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PREGABALIN TEVA 75MG CAPSULES HARD

Active substance(s): PREGABALIN

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FOLD
LINE.

PAGE 4: AFTER FOLDING REAR FACE (OUTSIDE OF REEL AFTER FOLDING AND TACKING)

EAS1400a
320 x 323

PREGABALIN TEVA 25 mg, 50 mg,
75 mg, 100 mg, 150 mg, 200 mg,
225 mg AND 300 mg
CAPSULES, HARD
PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

1

WHAT PREGABALIN TEVA IS
AND WHAT IT IS USED FOR

Pregabalin Teva belongs to a group of
medicines used to treat epilepsy,
neuropathic pain and Generalised Anxiety
Disorder (GAD) in adults.
Peripheral and central neuropathic pain:
Pregabalin Teva 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.
Epilepsy: Pregabalin Teva is used to treat a
certain form of epilepsy (partial seizures
with or without secondary generalisation)
in adults. Your doctor will prescribe
Pregabalin Teva for you to help treat your
epilepsy when your current treatment is
not controlling your condition. You should
take Pregabalin Teva in addition to your
current treatment. Pregabalin Teva is not
intended to be used alone, but should
always be used in combination with other
anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin
Teva 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
TEVA

Do NOT take Pregabalin Teva:
• 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 Teva.
• Some patients taking pregabalin 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 doctor immediately.
• Pregabalin has been associated with
dizziness and drowsiness (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 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 (see section 4).
• Some patients with diabetes who gain
weight while taking pregabalin 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 stiff or rigid muscles
(spasticity), that have similar side
effects to pregabalin 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;
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. If while taking Pregabalin
Teva 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 have had thoughts of
harming or killing themselves. If at any
time you have these thoughts,
immediately contact your doctor.
• When Pregabalin Teva 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.
Peel Here To Open

Pharma code 656 (01110001)
First bar is 105mm from top edge.

