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AXALID 300MG HARD CAPSULES

Active substance(s): PREGABALIN

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CP.AXA.JNT.C.PHA.V2P1

If you take more Axalid than you should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or bottle
of Axalid capsules with you. You may feel sleepy,
confused, agitated, or restless as a result of taking
more Axalid than you should.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Axalid 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
200 mg, 225 mg & 300 mg HARD CAPSULES
(pregabalin)

If you forget to take Axalid
It is important to take your Axalid 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.

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 further questions, ask your doctor or your 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.

If you stop taking Axalid
Do not stop taking Axalid unless your doctor tells
you to. If your treatment is stopped it should be done
gradually over a minimum of 1 week.

WHAT IS IN THIS LEAFLET
1. What Axalid is and what it is used for
2. What you need to know before you take Axalid
3. How to take Axalid
4. Possible side effects
5. How to store Axalid
6. Contents of the pack and other information

1.

WHAT AXALID IS AND WHAT IT IS USED
FOR

Axalid belongs to a group of medicines used to treat
epilepsy, neuropathic pain and Generalised Anxiety
Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Axalid 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.

500 mm

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

Do not take Axalid
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, pharmacist or nurse before
taking Axalid.
• 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.
• Axalid 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.
• Axalid 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 Axalid 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 Axalid is taken with other medicines that
may cause constipation (such as some types of
pain medicines) it is possible that
gastrointestinal problems may occur (for
example, 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 drug

After stopping long and short-term Axalid treatment,
you need to know that you may experience certain
side effects. These include, trouble sleeping,
headache, nausea, feeling anxious, diarrhoea, flulike
symptoms, convulsions, nervousness, depression,
pain, sweating, and dizziness. These symptoms may
occur more commonly or severely if you have been
taking Axalid for a longer period of time.

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.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.

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

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.

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 extreme joy (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, lack of energy and enthusiasm
(lethargy), insomnia, fatigue, feeling abnormal.
• Blurred vision, double vision.
• Vertigo or problems with balance, fall.
• Dry mouth, constipation, vomiting, flatulence,
diarrhoea, nausea, swollen abdomen
• Difficulties with erection
• Swelling of the body including extremities.
• Feeling drunk, or abnormal style of walking.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in limb
• Sore throat

Other medicines and Axalid
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Axalid and certain other medicines may influence
each other (interaction). When taken with certain
other medicines, Axalid 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 Axalid is taken together with
medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Axalid may be taken with oral contraceptives.
Axalid with food, drink and alcohol
Axalid capsules may be taken with or without food.

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 (seeing or hearing
things which are not there), 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, fall, 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.

It is advised not to drink alcohol while taking Axalid
Pregnancy and breast-feeding
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.
Axalid 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.
Driving and using machines
Axalid 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 AXALID

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.
Axalid 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 Axalid either
twice or three times a day. For twice a day take
Axalid once in the morning and once in the
evening, at about the same time each day. For
three times a day take Axalid once in the
morning, once in the afternoon and once in the
evening, at about the same time each day.

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.

If you have the impression that the effect of Axalid 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 Axalid 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 Axalid until your doctor tells you to
stop.

Customer: Pharmathen Originated by: MAT (AWG)

Colours

Product: Axalid Capsules Joint PIL
Dimensions: 500mm x 170mm
Item Code: CP.AXA.JNT.C.PHA.V2P1
Date:

09/05/2017

Revision: Addition of new indications
ARTWORK FOR SUBMISSION
Supersedes: CP.AXA.JNT.C.PHA.V1P1

POSSIBLE SIDE EFFECTS

Pantone
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Proof: 1

• Interrupted menstrual periods.
• Kidney failure, reduced urine volume, urinary
retention.
• Decrease in white blood cell count.
• 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).
• Inappropriate behaviour.
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,
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 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 AXALID

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 “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 Axalid 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
pregabalin.
- The other ingredients are:
Capsule content: pregelatinized starch,
mannitol, talc
Capsule shell: gelatin, titanium dioxide (E171),
red Iron Oxide (E172) (only for 75 mg, 100 mg,
200 mg, 225 mg, 300 mg) and yellow iron oxide
(E172) (only for 200 mg, 225 mg).
Printing Ink: Shellac, black iron oxide (E172),
propylene glycol (E1520), ammonium hydroxide
(E527)
What Axalid looks like and contents of the pack
25 mg capsules: White hard capsules, marked with
"25" on the body.
50 mg capsules: White hard capsules, marked with
"50" on the body.
75 mg capsules: White and Swedish orange hard
capsules, marked with "75" on the body.
100 mg capsules: Swedish orange hard capsules,
marked with "100" on the body.
150 mg capsules: White hard capsules, marked with
"150" on the body.
200 mg capsules: Red hard capsules, marked with
"200" on the body.
225 mg capsules: Red and white hard capsules,
marked with "225" on the body.
300 mg capsules: White and orange hard capsules,
marked with "300" on the body.
Axalid is available in a cardboard box containing the
appropriate number of PVC /aluminium foil blisters
containing for:
25 mg 14 or 56 number of hard capsules
50 mg 7, 14 or 56 number of hard capsules
75 mg 14 or 56 number of hard capsules
100 mg 7, 14 or 56 number of hard capsules
150 mg 14 or 56 number of hard capsules
200 mg 14 or 56 number of hard capsules
225 mg 14 or 56 number of hard capsules
300 mg 14 or 56 number of hard capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Kent Pharmaceuticals Limited,
DCC Vital,
Westminister Industrial Estate,
Repton Road, Measham, Swadlincote,
Derbyshire, DE12 7DT, England
Manufacturer:
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture,
Block No 5, Rodopi 69300, Greece
or
PHARMATHEN S.A.
Dervenakion 6, Pallini 15351, Attikis, Greece
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Denmark, Cyprus, Greece, Italy: Prelynca
United Kingdom: Axalid
This leaflet was last revised in: May 2017

CP.AXA.JNT.C.PHA.V2P1

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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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