Haloperidol 10mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Haloperidol

Dostopno od:

DE Pharmaceuticals

Koda artikla:

N05AD01

INN (mednarodno ime):

Haloperidol

Odmerek:

10mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04020100

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HALDOL
® 10MG TABLETS
(haloperidol)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
The name of your medicine is Haldol 10mg tablets but will be referred
to as
Haldol throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Haldol is and what it is used for
2.
What you need to know before you take Haldol
3.
How to take Haldol
4.
Possible side effects
5.
How to store Haldol
6.
Contents of the pack and other information
Haldol contains the active substance haloperidol. This belongs to a
group of
medicines called 'antipsychotics'.
Haldol 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, Haldol is used to treat schizophrenia in
patients
aged 13 to 17 years, and to treat behavioural problems in patients
aged 6 to
17 years.
Haldol 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 Huntington’s

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Haloperidol Tablets 10 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of Haloperidol.
Excipients of known effect:
Each tablet contains Lactose Monohydrate 192.6 mg equivalent to 183 mg
lactose,
and Ponceau 4R (E124) 0.2 mg.
For the full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Pink round biconvex 9 mm tablets with company logo on one side and
A491 and a
break-line on the other.
4
CLINICAL PARTICULARS
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.
4.2