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PREGABALIN TEVA 225MG CAPSULES HARD

Active substance(s): PREGABALIN

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TEVA UK Ref:

Version:

3

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CONTENTS OF THE PACK AND
OTHER INFORMATION

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.

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,
Pregabalin Teva 100 mg are pink opaque
hard gelatine size 2 capsules with overall 100x1, 120, 168, 168x1 or 200x1 capsules.
closed length 18.0 mm ± 0.3 mm, imprinted Additionally, Pregabalin Teva capsules are
packed in HDPE bottles with PP closure
by black sign 100 on capsule body.
containing 200 capsules.
Pregabalin Teva 150 mg are ivory opaque
Not all pack sizes may be marketed.
hard gelatine size 2 capsules with overall
closed length 18.0 mm ± 0.3 mm,
Marketing Authorisation Holder and
imprinted by black sign 150 on capsule
Manufacturer
body.
TEVA UK Limited,
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.

Eastbourne, BN22 9AG, UK

This leaflet was last revised in 06/2015.
PL 00289/1945-1952

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.

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 and
Generalised Anxiety Disorder (GAD) in
adults.
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).

30178-C
320 x 323

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
Peel Here To Open

Pharma code 368 (01110001)
First bar is 105mm from top edge.

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).

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.

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

6

12 June 2015

TEVA UK Ref:

22 June 2015: 3

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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:

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.
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety) Take your pack of Pregabalin Teva capsules
with you. You may feel sleepy, confused,
• Alcohol
agitated, or restless as a result of taking
Pregabalin Teva may be taken with oral
more Pregabalin Teva than you should.
contraceptives.
If you forget to take Pregabalin Teva
Pregabalin Teva with food, drink and
It is important to take your Pregabalin
alcohol
Teva capsules regularly at the same time
It is advised NOT to drink alcohol while
each day. If you forget to take a dose, take
taking Pregabalin Teva.
it as soon as you remember unless it is
Pregnancy and breast-feeding
time for your next dose. In that case, just
If you are pregnant or breast-feeding, think carry on with the next dose as normal. Do
you may be pregnant or are planning to
NOT take a double dose to make up for a
have a baby, ask your doctor or pharmacist forgotten dose.
for advice before taking this medicine.
If you stop taking Pregabalin Teva
Pregabalin Teva should NOT be taken
Do NOT stop taking Pregabalin Teva
during pregnancy or when breast-feeding, unless your doctor tells you to. If your
unless you are told otherwise by your
treatment is stopped it should be done
doctor. Effective contraception must be
gradually over a minimum of 1 week.
used by women of child-bearing potential.
After stopping long and short-term
Driving and using machines
Pregabalin Teva treatment, you need to
Pregabalin Teva may cause dizziness,
know that you may experience certain
sleepiness and decreased concentration.
side effects. These include, trouble sleeping,
You should NOT drive, operate complex
headache, feeling sick (nausea), feeling
machinery or engage in other potentially anxious, diarrhoea, flu-like symptoms,
hazardous activities until you know
convulsions, nervousness, depression,
whether this medicine affects your ability pain, sweating and dizziness. These
to perform these activities.
symptoms may occur more commonly or
severely if you have been taking Pregabalin
Teva for a longer period of time.
3 HOW TO TAKE PREGABALIN

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.
Your doctor will determine what dose is
appropriate for you.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can
Epilepsy or Generalised Anxiety Disorder: cause side effects, although not
everybody gets them.
• Take the number of capsules as
instructed by your doctor.
Very common: may affect more than 1 in
• The dose, which has been adjusted for
10 people
you and your condition, will generally be • Dizziness
between 150 mg and 600 mg each day.
• Drowsiness
• Your doctor will tell you to take
• Headache.
Pregabalin Teva either twice or three
Common: may affect up to 1 in 10 people
times a day. For twice a day take
• Increased appetite
Pregabalin Teva once in the morning
• Feeling of elation, confusion,
and once in the evening, at about the
disorientation, decrease in sexual
same time each day. For three times a
interest, irritability

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• 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.

