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PREGABALIN GENUS 20 MG/ML ORAL SOLUTION

Active substance(s): PREGABALIN / PREGABALIN / PREGABALIN

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Package Leaflet: Information for the user
Pregabalin Genus 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 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.

Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol

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

It is advised not to drink alcohol while taking Pregabalin Genus 20 mg/ml
oral solution.

1. What Pregabalin Genus 20 mg/ml oral solution is and what it
is used for
Pregabalin Genus 20 mg/ml oral solution belongs to a group of
medicines used to treat epilepsy and Generalised Anxiety Disorder
(GAD) in adults.
Epilepsy: Pregabalin Genus 20 mg/ml 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 Genus 20 mg/ml oral
solution for you to help treat your epilepsy when your current treatment
is not controlling your condition. You should take Pregabalin Genus
20 mg/ml oral solution in addition to your current treatment Pregabalin
Genus 20 mg/ml oral solution is not intended to be used alone, but
should always be used in combination with other anti-epileptic
treatment.
Generalised Anxiety Disorder: Pregabalin Genus 20 mg/ml 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 Genus
20 mg/ml oral solution
Do not take Pregabalin Genus 20 mg/ml 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 Genus
20 mg/ml oral solution
• 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 maybe taking other
medicines to treat, for example, pain or spascity, that have similar
side effects to Pregabalin Genus 20mg/ml oral solution 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 Genus 20 mg/ml 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 have had thoughts of harming or killing themselves. If at
any time you have these thoughts, immediately contact your doctor.

Pregabalin Genus 20 mg/ml oral solution may be taken with oral
contraceptives.
Pregabalin Genus 20 mg/ml oral solution with food, drink and
alcohol
Pregabalin may be taken with or without food.

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 Genus 20 mg/ml 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 Genus 20 mg/ml oral solution contains
Pregabalin Genus 20 mg/ml oral solution contains methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
which may cause allergic reactions (possibly delayed).
3. How to take Pregabalin Genus 20 mg/ml 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 Genus 20 mg/ml oral
solution either twice or three times a day. For twice a day take
Pregabalin Genus 20 mg/ml 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 Genus 20 mg/ml 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 Genus 20 mg/ml
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 Genus 20 mg/ml 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 Genus 20 mg/ml oral solution until your
doctor tells you to stop.
Administration:
Instructions for use
Pregabalin Genus 20 mg/ml oral solution is for oral use only.
1. Open the bottle: Press downward on the cap and turn it counterclockwise (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. If the PIBA is not already in place, remove the PIBA
and 5 ml oral syringe from the plastic overwrap. 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).

• 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.

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).
9. Replace the cap on the bottle (leaving the PIBA in place in the bottle
neck) (Figure 9).

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 Genus 20 mg/ml oral solution
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:
M960

Figure 2

Figure 1

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Table 1. Oral Syringe Withdrawals to Deliver Prescribed Dose of
Pregabalin Genus 20 mg/ml oral solution
Pregabalin
Genus
20 mg/ml
oral solution
Dose (mg)

Total
Solution
Volume
(ml)

25
50
75
100
150
200
225
300

1.25
2.5
3.75
5
7.5
10
11.25
15

Second
First
Third
Syringe
Syringe
Syringe
Withdrawal Withdrawal Withdrawal
(ml)
(ml)
(ml)
1.25
2.5
3.75
5
5
5
5
5

Not required
Not required
Not required
Not required
2.5
5
5
5

Not required
Not required
Not required
Not required
Not required
Not required
1.25
5

If you take more Pregabalin Genus 20 mg/ml oral solution than
you should
Call your doctor or go to the nearest hospital emergency unit immediately.
Take your box or bottle of Pregabalin Genus 20 mg/ml oral solution with
you. You may feel sleepy, confused, agitated, or restless as a result of
taking more Pregabalin Genus 20 mg/ml oral solution than you should.
Fits have also been reported.

• 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 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 Genus 20mg/ml 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 Genus 20 mg/ml oral solution
Keep this medicine out of the sight and reach of children.

If you forget to take Pregabalin Genus 20 mg/ml oral solution
It is important to take your Pregabalin 20 mg/ml 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 Genus 20 mg/ml oral solution
Do not stop taking Pregabalin Genus 20 mg/ml 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 Genus 20 mg/ml 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 Genus
20 mg/ml 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.

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.
Pregabalin Genus 20 mg/ml oral solution should be used within 60 days
of opening the bottle.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater. Ask your pharmacist
how to throw away medicines you no longer use. These measures will
help to protect the environment.
6. Contents of the pack and other information
What Pregabalin Genus 20 mg/ml 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 anhydrous,
disodium hydrogen phosphate anhydrous, sucralose, strawberry
flavouring 10131/P, purified water.

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
• 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

What Pregabalin Genus 20 mg/ml oral solution looks like and
contents of the pack
Pregabalin Genus 20 mg/ml oral solution is a clear colourless solution in a
white HDPE bottle containing 473 ml of oral solution, in a lithographed
cardboard carton. The carton also contains an oral syringe with 1.25ml
graduations and a total capacity of 5mls. A press-in bottle adapter is also
included.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Genus Pharmaceuticals Limited
T/A Genus Pharmaceuticals
Linthwaite
Huddersfield
HD7 5QH
UK
Manufacturer:
One Pharma S.A
60th km N. N. R.
Athinon-Lamias,
32 009 Sximatari Voiotias
Greece
This leaflet was last revised in June 2017

M960

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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