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PREGABALIN RANBAXY 150MG CAPSULES HARD

Active substance(s): PREGABALIN

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Package Leaflet: Information for the user
Pregablin Ranbaxy 50 mg capsules, hard
Pregablin Ranbaxy 75 mg capsules, hard
Pregablin Ranbaxy 100 mg capsules, hard
Pregablin Ranbaxy 150 mg capsules, hard
Pregablin Ranbaxy 225 mg capsules, hard
Pregablin Ranbaxy 300 mg capsules, hard
Pregabalin
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. See section 4.
What is in this leaflet:
1. What Pregablin Ranbaxy is and what it is
used for
2. What you need to know before you take
Pregablin Ranbaxy
3. How to take Pregablin Ranbaxy
4. Possible side effects
5. How to store Pregablin Ranbaxy
6. Contents of the pack and other
information
1. What Pregablin Ranbaxy is and what
it is used for
Pregablin Ranbaxy belongs to a group of
medicines used to treat epilepsy, neuropathic
pain and Generalised Anxiety Disorder (GAD)
in adults.
Epilepsy:
Pregablin Ranbaxy is used to treat a certain
form of epilepsy (partial seizures with or
without secondary generalisation) in adults.
Your doctor will prescribe Pregablin Ranbaxy
for you to help treat your epilepsy when your
current treatment is not controlling your
condition. You should take Pregablin Ranbaxy
in addition to your current treatment. Pregablin
Ranbaxy is not intended to be used alone, but
should always be used in combination with
other anti-epileptic treatment.
Peripheral and central neuropathic pain:
Pregabalin is used to treat long lasting pain
caused by damage to the nerves. A variety of
diseases can cause peripheral neuropathic pain,
such as diabetes or shingles. Pain sensations
may be described as hot, burning, throbbing,
shooting, stabbing, sharp, cramping, aching,
tingling, numbness, pins and needles. Peripheral
and central neuropathic pain may also be
associated with mood changes, sleep
disturbance, fatigue (tiredness), and can have an
impact on physical and social functioning and
overall quality of life.
Generalised Anxiety Disorder:
Pregablin Ranbaxy is used to treat
Generalised Anxiety Disorder (GAD). The
symptoms of GAD are prolonged excessive
anxiety and worry that are difficult to control.
GAD can also cause restlessness or feeling
keyed up or on edge, being easily fatigued
(tired), having difficulty concentrating or mind
going blank, feeling irritable, having muscle
tension or sleep disturbance. This is different
to the stresses and strains of everyday life.
2. What you need to know before you
take Pregablin Ranbaxy
Do not take Pregablin Ranbaxy
- if you are allergic to pregablin or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and Precautions


















Some patients taking Pregablin Ranbaxy
have reported symptoms suggesting an
allergic reaction. These symptoms include
swelling of the face, lips, tongue, and throat,
as well as diffuse skin rash. Should you
experience any of these reactions, you
should contact your physician immediately.
Pregablin Ranbaxy has been associated
with dizziness and somnolence, which
could increase the occurrence of
accidental injury (fall) in older patients.
Therefore, you should be careful until you
are used to any effect the medicine might
have.
Pregablin Ranbaxy 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.
Some patients with diabetes who gain
weight while taking Pregablin Ranbaxy
may need an alteration in their diabetic
medicines.
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
Pregablin Ranbaxy and the severity of these
effects may be increased when taken
together.
There have been reports of heart failure in
some patients when taking Pregablin
Ranbaxy; these patients were mostly older
with cardiovascular conditions. Before
taking this medicine you should tell your
doctor if you have a history of heart disease.
There have been reports of kidney failure
in some patients when taking Pregablin
Ranbaxy. If while taking Pregablin
Ranbaxy you notice decreased urination,
you should tell your doctor as stopping the
medicine may improve this.
A small number of people being treated
with anti-epileptics such as Pregablin
Ranbaxy have had thoughts of harming or
killing themselves. If at any time you have
these thoughts, immediately contact your
doctor.
When Pregablin Ranbaxy 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 paralysed bowel).
Tell your doctor if you experience
constipation, especially if you are prone to
this problem.
Before taking this medicine you should
tell your doctor if you have a history of
alcoholism or drug dependence. Let your
doctor know if you think you need more
medicine than prescribed.
There have been reports of convulsions
when taking Pregablin Ranbaxy or shortly
after stopping Pregablin Ranbaxy. If you
experience a convulsion, contact your
doctor immediately.
There have been reports of reduction in
brain function (encephalopathy) in some
patients taking Pregablin Ranbaxy when they
have other conditions. Tell your doctor if you
have a history of any serious medical
conditions, including liver or kidney disease.

