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GABAPENTIN ROSEMONT 50MG/ML ORAL SOLUTION

Active substance(s): GABAPENTIN

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joint pain, muscle pain, back pain, twitching
facial swelling, bruises, rash, itch, acne
difficulty with erection (impotence)
swelling in your legs and arms, difficulty with
walking, weakness, pain, feeling unwell, flu-like
symptoms
decrease in your white blood cells, increase in
weight
accidental injury, fracture, abrasion.







Additionally in clinical studies in children,
aggressive behaviour and jerky movements were
reported commonly.
Uncommon side effects (affects less than 1 in
100 people):
• allergic reactions such as hives
• decreased movement
• racing heartbeat
• swelling that may involve the face, trunk and
limbs
• abnormal blood test results suggesting
problems with the liver
• mental impairment
• fall
• increase in blood glucose levels (most often
observed in patients with diabetes)
• agitation (a state of chronic restlessness and
unintentional and purposeless motions.
Rare (may affect up to 1 in 1,000 people):
• decrease in blood glucose levels (most often
observed in patients with diabetes).
Not known (frequency cannot be estimated
from the available data):
• decreased platelets (blood clotting cells)
• hallucinations
• a group of side effects that could include
swollen lymph nodes (isolated small raised
lumps under the skin), fever, rash and
inflammation of your liver occurring together
• inflammation of the liver
• acute kidney failure, incontinence
• increased breast tissue, breast enlargement
• adverse events following the abrupt
discontinuation of gabapentin (anxiety, difficulty
sleeping, feeling sick, pain, sweating), chest
pain
• blood glucose fluctuations in patients with
diabetes
• change in blood test results (creatine phosphok
inase increased)
• problems with sexual functioning including
inability to achieve a sexual climax, delayed
ejaculation
• low blood sodium level.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed on this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App
Store. By reporting side effects, you can help
provide more information on the
safety of this medicine.
5. HOW TO STORE GABAPENTIN ROSEMONT







Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Discard 1 month after first opening.
Do not take Gabapentin after the expiry date
which is stated on the bottle label or carton.
The expiry date refers to the last day of the
month.

If your doctor tells you to stop taking this
solution, return any unused solution to your
pharmacist (chemist) for safe disposal. Only
keep this medicine if your doctor tells you to.
If the solution becomes discoloured or shows
any other signs of deterioration, you should
seek the advice of your pharmacist who will tell
you what to do.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines that are no longer
required. These measures will help to protect
the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

PATIENT INFORMATION LEAFLET

Gabapentin Rosemont 50mg/ml Oral Solution
(gabapentin)
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.

What Gabapentin contains
Each ml of solution contains 50mg of
gabapentin.
• The other ingredients are: acesulfame
potassium (E950), saccharin sodium, propylene
glycol (E1520), Methyl parahydroxybenzoate
(E218), Ethyl parahydroxybenzoate (E214).
carmellose sodium (E466), aniseed flavour and
purified water.

What is in this leaflet:
1. What Gabapentin is and what it is
used for
2. What you need to know before you take
Gabapentin
3. How to take Gabapentin
4. Possible side effects
5. How to store Gabapentin
6. Contents of the pack and other information

What Gabapentin looks like and contents of
the pack
• Gabapentin is a clear, colourless oral solution. It
comes in a brown glass bottle holding 150ml of
solution. In the pack there is also a 10ml oral
syringe, with markings at every 1ml and
intermediate marks at every 0.5ml.

