Gabapentin Accord 400 mg hard capsules – patient leaflet, side effects, dosage

1. What Gabapentin Accord is and what it is used for

Gabapentin Accord belongs 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 epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

The active substance in Gabapentin Accord is gabapentin.

Gabapentin Accord 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). The doctor treating you or your child 6 years of age and older will prescribe Gabapentin Accord to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child 6 years of age and older should take Gabapentin Accord in addition to the current treatment unless told otherwise. Gabapentin Accord 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.

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 Accord

Do not take Gabapentin Accord

• 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 or pharmacist before taking Gabapentin Accord if you:

• suffer from kidney problems your doctor may prescribe a different dosing schedule
• 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 Accord.
• are on haemodialysis (to remove waste products because of kidney failure), tell your doctor if you develop muscle pain and/or weakness
• 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
• 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 Accord 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 Accord” and “If you stop taking Gabapentin Accord”). If you have concerns that you may become dependent on Gabapentin Accord, it is important that you consult your doctor. Your doctor 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 to experience withdrawal symptoms. 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.

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 ‘Stop using Gabapentin Accord and seek medical attention immediately if you notice any of the following symptoms’

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 Accord

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 Accord. In addition, combination of Gabapentin Accord with opioids may cause sleepiness, sedation, decrease in breathing, or death.

Antacids for indigestion

If Gabapentin Accord and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Accord from the stomach may be reduced. It is therefore recommended that Gabapentin Accord is taken at the earliest two hours after taking an antacid.

Gabapentin Accord:

• 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 Accord with food

Gabapentin Accord can be taken with or without food.

Pregnancy, breast-feeding and fertility

• 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 breast-feeding or are planning to breast-feed, ask your doctor for advice before taking this medicine
• 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.

Pregnancy

Gabapentin Accord 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 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).

Some medicines used to treat epilepsy have

reported an increased risk of harm to the

developing baby, particularly when more than one seizure medication is taken at the same time. This means that where possible, your doctor should consider using one epilepsy medicine to control your epilepsy.

Breast-feeding

Gabapentin, the active substance of Gabapentin Accord, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Accord.

Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin Accord 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.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'

3. How to take Gabapentin Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more medicine than prescribed.

Your doctor will determine what dose is appropriate for you.

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.

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 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.

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 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 Accord 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 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.

Package leaflet: Information for the patient Gabapentin Accord 100 mg hard capsules Gabapentin Accord 300 mg hard capsules Gabapentin Accord 400 mg hard capsules

(6034490) Date : 31.03.2025, (R) 10_03_2026

Back Side

INP152 10 1505 9 6034490 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 Accord 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.

If you have the impression that the effect of Gabapentin Accord is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin Accord is for oral use. Always swallow the capsules with plenty of water.

Continue taking Gabapentin Accord until your doctor tells you to stop.

If you take more Gabapentin Accord 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 Accord 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 Accord

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 Accord

Do not suddenly stop taking Gabapentin Accord or reduce your dose. If you want to stop taking Gabapentin Accord 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 to 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 Accord 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.

Stop taking Gabapentin Accord 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).

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:

• 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

  • anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
  • Gabapentin Accord 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 Accord. Call your doctor right away if you have any of the following symptoms:
• skin rash and redness and/or hair loss
• hives
• fever
• swollen glands that do not go away
• swelling of your lip, face 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 Accord

• if you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.

Other side effects include:

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
• 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 (may affect up to 1 in 100 people):

• agitation (a state of chronic restlessness and unintentional and purposeless motions)
• 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)
• difficulty swallowing.

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)

  • trouble breathing, shallow breaths (respiratory depression).

Not known (frequency cannot be estimated from the available data):

• dependence and addiction (see section “How do I know if I am tolerant or addicted?”).

After marketing Gabapentin Accord the following side effects have been reported:

• decreased platelets (blood clotting cells)
• suicidal thoughts, 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
• chest pain
• breakdown of muscle fibres (rhabdomyolysis)
• change in blood test results (creatine phosphokinase increased)
• problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
• low blood sodium level
• worsening of myasthenia gravis (a disease causing muscle weakness).

Drug Withdrawal

After stopping a short or long-term treatment with Gabapentin Accord 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 Accord”).

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Gabapentin Accord, 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 or pharmacist. 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 Accord

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the blister, bottle and carton after “EXP”. The expiry date refers to the last day of that month.

Blister: Do not store above 30°C. Store in the original package, in order to protect from moisture.

HDPE bottle: Store in the original package, in order to protect from moisture. Keep the bottle tightly closed.

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 Accord contains

The active substance is gabapentin. Each hard gelatin capsule contains 100 mg, 300 mg or 400 mg gabapentin.

The other ingredients in Gabapentin Accord are: Capsule contents: maize starch, copovidone (E1201), poloxamer 407 and magnesium stearate (E470b). Capsule shell: gelatin and sodium laurilsulfate.

The capsules contain the colouring titanium dioxide (E171), iron oxide red (E172) (400 mg hard capsules) and iron oxide yellow (E172) (300 mg and 400 mg hard capsules). The printing ink used on capsules contains shellac (E904), propylene glycol (E1520), ammonia solution concentrated and indigo carmine aluminium lake (E132).

What Gabapentin Accord looks like and contents of the pack

Gabapentin Accord 100 mg hard capsules are opaque white/opaque white coloured size "3", approximately 15.40 to 16.20 mm in length, hard gelatin capsules imprinted with "G 100" on cap with blue ink containing white to off white powder.

Gabapentin Accord 300 mg hard capsules are opaque yellow/opaque yellow coloured size "1", approximately 18.90 to 19.70 mm in length, hard gelatin capsules imprinted with "G 300" on cap with blue ink containing white to off white powder.

Gabapentin Accord 400 mg hard capsules are opaque orange/opaque orange coloured size "0", approximately 21.00 to 21.80 mm in length, hard gelatin capsules imprinted with "G 400" on cap with blue ink containing white to off white powder.

Capsules are packed in PVC/PVdC- alu blister, alu-alu blister or HDPE bottle.

Pack sizes:

PVC/PVdC- alu blister and alu-alu blister: 20, 30, 50, 60, 84, 90, 98, 100, 200, 500 and 1000 capsules.

HDPE bottle: 100 and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF

United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

United Kingdom

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spain

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

Accord Healthcare Single Member S.A.

64^th Km National Road Athens,

Lamia, Schimatari, 32009,

Greece

This leaflet was last revised in March 2026.

(6034490) Date : 31.03.2025, (R) 10_03_2026