SERENACE 10 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HALOPERIDOL

Available from:

Norton Healthcare Limited T/A IVAX Pharmaceuticals UK

ATC code:

N05AD01

INN (International Name):

HALOPERIDOL

Dosage:

10 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antipsychotics

Authorization status:

Authorised

Authorization date:

1991-12-17

Patient Information leaflet

SERENACE 1.5 MG, 5 MG, 10 MG AND 20 MG TABLETS
haloperidol
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET:
1.
WHAT SERENACE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERENACE
3.
HOW TO TAKE SERENACE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SERENACE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SERENACE IS AND WHAT IT IS USED FOR
The name of your medicine is Serenace.
Serenace contains the active substance haloperidol. This belongs to a
group of medicines called
‘antipsychotics’.
Serenace is used in adults, adolescents and children for illnesses
affecting the way you think, feel or
behave. These include mental health problems (such as schizophrenia
and bipolar disorder) and
behavioural problems.
These illnesses may make you:
•
Feel confused (delirium)
•
See, hear, feel or smell things that are not there (hallucinations)
•
Believe things that are not true (delusions)
•
Feel unusually suspicious (paranoia)
•
Feel very excited, agitated, enthusiastic, impulsive or hyperactive
•
Feel very aggressive, hostile or violent.
In adolescents and children, Serenace is used to treat schizophrenia
in patients aged 13 to 17 years, and to
treat behavioural problems in patients aged 6 to 17 years.
Serenace is also used:
•
In adolescents and children aged 10 to 17 years and in adults for
movements or sounds you
can’t control (tics), for example in severe Tourette’s syndrome
•
In adults to help control movements in Huntingto

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serenace 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains haloperidol 10 mg.
Excipients: Each tablet contains 190mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pale pink biconvex tablet coded ‘NORTON 10’ on one face,
‘SERENACE’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4.1
THERAPEUTIC INDICATIONS
Adult patients aged 18 years and above
Treatment of schizophrenia and schizoaffective disorder.
Acute treatment of delirium when non-pharmacological treatments have
failed.
Treatment of moderate to severe manic episodes associated with bipolar
I disorder.
Treatment of acute psychomotor agitation associated with psychotic
disorder or manic episodes of bipolar I
disorder.
Treatment of persistent aggression and psychotic symptoms in patients
with moderate to severe Alzheimer’s
dementia and vascular dementia when non pharmacological treatments
have failed and when there is a risk of
harm to self or others.
Treatment of tic disorders, including Tourette’s syndrome, in
patients with severe impairment after educational,
psychological and other pharmacological treatments have failed.
Treatment of mild to moderate chorea in Huntington’s disease, when
other medicinal products are ineffective or
not tolerated.
Paediatric patients
Treatment of:
Schizophrenia in adolescents aged 13 to 17 years when other
pharmacological treatments have failed or are not
tolerated.
Persistent, severe aggression in children and adolescents aged 6 to 17
years with autism or pervasive
developmental disorders, when other treatments have failed or are not
tolerated.
Tic disorders, including Tourette’s syndrome, in children and
adolescents aged 10 to 17 years with severe
impairment after educational, psychological and other pharmacological
treatments have failed.
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