Patient leaflet - Gabapentin Accord-UK 400 mg capsules
1. What Gabapentin capsules are and what they are used for
Gabapentin capsules belong to a class of medicines called gabapentinoids. This medicine has been prescribed for you and should not be given to anyone else. It is used to treat:
- various forms of epilepsy – Gabapentin capsules can be used on their own in adults and children aged 12 years and over or in combination with other medicines to treat epilepsy in adults and children aged 6 years and over
- peripheral neuropathic pain - this is long lasting pain caused by damage to the nerves.
Gabapentinoids can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.
2. What you need to know before you take Gabapentin capsules
Do not take Gabapentin capsules 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, pharmacist or nurse before taking Gabapentin capsules if you:
- suffer from kidney problems your doctor may prescribe a different dosing schedule
- are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/ or weakness
- suffer with different types of seizures including absences
- 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)
- have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen
- are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake; it may mean you have a greater risk of becoming dependent on Gabapentin capsules.
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
- feel you need to take more Gabapentin capsules to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your doctor who will discuss your treatment and may change your dose or switch you to an alternative medication
- have myasthenia gravis (a disease causing muscle weakness) because this medicine may make your symptoms worse. Dependence
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction (a need to keep taking the medicine). Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine or reduce the dose (see section 3, “How to take Gabapentin capsules” and “If you stop taking Gabapentin capsules”). If you have concerns that you may become dependent on Gabapentin capsules, it is important that you consult your doctor. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely
- 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.
Uncommon (may affect up to 1 in 100 people):
- allergic reaction such as hives
- difficulty swallowing
- decreased movement, mental impairment
- racing heartbeat
- swelling that may involve the face, trunk and limbs
- abnormal blood test results suggesting problems with the liver
- fall
- increase in blood glucose levels (most often observed in patients with diabetes)
- agitation (a state of chronic restlessness and unintentional and purposeless motions).
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).
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
- yellowing of the skin and eyes (jaundice), inflammation of the liver
- acute kidney failure, incontinence
- increased breast tissue, breast enlargement, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
- chest pain
- change in blood test results (creatine phosphokinase increased)
- low blood sodium level
- worsening of myasthenia gravis (a disease causing muscle weakness).
Additionally, in clinical studies in children, aggressive behaviour and jerky movements were reported commonly. Respiratory tract infections, inflammation of the middle ear and ear drum, convulsions and bronchitis were also reported.
Drug Withdrawal
After stopping a short or long-term treatment with Gabapentin capsules or after reducing your dose, you need to know that you may experience certain side effects, so-called withdrawal effects (see section 3 “If you stop taking Gabapentin capsules”).
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Gabapentin
you do not stop taking your medicine without first consulting your doctor, as this may worsen your illness. Worsening of your epilepsy may put you and your unborn child at risk.
In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with the development of brain function (neurodevelopment disorders). However, babies of women who took gabapentin during pregnancy had an increased risk of low birth weight and preterm birth.
If used during pregnancy, gabapentin may lead to withdrawal symptoms in newborn infants. This risk might be increased when gabapentin is taken together with opioid analgesics (drugs for treatment of severe pain). 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 taking Gabapentin capsules.
Driving and using machines
When taking Gabapentin capsules you may become drowsy, dizzy or feel tired, especially at the start of treatment or after a dose increase. Make sure you are not affected before driving, operating machinery or taking part in other potentially hazardous activities.
Gabapentin capsules contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Gabapentin capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.
Gabapentin capsules are usually taken three times a day (morning, afternoon and evening). Always swallow the capsules whole with plenty of water, with or without food.
Your doctor will determine what dose is appropriate for you. If you are an elderly patient (over 65 years old), have kidney disease or are having haemodialysis, you should take Gabapentin capsules as prescribed by your doctor. Your doctor should have discussed with you how long the course of capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Continue taking Gabapentin capsules until your doctor tells you to stop. Dosage
Epilepsy:
Adults and children aged 12 years or over:
The usual starting dose is between 300mg and 900mg each day. The dose may then be increased gradually to a maximum of 3600mg each day.
Children aged 6 years and above:
The dose depends on the body weight of your child. The treatment is started with a low initial dose which is gradually increased over a period of about 3 days.
The usual dose to control epilepsy is 25-35mg per kg per day. Gabapentin capsules are not recommended for use in children below 6 years of age.
Peripheral neuropathic pain:
The usual starting dose is between 300mg and 900mg each day. The dose may then be increased gradually to a maximum of 3600mg each day. If you take more Gabapentin capsules than you should
If you or someone else accidentally takes too many capsules, or if you think a child has swallowed any, contact your doctor or go to your nearest hospital casualty department immediately. As Gabapentin capsules may make you drowsy, it is recommended that you ask someone else to drive you to the doctor or hospital, or that you call an ambulance. Symptoms of an overdose are dizziness, double vision, slurred speech, drowsiness or tiredness, loss of consciousness and mild diarrhoea. Overdose of gabapentin, particularly in combination with other CNS depressant medications, may result in coma.
