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PREGABALIN BRISTOL LABS 200 MG CAPSULES HARD

Active substance(s): PREGABALIN / PREGABALIN

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Package leaflet: Information for the patient

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

1. What this medicine is and what it is used for
Pregabalin belongs to a group of medicines used to treat epilepsy, neuropathic
pain and Generalised Anxiety Disorder (GAD) in adults.

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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 this medicine
Do not take this medicine:
• if you are allergic to the active substance or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
• 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 eye
sight, 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.
Taking other medicines
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.
Taking this medicine 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 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.

3.How to take this medicine
Always take this medicine exactly as your doctor or pharmacist 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.
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 of this medicine 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. Fits have also been reported
If you forget to take this medicine
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
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If you stop taking this medicine
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,
pharmacist or nurse.

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.

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480 mm x 140 mm







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
attacks, 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 heartbeat, 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).
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 this medicine








Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
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 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 this medicine contains
• The active substance is Pregabalin. Each hard capsule contains 25 mg,
50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
• The other ingredients are mannitol, maize starch, talc. The capsule shell
contains gelatin, titanium dioxide (E171). In addition, 75mg, 100mg, 200mg,
225mg and 300mg capsules contain iron oxide red (E172). The printing ink
composition is shellac (E904), propylene glycol (E1520), strong ammonia
solution (E527), black iron oxide (E172), potassium hydroxide (E525).
What this medicine looks like and contents of the pack
• 25 mg capsules: White cap / White body size ‘4’ hard gelatin capsules
imprinted with ‘138’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.
• 50 mg capsules: White cap / White body size ‘4’ hard gelatin capsules
imprinted with ‘139’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.
• 75 mg capsules: Orange cap / White body size ‘4’ hard gelatin capsules
imprinted with ‘140’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.
• 100 mg capsules: Orange cap / Orange body size ‘3’ hard gelatin capsules
imprinted with ‘141’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.





150 mg capsules: White cap / White body size ‘2’ hard gelatin capsules
imprinted with ‘142’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.
200 mg capsules: Orange cap / Orange body size ‘1’ hard gelatin capsules
imprinted with ‘143’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.
225 mg capsules: Light orange cap / White body size ‘1’ hard gelatin
capsules imprinted with ‘144’ on cap and ‘J’ on body with black ink, filled
with white to off white powder.
300 mg capsules: Orange cap / White body size ‘0’ hard gelatin capsules
imprinted with ‘145’ on cap and ‘J’ on body with black ink, filled with white to
off white powder.
This medicine is available in blister packs containing 14, 21, 56, 70, 84, 100
or 112 capsules. Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG, United Kingdom.
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin
Pregabalin

25mg Capsules, Hard; PL 17907/0584
50mg Capsules, Hard; PL 17907/0585
75mg Capsules, Hard; PL 17907/0586
100mg Capsules, Hard; PL 17907/0587
150mg Capsules, Hard; PL 17907/0588
200mg Capsules, Hard; PL 17907/0589
225mg Capsules, Hard; PL 17907/0590
300mg Capsules, Hard; PL 17907/0591

This leaflet was last revised in June 2017
To request a copy of this leaflet in Braille, large print or audio format then please
contact the marketing authorisation holder at the address (or telephone, fax, email)
above.
V5 14-06-17D0

XXXXXX

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.

Expand Transcript

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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