Patient leaflet - Gabapentin Teva 100 mg capsules hard
1. What Gabapentin Teva Hard Capsules are and what they are used for
Gabapentin Teva 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 Teva is gabapentin which belongs to a class of medicines called Gabapentinoids.
Gabapentin Teva are 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 Teva 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 Teva in addition to the current treatment unless told otherwise. Gabapentin Teva 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.
Gabapentinoids can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months. If this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.
2. What you need to know before you take Gabapentin Teva Hard Capsules
Do not take Gabapentin Teva:
if you are allergic to gabapentin or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Teva:
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 have myasthenia gravis (a disease causing muscle
weakness) because this medicine may make your symptoms worse
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 Teva 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.
Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your doctor should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.
Dependence
Some people may become dependent on Gabapentin Teva (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin Teva or reduce the dose (see section 3, “How to take Gabapentin Teva” and “If you stop taking Gabapentin Teva”). If you have concerns that you may become dependent on Gabapentin Teva, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Gabapentin Teva, it could be a sign that you have become dependent if you:
feel you need to take the medicine for longer than advised
by your doctor
- feel you need to take more than the recommended dose
- are using the medicine for reasons other than prescribed
have made repeated, unsuccessful attempts to quit or
control the use of the medicine
or 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.
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 doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Gabapentinoids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of gabapentinoids, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
A small number of people being treated with anti-epileptics such as Gabapentin Teva 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 Teva 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 Teva
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 Teva Hard Capsules. In addition, combination of Gabapentin Teva with opioids may cause sleepiness, sedation, decrease in breathing, or death.
Antacids for indigestion
If Gabapentin Teva and antacids containing aluminium and magnesium are taken at the same time, absorption of Gabapentin Teva from the stomach may be reduced. It is therefore recommended that Gabapentin Teva is taken at the earliest two hours after taking an antacid.
Gabapentin Teva:
- 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 Teva Hard Capsules with food
Gabapentin Teva 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 breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin Teva 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.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Gabapentin Teva. 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 Teva may lead to withdrawal symptoms in newborn infants. This risk might be increased when Gabapentin Teva are taken together with opioid analgesics (drugs for treatment of severe pain).
Breast-feeding
Gabapentin, the active substance of Gabapentin Teva Hard 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 Teva.
Fertility
There is no effect on fertility in animal studies.
Driving and using machines
Gabapentin Teva may produce dizziness, drowsiness and tiredness. You should not drive, operate complex machinery or take part in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Information about ingredient of Gabapentin Teva Hard Capsules
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.
3. How to take Gabapentin Teva Hard 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 doctor should have discussed with you how long the course of capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your doctor will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.
Epilepsy - the recommended dose is: Adults and adolescents
Take the number of capsules as instructed. Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor up to a maximum of 3600 mg each day and your
doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and
once in the evening.
Use in children
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 Teva 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 Teva 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 Teva is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin Teva is for oral use. Always swallow the capsules whole with plenty of water.
Gabapentin Teva can be taken with or without food.
Continue taking Gabapentin Teva until your doctor tells you to stop.
If you take more Gabapentin Teva 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 Teva 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 Teva
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 Teva
Do not suddenly stop taking Gabapentin Teva or reduce your dose. If you want to stop taking Gabapentin Teva 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. If your treatment is stopped or your dose is reduced, it should be done gradually over a period of weeks to months but over a minimum of 1 week. 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. After stopping a short or long-term treatment with Gabapentin Teva 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), diarrhoea, flu-like symptoms, pain, sweating, shaking, headache, depression, thoughts of harming or killing yourself, feeling abnormal, nervousness, dizziness, and feeling generally unwell. These effects usually occur within 48 hours after stopping Gabapentin Teva or reducing your dose. If you experience withdrawal effects, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Gabapentin Teva 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 Teva 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 a rash when you get this type of reaction. It may cause you to be hospitalized or to stop Gabapentin Teva. Call your doctor right away if you have any of the following symptoms:
- skin rash and redness and/or hair loss
- hives
- fever
- swollen glands that do not go away
- swelling of your lip, face and tongue
- yellowing of your skin or of the whites of the eyes
- unusual bruising or bleeding
- severe fatigue or weakness
- unexpected muscle pain
- frequent infections.
These symptoms may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin Teva.
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)
Not known (frequency cannot be estimated from the available data)
dependence and addiction (see section “How do I know if I am tolerant or addicted?”).
After marketing gabapentin 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 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)
- becoming dependent on Gabapentin Teva (‘drug dependence’)
- worsening of myasthenia gravis (a disease causing muscle weakness).
Drug Withdrawal
After stopping a short or long-term treatment with Gabapentin Teva 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 Teva’).
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Gabapentin Teva, 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.
Reporting of side effects
If you get any side effects, talk to your doctor or 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.
5. How to store Gabapentin Teva Hard Capsules
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 and blister or bottle after EXP. The expiry date refers to the last day of that month.
This medicine 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 Teva Hard Capsules contains
The active substance is gabapentin.
Each Gabapentin Teva 100 mg hard capsule contains 100 mg gabapentin.
Each Gabapentin Teva 300 mg hard capsule contains 300 mg gabapentin.
Each Gabapentin Teva 400 mg hard capsule contains 400 mg gabapentin.
The other ingredients are:
Capsule contents: maize starch, mannitol (E421), talc (E553b).
Capsule shell: gelatin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), iron oxide red (E172), purified water, sodium laurilsulfate.
Printing inks: Gabapentin Teva 100 mg, 300 mg and 400 mg Hard Capsules - Black printing ink: shellac (E904), black iron oxide (E172) and Gabapentin Teva 100 mg Hard Capsules - White printing ink: shellac (E904), titanium dioxide (E171).
What Gabapentin Teva Hard Capsules look like and contents of the pack
Gabapentin 100 mg Hard Capsules are hard capsules (approximately 16 mm in length), with a white opaque body with TV 3494 printed in black and light brown opaque cap with TV 3494 printed in white.
Gabapentin 300 mg Hard Capsules are hard capsules (approximately 19 mm in length), with a yellow opaque body with TV 3495 printed in black and light brown opaque cap with TV 3495 printed in black.
Gabapentin 400 mg Hard Capsules are hard capsules (approximately 22 mm in length), with an orange opaque body with TV 3496 printed in black and light brown opaque cap with TV 3496 printed in black.
Gabapentin Teva Hard Capsules are available in blisters and perforated unit dose blisters containing 20, 30, 50, 60, 90, 100 or 200 hard capsules, or a bottle containing 50, 100 or 200 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Pallagi út 13., Debrecen H-4042, Hungary
This leaflet was last revised in April 2026.
PL 00289/2630, PL 00289/2631 and PL 00289/2632
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