Nevalin Special Precautions

Patients with rare hereditary problems of galactose intolerance, the Lapp-Lactase deficiency or glucose-galactose malabsorption should not take this medicine.
In accordance with current clinical practice, some diabetic patients who gain weight on Pregabalin treatment may need to adjust hypoglycemic medications.
There have been reports of hypersensitivity reactions, including cases of angioedema. Pregalabin 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 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 medication.
Transient visual blurring and other changes in visual acuity have been reported in patients treated with pregabalin. Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
There are insufficient data for withdrawal of concomitant antiepileptic medicinal products, once seizures 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, diarrhea, hyperhidrosis, flu syndrome, nervousness, depression, pain, sweating, and dizziness. The patients should be informed about this at the start of treatments.
Pregabalin is not known to be active at receptor sites associated with drugs of abuse. Cases of misuse or abuse have been reported in the post-marketing database. As with any CNS active drug, carefully evaluate patients for history of drug misuse and abuse and observe them for signs of pregabalin abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).
Although the effects of discontinuation on the reversibility of renal failure have not been systematically studied, improved renal function following discontinuation or dose reduction of pregabalin has been reported.
Concerning discontinuation of long-term treatment of pregabalin there are no data of incidence and severity of withdrawal symptoms in relation to duration of use and dosage of pregabalin.
Although there has been no causal relationship identified between exposure to pregabalin and congestive heart failure, there have been reports of congestive heart failure in some patients receiving pregabalin. In short-term trials of patients without clinically significant heart or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications such as hypertension or congestive heart failure. Because there are limited data on congestive heart failure patients, pregabalin should be used with caution in these patients.
In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse events in general, CNS adverse events and especially somnolence was increased. This may be attributed to an additive effect due to concomitant medication (e.g., anti- spasticity agents) needed for this condition. This should be considered when prescribing pregabalin in this condition.
Effect on ability to drive and use machines: Pregabalin Capsule may have minor or moderate influence on the ability to drive and use machines. Pregabalin 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 medication affects their ability to perform these activities.