Pregabalin Teva 225 mg are opaque hard
gelatine size 1 capsules with overall closed
length 19.4 mm ± 0.3 mm, with flesh cap
and ivory body imprinted by black sign
225.
Pregabalin Teva 300 mg are opaque hard
gelatine size 0 capsules with overall closed
length 21.7 mm ± 0.3 mm, with pink cap
and ivory body imprinted by black sign
300.
For 25 mg capsules:
Pregabalin Teva capsules are packed in
OF THE PACK AND
PVC-Alu or unit dose blisters of 14, 14x1,
6 CONTENTS
OTHER INFORMATION
21, 21x1, 50x1, 56, 56x1, 60, 84, 84x1, 90,
100, 100x1 or 120 capsules.
What Pregabalin Teva contains
• The active substance is pregabalin.
For 50 mg capsules:
• Each 25 mg capsule, hard contains
Pregabalin Teva capsules are packed in
25 mg of pregabalin.
PVC-Alu or unit dose blisters of 14, 21,
• Each 50 mg capsule, hard contains
21x1, 56, 56x1, 60, 84, 84x1, 100, 100x1 or
50 mg of pregabalin.
120 capsules.
• Each 75 mg capsule, hard contains
For 75 mg capsules:
75 mg of pregabalin.
Pregabalin Teva capsules are packed in
• Each 100 mg capsule, hard contains
PVC-Alu or unit dose blisters of 14, 14x1,
100 mg of pregabalin.
50x1, 56, 56x1, 60, 70, 90, 100, 100x1 or
• Each 150 mg capsule, hard contains
120 capsules.
150 mg of pregabalin.
Additionally, Pregabalin Teva capsules are
• Each 200 mg capsule, hard contains
packed in HDPE bottles with PP closure
200 mg of pregabalin.
containing 200 capsules.
• Each 225 mg capsule, hard contains
For 100 mg capsules:
225 mg of pregabalin.
Pregabalin Teva capsules are packed in
• Each 300 mg capsule, hard contains
PVC-Alu blisters or unit dose blisters of
300 mg of pregabalin.
14, 21, 21x1, 56, 56x1, 84, 84x1, 100, 100x1
• The other ingredients are: mannitol,
or 120 capsules.
pregelatinised maize starch, talc,
titanium dioxide (E171), yellow iron
For 150 mg capsules:
oxide (E172) (25, 50, 75, 150, 225 and
Pregabalin Teva capsules are packed in
300 mg capsules), red iron oxide (E172) PVC-Alu or unit dose blisters of 14, 14x1,
(75, 100, 200, 225 and 300 mg
50x1, 56, 56x1, 60, 90, 100, 100x1, 120,
capsules), gelatin and black ink (which 168, 168x1 or 200x1 capsules.
contains shellac, propylene glycol,
Additionally, Pregabalin Teva capsules are
black iron oxide (E172) and potassium packed in HDPE bottles with PP closure
hydroxide).
containing 200 capsules.
What Pregabalin Teva looks like and
For 200 mg capsules:
contents of the pack
Pregabalin Teva capsules are packed in
Pregabalin Teva 25 mg are ivory opaque
PVC-Alu blisters or unit dose blisters of
hard gelatine size 3 capsules with overall 14, 21, 21x1, 84, 84x1, 100, 100x1 or 120
closed length 15.9 mm ± 0.3 mm,
capsules.
imprinted by black sign 25 on capsule
For 225 mg capsules:
body.
Pregabalin Teva capsules are packed in
Pregabalin Teva 50 mg are ivory opaque
PVC-Alu blisters or unit dose blisters of
hard gelatine size 2 capsules with overall 14, 14x1, 56, 56x1, 60, 100, 100x1 or 120
closed length 18.0 mm ± 0.3 mm,
capsules.
imprinted by radial black band on capsule Additionally, Pregabalin Teva capsules are
cap and black sign 50 and radial black
packed in HDPE bottles with PP closure
band on capsule body.
containing 200 capsules.
Pregabalin Teva 75 mg are opaque hard
For 300 mg capsules:
gelatine size 3 capsules with overall
Pregabalin Teva capsules are packed in
closed length 15.9 mm ± 0.3 mm, with
PVC-Alu or unit dose blisters of 14, 14x1,
pink cap and ivory body imprinted by
50x1, 56, 56x1, 60, 84, 84x1, 90, 100,
black sign 75.
100x1, 120, 168, 168x1 or 200x1 capsules.
Additionally, Pregabalin Teva capsules are
Pregabalin Teva 100 mg are pink opaque
hard gelatine size 2 capsules with overall packed in HDPE bottles with PP closure
closed length 18.0 mm ± 0.3 mm, imprinted containing 200 capsules.
by black sign 100 on capsule body.
Not all pack sizes may be marketed.
Pregabalin Teva 150 mg are ivory opaque Marketing Authorisation Holder and
hard gelatine size 2 capsules with overall
Manufacturer
closed length 18.0 mm ± 0.3 mm,
TEVA UK Limited,
imprinted by black sign 150 on capsule
Eastbourne, BN22 9AG, UK
body.
This leaflet was last revised in 08/2017
Pregabalin Teva 200 mg are flesh opaque
PL 00289/1945-1952
hard gelatine size 1 capsules with overall
closed length 19.4 mm ± 0.3 mm,
imprinted by black sign 200 on capsule
body.

Top of page cut-off to middle of registration mark = 44 mm

Do not use this medicine after the expiry
date which is stated on the blister, carton
or bottle. The expiry date refers to the last
day of that month.
This medicine does not require any
special storage conditions.
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.

