Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
pregabalin treatment. At the time of prescription patients
should be advised of the signs and symptoms and monitored
closely for skin reactions. If signs and symptoms suggestive of
these reactions appear, pregabalin should be withdrawn
immediately and an alternative treatment considered (as
appropriate).
Dizziness, somnolence, loss of consciousness, confusion and
mental impairment
Pregabalin treatment has been associated with dizziness and
somnolence, which could increase the occurrence of
accidental injury (fall) in the elderly population. Therefore, you
should be careful until you are used to any effect the
medicine might have.
Vision-related effects
NEUROLIEF® may cause blurring or loss of vision, or other
changes in eyesight, many of which are temporary. You
should immediately tell your doctor if you experience any
changes in your vision.
Treatment of central neuropathic pain due to spinal cord
injury
Certain side effects may be more common, such as
sleepiness, because patients with spinal cord injury may be
taking other medicines to treat, for example, pain or spasticity,
that have similar side effects to Pregabalin and the severity of
these effects may be increased when taken together.
Congestive heart failure
There have been reports of heart failure in some patients
when taking NEUROLIEF®; these patients were mostly elderly
with cardiovascular conditions. Before taking this medicine,
you should tell your doctor if you have a history of heart
disease.
Renal failure
There have been reports of kidney failure in some patients
when taking NEUROLIEF®. If while taking NEUROLIEF® you notice
decreased urination, you should tell your doctor as stopping
the medicine may improve this.
Suicidal ideation and behavior
Some patients being treated with anti-epileptics such as
NEUROLIEF® have had thoughts of harming or killing
themselves or shown suicidal behavior. If at any time you
have these thoughts or shown such behavior, immediately
contact your doctor.
Reduced lower gastrointestinal tract function
When NEUROLIEF® is taken with other medicines that may
cause constipation (such as some types of pain medicines) it
is possible that gastrointestinal problems may occur (e.g.,
constipation, blocked or paralyzed bowel). Tell your doctor if
you experience constipation, especially if you are prone to this
problem.
Concomitant use with opioids
Before taking this medicine, tell your doctor if you have ever
abused or been dependent on alcohol, prescription
medicines or illegal drugs; it may mean you have a greater
risk of becoming dependent on NEUROLIEF®.
Encephalopathy
There have been reports of reduction in brain function
(encephalopathy) in some patients taking NEUROLIEF® when
they have other conditions. Tell your doctor if you have a
history of any serious medical conditions, including liver or
kidney disease.
Dependence
Some people may become dependent on NEUROLIEF® (a
dose of 600 mg per day may be
achieved after an additional week.
Generalised anxiety disorder
The dose range is 150 to 600 mg per
day given as two or three divided
doses. The need for treatment should
be reassessed regularly.
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.
Elderly (over 65 years of age): Take this
medicine normally except if you have
problems with your kidneys. Your
doctor may prescribe a different
dosing schedule and/or dose if you
have problems with your kidneys.
If you take more NEUROLIEF® than you
should Call your doctor or go to the
nearest hospital emergency unit
immediately. Take your box of
NEUROLIEF® capsules with you. You
may feel sleepy, confused, agitated or
restless as a result of taking more
NEUROLIEF® than you should. Fits and
unconsciousness have also been
reported.
If you forget to take NEUROLIEF® It is
important to take your medicine
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.
If you stop taking NEUROLIEF® Do not
stop taking this medicine unless your
doctor tells you to. If your treatment is
stopped it should be done gradually
over a minimum of 1 week. After
stopping long and short-term
pregabalin treatment, you need to
know that you may experience certain
side effects. These include trouble
sleeping, headache, nausea, feeling
anxious, diarrhea, flu-like symptoms,
convulsions, nervousness, depression,
pain, sweating, and dizziness. It is not
clear at this time whether these
symptoms occur more commonly or
severely if you have been taking
pregabalin for a longer period of time.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.
