GABAPENTIN 300MG CAPSULES

Active substance: GABAPENTIN

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A824V2P1

PATIENT INFORMATION LEAFLET

GABAPENTIN 100mg CAPSULES
GABAPENTIN 300mg CAPSULES
GABAPENTIN 400mg CAPSULES
Please read this leaflet carefully before you start taking your medicine, even if you have taken
gabapentin before. It contains important information about your treatment.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Keep this leaflet, you may want to read it again.
This medicine has been prescribed for you personally. 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 get 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 is and what it is used for
2. Before you take gabapentin
3. How to take gabapentin
4. Possible side-effects
5. How to store gabapentin
6. Further Information
1. WHAT GABAPENTIN IS AND WHAT IT IS USED FOR
Gabapentin is used as an anticonvulsant for the treatment of various types of epilepsy. It is used to
reduce the risk of an epileptic fit or to stop one that is in progress.
Anticonvulsant drugs stop the excessive electrical activity in your brain which is causing epileptic fits.
You should take gabapentin in addition to your current treatment unless your doctor tells you
otherwise. It can also be used on its own to treat adults and children over 12 years of age.
Gabapentin belongs to a group of medicines used to treat chronic (long lasting) pain caused by
damage to the nerves. This pain is known as peripheral neuropathic pain. Peripheral neuropathic pain
is caused by a variety of diseases such as diabetes, shingles, trauma or diseases of the nervous
system. Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp,
cramping, aching, tingling, pins and needles etc.
Your doctor will have explained the reason for prescribing gabapentin capsules to you.
2. BEFORE YOU TAKE GABAPENTIN
Do not take these capsules if:
• you have had an allergic reaction to gabapentin or similar medicines or to any of the ingredients
listed in section 6, Further information
Take special care with gabapentin if:
• you suffer from kidney problems
• you develop signs such as persistent stomach pain, feeling sick and being sick. Contact your doctor
immediately if you develop any of these signs.
• you are taking any other medicines apart from your current epilepsy or neuropathic pain relief.
• you have had thoughts of harming or killing yourself. If at any time you have these thoughts,
immediately contact your doctor.
Patients with a history of psychosis
Check with your doctor or pharmacist before taking gabapentin, if you suffer from hallucinations,
thought disorders, nervousness or anxiety.
Pregnancy and breast-feeding
Check with your doctor or pharmacist before taking this medicine if you are pregnant, could be
pregnant or if you are breast feeding. This medicine should ONLY be used while pregnant/breastfeeding if clearly justified and directed by the treating physician.
Important information about some of the ingredients of gabapentin
Gabapentin 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.
Taking other medicines
It is important that you tell your doctor of pharmacist about any other medicines you are taking,
including herbal remedies and those you have obtained without a prescription.
• antacids containing aluminium and magnesium may cause decreased absorption of gabapentin
from the stomach. It is therefore recommended that gabapentin is taken about two hours after any
antacid administration.
• Gabapentin is not expected to interact with other anti-epileptic drugs or the oral contraceptive pill.
• If you require an operation or visit to your doctor or dentist, always let them know if you are taking
gabapentin.
• Gabapentin may interfere with some laboratory tests, if you require a urine test tell your doctor or
hospital that you are taking gabapentin
• Medicines containing morphine may increase the effect of gabapentin capsules.
Driving and operating machinery
Gabapentin can cause dizziness, drowsiness and tiredness. If affected you should not drive or operate
machinery.
3. HOW TO TAKE GABAPENTIN
Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the
information contained in this leaflet. Your doctor may advise you to take your medicine in a different
way, so you should always follow your doctor’s advice about when and how to take your medicine and
always read the label. Your pharmacist may be able help you if you are not sure.
• Your doctor will determine the dose that is appropriate for you.
• If you feel the dose is too strong or too weak for you, talk to your doctor or pharmacist.
• Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your
kidneys.
• Always swallow the capsules whole with plenty of water.
Epilepsy
Adults and children over 12 years:
900 – 3600mg daily in three divided doses i.e. in the morning, in the middle of the day and in the
evening.
The maximum time between two successive doses should not exceed 12 hours in a three times daily
schedule. Gabapentin can be taken with or without food.
Elderly
Elderly patients may require dosage adjustment by their doctor. If you have problems with your
kidneys, speak to your doctor before taking this medicine.
Children 6-12 years of age
The recommended dose of gabapentin is 25 to 35 mg/Kg/day given in three divided doses i.e. one in
the morning, one in the middle of the day and one in the evening. You should always follow your
doctors instructions.