• 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
Uncommon: may affect up to 1 in 100
• Muscle damage
people
• Loss of appetite, weight loss, low blood • Breast discharge, abnormal breast
growth, breast growth in males
sugar, high blood sugar
• Interrupted menstrual periods
• Change in perception of self,
• Kidney failure, reduced urine volume,
restlessness, depression, agitation,
urinary retention
mood swings, difficulty finding words,
hallucinations, abnormal dreams, panic • Decrease in white blood cell count
• Inappropriate behaviour
attacks, apathy, aggression, elevated
• Allergic reactions (which may include
mood, mental impairment, difficulty
difficulty breathing, inflammation of
with thinking, increase in sexual
the eyes (keratitis) and a serious skin
interest, problems with sexual
reaction characterised by rash, blisters,
functioning including inability to
peeling skin and pain).
achieve a sexual climax, delayed
ejaculation
If you experience swollen face or tongue
• Changes in eyesight, unusual eye
or if your skin turns red and starts to
movement, changes in vision including blister or peel you should seek immediate
tunnel vision, flashes of light, jerky
medical advice.
movements, reduced reflexes,
Certain side effects may be more
increased activity, dizziness on
common, such as sleepiness, because
standing, sensitive skin, loss of taste,
patients with spinal cord injury may be
burning sensation, tremor on
movement, decreased consciousness, taking other medicines to treat, for
example, pain or spasticity, that have
loss of consciousness, fainting,
similar side effects to pregabalin and the
increased sensitivity to noise, feeling
severity of these effects may be increased
unwell
• Dry eyes, eye swelling, eye pain, weak when taken together.
eyes, watery eyes, eye irritation
Reporting of side effects
• Heart rhythm disturbances, increased
If you get any side effects, talk to your
heart rate, low blood pressure, high
doctor or pharmacist. This includes any
blood pressure, changes in heart beat, possible side effects not listed in this
heart failure
leaflet. You can also report side effects
• Flushing, hot flushes
directly via the Yellow Card Scheme at:
• Difficulty breathing, dry nose, nasal
www.mhra.gov.uk/yellowcard
congestion
• Increased saliva production, heartburn, By reporting side effects you can help
provide more information on the safety of
numb around mouth
this medicine.
• Sweating, rash, chills, fever
• Muscle twitching, joint swelling,
muscle stiffness, pain including muscle 5 HOW TO STORE PREGABALIN
TEVA
pain, neck pain
• Breast pain
Keep this medicine out of the sight and
• Difficulty with or painful urination,
reach of children.
incontinence
Do not use this medicine after the expiry
• Weakness, thirst, chest tightness
date which is stated on the blister, carton
• Changes in blood and liver test results
or bottle. The expiry date refers to the last
(blood creatinine phosphokinase
day of that month.
increased, alanine amino transferase
increased, aspartate aminotransferase This medicine does not require any
increased, platelet count decreased,
special storage conditions.
neutropenia, increase in blood
Do not throw away any medicines via
creatinine, decrease in blood
wastewater or household waste. Ask your
potassium)
pharmacist how to throw away medicines
• Hypersensitivity, swollen face,
you no longer use. These measures will
itchiness, hives, runny nose, nose
help protect the environment.
bleed, cough, snoring

TEVA UK Ref:

231-30-30196-C LEA PREGABALIN A/S CAPS TUK
PREGABALIN TEVA
25 mg, 50 mg, 75 mg, 100 mg,
150 mg, 200 mg, 225 mg AND
300 mg CAPSULES, HARD

Version:

3

12 June 2015

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
PACKAGE LEAFLET: INFORMATION FOR THE USER adolescents (under 18 years of age) has not
been established and therefore, Pregabalin
Read all of this leaflet carefully before you
Teva should not be used in this age group.
start taking this medicine because it
contains important information for you.
Other medicines and Pregabalin Teva
• Keep this leaflet. You may need to read it Tell your doctor or pharmacist if you are
again.
taking, have recently taken or might take
• If you have any further questions, ask
any other medicines.
your doctor or pharmacist.
Pregabalin Teva and certain other medicines
• This medicine has been prescribed for
may influence each other (interaction). When
you only. Do not pass it on to others. It
taken with certain other medicines,
may harm them, even if their signs of
Pregabalin Teva may enhance the side
illness are the same as yours.
effects seen with these medicines, including
• If you get any side effects, talk to your
respiratory failure and coma. The degree of
doctor or pharmacist. This includes any
dizziness, sleepiness and decreased
possible side effects not listed in this
concentration may be increased if
leaflet. See section 4.
Pregabalin Teva is taken together with
WHAT IS IN THIS LEAFLET:
medicinal products containing:
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

• 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
Pregabalin Teva belongs to a group of
you may be pregnant or are planning to
medicines used to treat epilepsy and
have a baby, ask your doctor or pharmacist
Generalised Anxiety Disorder (GAD) in adults. for advice before taking this medicine.
Epilepsy: Pregabalin Teva is used to treat a
Pregabalin Teva should NOT be taken during
certain form of epilepsy (partial seizures
pregnancy or when breast-feeding, unless
with or without secondary generalisation) in you are told otherwise by your doctor.
adults. Your doctor will prescribe Pregabalin Effective contraception must be used by
Teva for you to help treat your epilepsy when women of child-bearing potential.
your current treatment is not controlling your
Driving and using machines
condition. You should take Pregabalin Teva
Pregabalin Teva may cause dizziness,
in addition to your current treatment.
sleepiness and decreased concentration.
Pregabalin Teva is not intended to be used
You should NOT drive, operate complex
alone, but should always be used in
machinery or engage in other potentially
combination with other anti-epileptic
hazardous activities until you know whether
treatment.
this medicine affects your ability to perform
Generalised Anxiety Disorder: Pregabalin
these activities.
Teva is used to treat Generalised Anxiety
Disorder (GAD). The symptoms of GAD are
3 HOW TO TAKE PREGABALIN TEVA
prolonged excessive anxiety and worry that
are difficult to control. GAD can also cause Always take this medicine exactly as your
restlessness or feeling keyed up or on edge, doctor has told you. Check with your doctor
being easily fatigued (tired), having difficulty or pharmacist if you are not sure.
concentrating or mind going blank, feeling
Your doctor will determine what dose is
irritable, having muscle tension or sleep
disturbance. This is different to the stresses appropriate for you.
and strains of everyday life.
Epilepsy or Generalised Anxiety Disorder:
• Take the number of capsules as instructed
YOU NEED TO KNOW BEFORE
by your doctor.
2 WHAT
YOU TAKE PREGABALIN TEVA
• The dose, which has been adjusted for
you and your condition, will generally be
Do NOT take Pregabalin Teva:
between 150 mg and 600 mg each day.
• if you are allergic to pregabalin or any of
• Your doctor will tell you to take Pregabalin
the other ingredients of this medicine
Teva either twice or three times a day. For
(listed in section 6).
twice a day take Pregabalin Teva once in
Warnings and precautions
the morning and once in the evening, at
Talk to your doctor or pharmacist before
about the same time each day. For three
taking Pregabalin Teva.
times a day take Pregabalin Teva once in
the morning, once in the afternoon and
• Some patients taking pregabalin have
once in the evening, at about the same
reported symptoms suggesting an allergic
time each day.
reaction. These symptoms include swelling
of the face, lips, tongue and throat, as
If you have the impression that the effect of
well as diffuse skin rash. Should you
Pregabalin Teva is too strong or too weak,
experience any of these reactions, you