6-SPECIAL POPULATION
Pregnancy and breast-feeding:
NEUROLIEF should not be taken during pregnancy or when
breast-feeding, unless you are told otherwise by your doctor.
Pregabalin use during the first 3 months of pregnancy may
cause birth defects in the unborn child that require medical
treatment. Effective contraception must be used by women
of childbearing potential. If you are pregnant or breast-feed-
ing, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking
this medicine.
Children and adolescents:
The safety and efficacy in children and adolescents (under 18
years of age) has not been established and therefore, this
medicine should not be used in this age group.
7-ADVERSE REACTIONS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very common side effects: (may affect more than 1 in 10
people): Dizziness, drowsiness, headache.
Common side effects: (may affect up to 1 in 10 people):
-Increased appetite.
-Feeling of elation, confusion, disorientation, decrease in
sexual interest, irritability.
-Disturbance in attention, clumsiness, memory impairment,
loss of memory, tremor, difficulty with speaking, tingling
feeling, numbness, sedation, lethargy, insomnia, fatigue,
feeling abnormal.
-Blurred vision, double vision.
-Vertigo, problems with balance, fall.
-Dry mouth, constipation, vomiting, flatulence, diarrhea,
nausea, swollen abdomen.
-Difficulties with erection.
-Swelling of the body including extremities.
-Feeling drunk, abnormal style of walking.
-Weight gain.
-Muscle cramp, joint pain, back pain, pain in limb.
-Sore throat.
Uncommon side effects (may affect up to 1 in 100 people):
-Loss of appetite, weight loss, low blood sugar, high blood
sugar.
-Change in perception of self, restlessness, depression,
agitation, mood swings, difficulty finding words, hallucinations,
abnormal dreams, panic attack, apathy, aggression, elevated
mood, mental impairment, difficulty with thinking, increase in
sexual interest, problems with sexual functioning including
inability to achieve a sexual climax, delayed ejaculation.
-Changes in eyesight, unusual eye movement, changes in
vision including tunnel vision, flashes of light, jerky movements,
reduced reflexes, increased activity, dizziness on standing,
sensitive skin, loss of taste, burning sensation, tremor on
movement, decreased consciousness, loss of consciousness,
fainting, increased sensitivity to noise, feeling unwell.
-Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye
irritation.
-Heart rhythm disturbances, increased heart rate, low blood
pressure, high blood pressure, changes in heartbeat, heart
failure.
-Flushing, hot flushes.
-Difficulty breathing, dry nose, nasal congestion.
-Increased saliva production, heartburn, numb around mouth.
-Sweating, rash, chills, fever.
-Muscle twitching, joint swelling, muscle stiffness, pain
including muscle pain, neck pain.
- Breast pain.
-Difficulty with or painful urination, incontinence.
-Weakness, thirst, chest tightness.
- Changes in blood and liver test results (blood creatinine
phosphokinase increased, alanine amino transferase
increased, aspartate aminotransferase increased, platelet
count decreased, neutropenia, increase in blood creatinine,
decrease in blood potassium).
- Hypersensitivity, swollen face, itchiness, hives, runny nose,
nose bleed, cough, snoring.
- Painful menstrual periods.
-Coldness of hands and feet.
Rare side effects (may affect up to 1in 1,000 people):
-Abnormal sense of smell, swinging vision, altered perception
of depth, visual brightness, vision loss.
-Dilated pupils, cross eyes.
-Cold sweat, tightness of the throat, swollen tongue.
-Inflammation of the pancreas.
-Difficulty in swallowing.
-Slow or reduced movement of the body.
-Difficulty with writing properly.
-Increased fluid in the abdomen.
-Fluid in the lungs.
-Convulsions.
-Changes in the recording of electrical changes (ECG) in the
heart which correspond to heart rhythm disturbances.
- Muscle damage.
-Breast discharge, abnormal breast growth, breast growth in
males.
- Interrupted menstrual periods.
