Patient leaflet - Gabapentin Bristol Labs 400 mg capsules

1. What Gabapentin Capsules are and what they are used for

Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

The active substance is gabapentin.

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 Capsules

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

Antacids for indigestion

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

Gabapentin 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.

Gabapentin:

is not expected to interact with other anti-epileptic 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 Capsules with food, drink and alcohol

The capsules can be taken with or without food.

Gabapentin 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 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 in addition to the current treatment unless told otherwise. Gabapentin 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.
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 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 pregnant or breast-feeding, think you may be
  pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentin 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.

2. What you need to know before you take

Gabapentin Capsules

There have been very few studies speciﬁcally looking at the use of gabapentin in pregnant women.

Do not take Gabapentin Capsules:

If you are allergic (hypersensitive) to gabapentin or any of
the other ingredients of this medicine (listed in section 6)
More research is needed to better understand the safety of use of gabapentin during pregnancy and whether it is associated with an increased risk of harm to the unborn child.

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
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)
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 • if you 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.
if you have previously suﬀered from withdrawal symptoms
such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
if you feel you need to take more of Gabapentin 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.
If you have myasthenia gravis (a disease causing muscle
weakness) because this medicine may make your symptoms worse.

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.

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.

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).

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

Fertility

There is no eﬀect on fertility in animal studies.

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.

Dependence

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.

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.

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.

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 medicinal product.

3. How to take Gabapentin Capsules

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 prescriber 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 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.

Method and route of administration

For oral use only. Always swallow the capsules whole with plenty of water. Continue taking Gabapentin until your doctor tells you to stop.

Gabapentin 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.

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

Size: 180 x 560 mm

Front

180 mm

10 mm

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 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 is not recommended for use in children below 6 years of age.

Peripheral Neuropathic Pain, the usual dose is: Adults: Take the number of capsules or tablets 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.

Your doctor may prescribe a diﬀerent dosing schedule and/or dose if you have problems with your kidneys or are undergoing haemodialysis.

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:

Mental impairment
Racing heartbeat
Swelling that may involve the face, trunk and limbs • Abnormal blood test results suggesting problems with the liver
Fall
Allergic reactions such as hives
Increase in blood glucose levels (most often observed in patients with diabetes)
Agitation (a state of chronic restlessness and unintentional and purposeless motions)
Decreased movement
Diﬃculty swallowing

If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin 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.

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)

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

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. 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. 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. 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.

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 or reduce your dose. If you want to stop taking Gabapentin or reduce your dose, discuss this with your doctor ﬁrst. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal eﬀects are kept to a minimum. This may occur over a period of weeks to months. 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 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, dizziness, feeling generally unwell, diarrhoea, ﬂu-like symptoms, convulsions, nervousness and thoughts of harming or killing yourself.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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
Adverse events following the abrupt discontinuation of gabapentin (anxiety, diﬃculty 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
Suicidal thoughts
dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
Worsening of myasthenia gravis (a disease causing muscle weakness)

Drug Withdrawal

When you stop taking Gabapentin, 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.

How do I know if I am tolerant or addicted?

If you notice any of the following signs whilst taking Gabapentin, 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
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 you talk to your prescriber.

4. Possible Side Eﬀects

Like all medicines, this medicine can cause side eﬀects, although not everybody gets them.

Stop using Gabapentin 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).

Anaphylaxis (serious, potentially life threatening allergic
reaction including diﬃculty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)

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)
breathing problems, which if severe you may need
emergency and intensive care to continue breathing normally
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 hospitalized or to stop Gabapentin. 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, unusual bruising or bleeding, severe fatigue or weakness, unexpected muscle pain, frequent infections, yellowing of your skin or of the whites of the eyes

The 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: 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
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 use this medicine after the expiry date (EXP) which is stated on the carton.
The expiry date refers to the last day of that month.
0 • Do not store above 25 C. Store in the original package. • 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
100mg, 300mg or 400mg Gabapentin.
The other ingredients are:
Capsule ﬁll: Lactose Monohydrate, Maize Starch, Talc. Capsule shell: Gelatin, Titanium dioxide (E171) The 300mg Capsules contain Yellow Iron Oxide (E172); the 400mg Capsules contain:
Yellow Iron Oxide (E172), Red Iron Oxide (E172) • Printing ink: Shellac, Strong ammonia solution, Black iron oxide(E172).

What Gabapentin Capsules look like and contents of the pack

100mg: Hard gelatin capsule with white cap/white body and printed with “BL 100”.

300mg: Hard gelatin capsule with yellow cap/yellow body and printed with “BL 300’’.

400mg: Hard gelatin capsule with orange cap/orange body and printed with “BL 400’’.

All strengths are available in blister pack of 10 x 10 capsules. 400mg strength is also available in blister pack of 5 x 20 capsules.

Marketing Authorisation Holder and Manufacturer:

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone:0044 (0)1442 200922

Email: info@bristol-labs.co.uk

Manufacturer

Bristol Laboratories Ltd.

Laporte Way, Luton, LU4 8WL, United Kingdom.

Gabapentin Bristol Labs 100 mg, 300 mg, 400 mg Capsules; PL 17907/0371, PL 17907/0372, PL 17907/0373

This leaﬂet was last revised in March 2026

To request a copy of this leaﬂet in Braille, large print or audio format then please contact the licence holder at the address (telephone or email) above.

V27 24-03-26 D0