2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
|
- Rosamond Jefferson
- 8 years ago
- Views:
Transcription
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trihexyphenidyl 2mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of trihexyphenidyl hydrochloride BP For excipients, see section PHARMACEUTICAL FORM Tablet White, flat bevel edged tablets with a breakline. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications 1. Treatment of parkinsonism 2. Prevention and control of drug-induced extrapyramidal symptoms (excluding tardive dyskinesia). 4.2 Posology and method of administration Route of administration: Oral Dosage Adults (only) All forms of parkinsonism Initial dose: 1 2 mg gradually increased by 1 2 mg increment to 6 10 mg daily according to the patient s response. Some patients may require mg daily or more. The maximum daily dose is 20 mg. Postencephalitic patients tolerate and require larger doses. Drug-induced parkinsonism Usual dose: Elderly: 5 10 mg daily Some cases may be controlled with 1 mg daily. Patients over 65 years of age may require a reduced dosage. The above dosage should be administered in 3 4 divided doses daily before or with meals.
2 Antimuscarinic treatment of parkinsonism should never be terminated suddenly. When changing from one drug to another, withdraw the one in small amounts while gradually increasing the dose of the other. Trihexyphenidyl tablets may be given with other drugs employed for the relief of parkinsonism e.g. other antimuscarinic drugs, levodopa and amantadine. Dose reduction may be required. 4.3 Contraindications Known hypersensitivity to trihexyphenidyl hydrochloride or any of the ingredients. Incipient glaucoma may be precipitated. The following are not absolute contraindications, nevertheless caution must be observed in patients with hypertension,cardiac, liver or kidney dysfunction, obstructive disease of the gastrointestinal or genitourinary tracts, glaucoma, and in males with a prostatic hypertrophy. 4.4 Special warnings and precautions for use Anticholinergic medications, including trihexyphenidyl, should not be withdrawn abruptly in patients on long-term therapy, to avoid recurrence of the original symptoms and possible anticholinergic rebound. Prescribers should be aware that Trihexyphenidyl hydrochloride is liable to abuse as it may produce euphoric effects or hallucinogenic properties. Since atropine-like drugs may cause psychiatric symptoms such as confusion, delusion and hallucinations, trihexyphenidyl should be used with extreme caution in elderly patients. As trihexyphenidyl may provoke or exacerbate tardive dyskinesia, it is not recommended for use in patients with this condition. Since trihexyphenidyl has been associated with clinical worsening of myasthenia gravis, the drug should be avoided or used with great caution in patients with myasthenia gravis. Patients with arteriosclerosis or those with a history of idiosyncrasy to other drugs may be more likely to develop severe mental reactions to trihexyphenidyl. Since the treatment is to be continued for an indefinite period the patient should be carefully supervised over the long term. Avoid sudden discontinuation of treatment. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency, glucose-galactose malabsorption should not take this medicine. 4.5 Interaction with other medicinal products and other forms of interaction Concurrent use of trihexyphenidyl hydrochloride with drugs possessing antimuscarinic effects such as antihistamines increases the side-effects such as blurred
3 vision, dry mouth, urine retention and constipation; concomitant use can also lead to confusion in the elderly. Interactions do not generally apply to antimuscarinics used by inhalation. Concurrent use of trihexyphenidyl hydrochloride with nefopam increases antimuscarinic effects. Concurrent use of tricyclic anti-depressants and monoamine oxidase inhibitors with trihexyphenidyl hydrochloride increases the antimuscarinic side-effects and may also cause excitation, confusion and hallucination. Concurrent use of trihexyphenidyl hydrochloride with ketoconazole reduces the absorption of the latter. Concurrent use of trihexyphenidyl with anti-histamine increases the antimuscarinic side-effects. Concurrent use of trihexyphenidyl hydrochloride with disopyramide increases the antimuscarinic effects. Concurrent use of trihexyphenidyl hydrochloride with phenothiazines increases the antimuscarinic effect (but reduces plasma concentrations). Increased antimuscarinic side-effects are observed with amantadine and absorption of levodopa is possibly reduced. Concurrent use of trihexyphenidyl hydrochloride with metoclopramide and domperidone antagonises gastro-intestinal effects. Antimuscarinics reduce the effects of sublingual nitrates due to failure to dissolve under the tongue owing to dry mouth. Parasympathomimetics antagonise the effects of antimuscarinics. 