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BBBA7086 Procyclidine 5 Mg-Ml Solution for Injection

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BBBA7086 Procyclidine 5 Mg-Ml Solution for Injection PATIENT INFORMATION LEAFLET PROCYCLIDINE HYDROCHLORIDE 5 mg/ml Solution for Injection • K • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If an please tell your doctor or pharmacist. 1. What is PROCYCLIDINE Injection and what is it used for? 2. Before you are given PROCYCLIDINE Injection 3. How you will be given PROCYCLIDINE Injection 4. Possible side effects 5. Storing PROCYCLIDINE Injection 6. Further information 1. What is PROCYCLIDINE Injection and what Are you taking any of the following drugs? is it used for? • T ranquillisers (e.g. thioridazine) • T ricyclic and related antidepressants What is PROCYCLIDINE Injection? (e.g. amitriptyline) PROCYCLIDINE Injection belongs to a group of • Monoamine oxidase inhibitors, otherwise known medicines called anticholinergics. Anticholinergics as MAOIs (used for depressive illness) block the effects of a substance called acetylcholine • Amantadine (used for parkinsonism and viral in your body. infections) What is PROCYCLIDINE Injection used for? • Antihistamines (used to treat allergies) PROCYCLIDINE Injection is used to treat and relieve • K etoconazole (used as antifungals) the symptoms of Parkinson’s disease such as stiff • T acrine, memantine, phenothiazines and neuroleptics (medicines used to treat mental writing and walking, overproduction of saliva and health problems including Alzheimer’s disease dribbling, sweating, uncontrolled eye movements and dementia) and depression. • Clozapine (used for schizophrenia) Some tranquillisers have side-effects like the • Quinidine and disopyramide (used for arrhythmias symptoms of Parkinson’s disease and they can also – too fast, too slow or irregular heart beat) cause restlessness and abnormal head and body • Nef opam (used for moderate pain) movements. PROCYCLIDINE Injection is also • Me toclopramide, cisapride and domperidone sometimes used to control these side effects. (used for gastro-intestinal disorders) • Levodopa (used for parkinsonism) 2. Before you are given PROCYCLIDINE • Nitrat e tablets that dissolve in the mouth Injection (used for angina attacks) Do not use PROCYCLIDINE Injection: If any of the above applies to you talk to your doctor Your doctor may decide that you should not be given or pharmacist. PROCYCLIDINE Injection if any of the points listed Pregnancy and breast feeding below applies to you: If you are pregnant, trying to become pregnant or • Ha ve you ever had an allergy (rash, itching, and breastfeeding, PROCYCLIDINE Injection will only be shortness of breath) to procyclidine or lactic acid? Special precautions to be taken: treatment outweighs the risk to the developing baby Your doctor may decide to take special precautions or new born baby. when giving you PROCYCLIDINE Injection if any of Driving and using machines the points listed below applies to you: PROCYCLIDINE Injection can cause blurred vision • Do you experience uncontrolled movements of the and at higher doses, dizziness, confusion and face and tongue (tardive dyskinesis)? hallucinations may occur. If you are affected in this • Do you suffer from glaucoma (eye disease caused way, do NOT drive or operate machinery while you by too much pressure within the eye)? are receiving PROCYCLIDINE 5 mg/ml Solution for • If you are a man, do you suffer from an enlarged Injection. prostate gland? • Do you often suffer from stomach cramps, 3. How you will be given PROCYCLIDINE abdominal pains or constipation? Injection • Do you suffer from kidney or liver disease? Important: If any of the above applies to you talk to your doctor PROCYCLIDINE Injection will be given to you as an or pharmacist. injection into a vein (intravenously) or muscle Taking other medicines (intramuscularly). Your doctor will decide on a dose Always tell your doctor if you are taking any other of PROCYCLIDINE Injection which is right for you. medicines because taking some medicines together Adults: can be harmful. Remember that the doctor at the Intravenous injection: hospital may not have been informed if you have • The usual starting dose is 2.5mg, three times a recently begun a course of treatment for another day, intravenously. Your doctor may then increase illness. this by 2.5mg to 5mg daily, every two or three days, until the desired effect is seen. This is known as the maintenance dose. Information for the Healthcare Professional PROCYCLIDINE HYDROCHLORIDE 5 mg/ml Solution for Injection 1. NAME OF THE MEDICINAL PRODUCT 4.4. Special Warnings and Special Precautions For Use Kemadrin 5mg/ml Solution for injection Procyclidine Hydrochloride 5mg/ml, Solution for Injection assessed when prescribing in Procyclidine