LOMOTIL diphenoxylate hydrochloride 2.5 mg atropine sulfate monohydrate 0.025 mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

diphenoxylate hydrochloride, Quantity: 2.5 mg; atropine sulfate monohydrate, Quantity: 25 microgram

Dostopno od:

iNova Pharmaceuticals (Australia) Pty Ltd

Farmacevtska oblika:

Tablet, uncoated

Sestava:

Excipient Ingredients: sorbitol solution (70 per cent) (non-crystallising); purified talc; light liquid paraffin; magnesium stearate; Acacia; sucrose

Pot uporabe:

Oral

Enote v paketu:

20 tablets, 100 tablets, 2 tablets, 8 tablets

Razred:

Medicine Registered

Tip zastaranja:

(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine

Terapevtske indikacije:

LOMITOL is indicated as an adjunctive therapy for acute and chronic diarrhoea.TGA Approved 13 February 1985 date of last amendment 7 August 2007

Povzetek izdelek:

Visual Identification: White to off white, uncoated, round, biconvex tablet marked LT on one side and the other side plain; Container Type: Blister Pack; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2000-06-23

Navodilo za uporabo

LOMOTIL
®
L
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LOMOTIL?
Lomotil contains the active ingredients diphenoxylate hydrochloride
and atropine sulfate monohydrate. Lomotil is used to for the
treatment of acute or chronic diarrhoea.
For more information, see Section 1. Why am I using Lomotil? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LOMOTIL?
Do not use if you have ever had an allergic reaction to diphenoxylate
or atropine or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, ARE PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Lomotil? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lomotil and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE LOMOTIL?
•
The usual starting dose is 2 tablets, three to four times daily, until
the diarrhoea is under control.
•
The usual maximum dose is 8 tablets in a day (24 hours).
More instructions can be found in Section 4. How do I use Lomotil? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LOMOTIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Lomotil.
•
Drink plenty of liquids, such as an oral rehydration solution.
•
Eat as little as possible for the first few days.
THINGS YOU
SHOULD NOT DO
•
Do not give Lomotil to children under 12 years of age.
DRIVING
OR USING
MACHINES
•
Make sure you know how you react to Lomotil before driving or
operating machinery. Lomotil can make
some people drowsy or dizzy.
DRINKING
ALCOHOL
•
Do not drink alcohol while using the medicine.
LOOKING AFTER
YOUR MEDICINE
•
Store below 30°C.
•
Store away from heat, direct light and steamy or damp pl

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION – LOMOTIL
®
(DIPHENOXYLATE AND ATROPINE) TABLETS
1
NAME OF THE MEDICINE
Diphenoxylate hydrochloride and atropine sulfate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each LOMOTIL
tablet contains diphenoxylate HCl 2.5 mg and atropine sulfate25
micrograms.
Excipients with known effect:
•
Sorbitol
•
Sucrose
For the full list of excipients, see Section 6.1 List of excipients.
LOMOTIL is a white to off white, uncoated, round, biconvex tablet
embossed “LT” on one
side and
plain on the other.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LOMOTIL
is indicated as an adjunctive therapy for acute and chronic diarrhoea.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended adult starting dose is 5 mg (two tablets) three or
four times daily.
After initial control is achieved, the dosage should be reduced to
meet the
requirements of the
individual patient. Control may often be maintained with as little
as 5 mg (two tablets) daily.
4.3
C
ONTRAINDICATIONS
1.
Known hypersensitivity to diphenoxylate HCl or atropine.
2.
Jaundice
3.
Diarrhoea associated with pseudomembranous enterocolitis which may
occur during or
up to several weeks following treatment with certain antibiotics.
4.
Diarrhoea associated with inflammatory bowel disease, (e.g. ulcerative
colitis,
Crohn’s
disease) and bacterial and amoebic colitis, as diphenoxylate may
exacerbate the
underlying condition (see Section 4.4 Special Warnings and Precautions
for Use).
LOMOTIL
is not recommended for children under 12 years of age. The
medication should
be kept out of reach of children since accidental overdosage
may result in severe, even
fatal respiratory depression.
2
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
INTERACTION WITH CNS DEPRESSANTS
Diphenoxylate may have an additive effect on certain
central nervous system depressants, e.g.
barbiturates, tranquillizers and alcohol (see Section 4.5 Interactions
with other medicines and
other forms of interactions).
MAO INHIBITORS
Concurrent use with