Country: Malta
Language: English
Source: Medicines Authority
HALOPERIDOL
Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium
N05AD01
HALOPERIDOL 5 mg
TABLET
HALOPERIDOL 5 mg
POM
PSYCHOLEPTICS
Withdrawn
2007-01-30
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HALDOL 5 MG TABLETS haloperidol 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 Haldol is and what it is used for 2. What you need to know before you take Haldol 3. How to take Haldol 4. Possible side effects 5. How to store Haldol 6. Contents of the pack and other information 1. WHAT HALDOL IS AND WHAT IT IS USED FOR The name of your medicine is Haldol. Haldol contains the active substance haloperidol. This belongs to a group of medicines called ‘antipsychotics’. Haldol is used in adults, adolescents and children for illnesses affecting the way you think, feel or behave. These include mental health problems (such as schizophrenia and bipolar disorder) and behavioural problems. These illnesses may make you: • Feel confused (delirium) • See, hear, feel or smell things that are not there (hallucinations) • Believe things that are not true (delusions) • Feel unusually suspicious (paranoia) • Feel very excited, agitated, enthusiastic, impulsive or hyperactive • Feel very aggressive, hostile or violent. In adolescents and children, Haldol is used to treat schizophrenia in patients aged 13 to 17 years, and to treat behavioural problems in patients aged 6 to 17 years. Haldol is also used: • In adolescents and children aged 10 to 17 years and in adults for movements or sounds you can’t control (tics), for example in severe Tourette’s syndrome • In adults to help control movements in Huntington’s disease. Haldol is sometimes used wh Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT HALDOL 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5mg tablet contains 5mg of haloperidol. Excipients with known effect: Each 5mg tablet contains 69.4mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Blue, circular, biconvex tablet, cross scored on one side and with the inscription “JANSSEN” on the other side. The score lines are only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 edu Read the complete document