- Kidney failure, reduced urine volume, urinary retention.
-Decrease in white blood cell count.
- Inappropriate behavior, suicidal behavior, suicidal thoughts.
-Allergic reactions which may include difficulty breathing,
inflammation of the eyes (keratitis) and serious skin reactions
characterized by reddish non-elevated, target-like or circular
patches on the trunk, often with central blisters, skin peeling,
ulcers of mouth, throat, nose, genitals and eyes. These serious
skin rashes can be preceded by fever and flu-like symptoms
(Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Jaundice (yellowing of the skin and eyes).
-Parkinsonism, that is symptoms resembling Parkinson’s
disease; such as tremor, bradykinesia (decreased ability to
move), and rigidity (muscle stiffness).
Very rare side effects (may affect up to 1 in 10,000 people):
-Liver failure.
-Hepatitis (inflammation of the liver).
8- STORAGE CONDITIONS
- Keep this medicine out of the reach of children.
- Do not use this medicine after the expiry date which is
stated on the blister and the outer packaging.
The expiry date refers to the last day of that month.
- Store below 30°C. Protect from the light.
- Do not use this medicine if you notice visible
signs of deterioration.
MANUFCATURER
Impulse Pharma Pvt. Ltd.
Tarapur, Boisar, Dist-Palghar 401 506 Maharashtra State, India
Marketing Authorization Holder and packed by
Pregabalin 75 mg hard capsules
Pregabalin 150mg hard capsules
1-FORM AND PRESENTATION
NEUROLIEF® 75 mg/150 mg: Capsules. Box of 30.
2-COMPOSITION
Each capsule of NEUROLIEF® 75mg contains: Pregabalin 75
mg.
Each capsule of NEUROLIEF® 150 mg contains: Pregabalin 150
mg.
Inactive ingredients: Microcrystalline cellulose, Sodium Starch
Glycolate, Colloidal anhydrous silica, Magnesium stearate.
3-INDICATIONS
Neuropathic pain: NEUROLIEF® is indicated for the treatment
of peripheral (diabetes or shingles) and central neuropathic
pain.
Epilepsy: NEUROLIEF® is indicated as adjunctive therapy in
adults with partial seizures with or without secondary
generalization in adults. Your doctor will prescribe
NEUROLIEF® for you to help treat your epilepsy when your
current treatment is not controlling your condition. You
should take pregabalin in addition to your current treatment.
Pregabalin is not intended to be used alone, but should
always be used in combination with other anti-epileptic
treatment.
Generalized Anxiety Disorder: NEUROLIEF® is used to treat
anxiety disorder (GAD) in adults.
4-WARNING and PRECAUTIONS
Diabetic patients
Some diabetic patients who gain weight on pregabalin
treatment may need to adjust hypoglycemic medicinal
products.
Hypersensitivity reactions
There have been reports in the post marketing experience of
hypersensitivity reactions, including cases of angioedema.
Pregabalin should be discontinued immediately if symptoms
of angioedema, such as facial, perioral, or upper airway
swelling occur. Should you experience any of these reactions,
you should contact your physician immediately.
Severe cutaneous adverse reactions (SCARs)
SCARs including Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN), which can be life-threatening or
fatal, have been reported rarely in association with
need to keep taking the medicine). They may have
withdrawal effects when they stop using NEUROLIEF®. If you
notice any of the following signs whilst taking NEUROLIEF®, it
could be a sign that you have become dependent:
• You need to take the medicine for longer than advised by
your prescriber
• You feel you need to take more than the recommended
dose
• You are using the medicine for reasons other than
prescribed
• You have made repeated, unsuccessful attempts to quit or
control the use of the medicine
• When you stop taking the medicine you feel unwell, and
you feel better once taking the medicine again.
If you notice any of these, speak to your doctor to discuss
the best treatment pathway for you, including when it is
appropriate to stop and how to do this safely
There have been reports of convulsions when taking
NEUROLIEF® or shortly after stopping NEUROLIEF®. If you
experience a convulsion, contact your doctor immediately.