1. WHAT GABAPENTIN IS AND WHAT IT IS
USED FOR



Manufacturer and Licence Holder
Manufactured by Rosemont Pharmaceuticals Ltd.,
Rosemont House, Yorkdale Industrial Park,
Braithwaite Street, LS11 9XE, Leeds, UK and
procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

PL 15184/1757 - Gabapentin Rosemont
50mg/ml Oral Solution

Leaflet revision date: 06/02/18

Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited, Tel: 01527
505414 to obtain the
leaflet in a format
suitable for you

Ref: 1757/060218/1/F

The name of your medicine is Gabapentin
50mg/ml Oral Solution (called Gabapentin in this
leaflet). Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage
to the nerves).
For epilepsy it is used:
• to treat various forms of epilepsy (seizures that
are initially limited to certain parts of the brain,
whether the seizure spreads to other parts of
the brain or not). Your doctor will prescribe
Gabapentin for you to help treat your epilepsy
when your current treatment is not fully
controlling your condition. You should take
Gabapentin in addition to your current treatment
unless told otherwise.
• Gabapentin can also be used on its own to treat
adults and children over 12 years of age.
For peripheral neuropathic pain (long lasting pain
caused by damage to the nerves).
• A variety of different diseases can cause
peripheral (primarily occurring in the legs and/or
arms) 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 etc.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE GABAPENTIN
Do not take this medicine if:
you are allergic (hypersensitive) to gabapentin
or any of the other ingredients (listed in Section
6). An allergic reaction can include a rash,
itching or shortness of breath.



Warnings and precautions
Talk to your doctor or pharmacist before taking
Gabapentin:
• if you suffer from kidney problems your doctor
may prescribe a different dosing schedule
• if you are on haemodialysis (to remove waste
products because of kidney failure), tell your
doctor if you develop muscle pain and/or
weakness
• if you develop signs such as persistent stomach
pain, feeling sick and being sick contact your
doctor immediately as these may be symptoms
of acute pancreatitis (an inflamed pancreas)
• if you have nervous system disorders,
respiratory disorders, or you are more than 65
years old, your doctor may prescribe you a
different dosing regimen.

Cases of abuse and dependence have been
reported for gabapentin from the post-marketing
experience. Talk to your doctor if you have a
history of abuse or dependence.
A small number of people taking epilepsy
medicines like Gabapentin have had thoughts of
harming or killing themselves. If at any time you
have these thoughts, talk to your doctor straight
away.
If any of the above apply to you (or you are not
sure), talk to your doctor or pharmacist before
taking Gabapentin.
Important Information about potentially serious
reactions
A small number of people taking Gabapentin get
an allergic reaction or potentially serious skin
reaction, which may develop into more serious
problems if they are not treated. You need to know
these symptoms to look out for while you are
taking Gabapentin.
Read the description of these symptoms in
section 4 of this leaflet under 'Contact your
doctor immediately if you experience any of the
following symptoms after taking this medicine as
they can be serious'.
Muscle weakness, tenderness or pain and
particularly, if at the same time, you feel unwell or
have a high temperature it may be caused by an
abnormal muscle breakdown which can be
life-threatening and lead to kidney problems. You
may also experience discoloration of your urine,
and a change in blood test results (notably blood
creatine phosphokinase increased). If you
experience any of these signs or symptoms,
please contact your doctor immediately.
Other medicines and Gabapentin
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
In particular, tell your doctor (or pharmacist) if you
are taking or have been recently taking any
medicines for convulsions, sleeping disorders,
depression, anxiety, or any other neurological or
psychiatric problems. This includes medicines
obtained without a prescription, including herbal
medicines. This is because Gabapentin can affect
the way some other medicines work. Also some
other medicines can affect the way Gabapentin
works.
Medicines containing opioids such as
morphine
In particular tell your doctor or pharmacist if you
are taking medicines containing opioids (such as
morphine), used for pain. This is because
morphine may increase the effect of Gabapentin.
In addition, combination of Gabapentin with
opioids may cause symptoms like sleepiness
and/or decrease in breathing.
Antacids for indigestion
If Gabapentin and antacids containing aluminium
and magnesium are taken at the same time,
absorption of Gabapentin from the stomach may
be reduced. It is therefore recommended that
Gabapentin is taken at the earliest two hours after
taking an antacid.
Gabapentin does not normally affect other
medicines for epilepsy or the oral contraceptive
pill.

Gabapentin may interfere with some laboratory
tests, if you require a urine test tell your doctor or
hospital that you are taking Gabapentin.
Gabapentin with food and drink
Gabapentin can be taken with or without food.

