Skip to Content

GABAPENTINE AMNEAL 300 MG CAPSULES

Active substance(s): GABAPENTIN

View full screen / Print PDF » Download PDF ⇩
Transcript
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 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

1. What Gabapentin is and what it is used for
Gabapentin 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 substance in Gabapentin is gabapentin.
Gabapentin 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 adolescents 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. What you need to know before you take Gabapentin
Do not take Gabapentin
• 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 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)
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.

PM-0000

Gabapentin hard capsules

PM-0000

Gabapentin hard capsules

Package leaflet: Information for the user

Gabapentin Amneal 100 mg hard capsules
Gabapentin Amneal 300 mg hard capsules
Gabapentin Amneal 400 mg hard capsules

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:
• 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.
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.
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.
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.
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.

3. How to take Gabapentin
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 capsules 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) each
day, usually once in the morning, once in the afternoon and once in the
evening.

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, immediately contact your doctor.

Gabapentin is not recommended for use in children below 6 years of age.

Important information about potentially serious reactions

Adults:
Take the number of capsules 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.

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 the symptoms to look out
for while you are taking Gabapentin.
Read the description of these symptoms in section 4 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
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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
Gabapentin. In addition, combination of Gabapentin with opioids may cause
symptoms like sleepiness and/or decrease in breathing.

Peripheral Neuropathic Pain, the recommended dose is

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.
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 have the impression that the effect of Gabapentin is too strong or too
weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin is for oral use. Always swallow the capsules with plenty of water.
Gabapentin can be taken with or without food.
Continue taking Gabapentin until your doctor tells you to stop.

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 your doctor
prescribed. Take along any capsules that you have not taken, together with
the carton and the blister so that the hospital can easily tell what medicine
you have taken.
If you forget to take Gabapentin
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.
If you stop taking Gabapentin
Do not stop taking Gabapentin 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 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.

4. Possible side effects
Like all medicines, this medicine 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)
• Gabapentin 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 Gabapentin.
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

After marketing Gabapentin 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,
• breakdown of muscle fibers (rhabdomyolysis)
• change in blood test results (creatine phosphokinase increased)
• problems with sexual functioning including inability to achieve a sexual
climax, delayed ejaculation
• low blood sodium level
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 MHRA Yellow Card Scheme, Website:
www.mhra.goc.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Gabapentin
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
after ‘EXP’. The expiry date refers to the last day of that month.
This medicine 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 protect the environment.

6. Contents of the pack and other information
What Gabapentin contains
• The active substance is gabapentin. Each capsule contains 100 mg,
300 mg or 400 mg gabapentin.
• The other ingredients are:
Capsule Contents:
Pregelatinized Maize Starch, Talc, Magnesium stearate

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.

Capsule shell:
Gelatin, Titanium dioxide (E171), Iron oxide yellow (E172) (for 300 mg and
400 mg), Iron oxide red (E172) (for 400 mg)

Other side effects include:

Printing ink
Shellac, Iron oxide black (E172), Propylene glycol (E1520), Ammonium
hydroxide (E527)

Very common (may affect more than 1 in 10 people):
• viral infection
• feeling drowsy, dizziness, lack of coordination
• feeling tired, fever
Common (may affect up to 1 in 10 people):
• 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 (feeling of dizziness or “spinning”)
• 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 (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
• abnormal blood test results suggesting problems with the liver
• mental impairment
• fall
• increase in blood glucose levels (most often observed in patients with
diabetes)
Rare (may affect up to 1 in 1,000 people):
• loss of consciousness
• decrease in blood glucose levels (most often observed in patients with
diabetes)

What Gabapentin looks like and contents of the pack
Gabapentin 100 mg hard capsules: White opaque hard gelatin capsules, Size
3 (length 15.7 ±0.4 mm), imprinted with "Amneal" on cap and “100 mg
Gabapentin" on body and filled with white to off white powder.
Gabapentin 300 mg hard capsules: Yellow, opaque hard gelatin capsules,
Size 1(length 19.1 ±0.4 mm), imprinted with "Amneal" on cap and "300 mg
Gabapentin" on body and filled with white to off white powder.
Gabapentin 400 mg hard capsules: Orange, opaque hard gelatin capsules,
Size 0 (length 21.4 ±0.4 mm), imprinted with "Amneal" on cap and "400 mg
Gabapentin" on body and filled with white to off white powder.
Gabapentin is available in blister containing 10, 20, 30, 50, 60, 90, 100, 120,
200 and 300 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
Amneal Netherlands B.V.,
Emmaplein 4D,
’s-Hertogenbosch,
5211 VW,
The Netherlands
This leaflet was last revised in May 2016.

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