NURIKA Hard capsule Ref.[50571] Active ingredients: Pregabalin

Hypersensitivity reactions

There have been reports of hypersensitivity reactions, including cases of angioedema and urticaria. NURIKA should be discontinued immediately if symptoms of angioedema, such as facial, perioral, or upper airway swelling occur (see section 4.8).

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 post-marketing 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 NURIKA (see section 4.8).

Use with anti-depressant medicines

When NURIKA is used in combination with anti-depressant medicines, respiratory failure has occurred.

Withdrawal symptoms

After discontinuation of short-term and long-term treatment with NURIKA, withdrawal symptoms have been observed in some patients. The following events have been reported: insomnia, headache, nausea, diarrhoea, anxiety, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of NURIKA treatment.

Convulsions, including status epilepticus and grand mal convulsions, may occur during NURIKA use or shortly after discontinuing NURIKA.

During discontinuation of long-term treatment with NURIKA, the incidence and severity of withdrawal symptoms may be dose-related.

Renal failure

Renal failure may occur with NURIKA. Improved renal function was reported following dose reduction or discontinuation of NURIKA.

Congestive heart failure

There have been post-marketing reports of congestive heart failure or deterioration of heart failure in some patients receiving NURIKA. These are mostly seen in elderly cardiovascular compromised patients during NURIKA treatment. Therefore NURIKA should be used with caution in patients with congestive heart failure (see section 4.8). Discontinuation of NURIKA may resolve the reaction.

Diabetic patients

In accordance with current clinical practice, some diabetic patients who gain weight on NURIKA treatment may need to adjust hypoglycaemic medicines.

Vision-related effects

There have been post-marketing reports of visual adverse reactions including loss of vision, visual blurring or other changes of visual acuity, many of which were transient. Discontinuation of NURIKA may result in resolution or improvement of these visual symptoms.

Treatment of central neuropathic pain due to spinal cord injury

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 medicines (e.g. anti-spasticity medicines) needed for this condition. This should therefore be considered when prescribing NURIKA in this condition.

Suicidal ideation and behaviour

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicines in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

Reduced lower gastrointestinal tract function

There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medicines that have the potential to produce constipation, such as opioid analgesics. When NURIKA and opioids will be used in combination, measures to prevent constipation may be considered (especially in female patients and the elderly).

Misuse, abuse potential or dependence

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).

Encephalopathy

Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy.

Respiratory depression

There have been reports of severe respiratory depression in relation to NURIKA 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 4.2).

Mannitol

NURIKA contains mannitol and may have a laxative effect.

Since NURIKA is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans, does not inhibit medicine metabolism in vitro and is not bound to plasma proteins, NURIKA is unlikely to produce, or be subject to, pharmacokinetic interactions.

No pharmacokinetic interactions were observed between NURIKA and the following medicines: phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone, ethanol, oral anti-diabetics, diuretics, insulin and anti-epileptic medicines (such as phenytoin, carbamazepine, phenobarbitone, tiagabine and topiramate), oral contraceptives (e.g. norethisterone and/or ethinyl oestradiol). NURIKA appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone and may potentiate the effects of ethanol and lorazepam.

In patients taking NURIKA and other central nervous system (CNS) depressant medicines, there have been post-marketing reports of respiratory failure and coma.

Pregnancy

NURIKA should not be used during pregnancy since safety and efficacy has not been established, therefore effective contraception must be used in women of childbearing potential.

Breastfeeding

NURIKA is excreted in breast milk therefore breastfeeding is not recommended, since the effects on newborns/infants are unknown.

NURIKA frequently causes dizziness and somnolence. Therefore, patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether NURIKA affects their ability to perform these activities.

The most frequently reported adverse reactions are dizziness and somnolence.

