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PREGABALIN RANBAXY 50MG CAPSULES HARD

Active substance(s): PREGABALIN

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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 Pregabalin Ranbaxy is and what it is
used for
2. What you need to know before you take
Pregabalin Ranbaxy
3. How to take Pregabalin Ranbaxy
4. Possible side effects
5. How to store Pregabalin Ranbaxy
6. Contents of the pack and other information
1. What Pregabalin Ranbaxy is and what it is
used for





There have been reports of convulsions when
taking Pregabalin Ranbaxy or shortly after
stopping Pregabalin Ranbaxy. If you
experience a convulsion, contact your doctor
immediately.
There have been reports of reduction in brain
function (encephalopathy) in some patients
taking Pregabalin 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, Pregabalin Ranbaxy should not be
used in this age group.
Other medicines and Pregabalin Ranbaxy
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregabalin Ranbaxy and certain other medicines
may influence each other (interaction). When
taken with certain other medicines, Pregabalin
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
Pregabalin Ranbaxy is taken together with
medicines containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol

Pregnancy, breast-feeding and fertility
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.
Pregabalin 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.

Do not take Pregabalin Ranbaxy
- if you are allergic to Pregabalin or any of the other
ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Pregabalin Ranbaxy.
• Some patients taking Pregabalin 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.
• Pregabalin Ranbaxy has been associated with
dizziness and somnolence, which could
increase the occurrence of accidental injury
(fall) in elderly patients. Therefore, you should
be careful until you are used to any effect the
medicine might have.
• Pregabalin 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 Pregabalin 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 Pregabalin
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 Pregabalin Ranbaxy;
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.
• There have been reports of kidney failure in some
patients when taking Pregabalin Ranbaxy. If
while taking Pregabalin 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 Pregabalin Ranbaxy
have had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Pregabalin 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
any drug abuse or dependence. Do not take
more medicine than prescribed.

Black




Serious side effects:
Tell your doctor or nurse straight away if you
notice any of the following side effects as you
may need urgent medical treatment:






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.





Changes in the recording of electrical changes
(ECG) in the heart which correspond to heart
rhythm disturbances, increased heart rate,
heart failure, changes in heart beat
Inflammation of the pancreas (which includes
symptoms such as severe upper stomach
pain, often with nausea and vomiting).
Kidney failure, reduced urine volume, urinary
retention
Decrease in white blood cell count, resulting in
flu like symptoms, such as high temperature,
sweating, chills and headache



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/bottle/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 Pregabalin Ranbaxy contains
The active substance is pregabalin.
Pregabalin Ranbaxy 50 mg:
Each capsule, hard contains 50 mg of Pregabalin.
Pregabalin Ranbaxy 75 mg:
Each capsule, hard contains 75 mg of Pregabalin.
Pregabalin Ranbaxy 100 mg:
Each capsule, hard contains 100 mg of Pregabalin.
Pregabalin Ranbaxy 150 mg:
Each capsule, hard contains 150 mg of Pregabalin.
Pregabalin Ranbaxy 225 mg:
Each capsule, hard contains 225 mg of Pregabalin.
Pregabalin Ranbaxy 300 mg:
Each capsule, hard contains 300 mg of Pregabalin.

Other side effects:
Pregabalin Ranbaxy may be taken with oral
contraceptives.

Epilepsy:
Pregabalin Ranbaxy is used to treat a certain form of
epilepsy (partial seizures with or without
secondary generalisation) in adults. Your doctor
will prescribe Pregabalin Ranbaxy for you to help
treat your epilepsy when your current treatment is
not controlling your condition. You should take
Pregabalin Ranbaxy in addition to your current
treatment. Pregabalin Ranbaxy is not intended to
be used alone, but should always be used in
combination with other anti-epileptic treatment.

2. What you need to know before you take
Pregabalin Ranbaxy

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



Pregabalin Ranbaxy belongs to a group of medicines
used to treat epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.

Generalised Anxiety Disorder:
Pregabalin 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.

5. How to store Pregabalin Ranbaxy



Pregabalin Ranbaxy with food, drink and alcohol
Pregabalin Ranbaxy capsules may be taken with or
without food.
It is advised not to drink alcohol while taking
Pregabalin Ranbaxy.

Peripheral and central neuropathic pain:
Pregabalin Ranbaxy 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.

