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YOUZAIN 800 MG FILM-COATED TABLETS

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

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YOUZAIN 600 mg AND 800 mg
FILM-COATED TABLETS
gabapentin

In addition, combination of Youzain with
opioids may cause symptoms like sleepiness
and/or decrease in breathing.

Package leaflet:
Information for the user

Antacids for indigestion
If Youzain and antacids containing aluminium
and magnesium are taken at the same time,
Read all of this leaflet carefully before you
start taking this medicine because it contains absorption of Youzain from the stomach may
be reduced. It is therefore recommended that
important information for you.
Youzain is taken at the earliest two hours
• Keep this leaflet. You may need to read it
after taking an antacid.
again.
• If you have any further questions, ask your Youzain:
• is not expected to interact with other
doctor or pharmacist.
antiepileptic medicines or the oral
• This medicine has been prescribed for you
contraceptive pill
only. Do not pass it on to others. It may
harm them, even if their symptoms are the • may interfere with some laboratory tests; if
you require a urine test, tell your doctor or
same as yours.
hospital what you are taking.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
Pregnancy, breast-feeding and fertility
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:

1. What Youzain Film-coated Tablets is and
what it is used for
2. What you need to know before you take
Youzain Film-coated Tablets
3. How to take Youzain Film-coated Tablets
4. Possible side effects
5. How to store Youzain Film-coated Tablets
6. Contents of the pack and other information

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.
Pregnancy
Youzain should not be taken during
pregnancy, unless you are told otherwise by
your doctor. Effective contraception must be
used by women of child-bearing potential.

There have been no studies specifically
looking at the use of gabapentin in pregnant
women, but other medications used to treat
seizures have reported an increased risk of
Youzain belongs to a group of medicines
harm to the developing baby, particularly
used to treat epilepsy and peripheral
when more than one seizure medication is
neuropathic pain (long lasting pain caused by taken at the same time. Therefore, whenever
damage to the nerves). The active substance possible, you should try to take only one
in Youzain is gabapentin.
seizure medication during pregnancy and
only under the advice of your doctor.
Youzain is used to treat:
• various forms of epilepsy (seizures that are Contact your doctor immediately if you
initially limited to certain parts of the brain, become pregnant, think you might be pregnant
whether the seizure spreads to other parts or are planning to become pregnant while
of the brain or not). Your doctor will
taking Youzain. Do not suddenly discontinue
prescribe Youzain for you to help treat your taking this medicine as this may lead to a
epilepsy when your current treatment is not breakthrough seizure, which could have
fully controlling your condition. You should serious consequences for you and your baby.
take Youzain in addition to your current
Breast-feeding
treatment unless told otherwise. Youzain
can also be used on its own to treat adults Gabapentin, the active substance of Youzain,
is passed on through human milk. Because
and adolescents over 12 years of age
the effect on the baby is unknown, it is not
• peripheral neuropathic pain (long lasting
recommended to breast-feed while using
pain caused by damage to the nerves). A
Youzain.
variety of different diseases can cause
peripheral neuropathic pain (primarily
occurring in the legs and/or arms), such as Fertility
There is no effect on fertility in animal studies
diabetes or shingles. Pain sensations may

1

What Youzain Film-coated Tablets is
and what it is used for

be described as hot, burning, throbbing,
shooting, stabbing, sharp, cramping,
aching, tingling, numbness, pins and
needles, etc.

2

What you need to know before you
take Youzain Film-coated Tablets

Do not take Youzain if you:
• are allergic to gabapentin or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Youzain if you:
• suffer from kidney problems, your doctor
may prescribe a different dosing schedule
• are on haemodialysis (to remove waste
products because of kidney failure), tell
your doctor if you develop muscle pain
and/or weakness
• develop signs such as persistent stomach
pain, feeling and being sick contact your
doctor immediately as these may be
symptoms of acute pancreatitis (an
inflamed pancreas).
Cases of abuse and dependence have been
reported for gabapentin from post-marketing
experience. Talk to your doctor if you have a
history of abuse or dependence.

Driving and using machines
Youzain may produce dizziness, drowsiness
and tiredness. You should not drive, operate
complex machinery or take part in other
potentially hazardous activities until you
know whether this medication affects your
ability to perform these activities.

3

How to take Youzain Film-coated
Tablets

Always take this medicine exactly as your
doctor or pharmacist 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 - the recommended dose is
Adults and adolescents:
Take the number of tablets as instructed. Your
doctor will usually build up your dose gradually.
The starting dose will generally be between
300 mg and 900 mg each day. Thereafter, the
dose may be increased as instructed by your
doctor, up to a maximum of 3600 mg each
day and your doctor will tell you to take this
in 3 separate doses, i.e. once in the morning,
once in the afternoon and once in the evening.

