Lyrica® (pregabalin)
Prescribing Information
Refer to Summary of Product Characteristics (SmPC) before pre-

severity of withdrawal symptoms may be dose-related (see side effects). scribing.
There have been post-marketing reports of congestive heart failure in Presentation: Lyrica is supplied in hard capsules containing 25mg, 50mg,
some patients receiving pregabalin. These were mostly elderly, 75mg, 100mg, 150mg, 200mg, 225mg (for Generalised Anxiety Disorder cardiovascular compromised patients who received treatment for a only), or 300mg and oral solution, where each ml contains 20 mg of neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction. There Indications: Treatment of peripheral and central neuropathic pain in
have been post-marketing reports of reduced lower gastrointestinal tract adults. Treatment of epilepsy, as adjunctive therapy in adults with partial function when pregabalin and opiates are co-prescribed. Measures to seizures with or without secondary generalisation. Treatment of General- prevent constipation may be considered. Cases of abuse have been reported (exercise caution in patients with a history of substance abuse). Dosage: Adults: 150 to 600mg (7.5 – 30ml) per day, given in either two or
Cases of encephalopathy have also been reported (take care in patients three divided doses taken orally. Treatment may be initiated at a dose of 150mg (7.5ml) per day and, based on individual patient response and Ability to drive and use machines: May affect ability to drive or operate
tolerability, may be increased to 300mg (15ml) per day after an interval of 3-7 days (for neuropathic pain) or 7 days (for epilepsy or GAD), the dose Interactions: Pregabalin appears to be additive in the impairment of cog-
may be increased to 450mg (22.5ml) per day after an additional 7 day nitive and gross motor function caused by oxycodone and may potentiate interval (for GAD), and to a maximum dose of 600mg (30ml) per day after the effects of ethanol and lorazepam. In the postmarketing experience, a further 7-day interval. Treatment should be discontinued gradually over there are reports of respiratory failure and coma in patients taking a minimum of one week. Renal impairment/ Haemodialysis: dosage pregabalin and other CNS depressant medications.
adjustment necessary; see SmPC. Hepatic impairment: No dosage Pregnancy and lactation: Lyrica should not be used during pregnancy
adjustment required. Elderly: Dosage adjustment required if impaired
unless benefit outweighs risk. Effective contraception must be used in renal function. Children and adolescents: The safety and efficacy of women of childbearing potential. Breast-feeding is not recommended Lyrica in children below the age of 12 years and in adolescents (12- 17 years of age) have not been established. Side effects: Adverse reactions during clinical trials were usually mild to
Contra-indications: Hypersensitivity to active substance or excipients.
moderate. Very commonly (≥1/10) reported side effects in placebo- Warnings and precautions: There have been reports of hypersensitivity
controlled, double-blind studies were somnolence and dizziness. reactions, including cases of angioedema. Pregabalin should be C ommonly (≥1/100, <1/10) reported side effects were appetite increased, discontinued immediately if symptoms of angioedema, such as facial, euphoric mood, confusion, libido decreased, irritability, ataxia, perioral, or upper airway swelling occur. Patients with galactose intoler- disturbance in attention, coordination abnormal, memory impairment, ance, the Lapp lactase deficiency or glucose-galactose malabsorption tremor, dysarthria, paraesthesia, vision blurred, diplopia, disorientation, should not take Lyrica capsules. Lyrica oral solution contains methyl par- balance disorder, insomnia, vertigo, dry mouth, constipation, vomiting, ahydroxybenzoate and propyl parahydroxybenzoate which may cause flatulence, erectile dysfunction, fatigue, oedema peripheral, feeling drunk, allergic reactions (possibly delayed). Some diabetic patients who gain lethargy, headache, sedation, oedema, gait abnormal and weight increased. weight may require adjustment to hypoglycaemic medication. Occurrence See SmPC for less commonly reported side effects. After discontinuation of dizziness and somnolence could increase accidental injury (fall) in of short and long-term treatment withdrawal symptoms have been elderly patients. There have also been post marketing reports of loss of observed in some patients; insomnia, headache, nausea, anxiety, diarrhoea, consciousness, confusion and mental impairment. Cases of renal failure flu syndrome, nervousness, depression, pain, hyperhidrosis and dizziness. have been reported and discontinuation of pregabalin did show oncerning discontinuation of long-term treatment, data suggest that the reversibility of this adverse effect. In controlled studies, a higher i ncidence and severity of withdrawal symptoms may be dose-related. (see proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases Overdose: In the post-marketing experience, the most commonly reported
with continued dosing. In the clinical studies where ophthalmologic adverse events observed when pregabalin was taken in overdose included testing was conducted, the incidence of visual acuity reduction and visual somnolence, confusional state, agitation, and restlessness. In rare field changes was greater in pregabalin-treated patients than in placebo- occasions, cases of coma have been reported. treated patients; the incidence of fundoscopic changes was greater in pla- Legal category: POM
cebo-treated patients. In the postmarketing experience, visual adverse Date of revision: November 2013
reactions have also been reported, most of which refer to transient vision Package quantities, marketing authorisation numbers and basic NHS
loss, visual blurring or other changes of visual acuity. Discontinuation of price: Lyrica 25mg, EU/1/04/279/003, 56 caps: £64.40, EU/1/04/279/004,
pregabalin may result in resolution or improvement of these visual 84 caps: £96.60; Lyrica 50mg, EU/1/04/279/009, 84 caps: £96.60; Lyrica symptoms. Suicidal ideation and behaviour have been reported in patients treated with EU/1/04/279/015, 84 caps: £96.60; Lyrica 150mg, EU/1/04/279/018, 56 anti-epileptic agents. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of EU/1/04/279/021, 84 caps: £96.60; Lyrica 300mg, EU/1/04/279/024, 56 suicidal ideation and behaviour. The data does not exclude the possibility of an increased risk for pregabalin. Patients should be monitored for signs EU/1/04/279/034, 56 caps: £64.40, Lyrica 20mg/ml oral solution of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road,
medical advice should signs of suicidal ideation or behaviour emerge. Insufficient data for withdrawal of concomitant antiepileptic medication, once seizure control with adjunctive Lyrica has been reached, in order to LY 20_0 Combined
reach monotherapy with Lyrica. After discontinuation of short and long- Further information is available on request from:
term treatment withdrawal symptoms have been observed in some Medical Information Department, Pfizer Limited, Walton Oaks, Dorking patients; insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, Road, Walton-on-the-Hill, Surrey KT20 7NS nervousness, depression, pain, convulsion, hyperhidrosis and dizziness. The patient should be informed about this at the start of the treatment. Adverse events should be reported. Reporting forms and
Convulsions (including status epilepticus and grand mal convulsions) may information can be found a
occur during treatment and shortly after withdrawal. Concerning Adverse events should also be reported to Pfizer Medical In-
discontinuation of long-term treatment, data suggest that the incidence and
formation on 01304 616161


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Head Nurse of Dept. of Cardiology at the Metropolitan Hospital Department of Economics at University Hospital Of Ioannina,Ioannina, Greece TECHNOLOGICAL INSTITUTE OF KALAMATA, Greece as an Assistant Professor in Health Management Dept of Health Management and Administration, Lancaster University, United Kingdom, as a post-graduate student Training in special organizational, management a

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