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PREGABALIN FOCUS 20 MG/ML ORAL SOLUTION

Active substance(s): PREGABALIN

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Package leaflet: Information for the user

Pregabalin Focus 20 mg/ml oral solution
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 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.
What is in this leaflet:
1. What Pregabalin oral solution is and what it is
used for
2. What you need to know before you take
Pregabalin oral solution
3. How to take Pregabalin oral solution
4. Possible side effects
5. How to store Pregabalin oral solution
6. Contents of the pack and other information

1. What Pregabalin oral solution is and what it is
used for
Pregabalin oral solution belongs to a group of
medicines used to treat epilepsy and Generalised
Anxiety Disorder (GAD) in adults.

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

Generalised Anxiety Disorder: Pregabalin oral
solution 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 oral solution

Do not take Pregabalin oral solution
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 oral solution.
• Some patients taking Pregabalin oral solution
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 oral solution 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 oral solution 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 oral solution;
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 oral
solution. If while taking Pregabalin oral solution
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 oral solution
have had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Pregabalin oral solution 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 oral solution or shortly after
stopping Pregabalin oral solution. If you
experience a convulsion, contact your doctor
immediately.
• There have been reports of reduction in brain
function (encephalopathy) in some patients
taking Pregabalin oral solution 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 oral solution
Please tell your doctor or pharmacist if you are
taking, have recently taken any other medicines,
including medicines obtained without a
prescription.
Pregabalin oral solution and certain other
medicines may influence each other (interaction).
When taken with certain other medicines,
Pregabalin oral solution 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 oral solution is
taken together with medicinal products
containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin oral solution may be taken with oral
contraceptives.
Pregabalin oral solution with food, drink and
alcohol
Pregabalin oral solution may be taken with or
without food.
It is advised not to drink alcohol while taking
Pregabalin oral solution

Pregnancy and breast-feeding
Pregabalin oral solution 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 oral solution 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 oral solution contains
Pregabalin oral solution oral solution contains
methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).

3. How to take Pregabalin oral solution
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.
Epilepsy or Generalised Anxiety Disorder:
• Take the solution as instructed by your doctor.
• The dose, which has been adjusted for you and
your condition, will generally be between 150
mg (7.5 ml) and 600 mg (30 ml) each day.
• Your doctor will tell you to take Pregabalin oral
solution either twice or three times a day. For
twice a day take Pregabalin oral solution once
in the morning and once in the evening, at
about the same time each day. For three times
a day take Pregabalin oral solution 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 oral solution 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 oral solution 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.

Continue taking Pregabalin oral solution until your
doctor tells you to stop.

Administration:
Instructions for use
Pregabalin oral solution is for oral use only.
1. Open the bottle: Press downward on the cap
and turn it counter-clockwise (Figure 1).
2. First time use only: A Press-In Bottle Adapter
(PIBA) is provided with the oral syringe. This is the
device that gets inserted into the neck of the
bottle to make it easier to withdraw the solution
using the oral syringe. With the bottle on a flat
surface, insert the PIBA into the bottle neck while
keeping the PIBA’s flat surface facing up and
pressing on it (Figure 2).
3. Push the syringe plunger to the bottom of the
barrel of the syringe (toward its tip) to remove
excess air. Attach the syringe to the PIBA with a
slight twisting motion (Figure 3).
4. Invert the bottle (with the syringe attached) and
fill the syringe with the liquid by pulling the
syringe plunger down to just beyond the
graduation mark corresponding to the quantity
in millilitres (ml) prescribed by your doctor
(Figure 4). Remove air bubbles from the syringe
by pushing the plunger up to the appropriate
graduation mark.
5. Return the bottle to an upright position with the
syringe still in the PIBA/bottle (Figure 5).
6. Remove the syringe from the bottle/PIBA (Figure 6).
7. Empty the contents of the syringe directly into
mouth by pushing the syringe plunger to the
bottom of the syringe barrel (Figure 7).
Note: Steps 4-7 may need to be repeated up to
three times to obtain the total dose (Table 1).
[For example, a 150 mg (7.5 ml) dose will require
two withdrawals from the bottle to achieve the
entire dose. Using the oral syringe, first withdraw 5
ml and empty contents of syringe directly into the
mouth, then refill the oral syringe with 2.5 ml and
empty the remaining contents into the mouth.]
8. Rinse the syringe by drawing water into the
syringe and pushing the syringe plunger to the
bottom of the syringe barrel, at least three times
(Figure 8).

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

175 x 500 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

06/05/2016
8 pt

9. Replace the cap on the bottle (leaving the PIBA
in place in the bottle neck) (Figure 9).
Table 1. Oral syringe withdrawals to Deliver
Prescribed Dose of Pregabalin 20mg/ml oral
solution

Total
First
Second
Third
Lyrica
Solution Syringe
Syringe
Syringe
Dose
Volume Withdrawal Withdrawal Withdrawal
(mg)
(ml)
(ml)
(ml)
(ml)
Not
required

Not
required

Not
required

Not
required

25

1.25

1.25

50

2.5

2.5

75

3.75

3.75

100

5

5

Not
required

150

7.5

5

2.5

200

10

5

5

Not
required

225

11.25

5

5

1.25

300

15

5

5

5

Not
required

Not
required
Not
required
Not
required

If you take more Pregabalin oral solution than you
should
Call your doctor or go to the nearest hospital
emergency unit immediately. Take your box or
bottle of Pregabalin oral solution with you. You may
feel sleepy, confused, agitated, or restless as a
result of taking more Pregabalin oral solution than
you should.
If you forget to take Pregabalin oral solution
It is important to take your Pregabalin oral solution
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 oral solution
Do not stop taking Pregabalin oral solution 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 oral
solution 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 oral solution 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 1in 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 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 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
• Decrease in white blood cell count
• Inappropriate behavior
• 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 oral solution 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 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 oral solution
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 bottle. The expiry
date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.

After first opening do not store above 25°C and use
within 3 months.
Do not throw away medicine via wastewater. Ask
your pharmacist how to throw away medicine you
no longer use. These measures will help to protect
the environment.
6. Contents of the pack and other information

What Pregabalin oral solution contains
The active substance is pregabalin. Each ml
contains 20 mg of pregabalin.
The other ingredients are: methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), sodium dihydrogen
phosphate dihydrate, disodium phosphate,
anhydrous (E339), sucralose (E955), strawberry
flavor, sodium hydroxide 1N (for pH adjustment),
purified water.

What Pregabalin oral solution looks like and
contents of the pack
Pregabalin oral solution 20 mg/ml oral solution is a
clear colourless solution with characteristic
strawberry odour in white HDPE bottles containing
250 ml of oral solution, in a cardboard carton. The
carton contains two HDPE bottles of 250 ml nominal
capacity with HDPE - lined tamper evident and
child-resistant screw caps. The carton also contains
a 5 ml, CE marked oral syringe with intermediate
graduations of 0.25 ml and two press-in bottle
adaptors (PIBA).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Focus Pharmaceuticals Ltd.,
Capital House, 85 King William Street
London, EC4N 7BL, United Kingdom

Manufacturer:
Anfarm Hellas SA Sximatari Viotias,32009, Greece
Tel:+30.22620.58678 / +30.22620.58391
fax: +30.22620.58392
This medicinal product is authorized in the Member
States of the EEA under the following names:
United Kingdom: Pregabalin Focus 20mg/ml oral
solution
Malta: Pregabalin 20mg/ml oral solution
This leaflet was last revised in April 2016.

103536/LF/046/01

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

175 x 500 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

06/05/2016
8 pt

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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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