Halkid 200mcg/ml Oral Solution

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

HALOPERIDOL

Dostępny od:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

Kod ATC:

N05AD01

INN (International Nazwa):

HALOPERIDOL 200 µg

Forma farmaceutyczna:

ORAL SOLUTION

Skład:

HALOPERIDOL 200 µg

Typ recepty:

POM

Dziedzina terapeutyczna:

PSYCHOLEPTICS

Status autoryzacji:

Authorised

Data autoryzacji:

2019-04-08

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HALKID
® 200MICROGRAMS/ML ORAL SOLUTION
haloperidol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING OR GIVING
THIS MEDICINE TO A CHILD TO
WHOM IT HAS BEEN PRESCRIBED BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU AND YOUR
CHILD.

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 or your child 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 or your child 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 Halkid 200micrograms/ml Oral Solution but
it will be referred to as
'Halkid' throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. WHAT HALKID IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE HALKID
3. HOW TO TAKE OR GIVE HALKID
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE HALKID
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT HALKID IS AND WHAT IT IS USED FOR
This medicine contains the active substance haloperidol. This belongs
to a group of medicines
called 'antipsychotics'.
Halkid is used in 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 or your child:

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, Halkid is used to treat schizophrenia in
patients aged 13 to 17 years,
and to treat behavioural problems in patients aged 6 to 17 years:
Halkid is also used in ad

Charakterystyka produktu

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Halkid
®
200micrograms/ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 200micrograms haloperidol.
Excipients with known effect:
Each ml of oral solution contains 0.8mg methyl parahydroxybenzoate
(E218).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral Solution
Clear, colourless solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Halkid 200micrograms/ml Oral Solution is indicated for use in children
when low doses of
haloperidol need to be administered for the treatment of the following
conditions:
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
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A low initial dose is recommended, which subsequently may be adjusted
according to the
patient’s response. Patients must always be maintained on the
minimal effective dose (see
section 5.2).
The dose recommendations for Halkid Oral Solution are presented in
Table 1.
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TABLE 1: HALOPERIDOL DOSE RECOMMENDATIONS FOR PEDIATRIC POPULATION
TREATMENT
OF
SCHIZOPHRENIA
IN
ADOLESCENTS
AGED
13
TO
17
YEARS
WHEN
OTHER
PHARMACOLOGICAL TREATMENTS HAVE FAILED OR ARE NOT TOLERATED
•
The recommended dose is 0.5 to 3 mg/day, administered orally,
preferably in
divided doses (2 to 3 times a day).
•
It is recommended to assess the individual benefit-risk when
considering doses
above 3 mg/day.
•
The maximum recommended dose is 5 mg/day.
•
The treatment duration must be individually evaluated.
TREATMENT OF PERSISTENT,