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GABAPENTIN GENUS PHARMACEUTICALS 100MG HARD CAPSULES

Active substance(s): GABAPENTIN

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TEXT FOR NON-MARKETED PACKS
PIL FOR
GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
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 Genus Pharmaceuticals Capsules are and what they are used for
2. What you need to know before you take Gabapentin Genus Pharmaceuticals Capsules
3. How to take Gabapentin Genus Pharmaceuticals Capsules
4. Possible side effects
5. How to store Gabapentin Genus Pharmaceuticals Capsules
6. Contents of the pack and other information

1. What Gabapentin Genus Pharmaceuticals Capsules are and what they are used for
Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic
pain.
The active ingredient in Gabapentin Genus Pharmaceuticals Capsules is gabapentin.
Epilepsy: Gabapentin is used to treat various forms of epilepsy (a brain disorder involving
repeated seizures). Your doctor will prescribe you Gabapentin 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.
The application of Gabapentin together with other epilepsy medicines is used to treat adults
and children aged 6 years and above.
Gabapentin can also be used on its own to treat adults and children over 12 years of age.
Peripheral neuropathic pain (Neuropathy): Gabapentin is used to treat long lasting pain
caused by damage to the nerves in adults. 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 Genus Pharmaceuticals
Capsules
DO NOT take Gabapentin Genus Pharmaceuticals Capsules
 if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in
section 6).

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PIL FOR
GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Genus Pharmaceuticals.
 if you develop thoughts of killing or harming yourself. 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.
 if you suffer from kidney problems please inform your doctor before taking Gabapentin
 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).
Important information about potentially serious reactions
A small number of people taking Gabapentin Genus Pharmaceuticals Capsules 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 discolouration 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 Genus Pharmaceuticals
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are taking any medicines containing morphine, please tell your doctor or pharmacist
as morphine may increase the effect of Gabapentin.
Gabapentin is not expected to affect other anti-epileptic drugs 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.
If Gabapentin Genus Pharmaceuticals Capsules and antacids (e.g. to treat heartburn or acid
indigestion) 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
Genus Pharmaceuticals Capsules are taken at the earliest 2 hours after taking an antacid.
Gabapentin with food
Gabapentin can be taken with or without food.

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GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
Pregnancy and breast-feeding
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
unborn child, particularly when more than one seizure medication is taken at the same time.
Therefore, whenever possible and only under the advice of your doctor, you should try to
take only one seizure medication during pregnancy.
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.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are
planning to become pregnant while taking Gabapentin Genus Pharmaceuticals Capsules
Breast-feeding
Gabapentin, the active substance of Gabapentin Genus Pharmaceuticals Capsules, is excreted
in human milk. Because the effect on the nursing infant is unknown, it is not recommended to
breast-feed your baby while using Gabapentin Genus Pharmaceuticals Capsules
Driving and using machines
Gabapentin may produce dizziness, drowsiness and tiredness. You should not drive, operate
complex machinery or engage in other potentially hazardous activities until you know
whether this medication affects your ability to perform these activities.
Gabapentin Genus Pharmaceuticals Capsules contains lactose
This medicinal product contains lactose. 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 Gabapentin Genus Pharmaceuticals Capsules
Always take Gabapentin Genus Pharmaceuticals Capsules 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.
If you have the impression that the effect of Gabapentin Genus Pharmaceuticals Capsules are
too strong or too weak, talk to your doctor or pharmacist.

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PIL FOR
GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
If you are an elderly patient (over 65 years of age), you can take Gabapentin Genus
Pharmaceuticals Capsules normally except if you have problems with your kidneys (dose
adjustment required).
Continue taking Gabapentin until your doctor tells you to stop.
Method and route of administration
Gabapentin is for oral use. Always swallow the capsules whole with plenty of water (e.g. a
glass of water).
Peripheral Neuropathic Pain (Neuropathy), the usual dose is:
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 gradually up to a maximum of 3600 mg each day
and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in
the afternoon and once in the evening.
Epilepsy, the usual 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 gradually up to a maximum of 3600 mg each day and
your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the
afternoon and once in the evening.
The maximum time period between the doses should not exceed 12 hours to prevent
breakthrough convulsions.
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 2535 mg per kilo of bodyweight per day. It is usually given in 3 divided doses, by taking the
capsule(s) each day, usually once in the morning, once in the afternoon and once in the
evening.
The maximum time period between the doses should not exceed 12 hours to prevent
breakthrough convulsions.
Gabapentin is not recommended for use in children below 6 years of age.
If you have kidneys problems or are receiving haemodialysis

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GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
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 Gabapentin Genus Pharmaceuticals Capsules than you should
Call your doctor or go to the nearest hospital emergency unit immediately. Take along any
capsules that are left, the container and the label so that the hospital can easily tell what
medicine you have taken.
Higher than recommended doses may result in an increase in undesirable effects including
loss of consciousness, dizziness, double vision, slurred speech, drowsiness, lethargy and mild
diarrhoea.
If you forget to take Gabapentin Genus Pharmaceuticals Capsules
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 Genus Pharmaceuticals Capsules
Do not stop taking Gabapentin Genus Pharmaceuticals Capsules 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 Genus Pharmaceuticals Capsules 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
 if you develop severe skin reactions like swelling of the lips and face, skin rash and
redness (these may be symptoms of a serious allergic reaction)
 if you develop signs such as persistent stomach pain, feeling sick and being sick
(symptoms of an inflammation of the pancreas)
 if you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness
 Gabapentin Genus Pharmaceuticals Capsules 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 hospitalised or to stop Gabapentin Genus Pharmaceuticals. Capsules
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

