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The body is also marked with a black band. Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Pregabalin treatment can be started at a dose of mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of mg per day after an additional 7-day interval. Pregabalin treatment can be started with a dose of mg per day given as two or three divided doses.
Based on individual patient response and tolerability, the dose may be increased to mg per day after 1 week. The maximum dose of mg per day may be achieved after an additional week. The dose range is to mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of mg per day.
Following an additional week the dose may be increased to mg per day. In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication see sections 4. Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.
As pregabalin clearance is directly proportional to creatinine clearance see section 5. For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment see Table 1. Creatinine clearance CL cr. The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents years of age have not been established.
Currently available data are described in sections 4. Elderly patients may require a dose reduction of pregabalin due to a decreased renal function see section 5. In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products. There have been reports in the postmarketing experience of hypersensitivity reactions, including cases of angioedema. Pregabalin should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur. Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury fall in the elderly population.
There have also been postmarketing reports of loss of consciousness, confusion and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product. In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients see section 5. In the postmarketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient. Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction. There are insufficient data for the withdrawal of concomitant anti-epileptic medicinal products, once seizure control with pregabalin in the add-on situation has been reached, in order to reach monotherapy on pregabalin.
After discontinuation of short-term and long-term treatment with pregabalin, withdrawal symptoms have been observed in some patients. The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
The patient should be informed about this at the start of the treatment. Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin. Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
There have been postmarketing reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction. In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased.
This may be attributed to an additive effect due to concomitant medicinal products e. This should be considered when prescribing pregabalin in this condition. There have been reports of severe respiratory depression in relation to pregabalin use. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly may be at higher risk of experiencing this severe adverse reaction. Dose adjustments may be necessary in these patients see section 4.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.
Therefore patients should be monitored for s of suicidal ideation and behaviours and appropriate treatment should be considered. Patients and caregivers of patients should be advised to seek medical advice should s of suicidal ideation or behaviour emerge. There are postmarketing reports of events related to reduced lower gastrointestinal tract function e.
When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered especially in female patients and elderly. Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS depression see section 4. In a case-control study of opioid users, those patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone adjusted odds ratio [aOR], 1.
Cases of misuse, abuse and dependence have been reported. 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 development of tolerance, dose escalation, drug-seeking behaviour have been reported. Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.
Lyrica contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Lyrica contains less than 1 mmol sodium 23 mg per hard capsule. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium-free'. Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.
Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically ificant effect on pregabalin clearance. Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone. No specific pharmacodynamic interaction studies were conducted in elderly volunteers. Interaction studies have only been performed in adults. As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential. Studies in animals have shown reproductive toxicity see section 5.
The potential risk for humans is unknown. Lyrica should not be used during pregnancy unless clearly necessary if the benefit to the mother clearly outweighs the potential risk to the foetus. Pregabalin is excreted into human milk see section 5.
A decision must be made whether to discontinue breast-feeding or to discontinue pregabalin therapy taking into the benefit of breast-feeding for the child and the benefit of therapy for the woman. After 3 months of treatment, there were no effects on sperm motility. A fertility study in female rats has shown adverse reproductive effects.
Fertility studies in male rats have shown adverse reproductive and developmental effects. The clinical relevance of these findings is unknown see section 5. Lyrica may have minor or moderate influence on the ability to drive and use machines. Lyrica may cause dizziness and somnolence and therefore may influence the ability to drive or use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities. The pregabalin clinical programme involved over 8, patients exposed to pregabalin, of whom over 5, were in double-blind placebo controlled trials.
The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased see section 4. Additional reactions reported from postmarketing experience are included in italics in the list below. System Organ Class. Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy.
Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy. Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, 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, lacrimation increased, eye irritation. Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness. Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure.
Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth. Blood creatine phosphokinase increased, blood glucose increased, platelet count decreased, blood creatinine increased, blood potassium decreased, weight decreased. After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed in some patients. The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, pain , hyperhidrosis and dizziness, suggestive of physical dependence.
The most common adverse events observed in the 12 week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis. The most common adverse events observed in the 14 day study with pregabalin treatment were somnolence, upper respiratory tract infection, and pyrexia see sections 4.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. In the postmarketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness. Seizures were also reported. Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary see section 4.
The active substance, pregabalin, is a gamma-aminobutyric acid analogue [ S aminomethyl methylhexanoic acid]. Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury. Efficacy has not been studied in other models of neuropathic pain. Pregabalin has been studied in 10 controlled clinical trials of up to 13 weeks with twice a day dosing BID and up to 8 weeks with three times a day TID dosing. In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by Week 1 and was maintained throughout the treatment period.
The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established. of a week placebo-controlled study of paediatric patients aged 4 to 16 years and a day placebo controlled study of paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and two 1 year open label safety studies in 54 and paediatric patients respectively, from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy see sections 4.
In the week placebo-controlled study, paediatric patients 4 to 16 years of age were ased to pregabalin 2. Median hour seizure frequencies at baseline and at the final visit were 4. Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing. Pregabalin did not achieve non-inferiority to lamotrigine based on the 6-month seizure freedom endpoint.Lyrica red capsule
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