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

• 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 or shortly after
stopping pregabalin. If you experience
a convulsion, contact your doctor
immediately.
• There have been reports of reduction in
brain function (encephalopathy) in
some patients taking pregabalin 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
Teva should not be used in this age group.
Other medicines and Pregabalin Teva
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Pregabalin Teva and certain other medicines
may influence each other (interaction).
When taken with certain other medicines,
Pregabalin Teva may enhance 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 Teva is taken together with
medicinal products containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol
Pregabalin Teva may be taken with oral
contraceptives.
Pregabalin Teva with food, drink and
alcohol
It is advised NOT to drink alcohol while
taking Pregabalin Teva.
Pregnancy and breast-feeding
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 Teva 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 Teva may cause 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.

• 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 Teva either twice or three
times a day. For twice a day take
Pregabalin Teva once in the morning
and once in the evening, at about the
same time each day. For three times a
day take Pregabalin Teva 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 Teva 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 Teva 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 Teva is for oral use only.
Swallow the capsule whole with water.
Pregabalin Teva capsules may be taken
with or without food.

Continue taking Pregabalin Teva until your
doctor tells you to stop.
If you take more Pregabalin Teva than you
should
Call your doctor or go to the nearest
hospital emergency unit immediately.
Take your pack of Pregabalin Teva capsules
with you. You may feel sleepy, confused,
agitated, or restless as a result of taking
more Pregabalin Teva than you should.
Fits have also been reported.
If you forget to take Pregabalin Teva
It is important to take your Pregabalin
Teva 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 Teva
Do NOT stop taking Pregabalin Teva
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 Teva treatment, you need to
know that you may experience certain
side effects. These include, trouble sleeping,
headache, feeling sick (nausea), feeling
anxious, diarrhoea, flu-like symptoms,
convulsions, nervousness, depression,
pain, sweating and dizziness. These
symptoms may occur more commonly or
severely if you have been taking Pregabalin
3 HOW TO TAKE PREGABALIN
Teva for a longer period of time.
TEVA
If you have any further questions on the
Always take this medicine exactly as your use of this medicine, ask your doctor or
pharmacist.
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
4 POSSIBLE SIDE EFFECTS
Your doctor will determine what dose is
appropriate for you.
Like all medicines, this medicine can
cause side effects, although not
Peripheral and central neuropathic pain,
epilepsy or Generalised Anxiety Disorder: everybody gets them.

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LINE.

PAGE 3: RIGHT HAND INSIDE FACE AFTER FOLDING AND TACKING

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, tiredness (fatigue),
feeling abnormal
• Blurred vision, double vision
• Vertigo, problems with balance, fall
• Dry mouth, constipation, vomiting,
flatulence, diarrhoea, feeling sick
(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: 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, 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 heart beat,
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: may affect up to 1 in 1000 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 behaviour
• Allergic reactions (which may include
difficulty breathing, inflammation of
the eyes (keratitis) and a serious skin
reaction characterised 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.
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.
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
Website at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5

HOW TO STORE PREGABALIN
TEVA

Keep this medicine out of the sight and
reach of children.

PREGABALIN TEVA
25 mg, 50 mg, 75 mg, 100 mg,
150 mg, 200 mg, 225 mg AND
300 mg CAPSULES, HARD
PACKAGE LEAFLET: INFORMATION FOR THE USER

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

1

WHAT PREGABALIN TEVA IS AND
WHAT IT IS USED FOR

Pregabalin Teva belongs to a group of
medicines used to treat epilepsy,
neuropathic pain and Generalised Anxiety
Disorder (GAD) in adults.
Peripheral and central neuropathic pain:
Pregabalin Teva 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.
Epilepsy: Pregabalin Teva is used to treat a
certain form of epilepsy (partial seizures with
or without secondary generalisation) in
adults. Your doctor will prescribe Pregabalin
Teva for you to help treat your epilepsy when
your current treatment is not controlling your
condition. You should take Pregabalin Teva in
addition to your current treatment. Pregabalin
Teva is not intended to be used alone, but
should always be used in combination with
other anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin
Teva 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 TEVA