Other medicines and NEUROLIEF®:
-Oxycodone (used as a pain-killer), Lorazepam (used for
treating anxiety) and Alcohol
NEUROLIEF® may potentiate the side effects seen with these
medicines, including respiratory failure and coma. The
degree of dizziness, sleepiness and decreased concentra-
tion may be increased. Tell your doctor or pharmacist if you
are taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription.
-Oral contraceptives, norethisterone and/or ethinyl estradiol:
NEUROLIEF® may be taken with oral contraceptives.
NEUROLIEF® with food, drinks and alcohol: This medicine
can be taken with or without food. It is advised not to drink
alcohol while taking this medicine.
Driving and using machines: This medicine may produce
dizziness, sleepiness and decreased concentration. You
should not drive, operate complex machinery or engage in
other potentially hazardous activities until you know whether
this medicine affects your ability to perform these activities.
5-POSOLOGY
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure. Your doctor will determine what dose is appropriate for
you.
The dose range is 150 to 600 mg per day given in either two
or three divided doses.
Neuropathic pain
Pregabalin treatment can be started at a dose of 150 mg per
day given as two or three divided doses. Based on individual
patient response and tolerability, the dose may be
increased to 300 mg per day after an interval of 3 to 7 days,
and if needed, to a maximum dose of 600 mg per day after
an additional 7-day interval.
Epilepsy
Pregabalin treatment can be started with a dose of 150 mg
per day given as two or three divided doses. Based on
individual patient response and tolerability, the dose may be
increased to 300 mg per day after 1 week. The maximum
pregabalin treatment. At the time of prescription patients
should be advised of the signs and symptoms and monitored
closely for skin reactions. If signs and symptoms suggestive of
these reactions appear, pregabalin should be withdrawn
immediately and an alternative treatment considered (as
appropriate).
Dizziness, somnolence, loss of consciousness, confusion and
mental impairment
Pregabalin treatment has been associated with dizziness and
somnolence, which could increase the occurrence of
accidental injury (fall) in the elderly population. Therefore, you
should be careful until you are used to any effect the
medicine might have.
Vision-related effects
NEUROLIEF® may cause blurring or loss of vision, or other
changes in eyesight, many of which are temporary. You
should immediately tell your doctor if you experience any
changes in your vision.
Treatment of central neuropathic pain due to spinal cord
injury
Certain side effects may be more common, such as
sleepiness, because patients with spinal cord injury may be
taking other medicines to treat, for example, pain or spasticity,
that have similar side effects to Pregabalin and the severity of
these effects may be increased when taken together.
Congestive heart failure
There have been reports of heart failure in some patients
when taking NEUROLIEF®; these patients were mostly elderly
with cardiovascular conditions. Before taking this medicine,
you should tell your doctor if you have a history of heart
disease.
Renal failure
There have been reports of kidney failure in some patients
when taking NEUROLIEF®. If while taking NEUROLIEF® you notice
decreased urination, you should tell your doctor as stopping
the medicine may improve this.
Suicidal ideation and behavior
Some patients being treated with anti-epileptics such as
NEUROLIEF® have had thoughts of harming or killing
themselves or shown suicidal behavior. If at any time you
have these thoughts or shown such behavior, immediately
contact your doctor.
Reduced lower gastrointestinal tract function
When NEUROLIEF® is taken with other medicines that may
cause constipation (such as some types of pain medicines) it
is possible that gastrointestinal problems may occur (e.g.,
constipation, blocked or paralyzed bowel). Tell your doctor if
you experience constipation, especially if you are prone to this
problem.
Concomitant use with opioids
Before taking this medicine, tell your doctor if you have ever
abused or been dependent on alcohol, prescription
medicines or illegal drugs; it may mean you have a greater
risk of becoming dependent on NEUROLIEF®.
