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
PUNCHLINE Incorporated Association Registered Number A0003225B Committee Members Debbie Dodd, Allan Miller, Pat Miller,Denise Pike, Ilze Yeates, Chris Riddiford, ANNUAL GENERAL MEETING, SUNDAY NOVEMBER 10 – SPECIAL GUEST SPEAKER! The 2013 AGM will be held at Mingarra Village, 77-115 Mt Dandenong Road, Croydon. Enter off WicklowAvenue and head to The Pavilion, at the far end of Chev
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
Lyrica® (pregabalin)