Do NOT take Pregabalin Teva:
• 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 Teva.
• Some patients taking pregabalin 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 doctor immediately.
• Pregabalin has been associated with
dizziness and drowsiness (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 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
(see section 4).
• Some patients with diabetes who gain
weight while taking pregabalin 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
stiff or rigid muscles (spasticity), that have
similar side effects to pregabalin 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;
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.
If while taking Pregabalin Teva 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
have had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Pregabalin Teva 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.
• There have been reports of convulsions
when taking pregabalin or shortly after
stopping pregabalin. If you experience a
convulsion, contact your doctor
immediately.
• There have been reports of reduction in
brain function (encephalopathy) in some
patients taking pregabalin 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
Teva should not be used in this age group.
Other medicines and Pregabalin Teva
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Pregabalin Teva and certain other medicines
may influence each other (interaction). When
taken with certain other medicines,
Pregabalin Teva may enhance 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
Teva is taken together with medicinal
products containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol
Pregabalin Teva may be taken with oral
contraceptives.
Pregabalin Teva with food, drink and alcohol
It is advised NOT to drink alcohol while
taking Pregabalin Teva.
Pregnancy and breast-feeding
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 Teva 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 Teva may cause 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 TEVA

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
Teva either twice or three times a day. For
twice a day take Pregabalin Teva once in
the morning and once in the evening, at
about the same time each day. For three
times a day take Pregabalin Teva 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 Teva 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 Teva
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 Teva is for oral use only.
Swallow the capsule whole with water.
Pregabalin Teva capsules may be taken with
or without food.
Continue taking Pregabalin Teva until your
doctor tells you to stop.
If you take more Pregabalin Teva than you
should
Call your doctor or go to the nearest
hospital emergency unit immediately. Take
your pack of Pregabalin Teva capsules with
you. You may feel sleepy, confused, agitated,
or restless as a result of taking more
Pregabalin Teva than you should. Fits have
also been reported.
If you forget to take Pregabalin Teva
It is important to take your Pregabalin Teva
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 Teva
Do NOT stop taking Pregabalin Teva 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 Teva treatment, you need to know
that you may experience certain side effects.
These include, trouble sleeping, headache,
feeling sick (nausea), feeling anxious,
diarrhoea, flu-like symptoms, convulsions,
nervousness, depression, pain, sweating and
dizziness. These symptoms may occur more
commonly or severely if you have been taking
Pregabalin Teva 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

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
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, tiredness (fatigue), feeling
abnormal
• Blurred vision, double vision
• Vertigo, problems with balance, fall
• Dry mouth, constipation, vomiting,
flatulence, diarrhoea, feeling sick
(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: 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, 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 heart beat, 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: may affect up to 1 in 1000 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 behaviour
• Allergic reactions (which may include
difficulty breathing, inflammation of the
eyes (keratitis) and a serious skin reaction
characterised 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.
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.
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 Website at:
www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or
Apple App Store.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5