Encephalopathy
There have been reports of reduction in brain function
(encephalopathy) in some patients taking NEUROLIEF® when
they have other conditions. Tell your doctor if you have a
history of any serious medical conditions, including liver or
kidney disease.
Dependence
Some people may become dependent on NEUROLIEF® (a
dose of 600 mg per day may be
achieved after an additional week.
Generalised anxiety disorder
The dose range is 150 to 600 mg per
day given as two or three divided
doses. The need for treatment should
be reassessed regularly.
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.
Elderly (over 65 years of age): Take this
medicine normally except if you have
problems with your kidneys. Your
doctor may prescribe a different
dosing schedule and/or dose if you
have problems with your kidneys.
If you take more NEUROLIEF® than you
should Call your doctor or go to the
nearest hospital emergency unit
immediately. Take your box of
NEUROLIEF® capsules with you. You
may feel sleepy, confused, agitated or
restless as a result of taking more
NEUROLIEF® than you should. Fits and
unconsciousness have also been
reported.
If you forget to take NEUROLIEF® It is
important to take your medicine
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.
If you stop taking NEUROLIEF® Do not
stop taking this medicine unless your
doctor tells you to. If your treatment is
stopped it should be done gradually
over a minimum of 1 week. After
stopping long and short-term
pregabalin treatment, you need to
know that you may experience certain
side effects. These include trouble
sleeping, headache, nausea, feeling
anxious, diarrhea, flu-like symptoms,
convulsions, nervousness, depression,
pain, sweating, and dizziness. It is not
clear at this time whether these
symptoms occur more commonly or
severely if you have been taking
pregabalin for a longer period of time.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.
6-SPECIAL POPULATION
Pregnancy and breast-feeding:
NEUROLIEF should not be taken during pregnancy or when
breast-feeding, unless you are told otherwise by your doctor.
Pregabalin use during the first 3 months of pregnancy may
cause birth defects in the unborn child that require medical
treatment. Effective contraception must be used by women
of childbearing potential. If you are pregnant or breast-feed-
ing, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking
this medicine.
Children and adolescents:
The safety and efficacy in children and adolescents (under 18
years of age) has not been established and therefore, this
medicine should not be used in this age group.
7-ADVERSE REACTIONS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Very common side effects: (may affect more than 1 in 10
people): Dizziness, drowsiness, headache.
Common side effects: (may affect up to 1 in 10 people):
-Increased appetite.
-Feeling of elation, confusion, disorientation, decrease in
sexual interest, irritability.
-Disturbance in attention, clumsiness, memory impairment,
loss of memory, tremor, difficulty with speaking, tingling
feeling, numbness, sedation, lethargy, insomnia, fatigue,
feeling abnormal.
-Blurred vision, double vision.
-Vertigo, problems with balance, fall.
-Dry mouth, constipation, vomiting, flatulence, diarrhea,
nausea, swollen abdomen.
-Difficulties with erection.
-Swelling of the body including extremities.
-Feeling drunk, abnormal style of walking.
-Weight gain.
-Muscle cramp, joint pain, back pain, pain in limb.
-Sore throat.
Uncommon side effects (may affect up to 1 in 100 people):
-Loss of appetite, weight loss, low blood sugar, high blood
sugar.
-Change in perception of self, restlessness, depression,
agitation, mood swings, difficulty finding words, hallucinations,
abnormal dreams, panic attack, apathy, aggression, elevated
mood, mental impairment, difficulty with thinking, increase in
sexual interest, problems with sexual functioning including
inability to achieve a sexual climax, delayed ejaculation.
-Changes in eyesight, unusual eye movement, changes in
vision including tunnel vision, flashes of light, jerky movements,
reduced reflexes, increased activity, dizziness on standing,
sensitive skin, loss of taste, burning sensation, tremor on
movement, decreased consciousness, loss of consciousness,
fainting, increased sensitivity to noise, feeling unwell.