Children and adolescents
The safety and efficacy in children and
adolescents (under 18 years of age) has not
been established and therefore, Pregablin
Ranbaxy should not be used in this age group.
Other medicines and Pregablin Ranbaxy
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Pregablin Ranbaxy and certain other
medicines may influence each other
(interaction). When taken with certain other
medicines, Pregablin Ranbaxy 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 Pregablin
Ranbaxy is taken together with medicinal
products containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol
Pregablin Ranbaxy may be taken with oral
contraceptives.
Pregablin Ranbaxy with food, drink and
alcohol
It is advised not to drink alcohol while taking
Pregablin Ranbaxy.
Pregnancy, breast-feeding and fertility
Pregablin Ranbaxy should not be taken
during pregnancy or when breast-feeding,
unless you are told otherwise by your doctor.
Effective contraception must be used by
women of child-bearing potential.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Pregablin Ranbaxy 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.
3. How to take Pregablin Ranbaxy
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is
appropriate for you.
Peripheral and central neuropathic pain,
Epilepsy or Generalised Anxiety Disorder:
• Take the number of capsules as instructed
by your doctor.
• The dose, which has been adjusted for
you and your condition, will generally be
between 150 mg and 600 mg each day.
• Your doctor will tell you to take Pregablin
Ranbaxy either twice or three times a day.
For twice a day take Pregablin Ranbaxy
once in the morning and once in the
evening, at about the same time each day.
For three times a day take Pregablin
Ranbaxy once in the morning, once in the
afternoon and once in the evening, at about
the same time each day.
If you have the impression that the effect of
Pregablin Ranbaxy is too strong or too weak,
talk to your doctor or pharmacist.
If you are an older patient (over 65 years of
age), you should take Pregablin Ranbaxy
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.
Pregablin Ranbaxy is for oral use only.
Swallow the capsule whole with water.
Pregablin Ranbaxy capsules may be taken
with or without food.
Continue taking Pregablin Ranbaxy until
your doctor tells you to stop.
If you take more Pregablin Ranbaxy than
you should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of Pregablin Ranbaxy capsules with
you. You may feel sleepy, confused, agitated,
or restless as a result of taking more Pregablin
Ranbaxy than you should.
If you forget to take Pregablin Ranbaxy
It is important to take your Pregablin
Ranbaxy capsules 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 Pregablin Ranbaxy
Do not stop taking Pregablin Ranbaxy 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 Pregablin
Ranbaxy treatment, you need to know that you
may experience certain side effects. These

Folded size : 50 x 50 mm
Pregabalin Tabs PIL
PIL size : 150 x 600 mm
Market: UK
SPIL/PKGDEV : AK08/Jul/2015-V01,
AK19/Aug/2015-V02

include, trouble sleeping, headache, nausea,
feeling anxious, diarrhoea, flulike symptoms,
convulsions, nervousness, depression, pain,
sweating, and dizziness. These symptoms may
occur more commonly or severely if you have
been taking Pregablin Ranbaxy for a longer
period of time.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
t h e Ye l l o w C a r d S c h e m e a t :
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.
5. How to store Pregablin Ranbaxy


Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Serious side effects:



If any of the following happen, stop taking
Pregablin Ranbaxy and contact a doctor or go
to the nearest hospital immediately, as you
may need urgent medical attention.








Hypersensitivity and allergic reactions
(which may include swollen face, swollen
tongue, difficulty breathing, itchiness)
Serious skin reaction characterized by
rash, blisters, peeling skin and pain.
If you experience swollen face or tongue or
if your skin turns red and starts to blister or
peel you should seek immediate medical
advice.
Inflammation of the pancreas (which
includes symptoms such as severe upper
stomach pain, often with nausea and vomiting)