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GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES

 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 Gabapentin Genus Pharmaceuticals Capsules
The following frequencies are used in evaluating side effects:
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 (a specific type of dizziness)
 High blood pressure, flushing or dilation of blood vessels
 Difficulty breathing, bronchitis, sore throat, cough, dry or runny 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
 Incontinence
 Difficulties getting an erection (impotence)
 Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flulike 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 as common.
Uncommon (may affect up to 1 in 100 people):
 Allergic reactions such as hives
 Decreased movement
 Racing heart beat
 Swelling that may involve the face, trunk and limbs

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100mg, 300mg AND 400mg HARD CAPSULES

 Abnormal blood test results suggesting problems with the liver

Since introduction to the market the following side-effects have been reported:
Not known (frequency cannot be estimated from the available data):
 Decreased platelets (blood clotting cells)
 Hallucinations
 Problems with abnormal movements such as writhing, jerking movements and stiffness
 Ringing in the ears
 Inflammation of the pancreas
 Inflammation of the liver, yellowing of the skin and eyes
 Severe skin reactions that require immediate medical attention, swelling of the lips and
face, skin rash and redness, hair loss
 Acute kidney failure
 Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty
sleeping, feeling sick, pain, sweating), chest pain
 Increased breast tissue, breast enlargement
 Sudden unexplained life-threatening conditions have been reported but it was not clear
whether this was due to treatment with gabapentin
 Blood glucose fluctuations in patients with diabetes, abnormal blood test results
suggesting problems with the liver
 Breakdown of muscle fibres (rhabdomyolysis)
 Change in blood test results (creatine phosphokinase increased)
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 Gabapentin Genus Pharmaceuticals Capsules
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, bottle and blister.
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Bottles: Keep the container tightly closed.
The capsules in bottles can be used for 12 weeks after first opening the bottle.
Blisters: Store in the original package. Keep blister in the outer carton.
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.

TEXT FOR NON-MARKETED PACKS
PIL FOR
GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
6. Contents of the pack and other information
What Gabapentin Genus Pharmaceuticals Capsules contains
Gabapentin Genus Pharmaceuticals 100 mg hard capsules
The active substance is gabapentin. Each capsule, hard contains 100 mg gabapentin.
Gabapentin Genus Pharmaceuticals 300 mg hard capsules,
The active substance is gabapentin. Each capsule, hard contains 300 mg gabapentin.
Gabapentin Genus Pharmaceuticals 400 mg hard capsules,
The active substance is gabapentin. Each capsule, hard contains 400 mg gabapentin.
 The other ingredients in Gabapentin Genus Pharmaceuticals capsules are:
Capsule contents:
Lactose anhydrous, maize starch, talc.
Capsule shell:
Gelatine, titanium dioxide (E171).
In addition: 300 mg capsules contain iron oxide yellow (E 172).
In addition: 400 mg capsules contain iron oxide yellow (E 172), iron oxide red (E 172).
What Gabapentin Genus Pharmaceuticals Capsules look like and contents of the pack
Capsule, hard
Gabapentin Genus Pharmaceuticals 100 mg hard capsules,
Hard gelatine capsule (size 3), with white opaque body and cap.
Gabapentin Genus Pharmaceuticals 300 mg hard capsules
Hard gelatine capsule (size 1), with yellow opaque body and cap.
Gabapentin Genus Pharmaceuticals 400 mg hard capsules,
Hard gelatine capsule (size 0), with orange opaque body and cap.
PVC/Alu blister or HDPE bottle with PP cap. The liner is made from polystyrene foam
coated on one side with an EvaWax pressure sensitive adhesive.
Pack sizes:
PVC/Alu blister:
5, 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 84, 90, 98, 100, 112, 120, 140, 150, 200 (2x100),
210, 250, 300, 400, 500, 1000 capsules.
As hospital pack only: 500 (5x100), 1000 (10x100) capsules.
Unit dose: 20x1, 60x1, 100x1 capsule.
HDPE bottle:
50, 100, 250 capsules

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PIL FOR
GABAPENTIN GENUS PHARMACEUTICALS
100mg, 300mg AND 400mg HARD CAPSULES
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, United Kingdom
Manufacturer
STADA Arzneimittel AG
Stadastr. 2-18, D-61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Nieuwe Donk 9, 4879 Etten-Leur
The Netherlands
Sanico NV
Veedijk 59, 2300 Turnhout
Belgium

This medicinal product is authorised in the Member States of the EEA under the
following names:
Denmark:
Belgium:
Luxembourg:
United Kingdom:
Denmark:
Belgium:
Luxembourg:
United Kingdom:
Denmark:
Belgium:
Luxembourg:
United Kingdom:

Gabapentin Stada 100 mg kapsler, hårde
Gabapentin EG 100 mg harde capsules
Gabapentin EG 100 mg
Gabapentin Genus Pharmaceuticals 100 mg hard capsules
Gabapentin Stada 300mg kapsler, hårde
Gabapentin EG 300 mg harde capsules
Gabapentin EG 300 mg
Gabapentin Genus Pharmaceuticals 300 mg hard capsules
Gabapentin Stada 400 mg kapsler, hårde
Gabapentin EG 400 mg harde capsules
Gabapentin EG 400 mg
Gabapentin Genus Pharmaceuticals 400 mg hard capsules

This leaflet was last revised in December 2014.

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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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