4.6 Pregnancy and lactation Pregnancy There is inadequate information regarding the use of trihexyphenidyl in pregnancy. Animal studies are insufficient with regard to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown, As with other medication trihexyphenidyl hydrochloride tablets should only be used during pregnancy if considered essential by the physician. Lactation It is unknown whether trihexyphenidyl is excreted in human breast milk. The excretion of trihexyphenidyl in milk has not been studied in animals. Infants may be very sensitive to the effects of antimuscarinic medications. Trihexyphenidyl should not be used during breastfeeding. 4.7 Effects on ability to drive and use machines Patients should be warned of the potential hazards of driving or operating machinery if they experience blurred vision or a reduction in alertness. Trihexyphenidyl
4 hydrochloride may affect the performance of skilled tasks such as driving and using machinery. 4.8 Undesirable effects Minor adverse effects include dry mouth, constipation, blurred vision, dizziness and gastro-intestinal disturbances and will be experienced by 30 50% of all patients treated. This is more frequent in the elderly but reduces with tolerance. Less commonly urinary retention, tachycardia, hypersensitivity, nervousness and with high doses in susceptible patients, mental confusion, excitement or euphoria, agitation, hallucinations, insomnia, restlessness and very occasionally paranoid delusions have been reported. There have been reports of abuse of trihexiphenidyl due to its euphoric and hallucinogenic properties and psychiatric disturbances which may necessitate discontinuation of treatment; impaired memory (immediate and short-term memory functions) has also been reported. 4.9 Overdose Symptoms of overdose with antimuscarinic agents include flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia, hypertension, nausea, vomiting. Symptoms of CNS stimulation include marked restlessness, confusion, excitement, paranoid and psychotic reactions, incoordination, hallucination and delirium and occasionally seizures or convulsions. A rash may appear on the face and upper trunk. In severe intoxication central stimulation may give way to CNS depression, coma, circulatory and respiratory failure and death. Treatment entails gastric lavage as there is no specific antidote. General supportive treatment should be carried out. Cold compresses and forcing of fluid are mandatory. Atropine antagonists may be useful. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of central nervous system depression should be considered. Hypoxia and acidosis should be corrected. Antiarrhythmic drugs are not recommended if dysrhythmias occur. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anticholinergic agents; tertiary amines ATC code: N04A A01 Trihexyphenidyl hydrochloride is an antimuscarinic agent with both central and peripheral actions. The stimulation of the CNS is followed by depression. It is also an antispasmodic agent exerting a direct inhibitory effect on the parasympathetic nervous system and also has a relaxing effect on the smooth muscles and reduces secretions especially the salivary and the bronchial. It also reduces perspiration. The biliary and pancreatic secretions are little affected. 5.2 Pharmacokinetic properties Trihexyphenidyl hydrochloride is well absorbed from the gastro-intestinal tract. The onset of action occurs within 1 hour of oral administration.
5 5.3 Preclinical safety data There are no pre-clinical data of relevance to the prescriber that are additional to that already included in other sections of the SPC. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Magnesium stearate Maize starch Pregelatinised maize starch Lactose 6.2 Incompatibilities None. 6.3 Shelf life 5 years for opaque plastic containers. 2 years for aluminium/opaque PVC blister packs. 6.4 Special precautions for storage Store in a cool dry place. Keep out of the reach of children. 6.5 Nature and contents of container Trihexyphenidyl 2 mg Tablets BP are packed in the following containers and closures. Opaque plastic containers (securitainers) with plastic caps for all pack sizes. Opaque plastic container composed of either high density polypropylene or high density polyethylene with a tamper-evident or child resistant tamper evident closure composed of high density polyethylene for all pack sizes (28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000) and packaging inclusion of standard polyether foam or polyethylene or polypropylene made filler. Blister packs of aluminium/opaque PVC. It is subsequently packed in printed boxboard cartons in pack sizes of 28, 30, 42, 56, 60, 84, 90 and 112. Not all pack sizes may be marketed. 6.6 Special precautions for disposal No special instructions for use/handling.
