Skip to Content

UK Edition. Click here for US version.

PREGABALIN TEVA 20 MG/ML ORAL SOLUTION

Active substance(s): PREGABALIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Pregabalin Teva 20 mg/ml
Oral Solution
Package leaflet:
Information for the user

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.

Other medicines and Pregabalin Teva
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Pregabalin Teva and certain other medicines
may influence each other (interaction). When
taken with certain other medicines, Pregabalin
Teva 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 Teva is taken
together with medicinal products containing:
• Oxycodone – (used as a pain-killer)
• Lorazepam – (used for treating anxiety)
• Alcohol.
Pregabalin Teva may be taken with oral
contraceptives.

Pregabalin Teva with food, drink and alcohol
It is advised NOT to drink alcohol while taking
1. What Pregabalin Teva is and what it is used
Pregabalin Teva.
for
2. What you need to know before you take
Pregnancy and breast-feeding
Pregabalin Teva
If you are pregnant or breast-feeding, think
3. How to take Pregabalin Teva
you may be pregnant or are planning to have
4. Possible side effects
a baby, ask your doctor or pharmacist for
5. How to store Pregabalin Teva
advice before taking this medicine.
6. Contents of the pack and other information
Pregabalin Teva should NOT be taken during
Pregabalin Teva is and what it pregnancy or when breast-feeding, unless
1 What
is used for
you are told otherwise by your doctor.
Effective contraception must be used by
Pregabalin Teva belongs to a group of
women of child-bearing potential.
medicines used to treat epilepsy and
Generalised Anxiety Disorder (GAD) in adults. Driving and using machines
Pregabalin Teva may produce dizziness,
Epilepsy: Pregabalin Teva is used to treat a
sleepiness and decreased concentration. You
certain form of epilepsy (partial seizures with
should NOT drive, operate complex machinery
or without secondary generalisation or engage in other potentially hazardous
epileptic fits starting on one specific part of
activities until you know whether this
the brain) in adults. Your doctor will prescribe
medicine affects your ability to perform these
Pregabalin Teva for you to help treat your
activities.
epilepsy when your current treatment is not
controlling your condition. You should take
Pregabalin Teva contains methyl
Pregabalin Teva in addition to your current
parahydroxybenzoate (E218) and propyl
treatment. Pregabalin Teva is not intended to parahydroxybenzoate (E216) which may
be used alone but should always be used in
cause allergic reactions (possibly delayed).
combination with other anti-epileptic
treatment.
3 How to take Pregabalin Teva
What is in this leaflet:

Generalised Anxiety Disorder: Pregabalin Teva
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.
Pregabalin which is contained in Pregabalin
Teva is also authorised to treat other
conditions which are not mentioned in this
leaflet. Ask your doctor or pharmacist if you
have further questions.

2

What you need to know before you
take Pregabalin Teva

(mg)

Volume Withdrawal Withdrawal Withdrawal
Rare side-effects which may affect up to 1 in
(ml)
(ml)
(ml)
(ml)

25

1.25

1.25

Not
required

Not
required

50

2.5

2.5

Not
required

Not
required

75

3.75

3.75

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

Not
required

Not
required

100

5

5

Your doctor will determine what dose is
appropriate for you.

Not
required

Not
required

150

7.5

5

2.5

Not
required

200

10

5

5

Not
required

225

11.25

5

5

1.25

300

15

5

5

5

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

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

If you have the impression that the effect of
Pregabalin Teva is too strong or too weak, talk
to your doctor or pharmacist.

Warnings and precautions
• 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
(falls) in elderly patients. Therefore, you
should be careful until you are used to any
effect the medicine might have.
• Pregabalin Teva 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.
• 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 Teva 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 Teva
have had thoughts of harming or killing
themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Pregabalin Teva 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 drug dependence. Let your
doctor know if you think you need 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 are an elderly patient (over 65 years of
age), you should take Pregabalin Teva
normally except if you have problems with
your kidneys.

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.

• 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
Note: Steps 4-7 may
Figure 7
consciousness, loss of consciousness,
need to be repeated
fainting, increased sensitivity to noise,
up to three times to
feeling unwell
obtain the total dose
• dry eyes, eye swelling, eye pain, weak eyes,
(Table 1).
watery eyes, eye irritation
[For example, a 150 mg
• heart rhythm disturbances, increased heart
(7.5 ml) dose will require
rate, low blood pressure, high blood
two withdrawals from the
pressure, changes in heart beat, heart
bottle to achieve the
failure
entire dose. Using the oral
• flushing, hot flushes
syringe, first withdraw
• difficulty breathing, dry nose, nasal
5 ml and empty contents
congestion
of syringe directly into the
• increased saliva production, heartburn,
mouth, then refill the oral
numb around mouth
syringe with 2.5 ml and
• sweating, rash, chills, fever
empty the remaining
• muscle twitching, joint swelling, muscle
contents into the mouth.]
stiffness, pain including muscle pain, neck
pain
8. Rinse the syringe by
Figure 8
• breast pain
drawing water into the
• difficulty with or painful urination,
syringe and pushing the
incontinence
syringe plunger to the