HOW TO STORE PREGABALIN TEVA

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 or
bottle. The expiry date refers to the last day
of that month.
This medicine does not require any special
storage conditions.
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 Teva contains
• The active substance is pregabalin.
• Each 25 mg capsule, hard contains 25 mg
of pregabalin.
• Each 50 mg capsule, hard contains 50 mg
of pregabalin.
• Each 75 mg capsule, hard contains 75 mg
of pregabalin.
• Each 100 mg capsule, hard contains 100 mg
of pregabalin.
• Each 150 mg capsule, hard contains 150 mg
of pregabalin.
• Each 200 mg capsule, hard contains 200 mg
of pregabalin.
• Each 225 mg capsule, hard contains 225 mg
of pregabalin.
• Each 300 mg capsule, hard contains 300 mg
of pregabalin.
• The other ingredients are: mannitol,
pregelatinised maize starch, talc, titanium
dioxide (E171), yellow iron oxide (E172) (25,
50, 75, 150, 225 and 300 mg capsules), red
iron oxide (E172) (75, 100, 200, 225 and 300
mg capsules), gelatin and black ink (which
contains shellac, propylene glycol, black
iron oxide (E172) and potassium hydroxide).
What Pregabalin Teva looks like and
contents of the pack
Pregabalin Teva 25 mg are ivory opaque
hard gelatine size 3 capsules with overall
closed length 15.9 mm ± 0.3 mm, imprinted
by black sign 25 on capsule body.
Pregabalin Teva 50 mg are ivory opaque hard
gelatine size 2 capsules with overall closed
length 18.0 mm ± 0.3 mm, imprinted by radial
black band on capsule cap and black sign 50
and radial black band on capsule body.
Pregabalin Teva 75 mg are opaque hard
gelatine size 3 capsules with overall closed
length 15.9 mm ± 0.3 mm, with pink cap
and ivory body imprinted by black sign 75.
Pregabalin Teva 100 mg are pink opaque
hard gelatine size 2 capsules with overall
closed length 18.0 mm ± 0.3 mm, imprinted
by black sign 100 on capsule body.
Pregabalin Teva 150 mg are ivory opaque
hard gelatine size 2 capsules with overall
closed length 18.0 mm ± 0.3 mm, imprinted
by black sign 150 on capsule body.
Pregabalin Teva 200 mg are flesh opaque
hard gelatine size 1 capsules with overall
closed length 19.4 mm ± 0.3 mm, imprinted
by black sign 200 on capsule body.
Pregabalin Teva 225 mg are opaque hard
gelatine size 1 capsules with overall closed
length 19.4 mm ± 0.3 mm, with flesh cap
and ivory body imprinted by black sign 225.
Pregabalin Teva 300 mg are opaque hard
gelatine size 0 capsules with overall closed
length 21.7 mm ± 0.3 mm, with pink cap and
ivory body imprinted by black sign 300.
For 25 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu or unit dose blisters of 14, 14x1, 21,
21x1, 50x1, 56, 56x1, 60, 84, 84x1, 90, 100,
100x1 or 120 capsules.
For 50 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu or unit dose blisters of 14, 21, 21x1,
56, 56x1, 60, 84, 84x1, 100, 100x1 or 120
capsules.
For 75 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu or unit dose blisters of 14, 14x1,
50x1, 56, 56x1, 60, 70, 90, 100, 100x1 or 120
capsules.
Additionally, Pregabalin Teva capsules are
packed in HDPE bottles with PP closure
containing 200 capsules.
For 100 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu blisters or unit dose blisters of 14,
21, 21x1, 56, 56x1, 84, 84x1, 100, 100x1 or
120 capsules.
For 150 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu or unit dose blisters of 14, 14x1,
50x1, 56, 56x1, 60, 90, 100, 100x1, 120, 168,
168x1 or 200x1 capsules.
Additionally, Pregabalin Teva capsules are
packed in HDPE bottles with PP closure
containing 200 capsules.
For 200 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu blisters or unit dose blisters of 14,
21, 21x1, 84, 84x1, 100, 100x1 or 120 capsules.
For 225 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu blisters or unit dose blisters of 14,
14x1, 56, 56x1, 60, 100, 100x1 or 120 capsules.
Additionally, Pregabalin Teva capsules are
packed in HDPE bottles with PP closure
containing 200 capsules.
For 300 mg capsules:
Pregabalin Teva capsules are packed in
PVC-Alu or unit dose blisters of 14, 14x1,
50x1, 56, 56x1, 60, 84, 84x1, 90, 100, 100x1,
120, 168, 168x1 or 200x1 capsules.
Additionally, Pregabalin Teva capsules are
packed in HDPE bottles with PP closure
containing 200 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.),
Prilaz baruna Filipovica 25, Zagreb 10000,
Croatia
This leaflet was last revised in 08/2017
PL 00289/1945-1952
EAS1399a

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