-Dry eyes, eye swelling, eye pain, weak eyes, watery eyes, eye
irritation.
-Heart rhythm disturbances, increased heart rate, low blood
pressure, high blood pressure, changes in heartbeat, heart
failure.
-Flushing, hot flushes.
-Difficulty breathing, dry nose, nasal congestion.
-Increased saliva production, heartburn, numb around mouth.
-Sweating, rash, chills, fever.
-Muscle twitching, joint swelling, muscle stiffness, pain
including muscle pain, neck pain.
- Breast pain.
-Difficulty with or painful urination, incontinence.
-Weakness, thirst, chest tightness.
- Changes in blood and liver test results (blood creatinine
phosphokinase increased, alanine amino transferase
increased, aspartate aminotransferase increased, platelet
count decreased, neutropenia, increase in blood creatinine,
decrease in blood potassium).
- Hypersensitivity, swollen face, itchiness, hives, runny nose,
nose bleed, cough, snoring.
- Painful menstrual periods.
-Coldness of hands and feet.
Rare side effects (may affect up to 1in 1,000 people):
-Abnormal sense of smell, swinging vision, altered perception
of depth, visual brightness, vision loss.
-Dilated pupils, cross eyes.
-Cold sweat, tightness of the throat, swollen tongue.
-Inflammation of the pancreas.
-Difficulty in swallowing.
-Slow or reduced movement of the body.
-Difficulty with writing properly.
-Increased fluid in the abdomen.
-Fluid in the lungs.
-Convulsions.
-Changes in the recording of electrical changes (ECG) in the
heart which correspond to heart rhythm disturbances.
- Muscle damage.
-Breast discharge, abnormal breast growth, breast growth in
males.
- Interrupted menstrual periods.
- Kidney failure, reduced urine volume, urinary retention.
-Decrease in white blood cell count.
- Inappropriate behavior, suicidal behavior, suicidal thoughts.
-Allergic reactions which may include difficulty breathing,
inflammation of the eyes (keratitis) and serious skin reactions
characterized by reddish non-elevated, target-like or circular
patches on the trunk, often with central blisters, skin peeling,
ulcers of mouth, throat, nose, genitals and eyes. These serious
skin rashes can be preceded by fever and flu-like symptoms
(Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Jaundice (yellowing of the skin and eyes).
-Parkinsonism, that is symptoms resembling Parkinson’s
disease; such as tremor, bradykinesia (decreased ability to
move), and rigidity (muscle stiffness).
Very rare side effects (may affect up to 1 in 10,000 people):
-Liver failure.
-Hepatitis (inflammation of the liver).
8- STORAGE CONDITIONS
- Keep this medicine out of the reach of children.
- Do not use this medicine after the expiry date which is
stated on the blister and the outer packaging.
The expiry date refers to the last day of that month.
- Store below 30°C. Protect from the light.
- Do not use this medicine if you notice visible
signs of deterioration.
MANUFCATURER
Impulse Pharma Pvt. Ltd.
Tarapur, Boisar, Dist-Palghar 401 506 Maharashtra State, India
Marketing Authorization Holder and packed by
Date of Revision: May 19, 2025
30 TabletsReg. N°: 105525/1
30 TabletsReg. N°: 105625/1
1-FORM AND PRESENTATION
NEUROLIEF® 75 mg/150 mg: Capsules. Box of 30.
2-COMPOSITION
Each capsule of NEUROLIEF® 75mg contains: Pregabalin 75
mg.
Each capsule of NEUROLIEF® 150 mg contains: Pregabalin 150
mg.
Inactive ingredients: Microcrystalline cellulose, Sodium Starch
Glycolate, Colloidal anhydrous silica, Magnesium stearate.
3-INDICATIONS
Neuropathic pain: NEUROLIEF® is indicated for the treatment
of peripheral (diabetes or shingles) and central neuropathic
pain.
