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PREGABALIN ACCORD HEALTHCARE 150 MG HARD CAPSULES

Active substance(s): PREGABALIN

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Pregabalin

Market

UK

Language

English

Size

170 x 600 mm (PIL)

Min. Font Size

9

Version No.

1 (Page 1 of 2)

Date

11/07/16 (Pregabalin (ACC-UK)DCP-PIL)

Package leaflet: Information for the user

Pregabalin Accord
Healthcare 25 mg hard
capsules
Pregabalin Accord
Healthcare 50 mg hard
capsules
Pregabalin Accord
Healthcare 75 mg hard
capsules
Pregabalin Accord
Healthcare 100 mg hard
capsules
Pregabalin Accord
Healthcare 150 mg hard
capsules
Pregabalin Accord
Healthcare 200 mg hard
capsules
Pregabalin Accord
Healthcare 225 mg hard
capsules
Pregabalin Accord
Healthcare 300 mg hard
capsules
pregabalin

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Pregabalin Accord Healthcare is and
what it is used for
2. What you need to know before you take
Pregabalin Accord Healthcare
3. How to take Pregabalin Accord Healthcare
4. Possible side effects
5. How to store Pregabalin Accord Healthcare
6. Contents of the pack and other information

1. What Pregabalin Accord
Healthcare is and what it is
used for
Pregabalin Accord Healthcare 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 Accord Healthcare 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
This medicine is used to treat a certain form of
epilepsy (partial seizures with or without
secondary generalisation) in adults. Your doctor
will prescribe Pregabalin Accord Healthcare for
you to help treat your epilepsy when your current
treatment is not controlling your condition. You
should take Pregabalin Accord Healthcare in
addition to your current treatment. Pregabalin
Accord Healthcare is not intended to be used
alone, but should always be used in combination
with other anti-epileptic treatment.
Generalised anxiety disorder
This medicine 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 Accord
Healthcare
Do not take Pregabalin Accord Healthcare
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 Accord Healthcare.
• Some patients taking this medicine 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.
• This medicine 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.
• This medicine 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 this medicine; 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 this medicine. If
while taking this medicine 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 Accord
Healthcare have had thoughts of harming or
killing themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Pregabalin Accord Healthcare 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 this medicine or shortly after stopping
this medicine. If you experience a convulsion,
contact your doctor immediately.
• There have been reports of reduction in brain
function (encephalopathy) in some patients
taking this medicine 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 Accord
Healthcare
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Pregabalin Accord Healthcare and certain other
medicines may influence each other (interaction).
When taken with certain other medicines,
Pregabalin Accord Healthcare 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
Accord Healthcare is taken together with
medicinal products containing:
Oxycodone - (used as a pain-killer)
Lorazepam - (used for treating anxiety)
Alcohol
This medicine may be taken with oral
contraceptives.
Pregabalin Accord Healthcare with food, drink
and alcohol
This medicine may be taken with or without food.
It is advised not to drink alcohol while taking this
medicine.
Pregnancy and breast-feeding
This medicine 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
This medicine may produce dizziness, sleepiness
and decreased concentration. You should not
drive, operate complex machinery or engage in
other potentially hazardous activities until you
know whether this medicine affects your ability to
perform these activities.

3. How to take Pregabalin
Accord Healthcare
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.
This medicine is for oral use only.
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 this medicine
either twice or three times a day. For twice a
day take this medicine once in the morning and
once in the evening, at about the same time
each day. For three times a day take this
medicine 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 this
medicine 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 this medicine 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 this medicine until your doctor
tells you to stop.
If you take more Pregabalin Accord
Healthcare than you should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of this medicine with you. You may feel
sleepy, confused, agitated, or restless as a result
of taking more this medicine than you should.
If you forget to take Pregabalin Accord
Healthcare
It is important to take your medicine regularly at

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Pregabalin

Market

UK

Language

English

Size

170 x 600 mm (PIL)

Min. Font Size

9

Version No.

1 (Page 2 of 2)

Date

11/07/16 (Pregabalin (ACC-UK)DCP-PIL)

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 Accord
Healthcare
Do not stop taking this medicine 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
Accord Healthcare 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 this medicine 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.
• 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.
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.
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).

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: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Pregabalin
Accord Healthcare
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 or bottle. The expiry
date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
HDPE bottle pack should be used within 30 days
(for 30’s count) and 180 days (for 200’s count)
after first opening.
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 Accord Healthcare contains
The active substance is pregabalin.
Each hard capsule contains either 25 mg, 50 mg,
75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300
mg of pregabalin.
The other ingredients are: starch pregelatinised
(maize), talc (E553b), gelatin, titanium dioxide
(E171), sodium laurilsulfate, black ink (which
contains shellac, propylene glycol, iron oxide
black (E172), and potassium hydroxide).
The 75 mg, 100 mg, 200 mg, 225 mg and 300
mg capsules also contain iron oxide red (E172).
What Pregabalin Accord Healthcare looks like
and contents of the pack
25 mg capsules
White opaque/White opaque, size “4” hard gelatin
capsules, imprinted with ‘PG’ on cap and ‘25’ on
body. Each capsule is approximately 14.4 mm in
length.
50 mg capsules
White opaque/White opaque, size “3” hard gelatin
capsules, imprinted with ‘PG’ on cap and ‘50’ on
body. Each capsule is approximately 15.8 mm in
length.
75 mg capsules
Red opaque/White opaque, size “4” hard gelatin
capsules, imprinted with ‘PG’ on cap and ‘75’ on
body. Each capsule is approximately 14.4 mm in
length.
100 mg capsules
Red opaque/Red opaque, size “3” hard gelatin
capsules, imprinted with ‘PG’ on cap and ‘100’ on
body. Each capsule is approximately 15.8 mm in
length.
150 mg capsules
White opaque/White opaque, size “2” hard gelatin
capsules, imprinted with ‘PG’ on cap and ‘150’ on
body. Each capsule is approximately 17.8 mm in
length.
200 mg capsules
Orange opaque/Orange opaque, size “1” hard
gelatin capsules, imprinted with ‘PG’ on cap and
‘200’ on body. Each capsule is approximately
19.3 mm in length.
225 mg capsules Orange opaque/White opaque,
size “1” hard gelatin capsules, imprinted with ‘PG’
on cap and ‘225’ on body. Each capsule is
approximately 19.3 mm in length.
300 mg capsules
Red opaque/White opaque, size “0” hard gelatin
capsules, imprinted with ‘PG’ on cap and ‘300’ on
body. Each capsule is approximately 21.4 mm in
length.
Pregabalin Accord Healthcare
25/50/75/100/150/200/225/300mg hard capsules
are available in clear PVC/Aluminium blister in
packs sizes of 14, 21, 56, 60, 84, 90, 100 or 112
hard capsules. Additionally Pregabalin Accord
Healthcare 75mg hard capsules are also
available in clear PVC/Aluminium blister in pack
sizes of 70 hard capsules.
Pregabalin Accord Healthcare
25/50/75/100/150/200/225/300mg hard capsules
are available in 100 x 1 hard capsules in clear
PVC/Aluminium perforated unit dose blisters.
Pregabalin Accord Healthcare
25/50/75/100/150/200/225/300mg hard capsules
are also available in a white opaque HDPE bottle
with white opaque polypropylene closure
containing 30 or 200 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow,
Middlesex, HA1 4HF
United Kingdom.
Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
This leaflet was approved in 07/2016.

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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or

INP032
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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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