Other side effects:
Very common: may affect more than 1 in 10
people
• Dizziness, drowsiness, headache.
Common: may affect up to 1 in 10 people
• Increased appetite
• Feeling of elation, confusion,
disorientation, changes 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, diarrhoea, nausea
• Difficulties with erection
• Swelling of the body including
extremities
• Swollen abdomen
• Feeling drunk, abnormal style of walking
• Weight gain
• Sore throat
• Muscle cramp, joint pain, back pain, pain
in limb, spasm in neck
Uncommon: 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, elevated
mood, aggression, difficulty finding words,
hallucinations, abnormal dreams, panic
attacks, apathy, problems with sexual
functioning including inability to achieve a
sexual climax, delayed ejaculation, mental
impairment, difficulty with thinking
• Changes in eyesight, unusual eye movement,
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, tunnel vision, flashes of
light, eye irritation
• Heart rhythm disturbances, increased
heart rate, low blood pressure, high blood
pressure, heart failure
• Flushing, hot flushes
• Difficulty breathing, dry nose
• Cough, nasal congestion, swollen face,
hives, itchiness, runny nose, nose bleed,
snoring
• Increased saliva production, heartburn,
numb around mouth
• Sweating, rash, chills, fever
• Coldness of hands and feet
• Muscle twitching, joint swelling, muscle
stiffness, pain including muscle pain, neck
pain
• Difficulty with or painful urination,
incontinence
• Weakness, thirst, chest tightness
• Breast pain
• Painful menstrual periods
• Generalised swelling
• Changes in blood and liver test results
(blood creatinine phosphokinase increased,
alanine amino transferase increased,
aspartate aminotransferase increased, platelet
count decreased, decrease in blood
potassium, increase in blood creatinine,
neutropenia).
Rare: may affect up to 1 in 1,000 people
• Changes in heart beat
• Abnormal sense of smell, changes in vision
including swinging vision, altered perception
of depth, visual brightness, vision loss
• Dilated pupils, cross eyes
• Inflammation of the eyes (keratitis)
• Cold sweat, tightness of the throat,
swollen tongue
• Difficulty in swallowing
• Slow or reduced movement of the body
• Difficulty with writing properly
• Fluid in the lungs
• Convulsions
• Changes in the recording of electrical
changes (ECG) in the heart which
correspond to heart rhythm disturbances
• Increased fluid in the abdomen
• 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.
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
Pregablin Ranbaxy and the severity of these
effects may be increased when taken together.




Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the blister/carton.
The expiry date refers to the last day of that
month.
This medicine does not require any
special storage conditions
Bottle: Once the bottle is opened the
capsules should be used within 30 days
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other
information
What Pregablin Ranbaxy contains
The active substance is pregabalin.
Pregablin Ranbaxy 50 mg: Each capsule,
hard contains 50 mg of pregablin.
Pregablin Ranbaxy 75 mg: Each capsule,
hard contains 75 mg of pregablin.
Pregablin Ranbaxy 100 mg: Each capsule,
hard contains 100 mg of pregablin.
Pregablin Ranbaxy 150 mg: Each capsule,
hard contains 150 mg of pregablin.
Pregablin Ranbaxy 225 mg: Each capsule,
hard contains 225 mg of pregablin.
Pregablin Ranbaxy 300 mg: Each capsule,
hard contains 300 mg of pregablin.
The other excipients are
Capsules content:
Mannitol, talc
Capsules shell:
Gelatin, titanium dioxide (E171), sodium
lauryl sulphate
only For 75 mg, 100 mg, 225 mg and 300 mg,
Iron oxide red (E172)
Printing Ink:
Shellac, propylene glycol, black iron oxide
(E172), potassium hydroxide
What Pregablin Ranbaxy looks like and
contents of the pack
50 mg capsules: Hard gelatin capsules of size
'2' with white opaque cap and white opaque
body imprinted with black ink 'rbx' with band on
cap and 'PG50' with band on body containing
white to off white powder. The length of the
capsule is approximately 17.0-18.2 mm.
75 mg capsules: Hard gelatin capsules of
size '4' with red opaque cap and white opaque
body imprinted with black ink 'rbx' on cap and
'PG75' on body containing white to off white
powder. The length of the capsule is
approximately 14.0-14.8 mm
100 mg capsules: Hard gelatin capsules of
size '3' with red opaque cap and red opaque
body imprinted with black ink 'rbx' on cap and
'PG100' on body containing white to off white
powder. The length of the capsule is
approximately 15.3-16.3 mm.
150 mg capsules: Hard gelatin capsules of
size '2' with white opaque cap and white
opaque body imprinted with black ink 'rbx' on
cap and 'PG150' on body containing white to
off white powder. The length of the capsule is
approximately 17.0-18.2 mm.
225 mg capsules: Hard gelatin capsules of
size '1' with red opaque cap and white opaque
body imprinted with black ink 'rbx' on cap and
'PG225' on body containing white to off white
powder. The length of the capsule is
approximately 18.6-19.7 mm.
300 mg capsules: Hard gelatin capsules of
size '0' with red opaque cap and white opaque
body imprinted with black ink 'rbx' on cap and
'PG300' on body containing white to off white
powder. The length of the capsule is
approximately 21.0-21.8 mm.
OPA/Al/PVC//Al blister
Pack sizes: 14, 21, 56, 84, 98 100 or 112
capsules, hard
PVC//Al blister
For 25, 50, 100 and 225 mg:
Pack sizes: 14, 21, 56, 84, 98, 100 or 112
capsules, hard.
For 75, 150 and 300mg
Pack sizes: 14, 21, 28, 56, 84, 98, 100 or 112
capsules, hard.
HDPE bottle with child resistance closure
(PP).
Pack sizes: 14, 21, 30, 56, 84, 98, 100 or 112
capsules, hard
HDPE bottle with screw cap (PP).
Pack size: 500 capsules, hard
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE
Manufacturer
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co-Tipperary,
Republic of Ireland
Basics GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Terapia SA
124 Fabrici Street,
400 632 Cluj Napoca
Romania
This leaflet was last revised in 08/2015.

