LOMOTIL

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

DIPHENOXYLATE HYDROCHLORIDE ; ATROPINE SULFATE

Sẵn có từ:

Mercury Pharmaceuticals Ltd

Mã ATC:

A07DA01

INN (Tên quốc tế):

DIPHENOXYLATE HYDROCHLORIDE ; ATROPINE SULFATE

Liều dùng:

2.5/0.025 Milligram

Dạng dược phẩm:

Tablets

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

diphenoxylate

Tình trạng ủy quyền:

Not marketed

Ngày ủy quyền:

1980-05-24

Tờ rơi thông tin

T
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOMOTIL
®
2.5MG/0.025MG TABLETS
DIPHENOXYLATE HYDROCHLORIDE / ATROPINE SULPHATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
•If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
The product is known by the name above but will be referred to as
Lomotil Tablets throughout the rest of this leaflet.
IN THIS LEAFLET:
1. What Lomotil Tablets are and what they are used for
2. Before you are take Lomotil Tablets
3. How to take Lomotil Tablets
4. Possible side effects
5. How to store Lomotil Tablets
6. Further information
1. WHAT LOMOTIL TABLETS ARE AND WHAT THEY ARE USED FOR
Lomotil Tablets contain diphenoxylate hydrochloride and atropine
sulphate, which are the active ingredients.
Diphenoxylate has the effect of slowing down the activity of the
intestines.
Lomotil is used in the treatment of acute diarrhoea.
When you have diarrhoea, your body loses water and important salts. As
well as giving you Lomotil, the doctor may give you
medicine to help replace the water and salts that you have lost. In
some cases the doctor will not give you Lomotil until after the
water and salts have been replaced. The diphenoxylate in Lomotil helps
stop diarrhoea by slowing down the movement of the
muscles in your intestines.
Atropine relieves the sharp pains you sometimes get with diarrhoea.
2. BEFORE YOU TAKE LOMOTIL TABLETS
DO NOT TAKE LOMOTIL TABLETS IF:
• you are allergic (hypersensitive) to diphenoxylate, atropine or
any of the other ingredients of Lomotil Tablets (see section 6 of this
leaflet)
• you have jaundice (yellowing of the whites of the eyes or your
skin)
• you have an obstruction of the bowels which

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lomotil 2.5mg / 0.025mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of diphenoxylate hydrochloride and 0.025mg
of atropine sulphate.
Excipients - contains sucrose 53.5mg and sorbitol solution 3.10mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White biconvex tablet with the name ‘GS10’ engraved on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults only:
Adjunctive therapy to appropriate rehydration in acute diarrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Oral.
Caution: The recommended dosage should not be exceeded. Once
satisfactory control is achieved, dosage should be
reduced to suit the requirements of the individual patient.
Adults only:
The recommended starting is four tablets followed by two tablets every
six hours until the diarrhoea is controlled.
Elderly:
Consideration should be given to the presence of other diseases and
concomitant drug therapy (see precautions).
Children:
Not recommended.
4.3 CONTRAINDICATIONS
Lomotil
is contraindicated in-patients with a known hypersensitivity to
diphenoxylate hydrochloride or atropine,
in-
patients with jaundice,
intestinal
obstruction,
acute ulcerative colitis,
myasthenia gravis,
pyloric stenosis,
paralytic
ileus,
prostatic enlargement,
in the treatment
of
diarrhoea associated with pseudomembranous enterocolitis and in
patients with a raised intracranial pressure, and patients with head
injury.
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