6 7 MARKETING AUTHORISATION HOLDER Crescent Pharma Limited Units 3 & 4, Quidhampton Business Units Polhampton Lane Hants RG25 3ED United Kingdom 8 MARKETING AUTHORISATION NUMBER(S) PL 20416/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 February DATE OF REVISION OF THE TEXT 17/09/ DOSIMETRY (IF APPLICABLE) 12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
4 Clinical Particulars
SUMMARY OF PRODUCT CHARACTERISTICS 1 Name of the Medicinal Product Procyclidine Syrup 5mg/5ml 2. Qualitative and Quantitative Composition Each 5ml dose contains 5mg Procyclidine Hydrochloride BP. 3. Pharmaceutical
More informationWhite, circular, biconvex, uncoated tablets with a score line on one side, plain on the other.
Nausicalm Cyclizine hydrochloride Ph. Eur. 50 mg Presentation White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other. Uses Actions The active ingredient-cyclizine
More informationBENZTROP 2 mg tablets are round, flat-faced, cross-scored on one side and embossed PMS- 2 on the other side.
Benztrop Benzatropine mesilate 2 mg tablets Presentation BENZTROP 2 mg tablets are round, flat-faced, cross-scored on one side and embossed PMS- 2 on the other side. Uses Actions Benzatropine is a centrally
More informationDESCRIPTION Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine.
DESCRIPTION Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3 -(Diphenylmethoxy)-1 H,5 H-tropane methanesulfonate.
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diazepam Tablets BP 2mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diazepam BP 2.00mg 3 PHARMACEUTICAL FORM Tablet 4. CLINICAL PARTICULARS
More informationSummary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT Librium 10mg Hard capsule Summary of Product Characteristics 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of chlordiazepoxide hydrochloride. Excipients:
More informationCOGENTIN Injection. (benztropine mesylate)
COGENTIN Injection (benztropine mesylate) NAME OF THE MEDICINE Benztropine mesylate is a synthetic compound resulting from the combination of the active portions of atropine and diphenhydramine. Chemical
More informationVALIUM PRODUCT MONOGRAPH. diazepam. 5 mg Tablets. Anxiolytic-sedative. Date of Revision: February 7, 2014
PRODUCT MONOGRAPH VALIUM diazepam 5 mg Tablets Anxiolytic-sedative Hoffmann-La Roche Ltd. 7070 Mississauga Road Mississauga, Ontario L5N 5M8 Date of Revision: February 7, 2014 www.rochecanada.com Submission
More informationTrihexyphenidyl Hydrochloride Oral Solution USP 2 mg per 5 ml
Trihexyphenidyl Hydrochloride Oral Solution USP 2 mg per 5 ml Rx ONLY DESCRIPTION Trihexyphenidyl Hydrochloride Oral Solution USP is a synthetic antispasmodic drug. It is designated chemically as α-cyclohexylα-phenyl-1-piperidinepropanol
More informationCODEINE PHOSPHATE 15 MG TABLETS CODEINE PHOSPHATE 30 MG TABLETS CODEINE PHOSPHATE 60 MG TABLETS PL 24837/0023-5 UK PAR TABLE OF CONTENTS
CODEINE PHOSPHATE 15 MG TABLETS CODEINE PHOSPHATE 30 MG TABLETS CODEINE PHOSPHATE 60 MG TABLETS PL 24837/0023-5 UK PAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for
More informationVISTARIL (hydroxyzine pamoate) Capsules and Oral Suspension
VISTARIL (hydroxyzine pamoate) Capsules and Oral Suspension DESCRIPTION Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4- [2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1
More informationAnti-Parkinsonism Drugs
Anti-Parkinsonism Drugs Pharma Team 429 Fahad Alrumaih Ibrahim Alshiddi Sultan Alsalem Ismail Raslan Suhail Asiri Parkinsonism - Could be: primary [idiopathic] or secondary [viral infection or drug induced
More informationNEUROTONE THR 00904/0005 UKPAR
NEUROTONE THR 00904/0005 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Product Information Leaflet
More informationNEW ZEALAND CONSUMER MEDICINE INFORMATION Arrow - Diazepam
NEW ZEALAND CONSUMER MEDICINE INFORMATION Arrow - Diazepam Diazepam 2mg and 5mg tablets What is in this leaflet This leaflet answers some common questions about ARROW - DIAZEPAM. It does not contain all
More informationPRESCRIBING INFORMATION. (pentazocine hydrochloride tablets) 50 mg. Narcotic Analgesic. 2905 Place Louis R.-Renaud March 26, 2014 Laval, QC H7V 0A3
PRESCRIBING INFORMATION N TALWIN TABLETS (pentazocine hydrochloride tablets) 50 mg Narcotic Analgesic sanofi-aventis Canada Inc. Date of Revision: 2905 Place Louis R.-Renaud March 26, 2014 Laval, QC H7V
More informationDiazepam 2 mg and 5 mg tablets This product may not be interchangeable with similar products on the New Zealand market
Arrow - Diazepam Diazepam 2 mg and 5 mg tablets This product may not be interchangeable with similar products on the New Zealand market Presentation Arrow - Diazepam 2 White, round, flat-bevel edged tablet
More informationUKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3
Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation Page 13 Summary of Product Characteristics
More informationPATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET CHLORDIAZEPOXIDE 5mg AND 10mg CAPSULES Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methadone 10mg/ml Injection / Physeptone 10mg/ml Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains: Methadone Hydrochloride
More informationDoxylamine succinate belongs to the ethanolamine class of antihistamines with sedative properties.
