Avomine Tablets 25mg

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

PROMETHAZINE TEOCLATE

Dostupné z:

Manx Pharma Ltd Taylor Group House, Wedgnock Lane Warwick, CV34 5YA, United Kingdom

ATC kód:

R06AD02

INN (Medzinárodný Name):

PROMETHAZINE TEOCLATE 25 mg

Forma lieku:

TABLET

Zloženie:

PROMETHAZINE TEOCLATE 25 mg

Typ predpisu:

OTC

Terapeutické oblasti:

ANTIHISTAMINES FOR SYSTEMIC USE

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2007-03-02

Príbalový leták

severe headaches with blurred vision, severe stomach
pains with vomiting, dizziness, difficulty with keeping
your balance, ringing in the ears or other ear problems
as well as feeling sick
a bad cough
Reye's Syndrome or symptoms of Reye's Syndrome
(including persistent vomiting, feeling tired or
sleepiness).
Do not take Avomine for more than 7 days without
contacting your doctor.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
YOU MUST TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE
ALREADY TAKING ANY OF THE FOLLOWING MEDICINES:
anticholinergic agents
medicines to help you sleep (hypnotics)
medicines for depression, mental illness or anxiety
(tricyclic antidepressants, sedatives)
medicines for crampy stomach pains, Parkinson's
disease or bladder problems.
If you are having skin tests for allergy, do not take this
medicine as it interferes with the results. You should stop
taking this medicine at least 72 hours before the skin tests.
TAKING AVOMINE WITH FOOD AND DRINK
While taking Avomine, you should avoid drinking alcohol
as the tablets will add to the effects of alcohol.
PREGNANCY AND BREAST-FEEDING
If you are pregnant, think you may be pregnant or are
breast-feeding your baby, you should not take Avomine,
unless they have been recommended for you by a doctor.
If you are breast-feeding your baby, Avomine may cause
your baby to be irritable and excited.
If you are having a pregnancy test, do not take this
product as it interferes with the results.
DRIVING AND OPERATING MACHINERY
These tablets may make you feel dizzy, sleepy,
disorientated or confused or cause you to have a
headache. You should not drive or operate machinery for
the first few days, and until you are sure that you are not
affected by these unwanted effects.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS IN
THIS PRODUCT
These tablets contain sodium metabisulphite which may
rarely cause hypersensitivity (allergic) reactions a

Súhrn charakteristických

1.
NAME OF THE MEDICINAL PRODUCT
Avomine 25mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Promethazine teoclate 25 mg.
3.
PHARMACEUTICAL FORM
Tablet.
White to pale cream, plain, circular biconvex tablets of 8.5 mm marked
“AVOMINE” on one side with a score line on the reverse.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Avomine is a long acting anti-emetic, indicated for:
-
prevention and treatment of nausea and vomiting, including motion
sickness
and post operative vomiting;
-
vertigo due to Meniere’s syndrome, labyrinitis and other causes.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Motion sickness_
Adults
For the prevention on long journeys: one 25 mg tablet each evening at
bedtime, starting
the day before setting out. The duration of action is such that a
second dose in 24 hours is
not often necessary.
For the prevention of motion sickness on short journeys: one 25 mg
tablet one or two
hours before travelling or as soon after as possible.
Treatment of motion sickness: One 25 mg tablet as soon as possible and
repeated the
same evening followed by a third tablet the following evening.
_Nausea and vomiting due to other causes _
_ _
Adults
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One 25 mg tablet at night is often sufficient, but two or three
tablets are sometimes
necessary. Alternatively, more frequent administration such as 25 mg
two or three times
a day may be required for some patients. It is often not necessary to
give more than four
of the 25 mg Avomine tablets in 24 hours.
Children
In the above indications children over 10 years of age may be given
the lower adult doses
described above. Children between 5 and 10 years may be given half the
adult dose.
Tablets are not suitable for administration to children aged between 2
and 5 years. An
oral liquid preparation is recommended in this age group. Not for use
in children under 2
years of age (see section 4.3).
Elderly
No specific dosage recommendations.
_Administration: _
Oral.
4.3
CONTRAINDICATIONS
Avomine should not be u