Haldol 2mg/ml oral solution

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Haloperidol

Saatavilla:

Essential Pharma Ltd

ATC-koodi:

N05AD01

INN (Kansainvälinen yleisnimi):

Haloperidol

Annos:

2mg/1ml

Lääkemuoto:

Oral solution

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 04020100; GTIN: 5012674034187

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HALDOL
® 2 MG/ML ORAL SOLUTION
haloperidol
Haldol is a registered trademark
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.
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
1.
WHAT HALDOL IS AND WHAT IT IS USED FOR
The name of your medicine is Haldol.
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 Huntingt

Valmisteyhteenveto

OBJECT 1
HALDOL 2MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 15-Jan-2019 | Janssen-Cilag
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
HALDOL 2 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml of the oral solution contains 2 mg of haloperidol
Excipients with known effect:
Each ml of the oral solution contains 1.9 mg of methyl
parahydroxybenzoate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear, colourless solution.
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 psyc