Pregabalin belongs to a group of medicines used to treat epilepsy, neuropathic pain
and Generalised Anxiety Disorder (GAD) in adults. Pregabalin is rapidly absorbed
when administered in the fasted state, with peak plasma concentrations occurring
within 1 hour. Pregabalin bioavailability is estimated to be ≥ 90%. Administration of
pregabalin with food has no significant effect on the extent of pregabalin bioavailabil-
ity. Pregabalin is not bound to plasma proteins. Pregabalin is eliminated by renal
excretion as unchanged drug.
Pregabalin belongs to a group of medicines used to treat epilepsy, neuropathic pain
Neuropathic pain: Lygalin® is indicated for the treatment of peripheral and central
neuropathic pain in adults.
- Epilepsy: Lygalin® is indicated as adjunctive therapy in adults with partial seizures
with or without secondary generalisation.
- Generalised Anxiety Disorder : Lygalin® is used to treat Generalised Anxiety
Disorder(GAD) in adults.
Dosage & Administration
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Peripheral and central neuropathic pain, epilepsy or Generalised Anxiety
- 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
- The doctor may prescribe a different dosing schedule and/or dose if the patient has
problems with his kidneys.
- Elderly patients may require a dose reduction of pregabalin due to a decreased renal
- The safety and efficacy in children and adolescents (under 18 years of age) has not
been established and therefore, pregabalin should not be used in this age group.
- Lygalin® capsules may be taken with or without food.
- Lygalin® capsules should be taken regularly at the same time each day. If you forget
to take a dose, take it as soon as you remember unless it is time for your next dose. In
that case, just carry on with the next dose as normal. Do not take a double dose to make
up for a forgotten dose.
Discontinuation of Lygalin:-
- If Lygalin® has to be discontinued, it is recommended this should be done gradually
over a minimum of 1 week independent of the indication.
-Each capsule of Lygalin 75 mg contains:
Pregabalin 75 mg
Hypersensitivity reactions; Lygalin® should be discontinued immediately if
symptoms of angioedema, such as facial, perioral, or upper airway swelling occur.
Effects on ability to drive and use machines:-
- Lygalin® may produce dizziness, sleepiness and decreased concentration. 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.
Lygalin® and certain other medicines may influence each other (interaction).
When taken with certain other medicines, Lygalin® may potentiate the side effects
seen with these medicines, including respiratory failure and coma. The degree of
dizziness, sleepiness and decreased concentration may be increased if Lygalin® is
taken together with medicines containing Oxycodone, Lorazepam or Alcohol.
Lygalin® 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. A decision must be made whether to
discontinue breast-feeding or to discontinue Lygalin® therapy taking into account the
benefit of breast-feeding for the child and the benefit of therapy for the woman.
Like all medicines, this medicine can cause side effects, although not everybody gets
- Dizziness, somnolence, headache.
- Nasopharyngitis, increased appetite, euphoric mood, confusion, irritability,
disorientation, insomnia, decreased libido, ataxia, abnormal coordination, tremor,
dysarthria, amnesia, memory impairment, disturbance in attention, paresthesia,
hypoaesthesia, sedation, balance disorder, lethargy, blurred vision, diplopia, vertigo,
vomiting, nausea, constipation, diarrhoea, abdominal distension, dry mouth, muscle
cramp, arthralgia, back pain, pain in limb, cervical spasm, erectile dysfunction,
peripheral oedema, abnormal gait, fall, feeling drunk, feeling abnormal, fatigue, weight
- Neutropaenia, hypersensitivity, anorexia, hypoglycaemia, hallucination, panic attack,
restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood
swings, depersonalization, word finding difficulty, abnormal dreams, libido increased,
anorgasmia, apathy, 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, hyperacusis, tachycardia, atrioventricular block
first degree, sinus bradycardia, congestive heart failure, hypotension, hypertension,
hot flushes, flushing, peripheral coldness, dyspnoea, epistaxis, cough, nasal congestion,
rhinitis, snoring, nasal dryness, gastrooesophageal reflux disease, salivary
hypersecretion, hypoaesthesia oral, elevated liver enzymes, rash papular, urticaria,
hyperhidrosis, pruritus, joint swelling, myalgia, muscle twitching, neck pain, muscle
stiffness, urinary incontinence, dysuria, sexual dysfunction, ejaculation delayed,
dysmenorrhoea, breast pain, generalised oedema, face oedema, chest tightness, pain,
pyrexia, thirst, chills, asthenia, blood creatine phosphokinase increased, blood glucose
increased, platelet count decreased, blood creatinine increased, blood potassium
decreased, weight decreased.
- The most commonly reported adverse reactions observed when pregabalin was taken in
overdose included somnolence, confusional state, agitation, and restlessness. Seizures
were also reported. In rare occasions, cases of coma have been reported. Treatment of
Lygalin® overdose should include general supportive measures and may include
haemodialysis if necessary.
Diabetic patients; some diabetic patients who gain weight on pregabalin treatment
may need to adjust hypoglycaemic medicinal products.
- Lygalin® has been associated with dizziness and somnolence, which could increase
the occurrence of accidental injury (fall) in elderly patients. Therefore, patients should
be careful until they are used to any effect the medicine might have. There have also
been 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 Lygalin® .
- Visual adverse reactions have been reported, including visual blurring, transient loss
of vision, or other changes of visual acuity, many of which were transient.
Discontinuation of Lygalin® may result in resolution or improvement of these visual
- Renal failure; cases of renal failure have been reported and in some cases
discontinuation of pregabalin did show reversibility of this adverse reaction.
- Withdrawal symptoms; After discontinuation of short-term and long-term treatment
with Lygalin®, 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.
- Congestive heart failure; There have been 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.
- Convulsions, including status epilepticus and grand mal convulsions, may occur
during pregabalin use or shortly after discontinuing pregabalin.
- 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.g. anti-spasticity agents) needed for this condition.
This should be considered when prescribing pregabalin in this condition.
- A small number of people being treated with antiepileptics such as Lygalin® have had
thoughts of harming or killing themselves. Patients (and caregivers of patients) should
be advised to seek medical advice.
- When Lygalin® is taken with other medicines that may cause constipation (such as
opioids) it is possible that gastrointestinal problems may occur (e.g. constipation,
blocked or paralysed bowel).
- Encephalopathy; cases of encephalopathy have been reported, mostly in patients
with underlying conditions that may precipitate encephalopathy.
- Blister of 10 Capsules, pack of 1 blister.
Store in a dry place at temperature below 25º C.