Skip to Content

UK Edition. Click here for US version.

GABAPENTIN MEDREICH 100MG CAPSULES

Active substance(s): GABAPENTIN / GABAPENTIN / GABAPENTIN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PC No.: 7530

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin Medreich 100mg Capsules
Gabapentin Medreich 300mg Capsules
Gabapentin Medreich 400mg 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, pharmacist or nurse. 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 taking 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 100mg, 300mg or 400mg Capsules belongs to a group of medicines used to treat epilepsy
and peripheral neuropathic pain (long lasting pain caused by damage to the nerves)
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 children over 12 years of age.
• Peripheral neuropathic pain (long lasting pain caused by damage to the nerves). 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 (hypersensitive) to the active substance of this medicine (gabapentin) or to 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)
• 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 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.
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 the 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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.
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.

Antacids for indigestion
If Gabapentin and antacids containing aluminum 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.
Gabapentin Capsules with food
Gabapentin can be taken with or without food.
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.
Breastfeeding
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 cause 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 contains lactose
These 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 GABAPENTIN
Always take Gabapentin 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.
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 300mg and 900mg each day. Thereafter, the dose may be
increased as instructed by your doctor, up to a maximum of 3600mg 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.
Gabapentin is not recommended for use in children below 6 years of age.
Peripheral Neuropathic Pain, the recommended 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 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.
121XXXX

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.
Route of administration
Gabapentin is for oral use. Always swallow the capsules or tablets with plenty of water. The tablet can
be divided into equal halves. 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 container and the label 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, gabapentin 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)
• breathing problems, which if severe you may need emergency and intensive care to
continue breathing normally
• 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
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 (affects more than 1 in 10 people):
• Viral infection, feeling drowsy, dizziness, lack of co-ordination.
• 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
• 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)

• Decrease in white blood cells, increase in weight
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):
• Agitation (a state of chronic restlessness and unintentional and purposeless motions)
• Loss of consciousness
• Decrease in blood glucose levels (most often observed in patients with diabetes)
• Trouble breathing, shallow breaths (respiratory depression)
Frequency not known (cannot be estimated from available data):
• bruising more easily than usual. This could be because of a blood problem (thrombocytopenia),
• seeing or hearing things which are not there (hallucinations),
• problems with abnormal movements such as writhing, jerking movements and stiffness,
• ringing in the ears (tinnitus),
• serious kidney disease (acute kidney failure),
• side effects following the sudden stopping of gabapentin (anxiety, difficulty in sleeping, feeling sick,
pain, sweating), chest pain,
• blood glucose variations in patients with diabetes,
• breast enlargement in men or women,
• a group of side effects that could include swollen lymph nodes (isolated small raised lumps under
skin), fever, rash, and inflammation of liver occurring together,
• alopecia (hair loss).
• anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing,
swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
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 relevant national reporting system
detailed below:
UK
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 CAPSULES
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to
the last day of that month.
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 Gabapentin Capsules contains
The active substance is Gabapentin. Each capsule contains either 100mg, 300mg or 400mg of
gabapentin.
The other ingredients are:
• Capsules Fill (100mg, 300mg, 400mg) - Lactose Monohydrate, Maize Starch, Talc.
• Capsule shell:
• (100mg Capsule Shell) - Titanium Dioxide (E171), Gelatin.
• (300mg Capsule Shell) - Yellow Iron Oxide (E172), Titanium Dioxide (E171), Gelatin
• (400mg Capsule Shell) - Yellow Iron Oxide (E172), Red Iron Oxide (E172), Titanium Dioxide
(E171), Gelatin.
• Printing ink: Shellac, Black Iron Oxide (E172), Potassium hydroxide
What Gabapentin Capsules looks like and contents of the pack
Gabapentin Medreich 100mg Capsules are white/white hard gelatin capsules marked 'MG 100'.
Gabapentin Medreich 300mg Capsules are yellow/yellow hard gelatin capsules marked 'MG 300'.
Gabapantin Medreich 400mg Capsules are orange/orange hard gelatin capsules marked 'MG 400'.
Pack Size: 100
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC,
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk
This leaflet was last approved in {07/2017}
121XXXX

Arial Bold

Font Type &
Size

Heading - 10 pts

COLOURS

Body - 8 pts

Red 032 C
Black

RA artwork code

0195/O/PIL/001/I

Version

V-5

ADCOCK INGRAM LIMITED
CUSTOMER: MEDREICH PLC, UK

COMPONENT: Gabapentin Capsules - S/L - English - PIL

ITEM CODE: 121XXXX

DIMENSION: 280 x 240 mm

REASON FOR CHANGE:

Change in text matter

SUPERSEDED ITEM CODE:

1213106

ARTWORK SCALE:

COLOUR SCHEME: 2 - Red 032 C & Black
SPECIFICATION:

Printed on 56 - 60 GSM Maplitho paper.

Head - PDC

Head TT

Head - QC

Head Tech. Services

Head CQA/QA

Prepared by:
Date:

Checked by:
Date:

Approved by:
Date:

Approved by:
Date:

Authorized by:
Date:

ADC/GAB/PIL/05

WIN\\192.168.1.33\pdc\Artworks\Medreich\UK Products\Gabapentin\Unit 7\PIL\Gabapentin Capsules SL English PIL_19.01.17.ai
Internal Approval Issued on

100%

CD Issued on

R-5/16.11.16(MA)/16(AK)/
19.01(GW)/17.02(MA)/10.07.17(AK)

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.

Hide