Gabapentin Medreich 100 mg capsules – patient leaflet, side effects, dosage

1. WHAT GABAPENTIN IS AND WHAT IT IS USED

FOR

Gabapentin Medreich 100mg, 300mg or 400mg Capsules (throughout the leaflet, product name is referred as Gabapentin) contains Gabapentin which belongs to a class of medicines called Gabapentinoids. This medicine has been prescribed for you to treat epilepsy and peripheral neuropathic pain (long lasting pain caused by damage to the nerves).

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 your 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. This medicine has been prescribed to you and should not be given to anyone else.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GABAPENTIN

Do not take gabapentin:

• If you are allergic (hypersensitive) to Gabapentin

  or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Talk to your doctor before taking this medicine 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

• 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.

• 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 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.

• have myasthenia gravis (a disease causing

  muscle weakness) because this medicine may make your symptoms worse.

Cases of abuse and dependence have been reported for gabapentin from the post-marketing experience. 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.

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 or reduce the dose (see section 3, “How to take Gabapentin” and “If you stop taking Gabapentin”). 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 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. 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.

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’ 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

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 symptoms like sleepiness, sedation, decrease in breathing, or death. Antacids for indigestion

If Gabapentin and antacids containing aluminum 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:

• 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 Capsules with food

Gabapentin can be taken with or without food.

Pregnancy, breast-feeding and fertility

• 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.

There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the developing baby, particularly when more than one seizure medication is taken at the same time. Therefore, whenever possible, you should try to take only one seizure medication during pregnancy and only under the advice your doctor. Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin. 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. 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 using Gabapentin. Fertility

There is no effect on fertility in animal studies.

Driving and using machines

Gabapentin 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.

Gabapentin contains lactose

These capsules contain lactose (a type of sugar). 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

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.

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 300mg and 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 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 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

50 mm

Gabapentin Medreich 100mg Capsules Gabapentin Medreich 300mg Capsules Gabapentin Medreich 400mg Capsules

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This leaflet was last revised in January 2026 Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK

E-mail: info@medreich.co.uk

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 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 is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

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

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.

If you take more Gabapentin 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 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

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

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 or reducing dose is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms (see section 2 under "Dependence"). These effects usually occur within 48 hours after stopping Gabapentin 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 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).

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)
• 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 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
• 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.

• 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 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
• Difficulty swallowing
• 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 in 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?”).

Drug Withdrawal

When you stop taking Gabapentin or reduce your dose, you may experience drug withdrawal symptoms (see section 2 under "Dependence")

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.

After marketing Gabapentin 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
• Acute kidney failure, incontinence

• Adverse events following the abrupt

  discontinuation of gabapentin (anxiety, difficulty in sleeping, feeling sick, pain, sweating), chest pain

• Yellowing of the skin and eyes (jaundice),

  inflammation of the liver

• Increased breast tissue, breast enlargement
• 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)

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 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 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 above 25°C. Store in the original Package.

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 Capsules contains

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

The other ingredients are:

• Capsules Fill (100mg, 300mg, 400mg) - Lactose

  Monohydrate, Maize Starch, 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.

• Printing Ink: Shellac, Black Iron Oxide (E172),

  Potassium Hydroxide

What Gabapentin Capsules looks like and contents of the pack

Gabapentin Medreich 100mg Capsules are white/white hard gelatin capsules marked 'MG 100'. Gabapentin Medreich 300mg Capsules are yellow/yellow hard gelatin capsules marked 'MG 300'. Gabapentin Medreich 400mg Capsules are orange/ orange hard gelatin capsules marked 'MG 400'.

Pack Size: 100

To request a copy of this leaflet in Braille, large print please call, 02088311580 (UK only) Please be ready to give the following information:

Product name Reference number

Gabapentin Medreich 100mg PL 21880/0075 Capsules

Gabapentin Medreich 300mg PL 21880/0076 Capsules

Gabapentin Medreich 400mg PL 21880/0077 Capsules

Red 032 C

Unit 7

MED/GAB/PIL/03

05.11/17/30.12.25(MA)

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