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PREGABALIN DR. REDDYS 200 MG CAPSULES HARD

Active substance(s): PREGABALIN

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Package leaflet: Information for the user
Pregabalin Dr. Reddy’s 25 mg Capsules, Hard
Pregabalin Dr. Reddy’s 50 mg Capsules, Hard
Pregabalin Dr. Reddy’s 75 mg Capsules, Hard
Pregabalin Dr. Reddy’s 100 mg Capsules, Hard
Pregabalin Dr. Reddy’s 150 mg Capsules, Hard
Pregabalin Dr. Reddy’s 200 mg Capsules, Hard
Pregabalin Dr. Reddy’s 225 mg Capsules, Hard
Pregabalin Dr. Reddy’s 300 mg Capsules, Hard
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 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
6. Contents of the pack and other information



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.

1. What Pregabalin is and what it is used for



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.

Pregabalin 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 is used to
treat long lasting pain caused by damage to the nerves. A variety
of diseases can cause peripheral neuropathic pain, such as
diabetes or shingles. Pain sensations may be described as hot,
burning, throbbing, shooting, stabbing, sharp, cramping, aching,
tingling, numbness, pins and needles. Peripheral and central
neuropathic pain may also be associated with mood changes,
sleep disturbance, fatigue (tiredness), and can have an impact on
physical and social functioning and overall quality of life.
Epilepsy: Pregabalin 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.

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.
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 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, 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.
It is not recommended to breast-feed your baby while using
Pregabalin as it is not known if Pregabalin may be found in breast
milk. Ask your doctor or pharmacist for advice before taking any
medicine while breast-feeding.
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 capsules contain lactose
If you have been told by your doctor that you have an 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 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 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.



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.

If you are an elderly patient (over 65 years of age), you should
take Pregabalin normally except if you have problems with your
kidneys.



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.

Swallow the capsule whole with water.
Continue taking Pregabalin until your doctor tells you to stop.

Your doctor may prescribe a different dosing schedule and/or
dose if you have problems with your kidneys.

If you take more Pregabalin than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box 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 side effects (may affect more than 1 in
10 people) are listed below:
 dizziness, drowsiness, headache
Common side effects (may affect up to 1 in 10 people) are
listed below:
 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 side effects (may affect up to 1 in 100 people) are
listed below:
 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, neutropenia, increase in blood creatinine,
decrease in blood potassium)
 hypersensitivity, swollen face, itchiness, hives, runny nose,
nose bleed, cough, snoring
 painful menstrual periods
 coldness of hands and feet
Rare side effects (may affect up to 1 in 1,000 people) are
listed below:
 abnormal sense of smell, swinging vision, altered perception
of depth, visual brightness, vision loss
 dilated pupils, cross eyes
 cold sweat, tightness of the throat, swollen tongue
 inflammation of the pancreas
 difficulty in swallowing
 slow or reduced movement of the body
 difficulty with writing properly
 increased fluid in the abdomen
 fluid in the lungs
 convulsions




changes in the recording of electrical changes (ECG) in the
heart which correspond to heart rhythm disturbances
muscle damage
breast discharge, abnormal breast growth, breast growth in
males
interrupted menstrual periods
kidney failure, reduced urine volume, urinary retention
decrease in white blood cell count
inappropriate behaviour
allergic reactions (which may include difficulty breathing,
inflammation of the eyes (keratitis) and a serious skin reaction
characterised by rash, blisters, peeling skin and pain)

If you experience swollen face or tongue or if your skin turns
red and starts to blister or peel you should seek immediate
medical advice.
Certain side effects may be more common, such as sleepiness,
because patients with spinal cord injury may be taking other
medicines to treat, for example, pain or spasticity, that have
similar side effects to pregabalin and the severity of these effects
may be increased when taken together.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at
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
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 blister after EXP. The expiry date refers to the last
day of that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Pregabalin capsules contain
 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 pregabalin.
 The other ingredients are: lactose monohydrate, maize
starch, talc, gelatine, titanium dioxide (E171), sodium lauryl
sulphate and black ink (which contains shellac, black iron
oxide (E172), potassium hydroxide). The 75, 100, 200, 225
and 300 mg capsules also contain red iron oxide (E172).
What Pregabalin capsules look like and contents of the pack
25 mg
capsules

50 mg
capsules

75 mg
capsules
100 mg
capsules
150 mg
capsules
200 mg
capsules
225 mg
capsules
300 mg
capsules

Opaque white coloured cap and opaque white
coloured body imprinted 'RDY' on the cap and
'291' on the body with black imprinting ink.
Size 4 (14.4 ± 0.4 mm).
Opaque white coloured cap and opaque white
coloured body imprinted 'RDY' on the cap and
'292' on the body with black imprinting ink. The
capsule body is marked with a black band.
Size 3 (15.8 ± 0.4 mm).
Opaque red coloured cap and opaque white
coloured body imprinted 'RDY' on the cap and
'293' on the body with black imprinting ink.
Size 4 (14.4 ± 0.4 mm).
Opaque red coloured cap and opaque red
coloured body imprinted 'RDY' on the cap and
'294' on the body with black imprinting ink.
Size 3 (15.8 ± 0.4 mm).
Opaque white coloured cap and opaque white
coloured body imprinted 'RDY' on the cap and
'295' on the body with black imprinting ink.
Size 2 (17.8 ± 0.4 mm).
Opaque light red coloured cap and opaque light
red coloured body imprinted 'RDY' on the cap
and '296' on the body with black imprinting ink.
Size 1 (19.3 ± 0.4 mm).
Opaque light red coloured cap and opaque white
coloured body imprinted 'RDY' on the cap and
'297' on the body with black imprinting ink.
Size 1 (19.3 ± 0.4 mm).
Opaque red coloured cap and opaque white
coloured body imprinted 'RDY' on the cap and
'298' on the body with black imprinting ink.
Size 0 (21.4 ± 0.4 mm).

Pregabalin is available in blister packs containing 14, 20, 21, 30,
56, 60, 84, 90 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 11/2015.

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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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