Each capsule of Lega Global® 150 mg contains:

• Pregabalin         150 mg 

Neuropathic pain:

• Lega Global® is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy:

• Lega Global® is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised Anxiety Disorder:

• Lega Global® is used to treat Generalised Anxiety Disorder (GAD) in adults. 

Hypersensitivity reactions: Lega Global® should be discontinued immediately if symptoms of angioedema, such as

• (facial, perioral, or upper airway swelling occur).

• Lega Global® and certain other medicines may influence each other (interaction). When taken with certain other medicines.
• Lega Global® 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 Lega Global® is taken together with medicines containing Oxycodone, Lorazepam or Alcohol.

• Lega Global® 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 Lega Global® 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
them.
Very common: 

• Dizziness, somnolence, headache.

Common: 

• 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 gain.

Uncommon:

• 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.

Overdosage:

• 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 Lega Global® overdose should include general supportive measures and may include haemodialysis if necessary.

Effects on ability to drive and use machines:

• Lega Global® 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.

• 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 
Disorder:

• 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 week.

* 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 function.

* 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.

* Lega Global® capsules may be taken with or without food. 
* Lega Global® 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 Lega Global®:

• If Lega Global® has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.

Diabetic patients;

• some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycaemic medicinal products.
• Lega Global® 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 Lega Global®.

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 Lega Global® may result in resolution or improvement of these visual symptoms.

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 Lega Global®, 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 Lega Global® have had thoughts of harming or killing themselves. Patients (and caregivers of patients) should be advised to seek medical advice.
• When Lega Global® 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.