SAP CODE : 5119470
PHARMA CODE : 19470
Note: 5119470 - for Submission only
5118768 - For commercialization

5119470

Black

50 mm

Pregablin Ranbaxy 50 mg capsules, hard
Pregablin Ranbaxy 75 mg capsules, hard
Pregablin Ranbaxy 100 mg capsules, hard
Pregablin Ranbaxy 150 mg capsules, hard
Pregablin Ranbaxy 225 mg capsules, hard
Pregablin Ranbaxy 300 mg capsules, hard
Pregabalin

50 mm

5119470
Package Leaflet: Information for the user

Pregablin Ranbaxy 50 mg capsules, hard
Pregablin Ranbaxy 75 mg capsules, hard
Pregablin Ranbaxy 100 mg capsules, hard
Pregablin Ranbaxy 150 mg capsules, hard
Pregablin Ranbaxy 225 mg capsules, hard
Pregablin Ranbaxy 300 mg capsules, hard
Pregabalin

50 mm

5119470
Package Leaflet: Information for the user

50 mm

Font Size: 9 pt.

Package Leaflet: Information for the user
Pregablin Ranbaxy 50 mg capsules, hard
Pregablin Ranbaxy 75 mg capsules, hard
Pregablin Ranbaxy 100 mg capsules, hard
Pregablin Ranbaxy 150 mg capsules, hard
Pregablin Ranbaxy 225 mg capsules, hard
Pregablin Ranbaxy 300 mg capsules, hard
Pregabalin
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. See section 4.
What is in this leaflet:
1. What Pregablin Ranbaxy is and what it is
used for
2. What you need to know before you take
Pregablin Ranbaxy
3. How to take Pregablin Ranbaxy
4. Possible side effects
5. How to store Pregablin Ranbaxy
6. Contents of the pack and other
information
1. What Pregablin Ranbaxy is and what
it is used for
Pregablin Ranbaxy belongs to a group of
medicines used to treat epilepsy, neuropathic
pain and Generalised Anxiety Disorder (GAD)
in adults.
Epilepsy:
Pregablin Ranbaxy is used to treat a certain
form of epilepsy (partial seizures with or
without secondary generalisation) in adults.
Your doctor will prescribe Pregablin Ranbaxy
for you to help treat your epilepsy when your
current treatment is not controlling your
condition. You should take Pregablin Ranbaxy
in addition to your current treatment. Pregablin
Ranbaxy is not intended to be used alone, but
should always be used in combination with
other anti-epileptic treatment.
Peripheral and central neuropathic pain:
Pregabalin is used to treat long lasting pain
caused by damage to the nerves. A variety of
diseases can cause peripheral neuropathic pain,
such as diabetes or shingles. Pain sensations
may be described as hot, burning, throbbing,
shooting, stabbing, sharp, cramping, aching,
tingling, numbness, pins and needles. Peripheral
and central neuropathic pain may also be
associated with mood changes, sleep
disturbance, fatigue (tiredness), and can have an
impact on physical and social functioning and
overall quality of life.
Generalised Anxiety Disorder:
Pregablin Ranbaxy is used to treat
Generalised Anxiety Disorder (GAD). The
symptoms of GAD are prolonged excessive
anxiety and worry that are difficult to control.
GAD can also cause restlessness or feeling
keyed up or on edge, being easily fatigued
(tired), having difficulty concentrating or mind
going blank, feeling irritable, having muscle
tension or sleep disturbance. This is different
to the stresses and strains of everyday life.
2. What you need to know before you
take Pregablin Ranbaxy
Do not take Pregablin Ranbaxy
- if you are allergic to pregablin or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and Precautions






















