NEURONTIN 100MG CAPSULES

Active substance: GABAPENTIN

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Neurontin 100mg 300mg 400mg caps

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1225 1226 1227E

DATE OF PROOF:

16/05//14

DATE:

PROOF HISTORY:
v.2 - waymade - 16/05/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED APRIL 2013 REPORTING OF SIDE EFFECTS
Manufacturer name & eccipients

Pg 1

Pg 4

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Neurontin
Neurontin capsules should not be stored above 30°C and should be stored in the original packaging.
Do not use after the expiry date printed on the carton, label or blister strip. The expiry date refers to the last
day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal.
Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show signs of any deterioration, you should seek the advice of your
pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will help to protect the environment.

6. Further information
Your medicine is called Neurontin capsules. It is available in three strengths and each capsule contains either
100mg, 300mg or 400mg of the active ingredient gabapentin.
Neurontin 100mg capsules are white, hard gelatin capsules imprinted with 'Neurontin 100mg' and the PD logo.

NEURONTIN® 100mg CAPSULES
NEURONTIN® 300mg CAPSULES
NEURONTIN® 400mg CAPSULES
(gabapentin)
Patient Information Leaflet

This product is known as the above names but will be referred to as Neurontin throughout this leaflet. Please
note that the leaflet also contains information about another presentation and strengths of the medicine,
Neurontin 600mg and 800mg Tablets.
Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

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.
In this leaflet:
1. What Neurontin is and what it is used for
2. Before you take Neurontin
3. How to take Neurontin
4. Possible side effects
5. How to store Neurontin
6. Further information

Neurontin 300mg capsules are yellow, hard gelatin capsules imprinted with 'Neurontin 300mg' and the PD
logo.

1. What Neurontin is and what it is used for

Neurontin 400mg capsules are orange, hard gelatin capsules imprinted with 'Neurontin 400mg' and the PD
logo.

Neurontin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting
pain caused by damage to the nerves).
The active ingredient in Neurontin is gabapentin.

Neurontin capsules also contain the following inactive ingredients:
Capsule contents: Lactose monohydrate, maize starch and talc.
Capsule shell: gelatin, purified water and sodium lauryl sulphate.
The 100 mg capsules contain the colouring titanium dioxide (E171); the 300 mg capsules contain the
colourings titanium dioxide (E171) and yellow iron oxide (E172) and the 400mg capsules contain the
colourings titanium dioxide (E171) and red and yellow iron oxide (E172).
The printing ink used on all capsules contains: shellac, titanium dioxide (E171) and indigo carmine (E132).
Neurontin capsules, all strengths, are available as blister packs of 100 capsules.
POM

PL No: 6464/1225 100mg
PL No: 6464/1226 300mg
PL No: 6464/1227 400mg

These products are manufactured by Pfizer Manufacturing Deutschalnd GmbH, D-79090 Freiburg, Germany
and are procured from within the EU and repackaged by the Product Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 15.05.2014
Neurontin® is a registered trademark of Warner-Lambert Company.

Neurontin 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 Neurontin for you to
help treat your epilepsy when your current treatment is not fully controlling your condition. You
should take Neurontin in addition to your current treatment unless told otherwise. Neurontin can
also be used on its own to treat adults and children over 12 years of age.

Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). A variety of
different diseases can cause peripheral neuropathic pain (primarily occurring in the legs and/or
arms), 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. Before you take Neurontin
Do not take Neurontin

if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Neurontin
Take special care with Neurontin:

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)
A small number of people being treated with anti-epileptics such as gabapentin have had thoughts of harming
or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Important information about potentially serious reactions
A small number of people taking Neurontin 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 the symptoms to look out
for while you are taking Neurontin.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Medicines containing morphine
If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may
increase the effect of Neurontin.
Antacids for indigestion
If Neurontin and antacids containing aluminium and magnesium are taken at the same time, absorption of
Neurontin from the stomach may be reduced. It is therefore recommended that Neurontin is taken at the
earliest two hours after taking an antacid.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PRE-PRESS NO.:

02-1808

PRODUCT:

Neurontin 100mg 300mg 400mg caps

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1225 1226 1227E

DATE OF PROOF:

16/05/14

DATE:

PROOF HISTORY:
v.2 - waymade - 16/05/14

DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED APRIL 2013 REPORTING OF SIDE EFFECTS
Manufacturer name & eccipients

Pg 2

Neurontin:

is not expected to interact with other antiepileptic drugs or the oral contraceptive pill.

