7/23/2019 SYNGAB BPI

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Name of the medicinal product: Syngab. Active Ingredient: pregabalin. The

capsule for oral administration contains 50mg, 75mg, 100mg, or 200mg of

pregabalin. Therapeutic indications: Pregabalin is indicated for the treatment of

neuropathic pain in adults and as adjunctie therapy in adults !ith partial sei"ures

!ith or !ithout secondary generali"ation. Posology and method of

administration: The dose range is 150 to #00mg per day gien in either t!o orthree diided doses. Pregabalin may be ta$en !ith or !ithout food.

Contraindications: %ypersensitiity to the actie substance or to any of the

e&cepients. Special warnings and special precautions for use: Patients !ith

rare hereditary problem of galactose intolerance, the 'app lactase de(ciency or

glucose)galactose malabsorption should not ta$e this medicine. Some diabetic

patient !ho gain !eight on pregabalin treatment may need to adjust hypoglycemic

medications. Pregabalin treatment has been associated !ith di""iness and

somnolence, !hich could increase the occurrence of accidental injury *fall+ in the

elderly population. Therefore, patients should be adised to e&ercise caution until

they are familiar !ith the potential eects of the medication. Interaction with

other medicinal products and other forms of interaction: Since pregabalin is

predominantly e&creted unchanged in the urine, undergoes negligible metabolism in

humans *-2 of a dose recoered in urine as metabolites+, does not inhibit drug

metabolism initro, and is not bound to plasma proteins. /t is unli$ely to produce, or

be subject to, pharmaco$inetic interactions. Pregnancy and lactation: There are

no adeuate data on the use of pregabalin in pregnant !omen. reast)feeding is

not recommended during treatment !ith pregabalin. Eects on a!ility to drive

and use machines: Pregabalin may cause di""iness and somnolence and therefore

may inuence the ability to drie or use machines. Patients are adised not to drie,

operate comple& machinery or engage in other potentially ha"ardous actiities until

it is $no!n !hether this medication aects their ability to perform these actiities."ndesira!le eects: The most commonly reported aderse reactions !ere

di""iness and somnolence. The common *314100, -1410+ aderse eects associated

!ith pregabalin appetite increased, euphoric mood, confusion, libido decreased,

irritability, ata&ia, disturbance in attention, coordination abnormal, memory

impairment, tremor, dysarthria, paresthesia, ision blurred, diplopia, ertigo, dry

mouth, constipation, omiting, atulence, erectile dysfunction, !eight increased,

fatigue, edema peripheral, feeling drun$, edema, giant abnormal. #verdose: /n

oerdoses upto 15g, no une&pected aderse reactions !ere reported. Treatment of

pregabalin oerdose should include general supportie measures and may include

haemodialysis if necessary. $ow supplied: Syngab 6apsules are aailable inlu4lu blister containing 18 hard capsules.