If you take too many capsules
If you accidentally take too many capsules, tell your doctor immediately, or go to your nearest hospital
casualty department as soon as possible. Take the pack with you so that the hospital can easily tell
what medicine you have taken.
If you stop taking your capsules
Do not stop taking your medicine unless your doctor tells you to. Stopping your medicine without
asking your doctor’s advice could put you at risk of rebound epilepsy, an epileptic seizure or recurring
seizures, if you are taking this medication for epilepsy.
4. POSSIBLE SIDE EFFECTS
Like all medicines, gabapentin may occasionally cause unwanted side effects in some patients.
Tell your doctor immediately if you experience any of the following symptoms after taking this
medicine. Although they are very rare, these symptoms can be serious.
• swelling of the lips and face, skin rash and redness and hair loss (these may be symptoms of a
serious allergic reaction).
• persistent stomach pain, feeling sick and being sick (these may be symptoms of acute pancreatitis).
• Serious or life-threatening allergic reaction that may affect parts of your body such as liver or blood
cells and skin. Notify your doctor if you have any of the following symptoms:
• skin rash
• hives
• fever
• swollen glands
• swelling of the lip and tongue
• bruising or bleeding
• yellowing of the skin or of the whites of the eyes
• severe fatigue or weakness
• unexpected muscle pain
• frequent infection
If any of these side effects below become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Very common side effects (affect more than one person in 10)
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever
Common side effects (affects more than one person in 100)
• Pneumonia, respiratory infection, urinary tract infection, inflammation of the ear
• Low white blood cell counts, decrease in white blood cells
• Anorexia, increased appetite, increase in weight
• Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty
with thinking.
• Convulsions, jerky movements, tremor, difficulty with co-ordination
• Difficulty with speaking
• Difficulty sleeping, headache, loss of memory
• Sensitive skin, pins and needles, decreased sensation
• Increased, decreased or absent reflexes.
• Blurred vision, double vision, unusual eye movement
• Vertigo
• 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
• Difficulties with erection
• Swelling in the legs and arms, difficulty with walking, weakness, pain, feeling unwell, flu-like
symptoms
• Accidental injury, fracture, abrasion
Uncommon side-effects (affects more than 1 person in 1000)
• Decreased platelets (blood clotting cells)
• Decreased movement
• Swelling that may involve the face, trunk and limbs
• Allergic reaction such as hives
• Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Adverse events following the abrupt discontinuation of gabapentin, anxiety, difficulty sleeping,
feeling sick, pain, sweating, chest pain
• Ringing in the ears
• Side effects occurring together that may include swollen lymph nodes (isolated small raised lumps
under the skin), fever, rash and inflammation of the liver
• Racing heartbeat
• Inflammation of the pancreas
• Inflammation of the liver, yellowing of the skin and eyes
• Acute kidney failure
• Incontinence
• Increased breast tissue, breast enlargement
• Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting
problems with the liver
Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported
commonly. Do not be alarmed by this list of side effects, most people take gabapentin without any
problems.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell
your doctor or pharmacist.
5. HOW TO STORE GABAPENTIN
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C. Store in the original package. Do not use after the expiry date on the pack.
Return any left-over capsules to your pharmacist. Only keep them if your doctor tells you to. 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 protect the environment.
6. FURTHER INFORMATION
What gabapentin contains and contents of the pack
The name of your medicine is gabapentin. Gabapentin hard capsules are available in three strengths:
Gabapentin 100mg Capsules are opaque white hard gelatin capsules marked with GABA 100mg.
Gabapentin 300mg Capsules are opaque yellow hard gelatin capsules marked with GABA 300mg.
Gabapentin 400mg Capsules are opaque orange hard gelatin capsules marked with GABA 400mg.

Neuropathic pain
Adults (over 18 years of age)
Your doctor will usually build up your dose by starting you on 300mg once a day on day one, 300mg
twice a day on day two and 300mg three times a day on day three. The dose may be increased to
3600mg each day given in three divided doses, i.e. in the morning, in the middle of the day and in the
evening. Gabapentin can be taken with or without food.

Gabapentin Capsules also contain the inactive ingredients: lactose monohydrate, maize starch, talc
and gelatin.
The 100mg capsules contain the colouring titanium dioxide (E171)
The 300mg capsules contain the colourings titanium dioxide (E171) and yellow iron oxide (E172)
The 400mg capsules contain the colourings titanium dioxide (E171), red iron oxide (E172) and yellow
iron oxide (E172).
The printing ink contains: shellac, black iron oxide (E172), soya lecithin and antifoam.
Gabapentin Capsules are available in blister packs containing 100 capsules, with each blister strip
containing 10 capsules.

If you think gabapentin is causing problems or alternatively if you experience complete pain relief
please talk to your doctor or pharmacist straight away.

Marketing authorisation holder and manufacturer
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K.

Keep taking your capsules for as long as your doctor has asked you to.

Distributed by:
Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K.

If you forget to take a dose
If you miss a dose, just 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 the one you have missed

PL 08215/0063, PL 08215/0064 and PL 08215/0065

Customer: AT

Designer: HM

Colours

Product: Gabapentin JNT PIL
Dimensions: 148mm x 450mm
Item Code: A824V2P1
Proof No and Date: 1 13/12/11

This leaflet was last updated in December 2011.
A824V2P1

Revision:
ARTWORK FOR SUBMISSION
Supersedes: n/a

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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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