talk to your doctor or pharmacist.
should contact your doctor immediately.
If you are an elderly patient (over 65 years
• Pregabalin has been associated with
of age), you should take Pregabalin Teva
dizziness and drowsiness (somnolence),
normally except if you have problems with
which could increase the occurrence of
accidental injury (fall) in elderly patients. your kidneys.
Therefore, you should be careful until you Your doctor may prescribe a different
are used to any effect the medicine might dosing schedule and/or dose if you have
have.
problems with your kidneys.
• Pregabalin may cause blurring or loss of
vision, or other changes in eyesight, many Pregabalin Teva is for oral use only.
Swallow the capsule whole with water.
of which are temporary. You should
Pregabalin Teva capsules may be taken with
immediately tell your doctor if you
or without food.
experience any changes in your vision
(see section 4).
Continue taking Pregabalin Teva until your
• Some patients with diabetes who gain
doctor tells you to stop.
weight while taking pregabalin may need
If you take more Pregabalin Teva than you
an alteration in their diabetic medicines.
• Certain side effects may be more common, should
such as sleepiness, because patients with Call your doctor or go to the nearest
hospital emergency unit immediately. Take
spinal cord injury may be taking other
your pack of Pregabalin Teva capsules with
medicines to treat, for example, pain or
stiff or rigid muscles (spasticity), that have you. You may feel sleepy, confused,
similar side effects to pregabalin and the agitated, or restless as a result of taking
severity of these effects may be increased more Pregabalin Teva than you should.
when taken together.
If you forget to take Pregabalin Teva
• There have been reports of heart failure in It is important to take your Pregabalin Teva
some patients when taking pregabalin;
capsules regularly at the same time each day.
these patients were mostly elderly with
If you forget to take a dose, take it as soon
cardiovascular conditions. Before taking
as you remember unless it is time for your
this medicine you should tell your doctor next dose. In that case, just carry on with
if you have a history of heart disease.
the next dose as normal. Do NOT take a
• There have been reports of kidney failure double dose to make up for a forgotten dose.
in some patients when taking pregabalin.
If while taking Pregabalin Teva you notice If you stop taking Pregabalin Teva
decreased urination, you should tell your Do NOT stop taking Pregabalin Teva unless
your doctor tells you to. If your treatment is
doctor as stopping the medicine may
stopped it should be done gradually over a
improve this.
minimum of 1 week.
• A small number of people being treated
with anti-epileptics such as pregabalin
After stopping long and short-term
have had thoughts of harming or killing
Pregabalin Teva treatment, you need to know
themselves. If at any time you have these that you may experience certain side effects.
thoughts, immediately contact your doctor.
These include, trouble sleeping, headache,
• When Pregabalin Teva is taken with other
feeling sick (nausea), feeling anxious,
medicines that may cause constipation
diarrhoea, flu-like symptoms, convulsions,
(such as some types of pain medicines) it
nervousness, depression, pain, sweating and
is possible that gastrointestinal problems
dizziness. These symptoms may occur more
may occur (e.g. constipation, blocked or
commonly or severely if you have been taking
paralysed bowel). Tell your doctor if you
Pregabalin Teva for a longer period of time.
experience constipation, especially if you
are prone to this problem.
If you have any further questions on the use
• Before taking this medicine you should
of this medicine, ask your doctor or
tell your doctor if you have a history of
pharmacist.
alcoholism or any drug abuse or
dependence. Do not take more medicine
4 POSSIBLE SIDE EFFECTS
than prescribed.
Like all medicines, this medicine can cause
• There have been reports of convulsions
side effects, although not everybody gets
when taking pregabalin or shortly after
them.
stopping pregabalin. If you experience a
convulsion, contact your doctor
Very common: may affect more than 1 in 10
immediately.
people
• There have been reports of reduction in
• Dizziness
brain function (encephalopathy) in some • Drowsiness
patients taking pregabalin when they have • Headache.

TEVA UK Ref:

231-30-30196-C LEA PREGABALIN A/S CAPS TUK
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.