4. Possible side effects

Driving and using machines
Pregabalin 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 Pregabalin Ranbaxy
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.
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 Pregabalin
Ranbaxy either twice or three times a day. For
twice a day take Pregabalin Ranbaxy once in
the morning and once in the evening, at about
the same time each day. For three times a day
take Pregabalin 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
Pregabalin Ranbaxy is too strong or too weak,
talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age),
you should take Pregabalin 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.
Pregabalin Ranbaxy is for oral use only. Swallow the
capsule whole with water.
Continue taking Pregabalin Ranbaxy until your
doctor tells you to stop.
If you take more Pregabalin Ranbaxy than you
should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of Pregabalin Ranbaxy capsules with you.
You may feel sleepy, confused, agitated, or restless
as a result of taking more Pregabalin Ranbaxy than
you should. Fits have also been reported.
If you forget to take Pregabalin Ranbaxy
It is important to take your Pregabalin 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 Pregabalin Ranbaxy
Do not stop taking Pregabalin 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 Pregabalin
Ranbaxy treatment, you need to know that you may
experience certain side effects. These 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
Pregabalin Ranbaxy for a longer period of time.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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,
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,
diarrhoea, 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,
spasm in neck
• Sore throat
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, difficulty
finding words, hallucinations, abnormal dreams,
panic attacks, 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, abnormal
uncontrolled movements of the limbs, 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
• Low blood pressure, high blood pressure
• Flushing, hot flushes
• Dry nose, nasal congestion
• Cough, 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
aminotransferase 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)
• 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
• Increased fluid in the abdomen
• Muscle damage
• Breast discharge, abnormal breast growth,
breast growth in males
• Interrupted menstrual periods
• Inappropriate behaviour.
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 Ranbaxy and the severity of these effects
may be increased when taken together.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
at : www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

Pregabalin Rx Caps PIL
SAP CODE :
PIL size : 140 x 540 mm
PHARMA CODE :
Market: UK
SPIL/PKGDEV - CG25/Aug/2017-V01, CG30/Aug/2017-V02,
CG25/Oct/2017-V03, V04, V05, V06, V07, CG26/Oct/2017-V08

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 Pregabalin 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
For 50, 100, 150, 225 and 300 mg
Pack sizes: 14, 21, 56, 84, 98 100 or 112
capsules, hard
For 75 mg
Pack sizes: 14, 21, 56, 70, 84, 98, 100 or 112
capsules, hard
PVC//Al blister
For 50, 100 and 225 mg:
Pack sizes: 14, 21, 56, 84, 98, 100 or 112
capsules, hard.
For 75 mg
Pack sizes: 14, 21, 28, 56, 70, 84, 98, 100 or 112
capsules, hard
For 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
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street,
400 632 Cluj-Napoca
Romania
This leaflet was last revised in October 2017.

xxxxxxx

Package leaflet: Information for the patient

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

Font Size: 9 pt.



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 Pregabalin Ranbaxy is and what it is
used for
2. What you need to know before you take
Pregabalin Ranbaxy
3. How to take Pregabalin Ranbaxy
4. Possible side effects
5. How to store Pregabalin Ranbaxy
6. Contents of the pack and other information
1. What Pregabalin Ranbaxy is and what it is
used for
Pregabalin Ranbaxy belongs to a group of medicines
used to treat epilepsy, neuropathic pain and
Generalised Anxiety Disorder (GAD) in adults.
Epilepsy:
Pregabalin Ranbaxy is used to treat a certain form of
epilepsy (partial seizures with or without
secondary generalisation) in adults. Your doctor
will prescribe Pregabalin Ranbaxy for you to help
treat your epilepsy when your current treatment is
not controlling your condition. You should take
Pregabalin Ranbaxy in addition to your current
treatment. Pregabalin 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 Ranbaxy 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:
Pregabalin 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
Pregabalin Ranbaxy
Do not take Pregabalin Ranbaxy
- if you are allergic to Pregabalin or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Pregabalin Ranbaxy.
• Some patients taking Pregabalin 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.
• Pregabalin Ranbaxy has been associated with
dizziness and somnolence, which could
increase the occurrence of accidental injury
(fall) in elderly patients. Therefore, you should
be careful until you are used to any effect the
medicine might have.
• Pregabalin 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 Pregabalin 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 Pregabalin
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 Pregabalin Ranbaxy;
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.
• There have been reports of kidney failure in some
patients when taking Pregabalin Ranbaxy. If
while taking Pregabalin 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 Pregabalin Ranbaxy
have had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Pregabalin 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.

Black



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

Before taking this medicine you should tell your
doctor if you have a history of alcoholism or
any drug abuse or dependence. Do not take
more medicine than prescribed.
There have been reports of convulsions when
taking Pregabalin Ranbaxy or shortly after
stopping Pregabalin Ranbaxy. If you experience
a convulsion, contact your doctor immediately.
There have been reports of reduction in brain
function (encephalopathy) in some patients
taking Pregabalin Ranbaxy when they have
other conditions. Tell your doctor if you have a
history of any serious medical conditions,
including liver or kidney disease.

4. Possible side effects

5. How to store Pregabalin Ranbaxy

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




Serious side effects:
Tell your doctor or nurse straight away if you
notice any of the following side effects as you
may need urgent medical treatment:








Children and adolescents
The safety and efficacy in children and adolescents
(under 18 years of age) has not been established
and therefore, Pregabalin Ranbaxy should not be
used in this age group.

