Promazine 25mg/5ml syrup

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Promazine hydrochloride

Disponible desde:

Rosemont Pharmaceuticals Ltd

Código ATC:

N05AA03

Designación común internacional (DCI):

Promazine hydrochloride

Dosis:

5mg/1ml

formulario farmacéutico:

Oral solution

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04020100; GTIN: 5016119044892

Información para el usuario

PROMAZINE HYDROCHLORIDE 25MG/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 your 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 Promazine Syrup is and what it is used for
2. What you need to know before you take Promazine Syrup
3. How to take Promazine Syrup
4. Possible side effects
5. How to store Promazine Syrup
6. Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE USER
_Continued overleaf_
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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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, yellowing of the skin, weakness or
breathlessness
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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
promazine
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fever
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low body temperature
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low blood pressure. You may feel dizzy when standing up
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unusual movements, often of the mouth, lips, eyes and tongue. These
movements can also include trembling
and shaking of the hands and feet

Ficha técnica

OBJECT 1
PROMAZINE HYDROCHLORIDE 25MG/5ML ORAL SYRUP
Summary of Product Characteristics Updated 07-Jun-2016 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Promazine Hydrochloride 25mg/5ml Oral Syrup
2. Qualitative and quantitative composition
Promazine Hydrochloride 25mg/5ml
3. Pharmaceutical form
Oral Syrup
4. Clinical particulars
4.1 Therapeutic indications
1. As an adjunct to short-term management of moderate to severe
psychomotor agitation
2. Agitation and restlessness in the elderly
4.2 Posology and method of administration
Posology
For oral administration only.
Dosage varies with the individual and the purpose for which the drug
is used, so the following dosages
are only for general guidance with regard to possible effectiveness
and good tolerance.
Initial dosages should be low, with increments at frequent, regular
intervals until the desired response is
obtained. Dosage intervals are usually six to eight hours, but in some
patients the 24 hour requirement
may be conveniently administered in a single bedtime dose.
The commencement and increase of dosage should be performed under
close supervision.
PSYCHOMOTOR AGITATION
Adults: 100mg to 200mg, four times daily.
Elderly: Half the normal starting dose may be sufficient for a
therapeutic response.
AGITATION AND RESTLESSNESS
Elderly: 25mg initially, increasing, if necessary, up to 50mg, four
times a day.
_Paediatric population_
Children: Promazine is not recommended for children
4.3 Contraindications
• Use in patients hypersensitive to the active ingredient or other
phenothiazines.
• Use in patients in coma or CNS depression
• Use in patients with bone marrow depression
• Use in patients with phaeochromocytoma
• Use during lactation
• Do not use during pregnancy, especially during the first three
months, unless there are compelling
reasons.
4.4 Special warnings and precautions for use
1. Acute withdrawal symptoms, including nausea, vomiting, sweating and
insomnia have been described
after abrupt cessation of antipsychotic drugs.