS
ANTACIDS WHICH PROVIDE EFFECTIVE RELIEF FROM HEARTBURN, INDIGESTION
AND ACID REFLUX.
YOU
MUST CONTACT A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL WORSE
AFTER 7 DAYS.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENNIE
® DEFLATINE
DO NOT TAKE RENNIE
® DEFLATINE:
•
If you have severe kidney disease or suffer from kidney stones.
BCH22005
•
If you have high calcium levels in the blood, kidneys or urine.
•
If you have low phosphate levels in the blood.
•
If you are allergic (hypersensitive) to any of the ingredients (
listed in Section 6).
WARNINGS AND PRECAUTIONS:
As with other antacid products, taking these t

Карактеристике производа

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rennie Deflatine Chewable Tablets Calcium Carbonate 680mg Magnesium
Carbonate 80mg Simeticone 25mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Calcium carbonate 680 mg (272 mg elemental calcium)
Magnesium Carbonate, heavy 80 mg (20 mg elemental magnesium)
Simeticone 25 mg
Excipientswith known effect: Each chewable tablet also contains
Sorbitol (E420) 430mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
A white, circular, flat tablet, with bevelled edges and a single score
line on one surface.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the effective relief of acid indigestion, heartburn, uncomfortable
bloating, flatulence and painful trapped wind.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
To be taken orally sucked or chewed.
Adults: One or two tablets to be sucked or chewed as required, to a
maximum of eleven tablets a day.
The maximum daily dose of 8 g calcium carbonate (corresponding to 11
Rennie Deflatine tablets) should not be exceeded and
should not be taken continuously for longer than 2 weeks.
Prolonged use should be avoided. If symptoms persist after 7 days,
further medical advice should be sought.
As with all antacids, if symptoms persist in spite of therapy,
diagnostic measures are strongly recommended in order to rule
out a more serious disease.
Paediatric population: Not recommended for use in children and
adolescents below age 18 due to a lack of sufficient data on
safety or efficacy.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
Rennie Deflatine should not be administered in the following cases:

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1

Hypercalcaemia, hypercalciuria and/or conditions resulting in
hypercalcaemia e.g. sarcoidosis

Nephrolithiasis due to calculi containing calcium deposits
Health