Patient leaflet - Gabapentin Noumed 400 mg capsules
1. WHAT GABAPENTIN NOUMED CAPSULES ARE AND WHAT THEY ARE USED FOR
Read the description of these symptoms in section 4 of this leaflet
Gabapentin Noumed 100mg, 300mg or 400mg Capsules (called Gabapentin capsules throughout 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).
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.
It contains gabapentin which belongs to a class of medicines called Gabapentinoids.
This medicine has been prescribed by your doctor or pharmacist to you and should not be given to anyone else.
Gabapentin capsules is used to treat:
Other medicines and Gabapentin capsules
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 capsules 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 capsules in addition to your current treatment unless told otherwise.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 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.
Gabapentin capsules can also be used on its own to treat adults and children over 12 years of age.
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 capsules. In addition, combination of Gabapentin capsules with opioids may cause symptoms like sleepiness, sedation, decrease in breathing or death.
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.
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 is taken at the earliest two hours after taking an antacid. Gabapentin capsules:
Gabapentin Noumed can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber 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.
- 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN NOUMED CAPSULES
Gabapentin capsules with food and drink:
Gabapentin capsules can be taken with or without food.
Do not take Gabapentin capsules:
Pregnancy, breast-feeding and fertility:
If you are allergic (hypersensitive) to gabapentin or to any of the other ingredients of this medicine (listed in section 6).
- 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.
Warnings and precautions:
Talk to your doctor or pharmacist before taking this medicine, if you:
- If you are planning to become pregnant you should discuss your treatment with your doctor as early as possible before you become pregnant.
- 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.
- You should not stop your treatment without discussing this with your doctor.
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
- If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.
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 prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.
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 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.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber 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.
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.
Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include:
trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.
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). 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.
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 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 Gabapentin, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
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. Fertility:
Talk to your doctor or pharmacist before taking 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;
There is no effect on fertility in animal studies.
Driving and using machines:
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 in_amed pancreas).
Gabapentin capsules 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.
- 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.
3. HOW TO TAKE GABAPENTIN NOUMED CAPSULES
If you have myasthenia gravis (a disease causing muscle weakness) because this medicine may make your symptoms worse.
Your doctor should have discussed with you how long the course of Gabapentin 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.
- Before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal drugs; it may mean you have a greater risk of becoming dependent on Gabapentin.
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.
Always take this medicine 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. Do not take more medicine than prescribed.
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. Dependence
Epilepsy, the recommended dose is Adults and adolescents:
Some people may become dependent on Gabapentin capsules (a need to keep taking the medicine).
They may have withdrawal effects when they stop using Gabapentin
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 capsules 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. 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 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. 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. Route of administration:
Gabapentin capsules is for oral use. Always swallow the capsules whole with plenty of water.
Continue taking Gabapentin capsules until your doctor tells you to stop. 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 Noumed 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 suddenly stop taking Gabapentin capsules or reduce your dose unless your doctor tells you to. 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. If your treatment is to be stopped or your dose is reduced, it should be done by reducing the dose gradually over a period of weeks to months so that any unpleasant withdrawal effects are kept to a minimum. If you stop taking Gabapentin Noumed suddenly or before your doctor tells you, there is an increased risk of seizures. 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.
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. These effects can include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, shaking, headache, depression, feeling abnormal, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, thoughts of harming or killing yourself, dizziness, 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, Gabapentin capsules can cause side effects, although not everybody gets them.
Stop using Gabapentin Noumed and seek medical attention immediate-ly 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
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 hospitalized 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 (affects more than 1 in 10 people):
- Viral infection • Feeling tired, fever
- feeling drowsy, dizziness, lack of coordination
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
LGABAP03/07 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
- Difficulty swallowing
- Swelling that may involve the face, trunk and limbs
- Abnormal blood test results suggesting problems with the liver
- Mental impairment • Fall • Difficulty with thinking
- Increase in blood glucose levels (most often observed in patients with diabetes)
Rare (may affect up to 1 in 1,000 people):
- Decrease in blood glucose levels (most often observed in patients with diabetes)
- Loss of consciousness
- Trouble breathing, shallow breaths (respiratory depression). Not known: frequency cannot be estimated from available data (reported since introduction to the market):
- Decreased platelets (blood clotting cells),
- Suicidal thoughts, hallucination,
- Problems with abnormal movements such as writhing, jerking movements and stiffness,
- Ringing in the ears (tinnitus),
- Yellowing of the skin and eyes (jaundice), inflammation of the liver,
- Acute kidney failure, incontinence,
- Increased breast tissue, breast enlargement,
- Adverse events following abrupt discontinuation of gabapentin (anxiety, difficulty in sleeping, feeling sick, pain, sweating), chest pain,
- Breakdown of muscle fibers (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,
- Anaphylaxis (serious, potentially life-threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment),
- Worsening of myasthenia gravis (a disease causing muscle weakness). Unknown frequency: dependence and addiction (see section “How do I know if I am tolerant or addicted?”)
Drug Withdrawal
- When you stop taking Gabapentin Capsules, you may experience drug withdrawal symptoms, which include: trouble sleeping, headache, nausea, feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness.
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 “If you stop taking Gabapentin capsules”).
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GABAPENTIN NOUMED 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 Noumed 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) - Maize Starch, Pregelatinised Maize Starch (1500), 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.
What Gabapentin Noumed Capsules looks like and contents of the pack
Gabapentin Noumed 100mg Capsules are white/white hard gelatin capsules.
Gabapentin Noumed 300mg Capsules are yellow/yellow hard gelatin capsules.
Gabapentin Noumed 400mg Capsules are orange/orange hard gelatin capsules.
Pack Size: 100
This leaflet was last revised in April 2026.
To listen to or request a copy of this leaflet in Braille, large print or audio, please call 020 33 99 8960 (UK only). Please be ready to give the following information Product Name Reference Number Gabapentin Noumed 100mg Capsules PL 44041/0019 Gabapentin Noumed 300mg Capsules PL 44041/0020 Gabapentin Noumed 400mg Capsules PL 44041/0021 Marketing Authorisation Holder and Manufacturer:
NOUMED LIFE SCIENCES LIMITED
Noumed House, Shoppenhangers Road,
Maidenhead, Berkshire, SL6 2RB, United Kingdom.