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PREGABALIN WARREN 100 MG HARD CAPSULES

Active substance(s): PREGABALIN

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Package leaflet: Information for the user

Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin

Warren
Warren
Warren
Warren
Warren
Warren
Warren
Warren

25 mg hard capsules,
50 mg hard capsules,
75 mg hard capsules,
100 mg hard capsules,
150 mg hard capsules,
200 mg hard capsules,
225 mg hard capsules,
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 Warren is and what it is used
for
2. What you need to know before you take
Pregabalin Warren
3. How to take Pregabalin Warren
4. Possible side effects
5. How to store Pregabalin Warren
6. Contents of the pack and other information
1. What Pregabalin Warren is and what it is
used for

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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 Warren or shortly after
stopping Pregabalin Warren. If you experience a
convulsion, contact your doctor immediately.
There have been reports of reduction in brain
function (encephalopathy) in some patients
taking Pregabalin Warren 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.

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

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

Peripheral and central neuropathic pain:
Pregabalin Warren 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.

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

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

Pregabalin Warren may be taken with
oral contraceptives.

Generalised Anxiety Disorder: Pregabalin Warren
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 Warren
Do not take Pregabalin Warren
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 Warren.
! Some patients taking Pregabalin Warren 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 Warren 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 Warren 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 Warren; 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 Warren. If
while taking Pregabalin Warren you notice
decreased urination, you should tell your doctor
as stopping the medicine may improve this.
! A small number of people being treated with antiepileptics such as Pregabalin Warren have had
thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately
contact your doctor.
! When Pregabalin Warren is taken with other
medicines that may cause constipation (such as

Pregabalin Warren with food, drink
and alcohol
Pregabalin Warren capsules may be
taken with or without food.
It is advised not to drink alcohol while
taking Pregabalin.
Pregnancy and breast-feeding
Pregabalin Warren 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 childbearing potential. If you are pregnant or breastfeeding, 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 Warren 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 Warren 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 Warren
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.

If you take more Pregabalin Warren than you
should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box of
Pregabalin Warren capsules with you. You may feel
sleepy, confused, agitated, or restless as a result of
taking more Pregabalin Warren than you should.
Fits have also been reported.
If you forget to take Pregabalin Warren
It is important to take your Pregabalin Warren
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 Warren
Do not stop taking Pregabalin Warren 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
Warren 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 Warren 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.

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Pregabalin Warren 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 Pregabalin
Warren either twice or three times a day. For
twice a day take Pregabalin Warren once in the
morning and once in the evening, at about the
same time each day. For three times a day take
Pregabalin Warren 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 Warren 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 Warren 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 Warren until your doctor
tells you to stop.

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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.

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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).

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 Warren 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
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme,
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 Warren
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 after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via waste water
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 Warren 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 or 300 mg of
pregabalin.
! The other ingredients are: lactose monohydrate,
maize starch, talc, gelatin, titanium dioxide
(E171), sodium laurilsulfate and printing ink
(which contains shellac, propylene glycol, strong
ammonia solution, black iron oxide (E172),
potassium hydroxide).
The 75 mg, 100 mg, 200 mg, 225 mg and
300 mg capsules also contain red iron oxide
(E172).
What Pregabalin Warren looks like and
contents of the pack
25 mg capsule
White hard gelatin
capsule of size “4'' with
“I'' printed on cap and
“33'' on body containing
white to off white powder.
50 mg capsule
White hard gelatin capsule of
size “3'' with “I'' printed on cap
and “34'' on body containing
white to off white powder.
75 mg capsule
White and orange hard gelatin
capsule of size “4'' with “I''
printed on cap and “35'' on
body containing white to off
white powder.
100 mg capsule
Orange hard gelatin capsule of
size “3'' with “I'' printed on cap
and “36'' on body containing
white to off white powder.
150 mg capsule
White hard gelatin capsule of
size “2'' with “I'' printed on cap
and “37'' on body containing
white to off white powder.
200 mg capsule
Orange hard gelatin capsule of
size “1'' with “I'' printed on cap
and “38'' on body containing
white to off white powder.
225 mg capsule
White and orange hard gelatin
capsule of size “1'' with “I''
printed on cap and “39'' on
body containing white to off
white powder.
300 mg capsule
White and orange hard gelatin
capsule of size “0'' with “I''
printed on cap and “40'' on
body containing white to off
white powder.
Pregabalin Warren is available in seven pack sizes
made of transparent PVC with an aluminium foil
backing: a 14 capsules pack containing 1 blister
strip, a 21 capsules pack containing 3 blister strips,
a 56 capsules pack containing 4 blister strips, a 70
capsules pack containing 5 blister strips, a 84
capsules pack containing 6 blister strips, a 100
capsules pack containing 10 blister strips, a 112 (2 x
56) capsules pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder:
WARREN GENERICS s.r.o.
U Staré tvrze 285/21
196 00 Praha 9
Czech Republic
Manufacturer:
IMUNA PHARM, a.s.
Jarková 269/17
082 22 Šarišské Michaľany
Slovak Republic
This leaflet was last revised in October 2017.

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