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PREGABALIN WOCKHARDT 300MG HARD CAPSULES

Active substance(s): PREGABALIN

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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 is and what it is used for
2. What you need to know before you take
pregabalin
3. How to take pregabalin
4. Possible side effects
5. How to store Pregabalin Wockhardt Hard
Capsules
6. Contents of the pack and other information
1. What pregabalin is and what it is used for
Pregabalin belongs to a group of medicines
used to treat epilepsy and Generalised Anxiety
Disorder (GAD) in adults.
Epilepsy: pregabalin is used to treat a certain
form of epilepsy (partial seizures with or
without secondary generalisation) in adults.
Your doctor will prescribe pregabalin for you to
help treat your epilepsy when your current
treatment is not controlling your condition.
You should take pregabalin in addition to your
current treatment. Pregabalin is not intended
to be used alone, but should always be used in
combination with other anti-epileptic
treatment.
Generalised Anxiety Disorder: pregabalin 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
Do not take pregabalin
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
• 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
physician immediately.
• Pregabalin 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 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 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 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 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 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
should not be used in this age group.
Other medicines and pregabalin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

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Package leaflet: Information for the user
Pregabalin Wockhardt 25 mg Hard Capsules
Pregabalin Wockhardt 50 mg Hard Capsules
Pregabalin Wockhardt 75 mg Hard Capsules
Pregabalin Wockhardt 100 mg Hard Capsules
Pregabalin Wockhardt 150 mg Hard Capsules
Pregabalin Wockhardt 200 mg Hard Capsules
Pregabalin Wockhardt 225 mg Hard Capsules
Pregabalin Wockhardt 300 mg Hard Capsules
Pregabalin
Pregabalin and certain other medicines may
influence each other (interaction). When taken
with certain other medicines, pregabalin 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 is taken together with medicinal
products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin may be taken with oral
contraceptives.
Pregabalin with food, drink and alcohol
Pregabalin Wockhardt Hard Capsules may be
taken with or without food.
It is advised not to drink alcohol while taking
pregabalin.
Pregnancy and breast-feeding
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.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
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.
Pregabalin Wockhardt Hard Capsules
contains lactose monohydrate
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. How to take pregabalin
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.
Pregabalin Wockhardt Hard Capsules are for
oral use only.
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
either twice or three times a day. For twice a
day take pregabalin once in the morning and
once in the evening, at about the same time
each day. For three times a day take
pregabalin 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 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 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.
Swallow the capsule whole with water.
Continue taking pregabalin until your doctor
tells you to stop.
If you take more pregabalin than you should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of pregabalin capsules with you. You
may feel sleepy, confused, agitated, or restless
as a result of taking more pregabalin than you
should.
If you forget to take pregabalin
It is important to take your pregabalin 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
Do not stop taking pregabalin unless your
doctor tells you to. If your treatment is stopped
it should be done gradually over a minimum of
1 week.
After stopping long and short-term pregabalin
treatment, you need to know that you may
experience certain side effects. These include,
trouble sleeping, headache, nausea, feeling
anxious, 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 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, fatigue, feeling
abnormal.
• Blurred vision, double vision.
• Vertigo, problems with balance, fall.

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Pregabalin 25mg Hard Capsules
Wockhardt UK

UK
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• 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.
• Sore throat.

Each hard capsule contains either 25 mg,
50 mg, 75 mg, 100 mg, 150 mg, 200 mg,
225 mg or 300 mg pregabalin.
The other ingredients are: lactose
monohydrate, maize starch, talc (E553b),
gelatine, titanium dioxide (E171) and black ink
(which contains shellac, black iron oxide (E172),
propylene glycol, potassium hydroxide).

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 attack, apathy, aggression,
elevated mood, mental impairment, difficulty
with thinking, increase in sexual interest,
problems with sexual functioning including
inability to achieve a sexual climax, delayed
ejaculation.
• Changes in eyesight, unusual eye movement,
changes in vision including tunnel vision,
flashes of light, jerky movements, reduced
reflexes, increased activity, dizziness on
standing, sensitive skin, loss of taste, burning
sensation, tremor on movement, decreased
consciousness, loss of consciousness, fainting,
increased sensitivity to noise, feeling unwell.
• Dry eyes, eye swelling, eye pain, weak eyes,
watery eyes, eye irritation.
• Heart rhythm disturbances, increased heart
rate, low blood pressure, high blood pressure,
changes in 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, neutropaenia, 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.