Data Sheet MERSYNDOL Tablet Paracetamol 450mg per tablet Codeine Phosphate 9.75mg per tablet Doxylamine Succinate 5mg per tablet MERSYNDOL FORTE Tablet Paracetamol 450mg per tablet Codeine Phosphate 30mg
More informationShare the important information in this Medication Guide with members of your household.
MEDICATION GUIDE BUPRENORPHINE (BUE-pre-NOR-feen) Sublingual Tablets, CIII IMPORTANT: Keep buprenorphine sublingual tablets in a secure place away from children. Accidental use by a child is a medical
More informationGlycopyrronium Bromide 0.5mg/mL and Neostigmine Metilsulfate 2.5mg/mL Solution for Injection
NEW ZEALAND DATA SHEET Glycopyrronium Bromide 0.5mg/mL and Neostigmine Metilsulfate 2.5mg/mL Solution for Injection Each 1mL contains Glycopyrrolate USP 0.5mg (Glycopyrronium Bromide) and Neostigmine Metilsulfate
More informationWhat Codeine Phosphate Tablets are used for
New Zealand Consumer Medicine Information CODEINE PHOSPHATE 15mg, 30mg & 60mg Tablets What is in this leaflet Please read this leaflet carefully before you start using Codeine Phosphate Tablets. This leaflet
More informationNEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate.
NEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate. PRESENTATION Eye Drops: NAPHCON-A Eye Drops are a combination of an antihistamine (pheniramine maleate) and a decongestant
More informationElements for a public summary. VI.2.1 Overview of disease epidemiology. VI.2.2 Summary of treatment benefits
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Pain is one of the most common reasons for a patient to seek medical attention. Moderate or severe intensity pain can be acute
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Prednicare Tablets 5mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Substance(s) Prednisolone
More informationRELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS
RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation summary
More informationAdjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.
Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,
More informationMucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665
Mucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient
More informationMOH CLINICAL PRACTICE GUIDELINES 2/2008 Prescribing of Benzodiazepines
MOH CLINICL PRCTICE GUIELINES 2/2008 Prescribing of Benzodiazepines College of Family Physicians, Singapore cademy of Medicine, Singapore Executive summary of recommendations etails of recommendations
More informationMEDICATION GUIDE. Bupropion Hydrochloride (bue-proe-pee-on HYE-droe-KLOR-ide) Extended-Release Tablets, USP (SR)
MEDICATION GUIDE Bupropion Hydrochloride (bue-proe-pee-on HYE-droe-KLOR-ide) Extended-Release Tablets, USP (SR) Read this Medication Guide carefully before you start taking bupropion hydrochloride extendedrelease
More informationMEDICATION GUIDE WELLBUTRIN (WELL byu-trin) (bupropion hydrochloride) Tablets
MEDICATION GUIDE WELLBUTRIN (WELL byu-trin) (bupropion hydrochloride) Tablets Read this Medication Guide carefully before you start using WELLBUTRIN and each time you get a refill. There may be new information.
More informationMEDICATION GUIDE Savella (Sa-vel-la) (milnacipran HCl) Tablets
MEDICATION GUIDE Savella (Sa-vel-la) (milnacipran HCl) Tablets Savella is not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric
More informationBENZODIAZEPINES. Benzodiazepines may be habit-forming (causing mental or physical dependence), especially when taken for a long time or in high doses.