If you are an elderly patient (over 65 years of
age), you should take the normal dose of
Gabapentin 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.

Pregnancy, breast-feeding and fertility
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.

Continue taking Gabapentin until your doctor tells
you to stop.

Pregnancy
Gabapentin 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.

Measuring your dose using the oral syringe
provided
Your pack contains a plastic oral syringe to
measure the right amount of liquid prescribed for
you. The numbers up the side show how many
millilitres (mls) of liquid you have inside the
syringe.
1. Open the bottle: press the cap and turn it
anticlockwise (figure 1).
2. Insert the syringe adaptor into the bottle neck
(figure 2).
3. Take the syringe and put it in the adaptor
opening (figure 2).
4. Turn the bottle upside down (figure 3).
5. Fill the syringe with a small amount of solution
by pulling the piston down (figure 4A). Then
push the piston upward in order to remove any
possible bubbles (figure 4B). Finally, pull the
piston down to the graduation mark
corresponding to the quantity in millilitres (ml)
prescribed by your doctor (figure 4C).
6. Turn the bottle the right way up.
7. Remove the syringe from the adaptor. Put the
end of the syringe into your mouth and push the
piston slowly back in to take the medicine.
8. Wash the syringe with water and let it dry
before you use it again.

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 harm to the
developing baby, particularly when more than
one seizure medication is taken at the same time.
Therefore, whenever possible, you should try to
take only one seizure medication during
pregnancy and only under the advice of your
doctor.
Contact your doctor immediately if you become
pregnant, think you might be pregnant or are
planning to become pregnant while taking
Gabapentin. Do not suddenly discontinue taking
this medicine as this may lead to a breakthrough
seizure, which could have serious consequences
for you and your baby.
Breast-feeding
Gabapentin is passed on through human milk.
Because the effect on the baby is unknown, it is
not recommended to breast-feed while using
Gabapentin.

Method and route of administration
Gabapentin is for oral use.

Ask your doctor or pharmacist for advice before
taking any medicine.

3. HOW TO TAKE GABAPENTIN ROSEMONT
Always take this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Gabapentin Rosemont Oral Solution contains
50mg of gabapentin in each 1ml.
Your doctor will determine what dose is appropriate for you.
If you have the impression that the effect of
Gabapentin is too strong or too weak, talk to your
doctor or pharmacist as soon as possible.

For use with silicone, PVC and polyurethane NG
or PEG tubes only.
For epilepsy:
Adults and young people over 12 years old
• The usual starting dose is between 300mg and
900mg a day (6 to 18ml).
• This will be increased gradually by your doctor.
• The maximum dose is 3,600mg a day (72ml).
• Take the medicine in three separate doses:
once in the morning, once in the afternoon and
once in the evening.
Children aged 6 years old and above
• The doctor will decide the dose, depending on
your child’s weight.
• The treatment is started with a low starting dose
which is gradually increased over about three
days.
• The usual dose is 25 to 35mg for each kilogram
of body weight a day.
• It is usually given in three separate doses: once
in the morning, once in the afternoon and once
in the evening.
Gabapentin is not recommended for use in
children under 6 years old.
For peripheral neuropathic pain:
Adults
• The usual starting dose is between 300mg and
900mg a day (6 to 18ml).
• This will be increased gradually by your doctor.
• The maximum dose is 3,600mg a day (72ml).
• Take the medicine in three separate doses:
once in the morning, once in the afternoon and
once in the evening.
If you have kidney problems or are receiving
haemodialysis Your doctor may prescribe a
different dosing schedule and/or dose if you have
problems with your kidneys or are undergoing
haemodialysis.
If you feel that the effect of Gabapentin is too
strong or too weak, talk to your doctor or
pharmacist as soon as possible.

Fertility
There is no effect on fertility in animal studies.