Infections and infestations

Frequent: Nasopharyngitis

Immune system disorders

Frequency unknown: Hypersensitivity reactions, angioedema, allergic reaction

Blood and lymphatic system disorders

Less frequent: Neutropenia

Metabolism and nutrition disorders

Frequent: Increased appetite

Less frequent: Anorexia, hypoglycaemia

Psychiatric disorders

Frequent: Euphoric mood, confusion, decreased libido, irritability, disorientation, insomnia

Less frequent: Depersonalisation, anorgasmia, restlessness, depression, agitation, mood swings, insomnia exacerbated, depressed mood, word finding difficulty, hallucination, abnormal dreams, libido increased, panic attack, apathy, disinhibition, elevated mood, aggression

Nervous system disorders

Frequent: Dizziness, somnolence, ataxia, disturbance in attention, abnormal co-ordination, memory impairment, tremor, dysarthria, paraesthesia, headache, amnesia, hypoaesthesia, balance disorder, lethargy

Less frequent: Cognitive disorder, visual field defect, nystagmus, speech disorder, myoclonus, hyporeflexia, dyskinesia, psychomotor hyperactivity, postural dizziness, hyperaesthesia, ageusia, burning sensation, intention tremor, stupor, syncope, hypokinesia, parosmia, dysgraphia, loss of consciousness, nystagmus, mental impairment, malaise, convulsions, parkinsonism

Frequency unknown: Reversible paralysis

Eye disorders

Frequent: Vision blurred, diplopia

Less frequent: Visual disturbance, dry eye, eye swelling, reduced visual acuity, eye pain, asthenopia, increased lacrimation, photopsia, eye irritation, mydriasis, oscillopsia, altered visual depth perception, peripheral vision loss, strabismus, visual brightness, keratitis

Ear and labyrinth disorders

Frequent: Vertigo

Less frequent: Hyperacusis

Cardiac disorders

Less frequent: Tachycardia, atrioventricular block first degree, sinus tachycardia, sinus dysrhythmia, sinus bradycardia, congestive heart failure, QT prolongation

Vascular disorders

Less frequent: Flushing, hot flushes, hypotension, peripheral coldness, hypertension

Respiratory, thoracic and mediastinal disorders

Less frequent: Dyspnoea, nasal dryness, cough, nasal congestion, epistaxis, rhinitis, snoring, throat tightness, pulmonary oedema

Frequency unknown: Respiratory depression

Gastrointestinal disorders

Frequent: Dry mouth, constipation, vomiting, flatulence, nausea, diarrhoea, abdominal distension

Less frequent: Salivary hypersecretion, gastro-oesophageal reflux disease, oral hypoaesthesia, ascites, dysphagia, pancreatitis, swollen tongue

Hepatobiliary disorders

Less frequent: Elevated liver enzymes, jaundice, hepatic failure, hepatitis

Skin and subcutaneous tissue disorders

Less frequent: Sweating, rash papular, cold sweat, urticaria, face swelling, Stevens-Johnson syndrome, pruritus

Musculoskeletal and connective tissue disorders

Frequent: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm

Less frequent: Muscle twitching, joint swelling, myalgia, muscle stiffness, neck pain, rhabdomyolysis

Renal and urinary disorders

Less frequent: Dysuria, urinary incontinence, oliguria, renal failure, urinary retention

Reproductive system and breast disorders

Frequent: Erectile dysfunction

Less frequent: Ejaculation delayed, sexual dysfunction, amenorrhoea, breast pain, breast discharge, dysmenorrhoea, breast hypertrophy, gynaecomastia

General disorders and administration site conditions

Frequent:Fatigue, peripheral oedema, feeling drunk, oedema, abnormal gait, fall, feeling abnormal

Less frequent: Asthenia, thirst, chest tightness, exacerbated pain, anasarca, pyrexia, rigors, face oedema, chills, generalised oedema

Investigations

Frequent: Increased weight

Less frequent: Increased alanine aminotransferase, increased blood creatine phosphokinase, increased aspartate aminotransferase, decreased platelet count, increased blood glucose, increased blood creatinine, decreased blood potassium, decreased weight, decreased white blood cell count

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after registration of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the ‘6.04 Adverse Drug Reactions Reporting Form’, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.