Some commonly used brand names are: BENZODIAZEPINES Ativan (lorazepam), Dalmane (flurazepam), Diastat or Valium (diazepam),, Doral (quazepam), Halcion (triazolam), Klonopin (clonazepam), Librium (chlordiazepoxide),
More informationPRODUCT MONOGRAPH. Pr PROLOPA. levodopa and benserazide combination. Capsules 50-12.5, 100-25, 200-50. Pharmaceutical standard: professed
PRODUCT MONOGRAPH Pr PROLOPA levodopa and benserazide combination Capsules 50-12.5, 100-25, 200-50 Pharmaceutical standard: professed Antiparkinson Agent Hoffmann-La Roche Limited Date of Preparation:
More informationAbstral Prescriber and Pharmacist Guide
Abstral Prescriber and Pharmacist Guide fentanyl citrate sublingual tablets Introduction The Abstral Prescriber and Pharmacist Guide is designed to support healthcare professionals in the diagnosis of
More informationSR 5. W2364A_NT.XATRAL SR5 PAK/SA 5/12/05 9:47 Page 1
W2364A_NT.XATRAL SR5 PAK/SA 5/12/05 9:47 Page 1 alfuzosin SR 5 mg (Alfuzosin HCI) COMPOSITION Each sustained-release, film-coated tablet contains: Alfuzosin hydrochloride......... 5 mg Excipients... q.s.
More informationEssential Shared Care Agreement Drugs for Dementia
Ref No. E040 Essential Shared Care Agreement Drugs for Dementia Please complete the following details: Patient s name, address, date of birth Consultant s contact details (p.3) And send One copy to: 1.
More informationHypromellose Eye Drops BP 0.3% w/v PL 23097/0006
Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient
More informationNew Zealand Data Sheet. 0.5 mg: pale blue tablet, 4.8 mm round, flat, bevelled-edge, with "0.5" impressed on one side.
New Zealand Data Sheet ATIVAN Lorazepam tablets 0.5 mg, 1.0 mg and 2.5 mg Presentation 0.5 mg: pale blue tablet, 4.8 mm round, flat, bevelled-edge, with "0.5" impressed on one side. 1 mg: (white, round
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER. ADRENALINE (TARTRATE) STEROP 1 mg/1 ml Solution for injection. Adrenaline (Levorenine, Epinephrine)
PACKAGE LEAFLET: INFORMATION FOR THE USER ADRENALINE (TARTRATE) STEROP 1 mg/1 ml Solution for injection Adrenaline (Levorenine, Epinephrine) Read all of this leaflet carefully before you start using this
More informationProchlorperazine 3 mg Buccal Tablets (PROCHLORPERAZINE MALEATE)
Package leaflet: Information for the user Prochlorperazine 3 mg Buccal Tablets (PROCHLORPERAZINE MALEATE) Read all of this leaflet carefully before you start taking this medicine because it contains important
More information**Form 1: - Consultant Copy** Telephone Number: Fax Number: Email: Author: Dr Bernard Udeze Pharmacist: Claire Ault Date of issue July 2011
Effective Shared Care Agreement for the treatment of Dementia in Alzheimer s Disease Donepezil tablets / orodispersible tablets (Aricept / Aricept Evess ) These forms (1 and 2) are to be completed by both
More informationInformation for Prescribing Anti-dementia Drugs. November 2012
Information for Prescribing Anti-dementia Drugs The aim of this document is to provide information about the prescribing of anti-dementia medication for adult patients with dementia following an assessment
More informationKalms Tablets THR 01074/0235 UKPAR
Kalms Tablets THR 01074/0235 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Patient Information Leaflet
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Progit 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of itopride hydrochloride.
More informationP AC K AG E L E AF L E T: INFORMAT I ON FO R THE USER. 500 mg, film-coated tablet Active substance: metformin hydrochloride
P AC K AG E L E AF L E T: INFORMAT I ON FO R THE USER Siofor 500 500 mg, film-coated tablet Active substance: metformin hydrochloride For use in children above 10 years and adults Read all of this leaflet
More informationSODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION PL 01502/0068 UKPAR TABLE OF CONTENTS
SODIUM CHLORIDE 0.9% W/V SOLUTION FOR INJECTION PL 01502/0068 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Steps taken after authorisation
More informationDEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314
DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics
More informationTradol SR 100mg Prolonged Release Tablets Tramadol hydrochloride
Package leaflet: Information for the user Tradol SR 100mg Prolonged Release Tablets Tramadol hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important
More informationDonepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa )
Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa ) ESCA: For the treatment of Alzheimer s disease. SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
More information1 What Anapen is and what it is used for?