Children aged 6 years and above:
The dose to be given to your child will be
decided by your doctor as it is calculated
against your child’s weight. The treatment is
started with a low initial dose which is
gradually increased over a period of
approximately 3 days. The usual dose to
control epilepsy is 25-35 mg per kg of body
Important information about potentially
weight per day. It is usually given in 3
serious reactions
separate doses, by taking the tablet(s) each
A small number of people taking Youzain get day, usually once in the morning, once in the
an allergic reaction or potentially serious skin afternoon and once in the evening.
reaction, which may develop into more
Youzain is not recommended for use in
serious problems if they are not treated. You
children below 6 years of age.
need to know the symptoms to look out for
while you are taking Youzain.
Peripheral Neuropathic Pain - the
recommended dose is
Read the description of these symptoms in
section 4 of this leaflet under ‘Contact your
Adults:
doctor immediately if you experience any of
Take the number of tablets as instructed by
the following symptoms after taking this
your doctor. Your doctor will usually build up
medicine as they can be serious’.
your dose gradually. The starting dose will
generally be between 300 mg and 900 mg
Muscle weakness, tenderness or pain and
each day. Thereafter, the dose may be
particularly, if at the same time, you feel
increased as instructed by your doctor, up to
unwell or have a high temperature, it may be a maximum of 3600 mg each day and your
caused by an abnormal muscle breakdown
doctor will tell you to take this in 3 separate
which can be life-threatening and lead to
doses, i.e. once in the morning, once in the
kidney problems. You may also experience
afternoon and once in the evening.
discolouration of your urine, and a change in
blood test results (notably blood creatine
For doses not realisable/practicable with this
phosphokinase increased). If you experience medicinal product other medicinal products
any of these signs or symptoms, please
are available.
contact your doctor immediately.
If you have kidney problems or are receiving
Other medicines and Youzain
haemodialysis
Your doctor may prescribe a different dosing
Tell your doctor or pharmacist if you are
schedule and/or dose if you have problems
taking, have recently taken or might take any with your kidneys or are undergoing
other medicines.
haemodialysis.
A small number of people being treated with
antiepileptics such as gabapentin have had
thoughts of harming or killing themselves. If
at any time you have these thoughts, contact
your doctor immediately.

Medicines containing opioids such as
morphine
If you are taking any medicines containing
opioids (such as morphine), please tell your
doctor or pharmacist as opioids may increase
the effect of Youzain.

If you are an elderly patient (over 65 years of
age), you should take the normal dose of
Youzain unless you have problems with your
kidneys. Your doctor may prescribe a different
dosing schedule and/or dose if you have
problems with your kidneys.

24-Nov-2016

Additionally in clinical studies in children,
If you have the impression that the effect of
Youzain is too strong or too weak, talk to your aggressive behaviour and jerky movements
were reported commonly.
doctor or pharmacist as soon as possible.
Uncommon: may affect up to 1 in 100 people
• allergic reaction such as hives
• decreased movement
• racing heartbeat
• swelling that may involve the face, trunk
and limbs
Youzain can be taken with or without food.
• abnormal blood test results suggesting
problems with the liver
Continue taking Youzain until your doctor tells
• mental impairment
you to stop.
• fall
If you take more Youzain than you should
• increase in blood glucose levels (most often
observed in patients with diabetes).
Higher than recommended doses may result
in an increase in side effects including loss of Rare: may affect up to 1 in 1,000 people
consciousness, dizziness, double vision,
• loss of consciousness
slurred speech, drowsiness and diarrhoea.
• decrease in blood glucose levels (most
Call your doctor or go to the nearest hospital
often observed in patients with diabetes)..
emergency unit immediately if you take more
After marketing gabapentin, the following
Youzain than your doctor prescribed. Take
side effects have been reported:
along any tablets that you have not taken,
• decreased platelets (blood clotting cells)
together with the blister and the carton so
that the hospital can easily tell what medicine • hallucinations
• problems with abnormal movements such
you have taken.
as writhing, jerking movements and
If you forget to take Youzain
stiffness
• ringing in the ears
If you forget to take a dose, take it as soon as • a group of side effects that could include
you remember unless it is time for your next
swollen lymph nodes (isolated small raised
dose.
lumps under the skin), fever, rash, and
Do not take a double dose to make up for a
inflammation of liver occurring together
forgotten dose.
• yellowing of the skin and eyes (jaundice),
inflammation of the liver
If you stop taking Youzain
• acute kidney failure, incontinence

increased
breast tissue, breast enlargement
Do not stop taking Youzain unless your doctor
• adverse events following the abrupt
tells you to. If your treatment is stopped it
discontinuation of gabapentin (anxiety,
should be done gradually over a minimum of
difficulty sleeping, feeling sick, pain,
1 week. If you stop taking Youzain suddenly or
sweating), chest pain
before your doctor tells you, there is an
• breakdown of muscle fibers
increased risk of seizures.
(rhabdomyolysis)
If you have any further questions on the use
• change in blood test results (creatine
of this medicine, ask your doctor or pharmacist.
phosphokinase increased)
• problems with sexual functioning including
inability to achieve a sexual climax, delayed
4 Possible side effects
ejaculation
• low blood sodium level.
Like all medicines, this medicine can cause
Method of administration