Version:

3

12 June 2015

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.
Uncommon: may affect up to 1 in 100 people • Each 300 mg capsule, hard contains 300
• Loss of appetite, weight loss, low blood
mg of pregabalin.
sugar, high blood sugar
• The other ingredients are: mannitol,
• Change in perception of self, restlessness,
pregelatinised maize starch, talc, titanium
depression, agitation, mood swings,
dioxide (E171), yellow iron oxide (E172)
difficulty finding words, hallucinations,
(25, 50, 75, 150, 225 and 300 mg
abnormal dreams, panic attacks, apathy,
capsules), red iron oxide (E172) (75, 100,
aggression, elevated mood, mental
200, 225 and 300 mg capsules), gelatin
impairment, difficulty with thinking,
and black ink (which contains shellac,
increase in sexual interest, problems with
propylene glycol, black iron oxide (E172)
sexual functioning including inability to
and potassium hydroxide).
achieve a sexual climax, delayed ejaculation
What Pregabalin Teva looks like and
• Changes in eyesight, unusual eye
contents of the pack
movement, changes in vision including
Pregabalin Teva 25 mg are ivory opaque
tunnel vision, flashes of light, jerky
hard gelatine size 3 capsules with overall
movements, reduced reflexes, increased
closed length 15.9 mm ± 0.3 mm, imprinted
activity, dizziness on standing, sensitive
by black sign 25 on capsule body.
skin, loss of taste, burning sensation,
tremor on movement, decreased
Pregabalin Teva 50 mg are ivory opaque
consciousness, loss of consciousness,
hard gelatine size 2 capsules with overall
fainting, increased sensitivity to noise,
closed length 18.0 mm ± 0.3 mm, imprinted
feeling unwell
by radial black band on capsule cap and
• Dry eyes, eye swelling, eye pain, weak
black sign 50 and radial black band on
eyes, watery eyes, eye irritation
capsule body.
• Heart rhythm disturbances, increased
heart rate, low blood pressure, high blood Pregabalin Teva 75 mg are opaque hard
gelatine size 3 capsules with overall closed
pressure, changes in heart beat, heart
length 15.9 mm ± 0.3 mm, with pink cap
failure
and ivory body imprinted by black sign 75.
• Flushing, hot flushes
• Difficulty breathing, dry nose, nasal
Pregabalin Teva 100 mg are pink opaque
congestion
hard gelatine size 2 capsules with overall
• Increased saliva production, heartburn,
closed length 18.0 mm ± 0.3 mm, imprinted
numb around mouth
by black sign 100 on capsule body.
• Sweating, rash, chills, fever
Pregabalin Teva 150 mg are ivory opaque
• Muscle twitching, joint swelling, muscle
stiffness, pain including muscle pain, neck hard gelatine size 2 capsules with overall
closed length 18.0 mm ± 0.3 mm, imprinted
pain
by black sign 150 on capsule body.
• Breast pain
• Difficulty with or painful urination,
Pregabalin Teva 200 mg are flesh opaque
incontinence
hard gelatine size 1 capsules with overall
• Weakness, thirst, chest tightness
closed length 19.4 mm ± 0.3 mm, imprinted
• Changes in blood and liver test results
by black sign 200 on capsule body.
(blood creatinine phosphokinase
Pregabalin Teva 225 mg are opaque hard
increased, alanine amino transferase
gelatine size 1 capsules with overall closed
increased, aspartate aminotransferase
length 19.4 mm ± 0.3 mm, with flesh cap
increased, platelet count decreased,
neutropenia, increase in blood creatinine, and ivory body imprinted by black sign 225.
decrease in blood potassium)
Pregabalin Teva 300 mg are opaque hard
• Hypersensitivity, swollen face, itchiness,
gelatine size 0 capsules with overall closed
hives, runny nose, nose bleed, cough,
length 21.7 mm ± 0.3 mm, with pink cap and
snoring
ivory body imprinted by black sign 300.
• Painful menstrual periods
For 25 mg capsules:
• Coldness of hands and feet.
Pregabalin Teva capsules are packed in
Rare: may affect up to 1 in 1000 people
PVC-Alu or unit dose blisters of 14, 14x1, 21,
• Abnormal sense of smell, swinging
21x1, 50x1, 56, 56x1, 60, 84, 84x1, 90, 100,
