CLOVOMET metoclopramide hydrochloride 10 mg film coated tablets blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

metoclopramide hydrochloride, Quantity: 10 mg

Disponibil de la:

Ipca Pharma (Australia) Pty Ltd

INN (nume internaţional):

metoclopramide hydrochloride

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: purified talc; stearic acid; macrogol 6000; pregelatinised maize starch; hypromellose; titanium dioxide; colloidal anhydrous silica; maize starch; microcrystalline cellulose

Calea de administrare:

Oral

Unități în pachet:

30, 50, 60, 100, 125, 150, 10, 20, 25

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

In Adults (20 years and over): As an adjunct to X-ray examination of the stomach and duodenum. To assist in intestinal intubation. To control nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties; uraemia; radiation sickness; malignant disease; postoperative vomiting; labour; infectious diseases. There is no clear benefit in motion sickness or other labyrinth disturbances. Metoclopramide hydrochloride has been found useful in the management of gastric retention after gastric surgery. Metoclopramide hydrochloride may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. Once control of diabetes has been established by diet and/or insulin, metoclopramide hydrochloride should be discontinued.,Young Adults: The use of metoclopramide hydrochloride in patients under 20 years should be restricted to the following situations: Severe intractable vomiting of known cause. Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. As an aid to gastrointestinal intubation

Rezumat produs:

Visual Identification: White to off-white, circular, biconvex film-coated tablets with breakline on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2015-12-17

Prospect

Clovomet CMI, Version 00
Page 1 of 7
CLOVOMET
_Metoclopramide hydrochloride anhydrous _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Clovomet. It does not
contain all the
available information. It does not take the place of talking to your
doctor or pharmacist. All
medicines have risks and benefits. Your doctor has weighed the risks
of you taking
Clovomet against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT CLOVOMET IS USED FOR
In adults over 20 years this medicine is used to:

treat nausea and vomiting caused by infectious diseases, kidney
disease, child birth,
other medications, cancer, or following surgery, chemotherapy or
radiation treatment.

activate stomach contractions in conditions where there is a need to
encourage normal
passage of food through the stomach and intestines.

with X-rays to help diagnose problems of the stomach and/or
intestines.

help with passing tubes into the intestine.
In young adults and children over 1 year of age this medicine is used
to:

treat severe vomiting of known cause or following chemotherapy or
radiation treatment.

help with passing tubes into the intestine.
This medicine works by blocking the action of a chemical in the brain
which causes nausea
and vomiting. It also acts in the stomach and upper intestine to
increase muscle contractions
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
BEFORE YOU TAKE CLOVOMET
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CLOVOMET IF YOU HAVE AN ALLERGY TO:

any medicine containing Metoclopramide

any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing
Clovomet CMI, Version 00
Page

Caracteristicilor produsului

Clovomet
Clovomet PI, Version 00
Page 1 of 8
PRODUCT INFORMATION
CLOVOMET
5 MG & 10 MG
_NAME OF MEDICINE: _
_ _
_ _
Metoclopramide hydrochloride anhydrous.
C
14
H
22
ClN
3
O
2
, HCl, H
2
O
CAS number: 54143 -57-6
Molecular weight: 354.3
_ _
_DESCRIPTION: _
Chemical name:
N-(diethyl-aminoethyl)-2-methoxy-4-amino-5-chlorbenzamide
monohydrochloride monohydrate.
Clovomet tablets also contain the excipients cellulose
microcrystalline, colloidal anhydrous
silica, maize starch, stearic acid and pregelatinised maize starch.
The coating for the tablets
consists of hypromellose, macrogol 6000, titanium dioxide and purified
talc.
_ _
_PHARMACOLOGY: _
Metoclopramide hydrochloride stimulates motility of the upper
gastrointestinal tract without
stimulating gastric, biliary, or pancreatic secretions.
Its mode of action is unclear. It seems to sensitise tissues to the
action of acetylcholine. The
effect
of
metoclopramide
hydrochloride
on
motility
is
not
dependent
on
intact
vagal
innervation, but it can be abolished by anticholinergic drugs.
Metoclopramide hydrochloride increases the tone and amplitude of
gastric (especially antral)
contractions, relaxes the pyloric sphincter and the duodenal bulb, and
increases peristalsis
of the duodenum and jejunum resulting in accelerated gastric emptying
and intestinal transit.
It increases the resting tone of the lower oesophageal sphincter. It
has little, if any effect on
the motility of the colon or gall bladder.
Metoclopramide hydrochloride has dopamine antagonist activity. Like
the phenothiazines
and related drugs, which are also dopamine antagonists, metoclopramide
hydrochloride
produces
sedation
and
may
produce
extra-pyramidal
reactions
(see
PRECAUTIONS).
Metoclopramide hydrochloride inhibits the central and peripheral
effects of apomorphine,
induces release of prolactin and causes a transient increase in
circulating aldosterone levels.
Clovomet
Clovomet PI, Version 00
Page 2 of 8
_PHARMACOKINETICS _
Absorption: The onset of pharmacological action is 1 to 3 minutes
following an intrav