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Pregabalin Abbreviated Prescribing Information

Abbreviated Prescribing Information: Pregabalin 20 milligram (mg)/millilitre (mL) oral solution. Consult Summary of Product Characteristics before prescribing. Presentation: Clear colourless oral solution, 1 mL contains 20 mg of pregabalin. Therapeutic Indications: Pregabalin is indicated for the treatment of peripheral and central neuropathic pain and Generalised Anxiety Disorder in adults. It is also indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Posology and Method of Administration: Pregabalin is for oral use only and it may be taken with or without food. The dose range is 150 to 600 mg (7.5 to 30 mL) per day given in either two or three divided doses. For neuropathic pain, treatment can be started at a dose of 150 mg (7.5 mL) per day, dose may be increased to 300 mg (15mL) per day after an interval of 3 to 7 days and may be further increased to 600 mg (30 mL) after an additional 7-day interval, if required. For epilepsy, following treatment with pregabalin 150 mg (7.5 mL) per day for a week, depending on response and tolerability, dose may be increased to 300 mg (15 mL) per day and a maximum dose of 600 mg (30 mL) per day may be achieved after an additional week. For generalised anxiety disorder, treatment can be started with a dose of 150 mg (7.5 mL) per day and the dose may be increased to 300 mg (15 mL) per day after 1 week. Following an additional week, the dose may be increased to 450 mg (22.5 mL) per day. The maximum dose of 600 mg (30 mL) per day may be achieved after an additional week. If pregabalin has to be discontinued, it should be done gradually over a minimum of 1 week. Paediatric population: The safety and efficacy of pregabalin in children has not been established. Elderly: This group of patients may require a dose reduction of pregabalin due to a decreased renal function. Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Special Warnings and Precautions for use: Some diabetic patients may need to adjust hypoglycaemic products. Should be discontinued immediately if symptoms of angioedema occur. Treatment has been associated with dizziness and somnolence. If vision is affected discontinuation should be considered. Cases of renal failure have been reported. All patients taking pregabalin should be informed of possibility of withdrawal symptoms. All patients on pregabalin should be monitored for signs of suicidal ideation and behaviours. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence. Cases of congestive heart failure have been reported in patients receiving pregabalin especially in elderly cardiovascular compromised patients. Increased incidence of adverse reactions in the treatment of central neuropathic pain due to spinal cord injury. Reports of reduced lower gastrointestinal tract function and severe respiratory depression have been reported. Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS depression. Cases of misuse, abuse and dependence have been reported. Cases of encephalopathy have been reported. Excipient warnings: It contains methyl and propyl parahydroxybenzoate, which may cause allergic reactions. Any warningfrom the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. Undesirable Effects: Very common: dizziness, somnolence, and headache. Common: Nasopharyngitis, appetite increase, euphoric mood, confusion, irritability, disorientation, insomnia, decreased libido, ataxia, abnormal coordination, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy, blurred vision, diplopia, vertigo, nausea, vomiting, constipation, diarrhoea, flatulence, abdominal distension, dry mouth, muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, erectile dysfunction, peripheral oedema, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue, weight increased. Uncommon: Neutropaenia, hypersensitivity, anorexia, hypoglycaemia, hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, increased libido, anorgasmia, apathy, syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorders, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise, peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, increased lacrimation, eye irritation, hyperacusis, tachycardia, first degree atrioventricular block, sinus bradycardia, congestive heart failure, hypotension, hypertension, hot flushes, flushing, peripheral coldness, dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness, Gastro-oesophageal reflux disease, salivary hypersecretion, oral hypoaesthesia, elevated liver enzymes, rash papular, urticaria, hyperhidrosis, pruritus, joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness, urinary incontinence, dysuria, sexual dysfunction, delayed ejaculation, dysmenorrhoea, breast pain, generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia, blood creatinine phosphokinase increased, blood glucose increased, decreased platelet count, increased blood creatinine, decreased blood potassium, weight decreased. Rare: Angioedema, allergic reaction, disinhibition, convulsions, parosmia, hypokinesia, dysgraphia, vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness, QT prolongation, sinus tachycardia, sinus arrhythmia, pulmonary oedema, throat tightness, ascites, pancreatitis, swollen tongue, dysphagia, jaundice, Stevens Johnson syndrome, cold sweat, toxic epidermal necrolysis, rhabdomyolysis, renal failure, oliguria, urinary retention, amenorrhoea, breast discharge, breast enlargement, gynaecomastia, decreased white blood cell count. Very Rare: Hepatic failure, hepatitis. Paediatric population: Most common adverse reactions reported in children include somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight gain and nasopharyngitis. Pack Size and NHS Price: 473 mL – £99.48. Marketing Authorisation Number: PL 00427/0247. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Sep-2022]

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400