patients with existing angle-closure (narrow angle) glaucoma or those considered to be 2. QUALITATIVE AND QUANTITATIVE COMPOSITION predisposed to glaucoma. Cautious prescribing is also indicated in Procyclidine Hydrochloride BP 5mg per ml (10mg in each 2ml patients predisposed to obstructive disease of the gastro-intestinal ampoule) tract and those with urinary symptoms associated with prostatic 3. PHARMACEUTICAL FORM hypertrophy. Solution for injection In a proportion of patients undergoing neuroleptic treatment, 4. CLINICAL PARTICULARS tardive dysknesias will occur. While anticholinergic agents do not cause this syndrome, when given in combination with neuroleptics 4.1. Therapeutic Indications they may exacerbate the symptoms of tardive dyskinesia or reduce Procyclidine is indicated for the treatment and symptomatic relief the threshold at which these symptoms appear in predisposed of all forms of Parkinson’s disease e.g. idiopathic (paralysis patients. In such individuals subsequent adjustment of neuroleptic agitans), postencephalitic and arteriosclerotic disease. therapy or reduction in anticholinergic treatment should be Procyclidine is also used to control troublesome extra-pyramidal considered. symptoms induced by neuroleptic drugs including Pseudo- Patients with mental disorders occasionally experience a Parkinsonism, acute dystonic reactions and akathisia. precipitation of a psychotic episode when procyclidine is 4.2. Posology and Method of Administration administered for the treatment of the extrapyramidal The variation in optimum dosage from one patient to another side effects of neuroleptics. should be taken into consideration by the physician. Elderly patients, especially those on high doses of anticholinergics Dosage in adults:- may be more susceptible to the adverse events associated with Parkinson’s disease:- Treatment is usually started at 2.5mg three times per day, patient may be particularly vulnerable to Central Nervous System increasing by 2.5 to 5mg daily at intervals of two or three days disturbances such as confusion, impairment of cognitive function until the optimum clinical response is achieved. and memory, disorientation and hallucinations. These effects are usually reversible on reduction or discontinuation of anticholinergic The usual maintenance dose to achieve optimal response is therapy. 15 to 30mg procyclidine per day. Addition of a fourth dose before retiring has been seen to be of procyclidine hydrochloride in patients with impaired renal or hepatic function. However, since procyclidine is metabolised in have been well tolerated, and at the discretion of the attending the liver and excreted via the urine care should be exercised when physician dosing to this level may be appropriate. administering procyclidine to patients with impairment of renal or In general younger patients or those with postencephalitic hepatic function. parkinsonism may require higher doses for a therapeutic response Procyclidine should not be withdrawn abruptly as rebound than older patients and those with arteriosclerotic parkinsonism. Parkinsonian symptoms may occur. Procyclidine may be combined with levodopa or amantadine in Abuse patients who are inadequately controlled on a single agent. Procyclidine, along with other anticholinergic drugs, has the Neuroleptic-induced extrapyramidal symptoms:- potential to be abused. Although the cases of abuse are rare, physicians should exercise caution in prescribing to Procyclidine Treatment is usually initiated at 2.5mg procyclidine three times patients with symptoms that may not be genuine. per day increasing by 2.5 mg daily until symptoms are relieved. 4.5 Interaction with other medicinal products and other forms The effective maintenance dose is usually 10 to 30 mg procyclidine of interaction per day. After a period of 3 to 4 months of therapy, Procyclidine Monoamine oxidase inhibitors or drugs with anticholinergic should be withdrawn and the patient observed to see whether the properties, such as amantadine, memantine, antihistamines, neuroleptic-induced extra-pyramidal symptoms recur. phenothiazines, tricyclic and related antidepressants, clozapine, If this is the case Procyclidine should be reintroduced to avoid disopyramide and nefopam may increase the anticholinergic action debilitating extra-pyramidal symptoms. Cessation of treatment of procyclidine. periodically is to be recommended even in patients who appear The use of drugs with cholinergic properties, such as tacrine, to require the drug for longer periods. may reduce the therapeutic response to Procyclidine. Furthermore, Procyclidine Injection may be given intramuscularly in doses of drugs with anticholinergic properties may antagonise the effect of 5 to 10mg, repeated after 20 minutes if necessary,
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