Driving and using machines
Gabapentin 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.
Gabapentin Rosemont contains methyl and
ethyl parahydroxybenzoates, potassium and
sodium:
• methyl and ethyl parahydroxybenzoates - these
may cause an allergic reaction which may
happen some time after starting the medicine
• potassium (3.8mg in a 1ml dose) - if you have
kidney problems or are on a low potassium diet,
you need to take this into account
• sodium (0.72mg in 1ml dose) - if you are on a
low sodium diet, you need to take this into
account.

4. Flush the tube again with the minimum volume
of water.

If you take more Gabapentin than you should
• Higher than recommended doses may result in
an increase in side effects including loss of
consciousness, dizziness, double vision, slurred
speech, drowsiness and diarrhoea.
• Call your doctor or go to the nearest hospital
emergency unit immediately if you take more
Gabapentin than you should. Take the medicine
pack with you.

9. Close the bottle with the plastic screw cap.
This medicine can also be administered via
nasogastric (NG) or percutaneous endoscopic
gastrostomy (PEG) tubes only. There is further
information in the SmPC, ask your doctor,
pharmacist or nurse for this information.
Taking this medicine via NG or PEG tubes
The minimum volume of water that is required to
flush tube sizes 8 Fr and below is 5mL and for
tube sizes 10 Fr and above it is 10mL.
1. Ensure the tube is clear before taking the
medicine.
2. Flush the tube with the minimum volume of
water required.
3. Administer the medicine into the tube with a
suitable measuring device. The syringe
included in the pack is only for patients who are
able to swallow the medicine. HCPs
administering this product to patients via a NG
or PEG tube must use another suitable device.

If you forget to take Gabapentin
• If you forget a dose, take it as soon as you
remember. However, if it is nearly time for the
next dose, skip the missed dose.
• Do not take a double dose to make up for a
forgotten dose.
If you stop taking Gabapentin
• Do not stop taking Gabapentin unless your
doctor tells you to.
• If your treatment needs to be stopped, it should
be done gradually over a minimum of a week.
• If you stop taking Gabapentin suddenly or
before your doctor tells you, there is an
increased risk of seizures.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Contact your doctor immediately if you
experience any of the following symptoms
after taking this medicine as they can be
serious:
Common side-effects (affects less than 1 in 10
people):
• convulsions/fits
• pneumonia, respiratory infections.
• breathing problems, which if severe you may
need emergency and intensive care to continue
breathing normally.
Rare (may affect up to 1 in 1,000 people):
loss of consciousness.



Not known (frequency cannot be estimated
from the available data):
• Gabapentin may cause a “serious, potentially
life-threatening allergic reaction (anaphylaxis)
including difficulty breathing, swelling of the lips,
throat and tongue, and hypotension requiring
emergency treatment”. You may or may not
have a rash when you get this type of reaction.
It may cause you to be hospitalized or to stop
Gabapentin.
• persistent stomach pain, feeling sick and being
sick as these may be symptoms of acute
pancreatitis (an inflamed pancreas)
• skin rash, hives, fever, swollen glands that do
not go away, swelling of your lip and tongue
• yellowing of your skin or the whites of the eyes
• unusual bruising or bleeding, severe fatigue or
weakness
• unexpected muscle pain
• signs of frequent infections such as fever, flu
like symptoms and sore throat
• ringing in the ears
• problems with abnormal movements such as
writhing, jerking movements and stiffness.
These symptoms may be the first signs of a serious reaction. A doctor should examine you to
decide if you should continue taking Gabapentin.
If you are on haemodialysis, tell your doctor if you
develop muscle pain and/or weakness
Other side effects include:
Very common side-effects (affects more than 1
in 10 people):
• viral infection
• feeling drowsy, dizziness, lack of coordination
• feeling tired, fever.
Common side-effects (affects less than 1 in 10
people):
• urinary tract infections, inflammation of the ear
or other infections
• low white blood cell counts
• anorexia, increased appetite
• anger towards others, confusion, mood
changes, depression, anxiety, nervousness,
difficulty with thinking
• jerky movements, difficulty speaking, loss of
memory, tremor, 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 your
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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gabapentin can cause side
effects, although not everybody gets them.
The following side effects may happen with this
medicine:

Ref: 1751/060218/1/B

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