GABAPENTIN 100 MG CAPSULES

Active substance: GABAPENTIN

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin 100 mg, 300 mg and 400 mg capsules, hard
gabapentin
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 Gabapentin capsules are and what they are used for
2. Before you take Gabapentin capsules
3. How to take Gabapentin capsules
4. Possible side effects
5. How to store Gabapentin capsules
6. Further information
1. WHAT GABAPENTIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Gabapentin capsules, hard (called Gabepentin capsules in the rest of this leaflet) belong to a
group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain
caused by damage to the nerves).
Gabapentin capsules are 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 capsules for you to help treat your epilepsy when your current
treatment is not fully controlling your condition. You should take Gabapentin capsules
in addition to your current treatment unless told otherwise. Gabapentin capsules 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 GABAPENTIN CAPSULES
Do not take Gabapentin capsules:
• if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of
Gabapentin capsules.
Take special care with Gabapentin capsules:
• 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 Gabapentin 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’
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 Gabapentin
capsules.
Antacids for indigestion - If Gabapentin capsules and antacids containing aluminium and
magnesium are taken at the same time, absorption of Gabapentin capsules from the
stomach may be reduced. It is therefore recommended that Gabapentin capsules are taken
at the earliest two hours after taking an antacid.
Gabapentin capsules:
• are 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 Gabapentin capsules with food and drink - Gabapentin capsules can be taken
with or without food.
Pregnancy - Gabapentin capsules 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 capsules. 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 Gabapentin capsules, is passed on
through human milk.
Because the effect on the baby is unknown, it is not recommended to breast-feed while
using Gabapentin capsules.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines - Gabapentin capsules 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 Gabapentin capsules - Gabapentin
capsules contain lactose (a type of sugar). If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE GABAPENTIN CAPSULES
Always take Gabapentin capsules 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 Gabapentin capsules 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
Gabapentin capsules 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 Gabapentin capsules until your doctor tells you to stop.
Method and route of administration
Gabapentin capsules are for oral use. Always swallow the capsules whole with plenty of water.
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 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.

Gabapentin capsules are not recommended for use in children below 6 years of age.
Peripheral Neuropathic Pain, 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 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 Gabapentin capsules 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 capsules 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 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 capsules - Do not stop taking Gabapentin 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 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, Gabapentin capsules 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 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 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
- 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 capsules.
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
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.
5. HOW TO STORE GABAPENTIN CAPSULES
Keep out of the sight and reach of children.
Do not use Gabapentin capsules after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
Do not store Gabapentin capsules above 30°C.
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
What Gabapentin capsules contains - The active substance is gabapentin. Each hard
capsule, contains either 100 mg, 300 mg or 400 mg gabapentin.
The other ingredients in Gabapentin capsules are: Capsule contents: Lactose monohydrate,
maize starch and talc. Capsule shell: gelatin. The 100mg capsules contain the colouring E171
(Titanium dioxide); the 300mg capsules contain the colourings: E171 (Titanium dioxide) and
E172 ( yellow iron oxide) and the 400mg capsules contain the colourings: E171 (Titanium
dioxide) and E172 ( red and yellow iron oxide). The printing ink used on all capsules contains
shellac, Iron oxide black (E172).
What Gabapentin capsules look like and contents of the pack - The 100 mg capsules are
white hard capsules marked with “100”. The 300 mg capsules are yellow hard capsules
marked with “300”. The 400 mg capsules are orange hard capsules marked with “400”.
Supplied in PVC/PVDC/aluminium foil blister packs of 100 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder - DOUBLE-E PHARMA LTD. 7th Floor, Hume House,
Ballsbridge , Dublin 4, Ireland
Manufacturer - Laboratoires BTT, ZI de Krafft, 67150 Erstein, France.
Distributed by - Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex CM6 3LY, UK.

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.
This leaflet was last approved in May 2012

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.

Living with Advanced MS? View our 7 part video series and learn more. Click Here

Close
Hide
(web5)