The 50 mg, 75 mg, 100 mg, 200 mg, 225 mg
and 300 mg capsules also contain red iron
oxide (E172).

Rare: may affect up to 1 in 1,000 people
• Abnormal sense of smell, swinging vision,
altered perception of depth, visual brightness,
vision loss.
• Dilated pupils, cross eyes.
• Cold sweat, tightness of the throat, swollen
tongue.
• Inflammation of the pancreas.
• Difficulty in swallowing.
• Slow or reduced movement of the body.
• Difficulty with writing properly.
• Increased fluid in the abdomen.
• Fluid in the lungs.
• Convulsions.
• Changes in the recording of electrical
changes (ECG) in the heart which correspond
to heart rhythm disturbances.
• Muscle damage.
• Breast discharge, abnormal breast growth,
breast growth in males.
• Interrupted menstrual periods.
• Kidney failure, reduced urine volume, urinary
retention.
• Decrease in white blood cell count.
• Inappropriate behaviour.
• Allergic reactions (which may include
difficulty breathing, inflammation of the eyes
(keratitis) and a serious skin reaction
characterized by rash, blisters, peeling skin
and pain).

225 mg capsules Hard capsules, size 1, with a
pinkish-orange cap and a
white body, with “225”
printed in black ink on the
body. The capsules contain a
white to off-white powder.

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 national
reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie;
e-mail: medsafety@hpra.ie

The 50 mg, 200 mg, 225 mg capsules also
contain yellow iron oxide (E172).
What Pregabalin Wockhardt Hard Capsules
look like and contents of the pack
25 mg capsules Hard capsules, size 4, with a
white cap and a white body,
with “25” printed in black ink
on the body. The capsules
contain a white to off-white
powder.
50 mg capsules Hard capsules, size 3, with a
white cap and a
pinkish-orange body, with
“50” printed in black ink on
the body. The capsules
contain a white to off-white
powder.
75 mg capsules Hard capsules, size 4, with a
brownish-red cap and a white
body, with “75” printed in
black ink on the body. The
capsules contain a white to
off-white powder.
100 mg capsules Hard capsules, size 3, with a
brownish-red cap and a
brownish-red body, with
“100” printed in black ink on
the body. The capsules
contain a white to off-white
powder.
150 mg capsules Hard capsules, size 2, with a
white cap and a white body,
with “150” printed in black ink
on the body. The capsules
contain a white to off-white
powder.
200 mg capsules Hard capsules, size 1, with a
pinkish-orange cap and a
pinkish-orange body, with
“200” printed in black ink on
the body. The capsules
contain a white to off-white
powder.

300 mg capsules Hard capsules, size 0, with a
brownish-red cap and a white
body, with “300” printed in
black ink on the body. The
capsules contain a white to
off-white powder.
Pregabalin Wockhardt Hard Capsules, hard are
available in PVC/Aluminium blisters containing
10, 14, 20, 21, 28, 30, 56, 60, 70 [for 75 mg
only], 84, 90, 100 or 84 (multipack: 2 x 42),
112 (multipack: 2 x 56), 120 (multipack: 2 x 60),
200 (multipack: 2 x 100) hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
0800 198 5000 (UK only).
Please be ready to give the following
information:
Product name
Pregabalin Wockhardt
25mg hard capsules

Reference number
29831/0589

This is a service provided by the Royal National
Institute of Blind People.
For patients in the Republic of Ireland please
call +44 1978 669272
This leaflet was last revised in 01/2016.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
UK & Ireland: Pregabalin Wockhardt 25 mg,
50 mg, 75 mg, 100 mg, 150 mg, 200 mg,
225 mg or 300 mg hard capsules.

By reporting side effects you can help provide
more information on the safety of this
medicine.
5. How to store Pregabalin Wockhardt Hard
Capsules
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 carton and blister after
EXP. The expiry date refers to the last day of
that month.
This medicinal product does not require any
special storage conditions.

What Pregabalin Wockhardt Hard Capsules
contain
The active substance is pregabalin.

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6. Contents of the pack and other
information

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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.

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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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