Epilepsy: NEUROLIEF® is indicated as adjunctive therapy in
adults with partial seizures with or without secondary
generalization in adults. Your doctor will prescribe
NEUROLIEF® for you to help treat your epilepsy when your
current treatment is not controlling your condition. You
should take pregabalin in addition to your current treatment.
Pregabalin is not intended to be used alone, but should
always be used in combination with other anti-epileptic
treatment.
Generalized Anxiety Disorder: NEUROLIEF® is used to treat
anxiety disorder (GAD) in adults.
4-WARNING and PRECAUTIONS
Diabetic patients
Some diabetic patients who gain weight on pregabalin
treatment may need to adjust hypoglycemic medicinal
products.
Hypersensitivity reactions
There have been reports in the post marketing experience of
hypersensitivity reactions, including cases of angioedema.
Pregabalin should be discontinued immediately if symptoms
of angioedema, such as facial, perioral, or upper airway
swelling occur. Should you experience any of these reactions,
you should contact your physician immediately.
Severe cutaneous adverse reactions (SCARs)
SCARs including Stevens-Johnson syndrome (SJS) and toxic
epidermal necrolysis (TEN), which can be life-threatening or
fatal, have been reported rarely in association with
need to keep taking the medicine). They may have
withdrawal effects when they stop using NEUROLIEF®. If you
notice any of the following signs whilst taking NEUROLIEF®, it
could be a sign that you have become dependent:
• You need to take the medicine for longer than advised by
your prescriber
• You feel you need to take more than the recommended
dose
• You are using the medicine for reasons other than
prescribed
• You have made repeated, unsuccessful attempts to quit or
control the use of the medicine
• When you stop taking the medicine you feel unwell, and
you feel better once taking the medicine again.
If you notice any of these, speak to your doctor to discuss
the best treatment pathway for you, including when it is
appropriate to stop and how to do this safely
There have been reports of convulsions when taking
NEUROLIEF® or shortly after stopping NEUROLIEF®. If you
experience a convulsion, contact your doctor immediately.
Other medicines and NEUROLIEF®:
-Oxycodone (used as a pain-killer), Lorazepam (used for
treating anxiety) and Alcohol
NEUROLIEF® may potentiate the side effects seen with these
medicines, including respiratory failure and coma. The
degree of dizziness, sleepiness and decreased concentra-
tion may be increased. Tell your doctor or pharmacist if you
are taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription.
-Oral contraceptives, norethisterone and/or ethinyl estradiol:
NEUROLIEF® may be taken with oral contraceptives.
NEUROLIEF® with food, drinks and alcohol: This medicine
can be taken with or without food. It is advised not to drink
alcohol while taking this medicine.
Driving and using machines: This medicine may produce
dizziness, sleepiness and decreased concentration. You
should not drive, operate complex machinery or engage in
other potentially hazardous activities until you know whether
this medicine affects your ability to perform these activities.
5-POSOLOGY
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure. Your doctor will determine what dose is appropriate for
you.
The dose range is 150 to 600 mg per day given in either two
or three divided doses.
Neuropathic pain
Pregabalin treatment can be started at a dose of 150 mg per
day given as two or three divided doses. Based on individual
patient response and tolerability, the dose may be
increased to 300 mg per day after an interval of 3 to 7 days,
and if needed, to a maximum dose of 600 mg per day after
an additional 7-day interval.
Epilepsy
Pregabalin treatment can be started with a dose of 150 mg
per day given as two or three divided doses. Based on
individual patient response and tolerability, the dose may be
increased to 300 mg per day after 1 week. The maximum
PI018/01
Council of Arab Health Ministers
Union of Arab pharmacists
This is a medicine:
- A medicine is a product which affects
your health and its consumption
contrary to instructions is dangerous
for you.
- Follow strictly the doctor's
prescription, the method of use and
the instructions of the pharmacist who
dispensed the medicine.
- The doctor and the pharmacist are
the experts in medicine, their benefits
and risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicine out of reach of
children.