If you forget to take Gabapentin capsules
If you miss 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 suddenly stop taking Gabapentin capsules or reduce your dose. If you want to stop taking Gabapentin capsules or reduce your dose, discuss this with your doctor first. They will tell you how to do this, it should be done gradually over a minimum period of 1 week for 900 -1,800 mg/ day, or minimum 3 weeks for 3,600 mg/day, up to several months, so that any unpleasant withdrawal effects are kept to a minimum. Your doctor will ensure that your plan for stopping treatment or reducing your dose is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Withdrawal symptoms can include: seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, nervousness, depression, thoughts of harming or killing yourself, feeling abnormal, dizziness, diarrhoea, flu-like symptoms, and feeling generally unwell. These effects usually occur within 48 hours after stopping Gabapentin capsules or reducing your dose. If you experience withdrawal effects, you should contact your doctor. 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:
Rare (may affect up to 1 in 1,000 people):
- breathing problems, shallow breaths (respiratory depression), which if severe you may need emergency and intensive care to continue breathing normally
Not known (frequency cannot be estimated from the available data):
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)
- breakdown of muscle fibres which can be life-threatening (rhabdomyolysis), symptoms include muscle weakness, tenderness, pain and spasms, feeling unwell or having a high temperature, discolouration of urine and change in blood test results
- suicidal thoughts, dependence and addiction (see section “How do I know if I am tolerant or addicted?”)
- anaphylaxis (serious, potentially life-threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
- 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 a 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, 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.
Stop using Gabapentin capsules and seek medical attention immediately if you notice any of the following symptoms:
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Other 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, sensations such as pins and needles, 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, 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, itchy skin, acne
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capsules, it could be a sign that you have become addicted:
- you may feel the need to keep taking the medication for longer than your doctor recommended
- you feel you need to use more than the recommended dose
- you are using the medicine for reasons other than prescribed
- you have made repeated, unsuccessful attempts to quit or control the use of the medicine
- when you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.
If you notice any of these signs, it is important to talk to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 the capsules above 25°C.
Do not take 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 contain
The active substance is gabapentin. Each capsule contains either 100mg, 300mg or 400mg gabapentin.
The other ingredients in the capsules are lactose monohydrate, maize starch, talc.
The capsule shell contains titanium dioxide (E171) and gelatin, yellow iron oxide (E172) (300mg and 400mg capsules) and red iron oxide (E172) (400mg capsules only).
The printing ink contains Shellac (E904), propylene glycol (E1520), black iron oxide (E172) and potassium hydroxide (E525). What Gabapentin capsules look like and contents of the pack
Gabapentin 100mg capsules are size 3, white-white, hard gelatin capsules printed with C and GJ.
Gabapentin 300mg capsules are size 1, yellow-yellow, hard gelatin capsules printed with C and GK.
Gabapentin 400mg capsules are Size 0, orange-orange hard gelatin capsules printed with C and GL.
The packs contain: 100 capsules.
Marketing Authorisation Holder and Manufacturer
Accord, Barnstaple, EX32 8NS, UK
This leaflet was last revised in August 2026.
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page 2 page 3 to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Gabapentinoids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentinoids, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. 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
Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using gabapentin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section
- 4. 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”. Other medicines and Gabapentin capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:
- medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems
- medicines containing opioids such as morphine; as opioids may increase the effect of Gabapentin capsules. In addition, combination of Gabapentin capsules with opioids may cause symptoms like sleepiness and/or decrease in breathing
- antacids containing aluminium and magnesium (used to reduce stomach acid): as absorption of Gabapentin capsules from the stomach may be reduced. It is therefore recommended that Gabapentin capsules are taken at least two hours after taking an antacid.
Urine Tests
Gabapentin capsules may interfere with urine tests. If you require a urine test, tell your doctor or hospital that you are taking Gabapentin capsules. Gabapentin capsules with food
Gabapentin capsules can be taken with or without food. Pregnancy and breast-feeding
- If you are pregnant or think you may be pregnant, you must tell your doctor straight away and discuss possible risks the medicine you are taking might pose to your unborn baby
If you are planning to become pregnant you should discuss your treatment with your doctor as
early as possible before you become pregnant
- You should not stop your treatment without discussing this with your doctor
- If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine.
Pregnancy
Gabapentin capsules can be used during the first trimester of pregnancy if needed. If you plan to become pregnant or if you are pregnant or think you may be pregnant, talk to your doctor straight away. If you have become pregnant and you have epilepsy, it is important that #