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

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If you stop taking Neurontin
Do not stop taking Neurontin unless your doctor tells you to. If your treatment is stopped it should be done
gradually over a minimum of 1 week. If you stop taking Neurontin 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.

4. Possible side effects

Pregnancy
Neurontin 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 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 Neurontin. 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, the active substance of Neurontin, is passed on through human milk. Because the effect on the
baby is unknown, it is not recommended to breast-feed while using Neurontin.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Neurontin 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.
Important information about some of the ingredients of Neurontin
Neurontin hard capsules contain lactose (a type of sugar). If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Neurontin
Always take Neurontin exactly as your doctor has told you. You should check with your doctor or pharmacist if
you are not sure.
Your doctor will determine what dose is appropriate for you.
If you have the impression that the effect of Neurontin is too strong or too weak, talk to your doctor or
pharmacist as soon as possible.
If you are an elderly patient (over 65 years of age), you should take the normal dose of Neurontin 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.
Continue taking Neurontin until your doctor tells you to stop.
Method and route of administration
Neurontin is for oral use. Always swallow the capsules or tablets with plenty of water. The tablet can be divided
into equal halves.
Epilepsy, the usual dose is:
Adults and adolescents:
Take the number of capsules or 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 weight per day. It is usually given in 3
separate doses, by taking the capsule(s) or tablet(s) each day, usually once in the morning, once in the
afternoon and once in the evening.
Neurontin is not recommended for use in children below 6 years of age.
Peripheral Neuropathic Pain, the usual dose is:
Adults:
Take the number of capsules or tablets as instructed by your doctor. 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.
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 take more Neurontin 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 Neurontin than your doctor prescribed. Take along any
capsules or tablets that you have not taken, together with the container and the label so that the hospital can
easily tell what medicine you have taken.
If you forget to take Neurontin
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a
double dose to make up for a forgotten dose.

Like all medicines, Neurontin can cause side effects, although not everybody gets them:
Contact your doctor immediately if you experience any of the following symptoms after taking this
medicine as they can be serious:

severe skin reactions that require immediate attention, swelling of the lips and face, skin rash and
redness and/or hair loss (these may be symptoms of a serious allergic reaction)

persistent stomach pain, feeling sick and being sick as these may be symptoms of acute
pancreatitis (an inflamed pancreas)

Neurontin may cause a serious or life-threatening allergic reaction that may affect your skin or other
parts of your body such as your liver or blood cells. You may or may not have rash when you get
this type of reaction. It may cause you to be hospitalized or to stop Neurontin. 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 Neurontin.
If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common side-effects (which may affect more than 1 person in 10):

Viral infection

Feeling drowsy, dizziness, lack of coordination

Feeling tired, fever
Common side-effects (which may affect more than 1 person in 100)

Pneumonia, respiratory infections, urinary tract infection, 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

Convulsions, jerky movements, difficulty with 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 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
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported
commonly.
Uncommon side effects (which may affect more than 1 person in a 1000):

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
Since introduction to the market the following side-effects have been reported:

Decreased platelets (blood clotting cells)

Hallucinations

Problems with abnormal movements such as writhing, jerking movements and stiffness

Ringing in the ears

A group of side effects that could include swollen lymph nodes (isolated small raised lumps under
the skin), fever, rash, and inflammation of liver occurring together

Yellowing of the skin and eyes (jaundice), 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

Breakdown of muscle fibres (rhabdomyolysis)

Change in blood test results (creatine phosphokinase increased)
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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