Lygalin 75

Lygalin 75

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. 

-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
  Very common: 
- 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.