PACKAGE LEAFLET: INFORMATION FOR THE USER Anapen 500 micrograms in 0.3 ml solution for injection (pre-filled syringe) Adrenaline (Epinephrine) Auto-Injector Read all of this leaflet carefully before you
More informationMEDICATION GUIDE SUBOXONE (Sub-OX-own) (buprenorphine and naloxone) Sublingual Film for sublingual or buccal administration (CIII)
MEDICATION GUIDE SUBOXONE (Sub-OX-own) (buprenorphine and naloxone) Sublingual Film for sublingual or buccal administration (CIII) IMPORTANT: Keep SUBOXONE in a secure place away from children. Accidental
More informationDRUGS OF ABUSE CLASSIFICATION AND EFFECTS
Drug and Drug use DRUGS OF ABUSE CLASSIFICATION AND EFFECTS A pharmaceutical preparation or a naturally occurring substance used primarily to bring about a change in the existing process or state (physiological,
More informationpatient group direction
DICLOFENAC v01 1/8 DICLOFENAC PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner
More informationPublic Assessment Report. Table of Contents
Public Assessment Report Lidocaine Injection BP with preservative 1% Lidocaine Injection BP with preservative 2% PL 01502/0070 PL 01502/0071 Hameln Pharmaceuticals Limited Table of Contents Page Lay Summary
More informationTALWIN Nx CIV pentazocine and naloxone hydrochlorides, USP Analgesic for Oral Use Only
TALWIN Nx CIV pentazocine and naloxone hydrochlorides, USP Analgesic for Oral Use Only TALWIN Nx is intended for oral use only. Severe, potentially lethal, reactions may result from misuse of TALWIN Nx
More informationMEDICATION GUIDE ZYBAN (zi ban) (bupropion hydrochloride) Sustained-Release Tablets
GlaxoSmithKline Research Triangle Park, NC 27709 2013, GlaxoSmithKline group of companies. All rights reserved. ZYB:XPI MEDICATION GUIDE ZYBAN (zi ban) (bupropion hydrochloride) Sustained-Release Tablets
More informationPaxil/Paxil-CR (paroxetine)
Generic name: Paroxetine Available strengths: 10 mg, 20 mg, 30 mg, 40 mg tablets; 10 mg/5 ml oral suspension; 12.5 mg, 25 mg, 37.5 mg controlled-release tablets (Paxil-CR) Available in generic: Yes, except
More informationMEDGUIDE SECTION. What is the most important information I should know about SEROQUEL? SEROQUEL may cause serious side effects, including:
MEDGUIDE SECTION Medication Guide SEROQUEL (SER-oh-kwell) (quetiapine fumarate) Tablets Read this Medication Guide before you start taking SEROQUEL and each time you get a refill. There may be new information.
More informationSalbutamol 1mg/ml Nebuliser Solution. Salbutamol 2mg/ml Nebuliser Solution PL 36390/0035 PL 36390/0036
Salbutamol 1mg/ml Nebuliser Solution Salbutamol 2mg/ml Nebuliser Solution PL 36390/0035 PL 36390/0036 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment
More informationThioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid
Package Leaflet: Information for the User Thioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid For use in adults Active substance: Alpha-lipoic acid, Trometamol salt (1:1) Read all
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eskazole Tablets 400 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albendazole 400 mg Excipients with known effect: Lactose, sunset yellow
More information2.6.4 Medication for withdrawal syndrome
.6.3 Self-medication Self-medication presents a risk during alcohol withdrawal, particularly when there is minimal supervision (low level and medium level 1 settings). Inform patients of the risk of selfmedication
More informationMedication Guide EQUETRO (ē-kwĕ-trō) (carbamazepine) Extended-Release Capsules
Medication Guide EQUETRO (ē-kwĕ-trō) (carbamazepine) Extended-Release Capsules Read this Medication Guide before you start taking EQUETRO and each time you get a refill. There may be new information. This
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PHENOLEPTIL 100 mg Tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Active substance mg Phenobarbital
More informationPHENYLEPHRINE HYDROCHLORIDE INJECTION USP
PRESCRIBING INFORMATION PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10 mg/ml Sandoz Canada Inc. Date of Preparation: September 1992 145 Jules-Léger Date of Revision : January 13, 2011 Boucherville, QC, Canada