vision, altered perception of depth, visual 100x1 or 120 capsules.
brightness, vision loss
For 50 mg capsules:
• Dilated pupils, cross eyes
Pregabalin Teva capsules are packed in
• Cold sweat, tightness of the throat,
PVC-Alu or unit dose blisters of 14, 21, 21x1,
swollen tongue
56, 56x1, 60, 84, 84x1, 100, 100x1 or 120
• Inflammation of the pancreas
capsules.
• Difficulty in swallowing
• Slow or reduced movement of the body
For 75 mg capsules:
• Difficulty with writing properly
Pregabalin Teva capsules are packed in
• Increased fluid in the abdomen
PVC-Alu or unit dose blisters of 14, 14x1,
• Fluid in the lungs
50x1, 56, 56x1, 60, 70, 90, 100 ,100x1 or 120
• Convulsions
capsules.
• Changes in the recording of electrical
Additionally, Pregabalin Teva capsules are
changes (ECG) in the heart which
packed in HDPE bottles with PP closure
correspond to heart rhythm disturbances containing 200 capsules.
• Muscle damage
For 100 mg capsules:
• Breast discharge, abnormal breast
Pregabalin Teva capsules are packed in
growth, breast growth in males
PVC-Alu blisters or unit dose blisters of 14,
• Interrupted menstrual periods
21, 21x1, 56, 56x1, 84, 84x1, 100, 100x1 or
• Kidney failure, reduced urine volume,
120 capsules.
urinary retention
• Decrease in white blood cell count
For 150 mg capsules:
• Inappropriate behaviour
Pregabalin Teva capsules are packed in
• Allergic reactions (which may include
PVC-Alu or unit dose blisters of 14, 14x1,
difficulty breathing, inflammation of the
50x1, 56, 56x1, 60, 90, 100, 100x1, 120, 168,
eyes (keratitis) and a serious skin reaction 168x1 or 200x1 capsules.
characterised by rash, blisters, peeling
Additionally, Pregabalin Teva capsules are
skin and pain).
packed in HDPE bottles with PP closure
If you experience swollen face or tongue or containing 200 capsules.
if your skin turns red and starts to blister or For 200 mg capsules:
peel you should seek immediate medical
Pregabalin Teva capsules are packed in
advice.
PVC-Alu blisters or unit dose blisters of 14,
Certain side effects may be more common, 21, 21x1, 84, 84x1, 100, 100x1 or 120 capsules.
such as sleepiness, because patients with
For 225 mg capsules:
spinal cord injury may be taking other
Pregabalin Teva capsules are packed in
medicines to treat, for example, pain or
PVC-Alu blisters or unit dose blisters of 14,
spasticity, that have similar side effects to
14x1, 56, 56x1, 60, 100, 100x1 or 120 capsules.
pregabalin and the severity of these effects Additionally, Pregabalin Teva capsules are
may be increased when taken together.
packed in HDPE bottles with PP closure
containing 200 capsules.
Reporting of side effects
If you get any side effects, talk to your
For 300 mg capsules:
doctor or pharmacist. This includes any
Pregabalin Teva capsules are packed in
possible side effects not listed in this leaflet. PVC-Alu or unit dose blisters of 14, 14x1,
You can also report side effects directly via 50x1, 56, 56x1, 60, 84, 84x1, 90, 100, 100x1,
the Yellow Card Scheme at:
120, 168, 168x1 or 200x1 capsules.
www.mhra.gov.uk/yellowcard
Additionally, Pregabalin Teva capsules are
packed in HDPE bottles with PP closure
By reporting side effects you can help
containing 200 capsules.
provide more information on the safety of
this medicine.
Not all pack sizes may be marketed.

5

HOW TO STORE PREGABALIN TEVA

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

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.),
Do not use this medicine after the expiry
Prilaz baruna Filipovica 25, Zagreb 10000,
date which is stated on the blister, carton or Croatia
bottle. The expiry date refers to the last day
This leaflet was last revised in 06/2015.
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

PL 00289/1945-1952
30196-C

155 x 500

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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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