Chlorpromazine 100mg/5ml oral solution

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Parsisiųsti Pakuotės lapelis (PIL)
15-06-2018
Parsisiųsti Prekės savybės (SPC)
15-06-2018

Veiklioji medžiaga:

Chlorpromazine hydrochloride

Prieinama:

Rosemont Pharmaceuticals Ltd

ATC kodas:

N05AA01

INN (Tarptautinis Pavadinimas):

Chlorpromazine hydrochloride

Dozė:

20mg/1ml

Vaisto forma:

Oral solution

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04020100; GTIN: 5016119003899

Pakuotės lapelis

                                CHLORPROMAZINE HYDROCHLORIDE 100MG/5ML ORAL SYRUP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
- BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or pharmacist.
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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.
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If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Chlorpromazine Syrup is and what it is used for
2. What you need to know before you take Chlorpromazine Syrup
3. How to take Chlorpromazine Syrup
4. Possible side effects
5. How to store Chlorpromazine Syrup
6. Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued overleaf_
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A PROLONGED PAINFUL ERECTION. If this happens to you, go to your
nearest hospital
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yellowing of the skin and whites of your eyes (jaundice) with fever
and possible liver damage.
IF YOU GET ANY OF THE FOLLOWING SIDE EFFECTS, SEE YOUR DOCTOR AS SOON
AS POSSIBLE:
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blood clots in the veins especially in the legs (symptoms include
swelling, pain and redness in the leg), which may
travel through blood vessels to the lungs causing chest pain and
difficulty in breathing. If you notice any of these
symptoms seek medical advice IMMEDIATELY
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feeling depressed, agitated, lack of emotion
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fits
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blood problems. You may notice signs such as high temperature or
chills, sore throat, ulcers in your mouth or throat
and unusual tiredness
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heart changes including fast heart beats, unusual heart beats, heart
attack. Symptoms of a
heart attack are chest pain which may spread to the shoulders,
neck or arms and shortness of breath. If you get these see a
doctor straight away. Unexplained deaths have been reported but
it is not proven that they were caused by chlorpromazine
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low body temperature
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low blood pressure.
                                
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Prekės savybės

                                OBJECT 1
CHLORPROMAZINE HYDROCHLORIDE 100MG/5ML ORAL
SYRUP
Summary of Product Characteristics Updated 06-Aug-2013 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Chlorpromazine Hydrochloride 100mg/5ml Oral Syrup
2. Qualitative and quantitative composition
Chlorpromazine Hydrochloride 100mg/5ml
3. Pharmaceutical form
Brown-red syrup with odour and taste of mint and apricot for oral
administration
4. Clinical particulars
4.1 Therapeutic indications
Chlorpromazine is a phenothiazine neuroleptic. It is indicated in the
following conditions:
- Schizophrenia and other psychoses (especially paranoid), mania and
hypomania;
- In severe anxiety, psychomotor agitation, excitement and violent or
dangerously impulsive behaviour.
Chlorpromazine is used as an adjunct in the short term management of
these conditions;
- Nausea and vomiting of terminal illness (where other drugs have
failed or are not available);
- Childhood schizophrenia and autism;
- Intractable hiccups.
4.2 Posology and method of administration
Posology
For oral administration only.
Dosage should be low to begin with and gradually increased under close
supervision until the optimum
dosage within the recommended range is reached. Individual response
and dosage requirements may vary
greatly.
DOSAGE FOR SCHIZOPHRENIA, OTHER PSYCHOSES, MANIA, HYPOMANIA, ANXIETY,
PSYCHOMOTOR AGITATION,
EXCITEMENT, VIOLENT OR DANGEROUSLY IMPULSIVE BEHAVIOUR
_Adults_: Initially 25mg three times daily or 75mg at bedtime
increasing daily by 25mg to an effective
maintenance dose. This maintenance dose is usually 70 to 300mg daily,
but may be up to 1g daily in some
patients.
_Children under 1 year_: Not recommended unless the need is life
saving.
_Children 1 - 5 years: _0.5mg/Kg bodyweight every 4 - 6 hours to a
maximum recommended dose of 40mg
daily.
_Children 6 - 12 years:_ 1/3 to 1/2 the adult dose up to a maximum
recommended dose of 75 mg daily.
_Elderly or disabled patients_: Start with 1/3 to 1/2 the usual adult
dose with a more gradual increase in
dosage.
DOSAGE
                                
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