More informationDoncaster & Bassetlaw Medicines Formulary
Doncaster & Bassetlaw Medicines Formulary Section 4.9: Drugs Used in Parkinsonism and related Disorders Co-Beneldopa 12.5/50, 25/100 and 50/200 (Madopar) Capsules Co-Beneldopa 12.5/50 and 25/100 Dispersible
More informationHow To Treat Vesenitis With Prochlorperazine
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prochlorperazine 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Prochlorperazine Maleate 5 mg Also contains
More informationPackage leaflet: Information for the user. Ondemet 4mg and 8mg Tablets (Ondansetron)
Package leaflet: Information for the user Ondemet 4mg and 8mg Tablets (Ondansetron) Read all of this leaflet carefully before you start taking this medicine because it contains important information for
More informationAdrenaline (epinephrine) 1:1000 Injection BP Summary of Product Characteristics
Adrenaline (epinephrine) 1:1000 Injection BP Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Adrenaline (epinephrine) 1:1000 Injection BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More informationUBISTESIN 1:200,000 and UBISTESIN FORTE 1:100,000
UBISTESIN 1:200,000 and UBISTESIN FORTE 1:100,000 Articaine hydrochloride and adrenaline hydrochloride Consumer Medicine Information WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you
More information1. What Xylocaine with adrenaline is and what it is used for
Package leaflet: Information for the user Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 Solution for Injection lidocaine, adrenaline (epinephrine) Read all of this leaflet carefully before
More informationAscorbic Acid 50 mg Tablets. Ascorbic Acid 100 mg Tablets. Ascorbic Acid 200 mg Tablets. Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287
Ascorbic Acid 50 mg Tablets Ascorbic Acid 100 mg Tablets Ascorbic Acid 200 mg Tablets Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287 PL 20416/0288 PL 20416/0289 UKPAR TABLE OF CONTENTS Lay Summary
More informationPARACETAMOL 500MG TABLETS B.P. (PARACETAMOL) PL 17907/0146 UKPAR TABLE OF CONTENTS
PARACETAMOL 500MG TABLETS B.P. (PARACETAMOL) PL 17907/0146 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation Page
More informationPackage leaflet: Information for the patient. Tramadol hydrochloride/paracetamol 37.5 mg/325 mg Film-coated Tablets
Package leaflet: Information for the patient Tramadol hydrochloride/paracetamol 37.5 mg/325 mg Film-coated Tablets tramadol hydrochloride/paracetamol Read all of this leaflet carefully before you start
More informationPHOSPHATE-SANDOZ Tablets (High dose phosphate supplement)
1 PHOSPHATE-SANDOZ Tablets (High dose phosphate supplement) PHOSPHATE-SANDOZ PHOSPHATE-SANDOZ Tablets are a high dose phosphate supplement containing sodium phosphate monobasic. The CAS registry number
More informationNaltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance
Naltrexone Shared Care Guideline for the treatment of alcohol dependence and opioid dependance Introduction Indication/Licensing information: Naltrexone is licensed for use as an additional therapy, within
More informationSee 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)
More informationArnicare Arnica 30c pillules NR 01175/0181 UKPAR
Arnicare Arnica 30c pillules NR 01175/0181 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of product characteristics Page 12 Product
More informationskin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains of organisms.
Part II SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL P 5 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Marbofloxacin 5mg per tablet
More informationDechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS
Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS Tel: 01939 211200 Fax: 01939 211201 Email: info.uk@dechra.com
More informationMEDICATION GUIDE. Tranxene* (TRAN-zeen) T-TAB (clorazepate dipotassium) tablets
MEDICATION GUIDE Tranxene* (TRAN-zeen) T-TAB (clorazepate dipotassium) tablets Read this Medication Guide before you start taking TRANXENE and each time you get a refill. There may be new information.