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.

Other medicines and Pregabalin Ranbaxy
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.



Pregabalin Ranbaxy and certain other medicines may
influence each other (interaction). When taken with
certain other medicines, Pregabalin 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 Pregabalin Ranbaxy is taken
together with medicines containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol



Pregabalin Ranbaxy may be taken with oral
contraceptives.
Pregabalin Ranbaxy with food, drink and alcohol
Pregabalin Ranbaxy capsules may be taken with or
without food.
It is advised not to drink alcohol while taking
Pregabalin Ranbaxy.
Pregnancy, breast-feeding and fertility
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.
Pregabalin 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.
Driving and using machines
Pregabalin 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 Pregabalin Ranbaxy
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.
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 Pregabalin
Ranbaxy either twice or three times a day. For
twice a day take Pregabalin Ranbaxy once in
the morning and once in the evening, at about
the same time each day. For three times a day
take Pregabalin 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
Pregabalin Ranbaxy is too strong or too weak,
talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age),
you should take Pregabalin 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.
Pregabalin Ranbaxy is for oral use only. Swallow the
capsule whole with water.
Continue taking Pregabalin Ranbaxy until your
doctor tells you to stop.
If you take more Pregabalin Ranbaxy than you
should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of Pregabalin Ranbaxy capsules with you.
You may feel sleepy, confused, agitated, or restless
as a result of taking more Pregabalin Ranbaxy than
you should. Fits have also been reported.
If you forget to take Pregabalin Ranbaxy
It is important to take your Pregabalin 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 Pregabalin Ranbaxy
Do not stop taking Pregabalin 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 Pregabalin
Ranbaxy treatment, you need to know that you
may experience certain side effects. These
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 Pregabalin Ranbaxy for a longer
period of time.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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.




Changes in the recording of electrical changes
(ECG) in the heart which correspond to heart
rhythm disturbances, increased heart rate,
heart failure, changes in heart beat
Inflammation of the pancreas (which includes
symptoms such as severe upper stomach
pain, often with nausea and vomiting).
Kidney failure, reduced urine volume, urinary
retention
Decrease in white blood cell count, resulting in
flu like symptoms, such as high temperature,
sweating, chills and headache

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,
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,
diarrhoea, 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,
spasm in neck
• Sore throat
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, difficulty
finding words, hallucinations, abnormal dreams,
panic attacks, 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, abnormal
uncontrolled movements of the limbs,
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
• Low blood pressure, high blood pressure
• Flushing, hot flushes
• Dry nose, nasal congestion
• Cough, 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
aminotransferase 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)
• 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
• Increased fluid in the abdomen
• Muscle damage
• Breast discharge, abnormal breast growth,
breast growth in males
• Interrupted menstrual periods
• Inappropriate behaviour.



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/bottle/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 Pregabalin Ranbaxy contains
The active substance is pregabalin.
Pregabalin Ranbaxy 50 mg:
Each capsule, hard contains 50 mg of Pregabalin.
Pregabalin Ranbaxy 75 mg:
Each capsule, hard contains 75 mg of Pregabalin.
Pregabalin Ranbaxy 100 mg:
Each capsule, hard contains 100 mg of Pregabalin.
Pregabalin Ranbaxy 150 mg:
Each capsule, hard contains 150 mg of Pregabalin.
Pregabalin Ranbaxy 225 mg:
Each capsule, hard contains 225 mg of Pregabalin.
Pregabalin Ranbaxy 300 mg:
Each capsule, hard contains 300 mg of Pregabalin.
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 Pregabalin 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
For 50, 100, 150, 225 and 300 mg
Pack sizes: 14, 21, 56, 84, 98 100 or 112
capsules, hard
For 75 mg
Pack sizes: 14, 21, 56, 70, 84, 98, 100 or 112
capsules, hard
PVC//Al blister
For 50, 100 and 225 mg:
Pack sizes: 14, 21, 56, 84, 98, 100 or 112
capsules, hard.
For 75 mg
Pack sizes: 14, 21, 28, 56, 70, 84, 98, 100 or 112
capsules, hard
For 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
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street,
400 632 Cluj-Napoca
Romania
This leaflet was last revised in October 2017.

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 Ranbaxy and the severity of these effects
may be increased when taken together.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
at : www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

Folded size : 50 x 50 mm SAP CODE :
Pregabalin Rx Caps Folded PIL
PHARMA CODE :
PIL size : 150 x 600 mm
Market: UK
SPIL/PKGDEV - CG25/Aug/2017-V01, CG30/Aug/2017-V02, CG01/Sep/2017-V03,
CG25/Oct/2017-V04, V05, V06, V07, V08, CG26/Oct/2017-V09

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Package Leaflet: Information for the patient

Package Leaflet: Information for the patient

50 mm

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

50 mm

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

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Package Leaflet: Information for the patient

50 mm

50 mm

Font Size: 9 pt.

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