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PREGABALIN CADUCEUS 75MG CAPSULES HARD

Active substance(s): PREGABALIN

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Package leaflet: Information for the user

Pregabalin Caduceus 25mg, 50mg, 75mg, 100mg,
150mg, 200mg, 225mg and 300mg Capsules, hard
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, pharmacist or
nurse.
• 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
• The full name of this medicine is Pregabalin Caduceus 25mg, 50mg,
75mg, 100mg, 150mg, 200mg, 225mg and 300mg Capsules, hard but
within the leaflet it will be referred to as Pregabalin Capsules.
What is in this leaflet
1. What Pregabalin Capsules are and what they are used for
2. What you need to know before you take Pregabalin Capsules
3. How to take Pregabalin Capsules
4. Possible side effects
5. How to store Pregabalin Capsules
6. Contents of the pack and other information
1. What Pregabalin Capsules are and what they are used for
Pregabalin Capsules belongs to a group of medicines used to treat
Central neuropathic pain, Epilepsy and Generalised Anxiety Disorder
(GAD) in adults.
Central neuropathic pain: Pregabalin Capsules are used to treat long
lasting pain caused by damage to the nerves. Pain sensations may
be described as hot, burning, throbbing, shooting, stabbing, sharp,
cramping, aching, tingling, numbness, pins and needles. 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 Capsules are used to treat a certain form of
epilepsy (partial seizures with or without secondary generalisation) in
adults. Your doctor will prescribe Pregabalin Capsules for you to help
treat your epilepsy when your current treatment is not controlling
your condition. You should take Pregabalin Capsules in addition to
your current treatment. Pregabalin Capsules are not intended to be
used alone, but should always be used in combination with other antiepileptic treatment.
Generalised Anxiety Disorder: Pregabalin Capsules are 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.
Pregabalin Capsules may also be prescribed to treat conditions not
listed in this leaflet. If you have any questions, ask your doctor or
pharmacist.

• When Pregabalin Capsules are 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
Capsules or shortly after stopping Pregabalin Capsules. If you
experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function
(encephalopathy) in some patients taking Pregabalin Capsules 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 Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Pregabalin Capsules and certain other medicines may influence
each other (interaction). When taken with certain other medicines,
Pregabalin Capsules 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 Capsules are taken together with medicinal products
containing:
Oxycodone – (used as a painkiller)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin Capsules may be taken with oral contraceptives.
Pregabalin Capsules with food, drink and alcohol
Pregabalin Capsules capsules may be taken with or without food.
It is advised not to drink alcohol while taking Pregabalin Capsules.
Pregnancy and breast-feeding
Pregabalin Capsules 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 Capsules 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.

2. What you need to know before you take Pregabalin Capsules

3. How to take Pregabalin Capsules

Do not take Pregabalin Capsules
• if you are allergic to pregabalin or any of the other ingredients of this
medicine (listed in section 6).

Always take this medicine exactly as your doctor has told you. Check
with your doctor, pharmacist or nurse if you are not sure.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pregabalin
Capsules.
• Some patients taking Pregabalin Capsules 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
doctor immediately.
• Pregabalin Capsules 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 Capsules 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 Capsules; 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 Capsules. If while taking Pregabalin Capsules 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 Capsules have had thoughts of harming or killing
themselves. If at any time you have these thoughts, immediately
contact your doctor.
Continued top of next column

Your doctor will determine what dose is appropriate for you.
Pregabalin Capsules are for oral use only.
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 150mg and 600mg each day.
• Your doctor will tell you to take Pregabalin Capsules either twice
or three times a day. For twice a day take Pregabalin Capsules once
in the morning and once in the evening, at about the same time
each day. For three times a day take Pregabalin Capsules 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 Capsules 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 Capsules 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 Capsules until your doctor tells you to
stop.
If you take more Pregabalin Capsules 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 Capsules than you should.

Continued over page

If you forget to take Pregabalin Capsules
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 Capsules
Do not stop taking Pregabalin Capsules 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 Capsules 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 Capsules for
a longer period of time.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

• 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).
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, pharmacist or nurse.
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 Capsules

4. Possible side effects

Keep this medicine out of the sight and reach of children.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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.

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.
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,
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 (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.
Continued top of next column

AAAI7055

Do not store above 30°C.
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 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg or 300mg
pregabalin.
• The other ingredients are: mannitol, co-processed corn starch
(consisting of corn starch and pregelatinised corn starch), talc,
gelatine, titanium dioxide (E171) and black ink, (which contains
shellac, black iron oxide (E172), potassium hydroxide). The 75mg,
100mg, 200mg, 225mg and 300mg capsules also contain red iron
oxide (E172).
What Pregabalin Capsules looks like and contents of the pack
25mg capsules
50mg capsules

75mg capsules

White capsules, hard, size 4 (14.4 ± 0.4 mm),
with “PGB 25” marked on the body.
White capsules, hard, size 3 (15.8 ± 0.4 mm),
with “PGB 50” marked on the body. The capsule
body is marked with a black band.
White and orange capsules, hard, size 4
(14.4 ± 0.4 mm), with “PGB 75” marked on the
body.

100mg capsules

Orange capsules, hard, size 3 (15.8 ± 0.4 mm),
with “PGB 100” marked on the body.

150mg capsules

White capsules, hard, size 2 (17.8 ± 0.4 mm),
with “PGB 150” marked on the body.

200mg capsules

225mg capsules

300mg capsules

Light orange capsules, hard, size 1
(19.3 ± 0.4 mm), with “PGB 200” marked on the
body.
White and light orange capsules, hard, size 1
(19.3 ± 0.4 mm), with “PGB 225” marked on the
body.
White and orange capsules, hard, size 0
(21.4 ± 0.4 mm), with “PGB 300” marked on the
body.

Pregabalin Capsules 25mg are available in two pack sizes made of
PVC with an aluminium foil backing: 56 capsules pack and 84 capsules
pack.
Pregabalin Capsules 50mg, 100mg and 200mg are available in one
pack size made of PVC with an aluminium foil backing: 84 capsules
pack.
Pregabalin Capsules 75mg, 150mg, 225mg and 300mg are available
in one pack size made of PVC with an aluminium foil backing: 56
capsules pack.
Marketing Authorisation Holder
Caduceus Pharma Ltd
6th Floor
94 Wigmore Street
London
W1U 3RF
UK
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in February 2016.

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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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