PREGABALIN SANDOZ

4). Treatment should be given for the shortest possible duration. Posology The dose range is 150 to 600 mg per day given in either two or three divided doses. Neuropathic pain Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses.

Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. Epilepsy Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses.

Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. Generalised anxiety disorder The dose range is 150 to 600 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 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week.

Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week. 8). Renal impairment Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug.

2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula: Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).

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).

Table 1. 2). Paediatric population The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. 2 but no recommendation on a posology can be made. 2). Method of administration Pregabalin Sandoz may be taken with or without food.

Pregabalin Sandoz is for oral use only.

4) General disorders and administration site conditions: After disocntinuation of short terms and long term treatment with Gabapentinoids withdrawal symptoms have been observed. The following symptoms have been reported: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, suicidal ideation, pain, hyperhidrosis and dizziness.

These symptoms may indicate drug dependence. The patient should be informed about this at the start of the treatment. 4). The pregabalin clinical program involved over 8,900 patients exposed to pregabalin, of whom over 5,600 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. In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving pregabalin and 5% for patients receiving placebo.

The most common adverse reactions resulting in discontinuation from pregabalin treatment groups were dizziness and somnolence. In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The adverse reactions listed may also be associated with the underlying disease and / or concomitant medicinal products. 4). Additional reactions reported from post-marketing experience are included in italics in the list below.

Table 2. Pregabalin Adverse Drug Reactions System Organ Class Adverse drug reactions Infections and infestations Common Nasopharyngitis Blood and lymphatic system disorders Uncommon Neutropaenia Immune system disorders Uncommon Hypersensitivity Rare Angioedema, allergic reaction Metabolism and nutrition disorders Common Appetite increased Uncommon Anorexia, hypoglycaemia Psychiatric disorders Common Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased Uncommon Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy Rare Disinhibition, suicidal behaviour, suicidal ideation Not known Drug dependence Nervous system disorders Very Common Dizziness, somnolence, headache Common Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy Uncommon Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental System Organ Class Adverse drug reactions impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise Rare Convulsions, parosmia, hypokinesia, dysgraphia, parkinsonism Eye disorders Common Vision blurred, diplopia Uncommon Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, dry eye, lacrimation increased, eye irritation Rare Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness Ear and labyrinth disorders Common Vertigo Uncommon Hyperacusis Cardiac disorders Uncommon Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure Rare QT prolongation, sinus tachycardia, sinus arrhythmia Vascular disorders Uncommon Hypotension, hypertension, hot flushes, flushing, peripheral coldness Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness Rare Pulmonary oedema, throat tightness, Not known Respiratory depression Gastrointestinal disorders Common Vomiting, nausea, constipation, diarrhoea, flatulence, abdominal distension, dry mouth Uncommon Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral Rare Ascites, pancreatitis, swollen tongue, dysphagia Hepatobiliary disorders Uncommon Elevated liver enzymes* Rare Jaundice System Organ Class Adverse drug reactions Very rare Hepatic failure, hepatitis Skin and subcutaneous tissue disorders Uncommon Rash papular, urticaria, hyperhidrosis, pruritus Rare Toxic epidermal necrolysis, Stevens Johnson syndrome, cold sweat Musculoskeletal and connective tissue disorders Common Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm Uncommon Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness Rare Rhabdomyolysis Renal and urinary disorders Uncommon Urinary incontinence, dysuria Rare Renal failure, oliguria, urinary retention Reproductive system and breast disorders Common Erectile dysfunction Uncommon Sexual dysfunction, ejaculation delayed, dysmenorrhoea, breast pain Rare Amenorrhoea, breast discharge, breast enlargement, gynaecomastia General disorders and administration site conditions Common Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue Uncommon Generalised oedema, face oedema, chest tightness, pain, pyrexia, thirst, chills, asthenia Investigations Common Weight increased Uncommon Blood creatine phosphokinase increased, blood glucose […]

Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.

Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.

, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.

These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with Pregabalin should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.

Drug withdrawal syndrome Prior to starting treatment with Pregabalin, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with Pregabalin. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.

When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months. Patients should be informed of this when the medication is first prescribed.

The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction. If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions.

Reduce the dose by a fixed amount at each decrement, unless clinical risk is such that rapid withdrawal is needed. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Diabetic patients In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.

Hypersensitivity reactions 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.

Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported rarely in association with pregabalin treatment.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, pregabalin should be withdrawn immediately and an alternative treatment considered (as appropriate).

Dizziness, somnolence, loss of consciousness, confusion and mental impairment 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.

Vision-related effects 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. 1). 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. Renal failure Cases of renal failure have been reported and in some cases discontinuation of pregabalin did show reversibility of this adverse reaction.

Withdrawal of concomitant antiepileptic medicinal products There are […]

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