weakness, thirst, chest tightness
bottom of the syringe
• changes in blood and liver test results
barrel, at least three
(blood creatinine phosphokinase increased,
times (Figure 8).
alanine amino transferase increased,
9. Replace the closure on
aspartate aminotransferase increased,
the bottle (leaving the
platelet count decreased, neutropenia,
PIBA in place in the
increase in blood creatinine, decrease in
bottle neck) (Figure 9).
blood potassium)
Figure 9
• hypersensitivity, swollen face, itchiness,
Table 1 - Oral Syringe Withdrawals to
hives, runny nose, nose bleed, cough,
Deliver Prescribed Dose of Pregabalin Teva
snoring

painful menstrual periods
Pregabalin Total
Third
First
Second
• coldness of hands and feet.
Dose
Solution Syringe
Syringe
Syringe
7. Empty the contents of
the syringe directly into
mouth by pushing the
syringe plunger to the
bottom of the syringe
barrel (Figure 7).

Your doctor may prescribe a different dosing
schedule and/or dose if you have problems
with your kidneys.
Continue taking Pregabalin Teva until your
doctor tells you to stop.
Administration:
Instructions for use
Pregabalin Teva is for oral
use only and may be taken
with or without food.
1. Open the bottle: Press
downward on the closure
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).

Figure 1

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

Figure 2

4

Possible side effects

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

If you experience a swollen face or tongue or
if your skin turns red and starts to blister or
peel you should seek immediate medical
advice.
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 Teva

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 and bottle after
EXP. The expiry date refers to the last day of
that month.
Do not store above 30°C. Use this medicine
within 2 months of first opening the bottle.
Do not throw away any medicines via
wastewater. 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

Very common side-effects which may affect
more than 1 in 10 people:
• dizziness, drowsiness, headache.
Figure 3

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.

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

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
characterised by rash, blisters, peeling skin
and pain).

Figure 4

Figure 5

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).
Figure 6

What Pregabalin Teva contains
• The active substance is pregabalin. Each ml
contains 20 mg of pregabalin.
Common side-effects which may affect up to • The other excipients are methyl
1 in 10 people:
parahydroxybenzoate (E218), propyl
• increased appetite
parahydroxybenzoate (E216), monobasic
• feeling of elation, confusion, disorientation,
sodium phosphate anhydrous, disodium
changes in sexual interest, irritability
phosphate anhydrous, sucralose, artificial
• disturbance in attention, clumsiness,
strawberry flavour (contains natural
memory impairment, loss of memory,
flavouring substances and propylene glycol
tremor, difficulty with speaking, tingling
(E1520)) and purified water.
feeling, numbness, sedation, lethargy,
What Pregabalin Teva looks like and contents
insomnia, fatigue, feeling abnormal
of the pack
• blurred vision, double vision
Pregabalin Teva is a clear colourless oral
• vertigo, problems with balance, fall
solution with a strawberry odour in a bottle
• dry mouth, constipation, vomiting,
with
a child resistant closure containing
flatulence, diarrhoea, nausea, swollen
473
ml
of oral solution, in a cardboard carton.
abdomen
The carton also contains a graduated 5 ml
• difficulties with erection
oral syringe and a press-in bottle adapter
• swelling of the body including extremities
(PIBA).
• feeling drunk, abnormal style of walking
• weight gain
Marketing Authorisation Holder
• muscle cramp, joint pain, back pain, pain in
TEVA UK Limited,
limb
Eastbourne, BN22 9AG, UK
• sore throat.
Manufacturer
Uncommon side-effects which may affect up
Teva Operations Poland Sp. z.o.o., ul.
to 1 in 100 people:
Mogilska 80. Krakow 31-546, Poland
• loss of appetite, weight loss, low blood
sugar, high blood sugar
This leaflet was last revised in 04/2015.
• change in perception of self, restlessness,
PL 00289/1920
depression, agitation, mood swings,
difficulty finding words, hallucinations,
abnormal dreams, panic attack, apathy,
aggression, elevated mood, mental
impairment, difficulty with thinking,
problems with sexual functioning including
inability to achieve a sexual climax, delayed
ejaculation
20097-A
160 x 600

Expand view ⇕

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.

Hide