Youzain is for oral use. Always swallow the
tablets whole with plenty of water (e.g. a
glass of water).

side effects, although not everybody gets
them.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
Contact your doctor immediately if you
effects not listed in this leaflet. You can also
experience any of the following symptoms
report side effects directly via the Yellow Card
after taking this medicine as they can be
Scheme at: www.mhra.gov.uk/yellowcard
serious:
By reporting side effects you can help provide
• severe skin reactions that require
more information on the safety of this
immediate attention, swelling of the lips
and face, skin rash and redness, and/or hair medicine.
loss (these may be symptoms of a serious
to store Youzain Film-coated
allergic reaction)
5 How
Tablets
• persistent stomach pain, feeling and being
sick as these may be symptoms of acute
Keep this medicine out of the sight and reach
pancreatitis (an inflamed pancreas)
of children.
• Youzain may cause a serious or
life-threatening allergic reaction that may
Do not use this medicine after the expiry date
affect your skin or other parts of your body which is stated on the carton after EXP. The
such as your liver or blood cells. You may or expiry date refers to the last day of that
may not have rash when you get this type
month.
of reaction. It may cause you to be
hospitalised or to stop Youzain.
Do not store above 30°C.
Call your doctor right away if you have any of
the following symptoms:
• skin rash
• hives
• fever
• swollen glands that do not go away
• swelling of your lip and tongue
• yellowing of your skin or of the whites of
the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections.
These symptoms may be the first signs of a
serious reaction. A doctor should examine
you to decide if you should continue taking
Youzain.

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 Youzain Film-coated Tablets contains
The active substance is gabapentin.
Each 600 mg film-coated tablet contains
600 mg gabapentin.
Each 800 mg film-coated tablet contains
800 mg gabapentin.

The other ingredients in Youzain Film-coated
Tablets are:
If you are on haemodialysis, tell your doctor if Tablet core: Copovidone, cellulose
microcrystalline, crospovidone (Type A), talc,
you develop muscle pain and/or weakness.
magnesium stearate.
Other side effects include:
Film-coating: polyvinyl alcohol, talc,
macrogol 3350, titanium dioxide (E171).
Very common: may affect more than 1 in 10
people
What Youzain Film-coated Tablets looks like
• viral infection
and contents of the pack
• feeling drowsy, dizziness, lack of
Each 600 mg tablet is a white to off white,
coordination
oval shaped bevelled edge film-coated tablet.
• feeling tired, fever.
One side engraved “7173” and on the other
Common: may affect up to 1 in 10 people
side engraved “93”. Dimensions:
• pneumonia, respiratory infections, urinary approximately 19.5 x 9.5 mm.
tract infection, inflammation of the ear or
Each 800 mg tablet is a white to off white,
other infections
oval shaped bevelled edge film-coated tablet.
• low white blood cell counts
One side engraved “7174” and on the other
• anorexia, increased appetite
side engraved “93”. Dimensions:
• anger towards others, confusion, mood
approximately 21.5 x 10.5 mm.
changes, depression, anxiety, nervousness,
Supplied in blisters of 30, 50, 90, 100 and 200
difficulty with thinking
tablets.
• convulsions, jerky movements, difficulty
with speaking, loss of memory, tremor,
Not all pack sizes may be marketed.
difficulty sleeping, headache, sensitive skin,















decreased sensation (numbness), difficulty
with coordination, unusual eye movement,
increased, decreased or absent reflexes
blurred vision, double vision
vertigo
high blood pressure, flushing or dilation of
blood vessels
difficulty breathing, bronchitis, sore throat,
cough, dry nose
vomiting (being sick), nausea (feeling sick),
problems with teeth, inflamed gums,
diarrhoea, stomach pain, indigestion,
constipation, dry mouth or throat,
flatulence
facial swelling, bruises, rash, itch, acne
joint pain, muscle pain, back pain, twitching
difficulties with erection (impotence)
swelling in the legs and arms, difficulty
with walking, weakness, pain, feeling
unwell, flu-like symptoms
decrease in white blood cells, increase in
weight
accidental injury, fracture, abrasion.

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Gyógyszergyár Zrt., Pallagi út 13,
Debrecen, 4042, Hungary
This leaflet was last revised in 11/2016
PL 00289/2020
PL 00289/2021

12345-A

24-Nov-2016

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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