Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trifluoperazine hydrochloride
Kent Pharma (UK) Ltd
N05AB06
Trifluoperazine hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIFLUOPERAZINE 1MG AND 5MG TABLETS (Trifluoperazine Hydrochloride) 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 is and what it is used for 2. What you need to know before you take Trifluoperazine 3. How to take Trifluoperazine 4. Possible side effects 5. How to store Trifluoperazine 6. Contents of the pack and other information 1 WHAT TRIFLUOPERAZINE IS AND WHAT IT IS USED FOR Trifluoperazine belongs to a group of medicines called phenothiazines. They act on the central nervous system and produce a calming effect, relieving anxiety and tension. Trifluoperazine is used for the following: Low dose • For short term treatment of anxiety and agitation • To treat feeling or being sick (nausea and vomiting) High dose • To treat and prevent relapse of mental disorders such as schizophrenia • To treat severe agitation, or mental disorders where dangerous or impulsive behaviour may be likely 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIFLUOPERAZINE DO NOT TAKE TRIFLUOPERAZINE IF: • You are allergic (hypersensitive) to Trifluoperazine, other phenothiazines or any of the other ingredients of this medicine (listed in Section 6) • You have loss of consciousness (comatose state) • You have slower breathing or heartbeat, loss of motor skills, unclear speech, thinking or vision (CNS depression) • You have an untreated growth on your adrenal gland (phaeochromocytoma) • You have blood problems • You have liver problems • Y Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trifluoperazine Tablets BP 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains trifluoperazine hydrochloride BP 6mg equivalent to trifluoperazine 5mg. Excipients with known effect Lactose Sucrose Sodium benzoate (E211) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablets for oral administration. 4.1 THERAPEUTIC INDICATIONS In 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. In 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 an adjunct in the short-term management of severe psychomotor agitation and of dangerously impulsive behaviour in, for example, mental subnormality. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS: _Low dosage:_ This tablet strength is not suitable for the initiation of this dosage regime which starts with 2mg to 4mg daily in divided doses according to the severity of the patient’s condition. If necessary, dosage may be increased to 6mg daily, but above this level extrapyramidal symptoms are more likely to occur in some patients. _High dosage:_ The recommended starting dose for physically fit adults is 5mg twice daily; after a week this may be increased to 15mg daily. If necessary, further increases of 5mg may be made at 3-day intervals, but not more often. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established. As with all major tranquillisers clinical improvement may not be evident for several weeks after starting treatment, and there may also be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal Citiți documentul complet