Rennie Deflatine chewable tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Tờ rơi thông tin Tờ rơi thông tin (PIL)
01-06-2019

Thành phần hoạt chất:

Magnesium carbonate; Simeticone; Calcium carbonate

Sẵn có từ:

Bayer Plc

Mã ATC:

A02AF02

INN (Tên quốc tế):

Magnesium carbonate; Simeticone; Calcium carbonate

Liều dùng:

80mg ; 25mg ; 680mg

Dạng dược phẩm:

Chewable tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Never Valid To Prescribe As A VMP

Tóm tắt sản phẩm:

BNF: 01010201; GTIN: 5010605296024 5010605296055

Tờ rơi thông tin

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PIL 135 x 197
Rennie
Deflatine
Tablets
Leaflet
UK
Please note that any low resolution paper Canon colour
copies associated with this job should be referred to for
content, layout and colour separation only.
UNDER NO CIRCUMSTANCES SHOULD THIS
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18/36 Pack
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BAY371331
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00000000
CALCIUM CARBONATE, MAGNESIUM CARBONATE, 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 14 DAYS.
WHAT IS 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, BILIOUSNESS, FLATULENCE,
AND TRAPPED WIND. EACH TABLET IS FORMULATED
WITH SIMETICONE, A H
                                
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Đặc tính sản phẩm

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rennie Deflatine
Rennie Heartburn, Indigestion and Wind Relief 680mg/80mg/25mg Chewable
Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Carbonate
680.0 mg
Magnesium Carbonate, heavy
80.0 mg
Simethicone
25.0 mg
Also contains Sorbitol (E420)
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Chewable Tablet
Cream white flat round tablet, scored on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the effective relief of acid indigestion, nervous indigestion,
heartburn,
upset stomach, uncomfortable bloating, biliousness, flatulence,
painful trapped
wind, and indigestion and heartburn during pregnancy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Tablets to be taken orally, sucked or chewed.
Adults and children over 12 years
One or two tablets to be sucked or chewed as required. A maximum daily
dose of
8g calcium carbonate, corresponding to 11 tablets a day, must not be
exceeded.
Children
Not recommended for children under 12 years.
As with all antacids, if symptoms persist despite 14 days of
continuous
therapy, diagnostic measures are strongly recommended in order to rule
out a
more serious disease.
4.3
CONTRAINDICATIONS
Rennie should not be administered to patients with:
•
Hypersensitivity to any of the ingredients of the product
•
Hypercalcaemia and/or conditions resulting in hypercalcaemia
•
Nephrolithiasis due to calculi containing calcium deposits
•
Severe renal insufficiency
•
Hypophosphataemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
•
Prolonged use should be avoided.
•
The stated dose should not be exceeded. If, after 14 days of
treatment,
symptoms persist or only partly disappear the patient should consult a
doctor.
•
Caution should be exercised in patients with mild to moderate
impairment of
renal
function
(see
section
4.3
–
contraindication
in
severe
renal
insufficiency). If Rennie is used in such patients, plasma calcium,
phosphate
and magnesium levels should be regu
                                
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