There have been reports of reduction in
brain function (encephalopathy) in some
patients taking Pregablin Ranbaxy when they
have other conditions. Tell your doctor if you
have a history of any serious medical
conditions, including liver or kidney disease.

Children and adolescents
The safety and efficacy in children and
adolescents (under 18 years of age) has not
been established and therefore, Pregablin
Ranbaxy should not be used in this age group.
Other medicines and Pregablin Ranbaxy
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Pregablin Ranbaxy and certain other
medicines may influence each other
(interaction). When taken with certain other
medicines, Pregablin Ranbaxy 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 Pregablin
Ranbaxy is taken together with medicinal
products containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol
Pregablin Ranbaxy may be taken with oral
contraceptives.
Pregablin Ranbaxy with food, drink and
alcohol
It is advised not to drink alcohol while taking
Pregablin Ranbaxy.
Pregnancy, breast-feeding and fertility
Pregablin Ranbaxy should not be taken
during pregnancy or when breast-feeding,
unless you are told otherwise by your doctor.
Effective contraception must be used by
women of child-bearing potential.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Pregablin Ranbaxy 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.
3. How to take Pregablin Ranbaxy
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is
appropriate for you.
Peripheral and central neuropathic pain,
Epilepsy or Generalised Anxiety Disorder:
• Take the number of capsules as instructed
by your doctor.
• The dose, which has been adjusted for
you and your condition, will generally be
between 150 mg and 600 mg each day.
• Your doctor will tell you to take Pregablin
Ranbaxy either twice or three times a day.
For twice a day take Pregablin Ranbaxy
once in the morning and once in the
evening, at about the same time each day.
For three times a day take Pregablin
Ranbaxy once in the morning, once in the
afternoon and once in the evening, at about
the same time each day.
If you have the impression that the effect of
Pregablin Ranbaxy is too strong or too weak,
talk to your doctor or pharmacist.
If you are an older patient (over 65 years of
age), you should take Pregablin Ranbaxy
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.
Pregablin Ranbaxy is for oral use only.
Swallow the capsule whole with water.
Pregablin Ranbaxy capsules may be taken
with or without food.
Continue taking Pregablin Ranbaxy until
your doctor tells you to stop.
If you take more Pregablin Ranbaxy than
you should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of Pregablin Ranbaxy capsules with
you. You may feel sleepy, confused, agitated,
or restless as a result of taking more Pregablin
Ranbaxy than you should.
If you forget to take Pregablin Ranbaxy
It is important to take your Pregablin
Ranbaxy capsules 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 Pregablin Ranbaxy
Do not stop taking Pregablin Ranbaxy 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 Pregablin
Ranbaxy treatment, you need to know that you
may experience certain side effects. These
include, trouble sleeping, headache, nausea,

Pregabalin Tabs PIL
PIL size : 140 x 540 mm
Market: UK
SPIL/PKGDEV : CG19/May/2015-V01, CG20/May/2015-V02,
CG17/Jun/2015-V03, V04, AK04/Jul/2015-V05,
AK19/Aug/2015-V06

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
t h e Ye l l o w C a r d S c h e m e a t :
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

4. Possible side effects

5. How to store Pregablin Ranbaxy

Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Serious side effects:



feeling anxious, diarrhoea, flulike symptoms,
convulsions, nervousness, depression, pain,
sweating, and dizziness. These symptoms may
occur more commonly or severely if you have
been taking Pregablin Ranbaxy for a longer
period of time.

