Patient leaflet - Gabapentin Relonchem 400 mg hard capsules
1. What Gabapentin Relonchem is and what it is used for
Gabapentin Relonchem 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 in Gabapentin Relonchem is gabapentin.
This Gabapentin Relonchem has been prescribed for you 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 Relonchem 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 Relonchem in addition to the current treatment unless told otherwise. Gabapentin Relonchem 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 or pins and needles etc.
It contains the gabapentin which belongs to a class of medicines called Gabapentinoids.
This medicine has been prescribed to you and should not be given to anyone else.
Gabapentin Relonchem 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 Relonchem
Do not take Gabapentin Relonchem:
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 or pharmacist before taking Gabapentin Relonchem • 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.
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 Relonchem • 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 Relonchem
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.
If you have myasthenia gravis (a disease causing muscle
weakness) because this medicine may make your symptoms worse.
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 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 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 Relonchem 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 Relonchem, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Dependence
Some people may become dependent on Gabapentin Relonchem (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Relonchem or reduce the dose (see section 3, “How to take Gabapentin Relonchem” and “If you stop taking Gabapentin Relonchem”). If you have concerns that you may become dependent on Gabapentin Relonchem, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Gabapentin Relonchem, it could be a sign that you have become dependent. • you feel you need to take the medicine for longer than advised
by your prescriber
you feel you need to take 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, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to do this safely.
A small number of people being treated with anti-epileptics such as gabapentin have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.
Important information about potentially serious reactions
Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin. Stop using gabapentin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of these symptoms in section 4 of this leaflet under ‘Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious’
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 Relonchem
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 Relonchem. In addition, combination of Gabapentin Relonchem with opioids may cause sleepiness, sedation, decrease in breathing, or death.
Antacids for indigestion
If Gabapentin Relonchem and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Relonchem from the stomach may be reduced. It is therefore recommended that Gabapentin Relonchem is taken two hours after taking an antacid at the earliest.
Gabapentin Relonchem
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 Relonchem with food
Gabapentin Relonchem 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. • You should not stop your treatment without discussing this
with your doctor.
If you are planning to become pregnant you should
discuss your treatment with your doctor or pharmacist as early as possible before you become pregnant. • If you are breast feeding or planning to breast-feed,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin Relonchem 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).
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Relonchem.
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, the active substance of Gabapentin Relonchem, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Gabapentin Relonchem.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Relonchem 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.
Gabapentin Relonchem contains lactose
Gabapentin Relonchem hard 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.
Gabapentin Relonchem contains sodium
Gabapentin Relonchem hard capsules contains less than 1 mmol sodium (23 mg) per 100 mg, 300 mg and 400 mg hard capsules, that is to say essentially ‘sodium-free’.
3. How to take Gabapentin Relonchem
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.
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 three 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 then 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 Relonchem 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 Relonchem 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 Relonchem is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Relonchem is for oral use.
Always swallow the capsules with plenty of water. Continue taking Gabapentin Relonchem until your doctor tells you to stop.
If you take more Gabapentin Relonchem than you should
Higher doses than recommended 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 Relonchem 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 Relonchem
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 Relonchem
Do not suddenly stop taking this medicine or reduce your dose. If you want to stop taking this medicine or reduce your dose, discuss this with your doctor first. They will tell you how to do this. If your treatment is stopped or your dose is reduced, it should be done gradually over a minimum of 1 week. After stopping a short or long-term treatment with this medicine 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, and feeling generally unwell.
These effects usually occur within 48 hours after stopping Gabapentin Relonchem 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.
Drug Withdrawal
When you stop taking Gabapentin Relonchem, you may experience drug withdrawal effects, which include:
seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain,
sweating, shaking, headache, depression, feeling abnormal, dizziness, and feeling generally unwell.
Stop using Gabapentin Relonchem 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 • Gabapentin Relonchem 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 hospitalised or to stop Gabapentin Relonchem. 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 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 Relonchem.
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
- 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)
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)
Unknown frequency: dependence and addiction How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Gabapentin Relonchem, 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 doctor.
After marketing Gabapentin Relonchem 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
- Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
- Breakdown of muscle fibres (rhabdomyolysis) • Change in blood test results (creatine phosphokinase increase) • 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) • Becoming dependent on Gabapentin Relonchem (‘drug dependence’)
- Worsening of myasthenia gravis (a disease causing muscle weakness)
After stopping a short or long-term treatment with Gabapentin Relonchem 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 Relonchem”).
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 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 Relonchem
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton as ‘Exp’.
The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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 Relonchem contains
The active substance is gabapentin.
Each Gabapentin Relonchem 100 mg hard capsule contains 100 mg gabapentin.
Each Gabapentin Relonchem 300 mg hard capsule contains 300 mg gabapentin.
Each Gabapentin Relonchem 400 mg hard capsule contains 400 mg gabapentin.
The other ingredients in Gabapentin Relonchem hard capsules are: Capsule contents: lactose monohydrate, maize starch, purified talc Capsule shell: gelatin, purified water and sodium lauryl sulphate The 100 mg capsules contain the colouring E171 (titanium dioxide), the 300 mg capsules contain the colouring E171 (titanium dioxide) and E172 (yellow iron oxide), the 400 mg capsules contain the colouring E171 (titanium dioxide), E172 (yellow iron oxide) and E172 (red iron oxide).
The printing ink on all capsules contain E904 (shellac), E171 (titanium oxide), E1520 (propylene glycol) and E133 (FD & C Blue #2 aluminium lake).
What Gabapentin Relonchem looks like and contents of the pack
100 mg: A white powder in size “3” hard gelatin capsules with white cap and white body ‘103’ printed on body.
300 mg: A white powder in size “1” hard gelatin capsules with yellow cap and yellow body ‘104’ printed on body. 400 mg: A white powder in size “0” hard gelatin capsules with orange cap and orange body ‘105’ printed on body. Supplied in PVC/PE/PVDC/aluminium foil blister packs of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500 or 1000 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited,
Cheshire House, Gorsey Lane,
Widnes, Cheshire, WA8 0RP, UK.
Gabapentin Relonchem 100 mg hard capsules : PL 20395/0312 Gabapentin Relonchem 300 mg hard capsules : PL 20395/0313 Gabapentin Relonchem 400 mg hard capsules : PL 20395/0314
This leaflet was last revised in December 2025.
Code No: TN/DRUGS/TN00002269
POM
180 mm
180 mm