Trifluoperazine 1mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
11-11-2022
Summary of Product characteristics
(SPC)
14-05-2020
Public Assessment Report
(PAR)
17-02-2006
Active ingredient:
Trifluoperazine hydrochloride
Available from:
Advanz Pharma
ATC code:
N05AB06
INN (International Name):
Trifluoperazine hydrochloride
Dosage:
1mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04020100; GTIN: 5060010283935
Patient Information leaflet
PATIENT LEAFLET: INFORMATION FOR THE USER
TRIFLUOPERAZINE 1MG AND 5MG TABLETS
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 ‘Trifluoperazine tablets are and what are they used for
2. What you need to know before you take Trifluoperazine tablets
3. How to take Trifluoperazine tablets
4. Possible side effects
5. How to store Trifluoperazine tablets
6. Contents of the pack and other information
1. WHAT ‘TRIFLUOPERAZINE TABLETS ARE AND WHAT ARE THEY USED FOR
These tablets contain the active ingredient trifluoperazine, they are
available in two strengths, 1 and 5
milligrammes (mg). Your doctor will have prescribed one strength of
tablet for you. The strength
will be shown on your tablet pack.
This medicine belongs to a class of drugs called phenothiazine
tranquillisers. You may also hear it
referred to as a neuroleptic drug. It influences the activity of
certain brain cells by decreasing the
effect of dopamine, a natural chemical in the brain.
At a low dosage ‘Trifluoperazine’ is used to manage anxiety,
depression caused by anxiety and
agitation. It is used in this way for short periods of time.
‘Trifluoperazine’ may also be used to treat
nausea (feeling sick) and vomiting (being sick).
At high doses ‘Trifluoperazine’ is used to treat schizophrenia and
related conditions. It can also be
used for short periods of time to treat very bad agitation or
dangerous behaviour.
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIFLUOPERAZINE TABLETS
DO NOT TAKE TRIFLUOPERAZINE TABLETS:
• If
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Summary of Product characteristics
OBJECT 1
TRIFLUOPERAZINE 1MG TABLETS
Summary of Product Characteristics Updated 01-Jun-2020 | ADVANZ Pharma
•
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
Trifluoperazine Tablets 1 mg
2. Qualitative and quantitative composition
Trifluoperazine hydrochloride 1.2 mg BP (equivalent to trifluoperazine
1 mg)
Excipient(s) with known effect – Sucrose and Lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Blue sugar coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Low dosage: 'Trifluoperazine' is indicated as an adjunct in the
short-term management of anxiety states,
depressive symptoms secondary to anxiety, and agitation. It is also
indicated in the symptomatic
treatment of nausea and vomiting.
High dosage: 'Trifluoperazine' is indicated for the treatment of
symptoms and prevention of relapse in
schizophrenia and in other psychoses, especially of the paranoid type,
but not in depressive psychoses. It
may also be used as
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