If any of the following happen, stop taking
Pregablin Ranbaxy and contact a doctor or go
to the nearest hospital immediately, as you
may need urgent medical attention.





Hypersensitivity and allergic reactions
(which may include swollen face, swollen
tongue, difficulty breathing, itchiness)
Serious skin reaction characterized by
rash, blisters, peeling skin and pain.
If you experience swollen face or tongue or
if your skin turns red and starts to blister or
peel you should seek immediate medical
advice.
Inflammation of the pancreas (which
includes symptoms such as severe upper
stomach pain, often with nausea and vomiting)

Other side effects:
Very common: may affect more than 1 in 10
people
• Dizziness, drowsiness, headache.
Common: may affect up to 1 in 10 people
• Increased appetite
• Feeling of elation, confusion,
disorientation, changes 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, diarrhoea, nausea
• Difficulties with erection
• Swelling of the body including
extremities
• Swollen abdomen
• Feeling drunk, abnormal style of walking
• Weight gain
• Sore throat
• Muscle cramp, joint pain, back pain, pain
in limb, spasm in neck
Uncommon: 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, elevated
mood, aggression, difficulty finding words,
hallucinations, abnormal dreams, panic
attacks, apathy, problems with sexual
functioning including inability to achieve a
sexual climax, delayed ejaculation, mental
impairment, difficulty with thinking
• Changes in eyesight, unusual eye movement,
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, tunnel vision, flashes of
light, eye irritation
• Heart rhythm disturbances, increased
heart rate, low blood pressure, high blood
pressure, heart failure
• Flushing, hot flushes
• Difficulty breathing, dry nose
• Cough, nasal congestion, swollen face,
hives, itchiness, runny nose, nose bleed,
snoring
• Increased saliva production, heartburn,
numb around mouth
• Sweating, rash, chills, fever
• Coldness of hands and feet
• Muscle twitching, joint swelling, muscle
stiffness, pain including muscle pain, neck
pain
• Difficulty with or painful urination,
incontinence
• Weakness, thirst, chest tightness
• Breast pain
• Painful menstrual periods
• Generalised swelling
• Changes in blood and liver test results
(blood creatinine phosphokinase increased,
alanine amino transferase increased,
aspartate aminotransferase increased, platelet
count decreased, decrease in blood
potassium, increase in blood creatinine,
neutropenia).
Rare: may affect up to 1 in 1,000 people
• Changes in heart beat
• Abnormal sense of smell, changes in vision
including swinging vision, altered perception
of depth, visual brightness, vision loss
• Dilated pupils, cross eyes
• Inflammation of the eyes (keratitis)
• Cold sweat, tightness of the throat,
swollen tongue
• Difficulty in swallowing
• Slow or reduced movement of the body
• Difficulty with writing properly
• Fluid in the lungs
• Convulsions
• Changes in the recording of electrical
changes (ECG) in the heart which
correspond to heart rhythm disturbances
• Increased fluid in the abdomen
• 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.
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
Pregablin Ranbaxy and the severity of these
effects may be increased when taken together.







Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the blister/carton.
The expiry date refers to the last day of that
month.
This medicine does not require any
special storage conditions
Bottle: Once the bottle is opened the
capsules should be used within 30 days
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other
information
What Pregablin Ranbaxy contains
The active substance is pregabalin.
Pregablin Ranbaxy 50 mg: Each capsule,
hard contains 50 mg of pregablin.
Pregablin Ranbaxy 75 mg: Each capsule,
hard contains 75 mg of pregablin.
Pregablin Ranbaxy 100 mg: Each capsule,
hard contains 100 mg of pregablin.
Pregablin Ranbaxy 150 mg: Each capsule,
hard contains 150 mg of pregablin.
Pregablin Ranbaxy 225 mg: Each capsule,
hard contains 225 mg of pregablin.
Pregablin Ranbaxy 300 mg: Each capsule,
hard contains 300 mg of pregablin.
The other excipients are
Capsules content:
Mannitol, talc
Capsules shell:
Gelatin, titanium dioxide (E171), sodium
lauryl sulphate
only For 75 mg, 100 mg, 225 mg and 300 mg,
Iron oxide red (E172)
Printing Ink:
Shellac, propylene glycol, black iron oxide
(E172), potassium hydroxide
What Pregablin Ranbaxy looks like and
contents of the pack
50 mg capsules: Hard gelatin capsules of size
'2' with white opaque cap and white opaque
body imprinted with black ink 'rbx' with band on
cap and 'PG50' with band on body containing
white to off white powder. The length of the
capsule is approximately 17.0-18.2 mm.
75 mg capsules: Hard gelatin capsules of
size '4' with red opaque cap and white opaque
body imprinted with black ink 'rbx' on cap and
'PG75' on body containing white to off white
powder. The length of the capsule is
approximately 14.0-14.8 mm
100 mg capsules: Hard gelatin capsules of
size '3' with red opaque cap and red opaque
body imprinted with black ink 'rbx' on cap and
'PG100' on body containing white to off white
powder. The length of the capsule is
approximately 15.3-16.3 mm.
150 mg capsules: Hard gelatin capsules of
size '2' with white opaque cap and white
opaque body imprinted with black ink 'rbx' on
cap and 'PG150' on body containing white to
off white powder. The length of the capsule is
approximately 17.0-18.2 mm.
225 mg capsules: Hard gelatin capsules of
size '1' with red opaque cap and white opaque
body imprinted with black ink 'rbx' on cap and
'PG225' on body containing white to off white
powder. The length of the capsule is
approximately 18.6-19.7 mm.
300 mg capsules: Hard gelatin capsules of
size '0' with red opaque cap and white opaque
body imprinted with black ink 'rbx' on cap and
'PG300' on body containing white to off white
powder. The length of the capsule is
approximately 21.0-21.8 mm.
OPA/Al/PVC//Al blister
Pack sizes: 14, 21, 56, 84, 98 100 or 112
capsules, hard
PVC//Al blister
For 25, 50, 100 and 225 mg:
Pack sizes: 14, 21, 56, 84, 98, 100 or 112
capsules, hard.
For 75, 150 and 300mg
Pack sizes: 14, 21, 28, 56, 84, 98, 100 or 112
capsules, hard.
HDPE bottle with child resistance closure
(PP).
Pack sizes: 14, 21, 30, 56, 84, 98, 100 or 112
capsules, hard
HDPE bottle with screw cap (PP).
Pack size: 500 capsules, hard
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE
Manufacturer
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co-Tipperary,
Republic of Ireland
Basics GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Terapia SA
124 Fabrici Street,
400 632 Cluj Napoca
Romania
This leaflet was last revised in 08/2015.

SAP CODE : 5119471
PHARMA CODE : 19471
Note: 5119471 - for Submission only
5118791 - For commercialization

5119471

Black

Some patients taking Pregablin Ranbaxy
have reported symptoms suggesting an
allergic reaction. These symptoms include
swelling of the face, lips, tongue, and throat,
as well as diffuse skin rash. Should you
experience any of these reactions, you
should contact your physician immediately.
Pregablin Ranbaxy has been associated
with dizziness and somnolence, which
could increase the occurrence of
accidental injury (fall) in older patients.
Therefore, you should be careful until you
are used to any effect the medicine might
have.
Pregablin Ranbaxy 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.
Some patients with diabetes who gain
weight while taking Pregablin Ranbaxy
may need an alteration in their diabetic
medicines.
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
Pregablin Ranbaxy and the severity of these
effects may be increased when taken
together.
There have been reports of heart failure in
some patients when taking Pregablin
Ranbaxy; these patients were mostly older
with cardiovascular conditions. Before
taking this medicine you should tell your
doctor if you have a history of heart disease.
There have been reports of kidney failure
in some patients when taking Pregablin
Ranbaxy. If while taking Pregablin
Ranbaxy you notice decreased urination,
you should tell your doctor as stopping the
medicine may improve this.
A small number of people being treated
with anti-epileptics such as Pregablin
Ranbaxy have had thoughts of harming or
killing themselves. If at any time you have
these thoughts, immediately contact your
doctor.
When Pregablin Ranbaxy 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 paralysed bowel).



Tell your doctor if you experience
constipation, especially if you are prone to
this problem.
Before taking this medicine you should
tell your doctor if you have a history of
alcoholism or drug dependence. Let your
doctor know if you think you need more
medicine than prescribed.
There have been reports of convulsions
when taking Pregablin Ranbaxy or shortly
after stopping Pregablin Ranbaxy. If you
experience a convulsion, contact your
doctor immediately.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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