More informationThorazine (chlorpromazine)
Generic name: Chlorpromazine Available strengths: 10 mg, 25 mg, 50 mg, 100 mg, 200 mg tablets; 100 mg/ml oral concentrate; 25 mg/ml injection Available in generic: Yes Drug class: First-generation (conventional)
More informationTrama Injection Solution for Injection
Insert Leaflet Trama Injection Solution for Injection Composition Active substance Each 2 ml ampoule contains 100 mg tramadol hydrochloride. Inactive substances Sodium acetate, water for injection. Therapeutic
More informationRubifen SR 20 mg slow release tablets
Rubifen 10 mg immediate release tablets Rubifen SR 20 mg slow release tablets methylphenidate hydrochloride What is in this leaflet This leaflet answers some common questions about Rubifen. It does not
More informationBerkshire West CCGs Alcohol Treatment Pathway for Nalmefene (Selincro) Primary Care Guidance
Berkshire West CCGs Alcohol Treatment Pathway for Nalmefene (Selincro) Primary Care Guidance Nalmefene (trade name Selincro) was given approval by NICE in November 2014 and should be available to use with
More informationSummary of Product Characteristics Medical Helium
Summary of Product Characteristics Medical Helium www.uk.airliquide.com 1. NAME OF THE MEDICINAL PRODUCT Medical Helium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Helium BP 1988 100%. 3. PHARMACEUTICAL
More informationCore Safety Profile. Pharmaceutical form(s)/strength: 50mg tablets IE/H/PSUR/0028/002 Date of FAR: 17.07.2013
Core Safety Profile Active substance: Naltrexone Hydrochloride Pharmaceutical form(s)/strength: 50mg tablets P-RMS: IE/H/PSUR/0028/002 Date of FAR: 17.07.2013 4.2 Posology and method of administration
More informationData Sheet. Paraldehyde
Data Sheet Paraldehyde Paraldehyde Injection Solution 100% Presentation Paraldehyde Injection BP is a sterile liquid containing paraldehyde BP with hydroquinone 100 micrograms/ml as an antioxidant. It
More informationMaintenance of abstinence in alcohol dependence
Shared Care Guideline for Prescription and monitoring of Acamprosate Calcium Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist, Alcohol Services Dr Donnelly
More informationAcetylcholinesterase Inhibitors and Memantine Clinical Indication: Treatment of Dementia in Alzheimer s Disease (AD)
SHARED CARE PROTOCOL AND INFORMATION FOR GPS Acetylcholinesterase Inhibitors and Memantine Clinical Indication: Treatment of Dementia in Alzheimer s Disease (AD) Version: 3 Date Approved: June 2011 Review
More informationNōdia DESCRIPTION PHARMACOLOGY. Loperamide hydrochloride USP 2 mg Tablets. Pharmacological classification - antidiarrhoeal.
Nōdia Loperamide hydrochloride USP 2 mg Tablets DESCRIPTION Nōdia 2 mg tablets are green, capsule-shaped tablets with a break-line on one side. Each tablet contains 2 mg loperamide hydrochloride and typically
More informationLidocaine 2% w/v solution for injection Summary of Product Characteristics
Lidocaine 2% w/v solution for injection Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Lidocaine 2% w/v solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml
More informationN-methyl-D-aspartate (NMDA) Receptor Antagonist Memantine (CWM TAF ONLY)
Bro Taf Localities Drugs & Therapeutics Committee SHARED CARE Drugs: Acetylcholinesterase inhibitors - Donepezil, Rivastigmine and Galantamine (Cardiff and Vale and Cwm Taf) Protocol No. CV 52 N-methyl-D-aspartate
More informationSummary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole)
EMA/303592/2015 Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole) This is a summary of the risk management plan (RMP) for Aripiprazole Pharmathen, which details the measures
More informationMEDICATION GUIDE WELLBUTRIN XL * (WELL byu-trin) (bupropion hydrochloride extended-release tablets)
MEDICATION GUIDE WELLBUTRIN XL * (WELL byu-trin) (bupropion hydrochloride extended-release tablets) Read this Medication Guide carefully before you start using WELLBUTRIN XL and each time you get a refill.
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aknemycin Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10 g of solution contains 0.2 g of erythromycin. Structural formula of
More informationMedical Gas Data Sheet (MGDS) 5% carbon dioxide/air medical gas mixture
Medical Gas Data Sheet (MGDS) 5% carbon dioxide/air medical gas mixture Essential safety information Summary of Product Characteristics (SPC) pages 2-5 Additional Safety Information pages 6-7 BOC: Living
More informationMEDICATION GUIDE. What is Morphine Sulfate Oral Solution?
MEDICATION GUIDE Morphine Sulfate (mor-pheen) (CII) Oral Solution IMPORTANT: Keep Morphine Sulfate Oral Solution in a safe place away from children. Accidental use by a child is a medical emergency and
More information