Haloperidol 5mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Haloperidol

Available from:

Pinewood Healthcare

ATC code:

N05AD01

INN (International Name):

Haloperidol

Dosage:

1mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5099186001340 5099186001418

Patient Information leaflet

23LF01492PW
23LF01492PW
Driving and using machines
Haloperidol can affect your ability to drive and use tools or
machines. Side effects, such as feeling sleepy, may affect your
alertness,
particularly when you first start taking it or after a high dose. Do
not drive or use any tools or machines without discussing this with
your
doctor first.
Haloperidol contains methylhydroxybenzoate and propylhydroxybenzoate
• Methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216): may
cause allergic reactions (possibly delayed).
3. HOW TO TAKE HALOPERIDOL
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
How much should you take
Your doctor will tell you how much Haloperidol to take and for how
long. Your doctor will also tell you whether to take Haloperidol one
or
more times a day. It may be some time before you feel the full effect
of the medicine. Your doctor will normally give you a low dose to
start, and then adjust the dose to suit you. It is very important you
take the correct amount.
Your dose of haloperidol will depend on:
• your age
• what conditions you are being treated for
• whether you have problems with your kidneys or liver
• other medicines you are taking.
Adults
• Your dose will normally be between 0.5 mg and 10 mg each day.
• Your doctor may adjust this to find the dose that suits you best.
• The highest dose adults should take depends on the condition you
are being treated for and varies between 5 mg and 20 mg each day.
Elderly people
• Elderly people will normally start on 0.5 mg each day or half the
lowest adult dose.
• The amount of Haloperidol you take will then be adjusted until the
doctor finds the dose that suits you best.
• The highest dose elderly people should take is 5 mg each day
unless your doctor decides a higher dose is needed.
Children and adolescents 6 to 17 years of age
• Your dose will normally be between 0.5 mg and 3 mg each day.
• Adolescents up to 17 years of age being t

Summary of Product characteristics

OBJECT 1
HALOPERIDOL ORAL SOLUTION BP 5 MG/5 ML
Summary of Product Characteristics Updated 14-Mar-2018 | Pinewood
Healthcare
1. Name of the medicinal product
Haloperidol Oral Solution BP 5 mg/5 ml
2. Qualitative and quantitative composition
Each 5 ml contains 5 mg of Haloperidol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral 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 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 Posology and method of administration
Posology
_Adults _
A low initial dose is recommended, which subsequently may be adjusted
accordi