Patient leaflet - Gabapentin Mylan 300 mg hard capsules
1. What Gabapentin is and what it is used for
This medicine has been prescribed for you to treat epilepsy and peripheral neuropathic pain.
Gabapentin belongs to a group of medicines called Gabapentinoids.
This medicine has been prescribed to you and should not be given to anyone else.
Epilepsy
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). Your doctor will prescribe Gabapentin for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You 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
Gabapentin is used to treat long lasting pain caused by damage to the nerves. A variety of different diseases can cause peripheral (primarily occurring in the legs and/or arms) neuropathic pain, 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. Gabapentinoids 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 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:
- if you suffer from kidney problems
- if you are on haemodialysis (to remove waste products because of kidney failure) • if you have myasthenia gravis (a disease causing muscle weakness) because this medicine may make your symptoms worse
if you have nervous system disorders, breathing disorders, or you are more than 65 years old.
Your doctor may prescribe you a different dosing schedule
- 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 • 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 Neurontin 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.
Cases of abuse and dependence have been reported for gabapentin. Talk to your doctor if you have a history of abuse or dependence.
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.
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.
Some people may become dependent on Gabapentin (a need to keep taking the medicine). They may have withdrawal effects when they stop using Gabapentin or reduce the dose (see section 3, ‘How to take Gabapentin’ and ‘If you stop taking Gabapentin’). If you have concerns that you may become dependent on Gabapentin, it is important that you consult your doctor.
If you notice any of the following signs whilst taking Gabapentin, 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.
During treatment
If you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately as these may be signs of acute pancreatitis (an inflamed pancreas).
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, contact your doctor immediately.
Increase in seizures or new types of seizure have been seen in some people taking gabapentin. Talk to your doctor or pharmacist if you notice a change to your condition.
If you experience any signs such as feeling dizzy and drowsy (which could increase accidental injury), confusion, loss of consciousness and reduced mental state while taking gabapentin, talk to you doctor or pharmacist for advice.
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 signs in section 4 of this leaflet under ‘Stop taking this medicine and contact your doctor immediately or go to the nearest hospital casualty department straight away if you experience any of the following signs after taking this medicine as they can be serious’
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 sleepiness, sedation, decrease in breathing or death.
Gabapentin is not expected to interact with other antiepileptic medicines or oral contraceptive pills containing norethindrone or ethinyl estradiol.
Gabapentin may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking Gabapentin.
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 least two hours after taking an antacid.
Pregnancy and breast-feeding
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 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.
Do not suddenly stop taking this medicine as this may lead to 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, passes into human milk. Because the effect on the nursing newborn is unknown, it is not recommended to breast-feed your baby while taking Gabapentin.
Driving and using machines
Gabapentin may cause dizziness, drowsiness and tiredness. You should not drive, operate machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Gabapentin hard 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 medicine
Gabapentin hard capsules contain sodium
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’,
3. How to take Gabapentin
Always take this medicine exactly as your doctor 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.
If you have the impression that the effect of Gabapentin is too strong or too weak, talk to your doctor or pharmacist.
Your prescriber should have discussed with you how long the course of tablets 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.
Always swallow the capsules whole with plenty of water. This medicine may be taken with or without food.
Continue taking Gabapentin until your doctor tells you to stop.
Epilepsy:
Use in 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 stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.
Use in 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 recommended dose to control epilepsy is 25-35 mg/kg/day. It is usually given in 3 divided 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:
Take the number of capsules as instructed by your doctor. Your doctor will usually build up your dose gradually.
The recommended starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.
Older patients
If you are an elderly patient (over 65 years of age), you should take Gabapentin normally except you have problems with your kidneys.
Patients with 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 take more Gabapentin than you should
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 the nearest hospital emergency unit immediately. Take along any capsules that are left, the container and the label so that the hospital can easily tell what medicine you have taken.
As this medicine 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. Signs of an overdose include dizziness, double vision, slurred speech, loss of consciousness, drowsiness and mild diarrhoea.
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 capsule.
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 is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms. Withdrawal symptoms such as trouble sleeping, headache, feeling sick (nausea), feeling anxious, diarrhoea, flu-like symptoms, convulsions, nervousness, depression, thoughts of harming or killing yourself, pain, sweating, and dizziness. 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 taking Gabapentin and contact your doctor immediately or go to the nearest hospital casualty department straight away if you experience any of the following symptoms after taking this medicine as they can be serious:
Common (may affect up to 1 in 10 people):
- serious chest infection which may cause fever, chills, shortness of breath, cough, phlegm and occasionally blood (pneumonia)
- fits (convulsions)
- decreased white blood cell count (leucopenia) which may cause you to suffer from more frequent infections e.g. sore throat, fever, severe chills and mouth ulcers etc.
Rare (may affect up to 1 in 1,000 people):
- loss of consciousness
- breathing problems – if these become severe you may need emergency and intensive care to continue breathing normally
Not known (frequency cannot be estimated from the available data):
- anaphylaxis (serious, potentially life threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)
- 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).
- severe skin reactions that require immediate attention such as swelling of the lips and face, skin rash and redness (these may be signs of a serious allergic reaction). • a severe condition of the skin (Erythema multiforme) that may affect the mouth and other parts of the body signs include red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body. The spots may blister or may progress to form raised, red, pale-centered marks. Those affected may have fever, sore throat, headache and/or diarrhoea.
an inflamed pancreas which may cause stomach pain (spreading to the back) and being sick. • kidney disease leading to passing less urine than usual, feeling or being sick, or confused
(acute kidney failure).
- destruction of muscle fibres associated with muscle cramps, muscle pain, fever and red-brown discoloration of the urine (rhabdomyolysis)
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 hospitalised or to stop Gabapentin.
Call your doctor right away if you have any of the following signs:
- 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 signs may be the first signs of a serious reaction. A doctor should examine you to decide if you should continue taking Gabapentin.
Other possible side effects:
Very common (may affect more than 1 in 10 people):
- viral infection.
- feeling drowsy, dizziness, lack of coordination.
- feeling tired.
Common (may affect up to 1 in 10 people):
- urinary tract infection, general infections, inflammation of the ear
- loss of appetite or an increased appetite
- anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking
- jerky movements, difficulty with speaking, loss of memory, shaking, difficulty sleeping, headache, numbness, tingling or pins and needles, decreased sensation, difficulty with coordination
- rapid unusual eye movement, increased, decreased or absent reflexes • blurred vision, double vision
- spinning sensation (vertigo)
- high blood pressure, flushing or dilation of blood vessels
- shortness of breath, chest infection (bronchitis), sore throat and discomfort when swallowing, cough, runny or blocked nose
- vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, wind
- facial swelling, bruises, acne
- joint pain, muscle pain, back pain, twitching
- difficulty getting or maintaining an erection
- swelling in the legs and arms difficulty with walking, pain, generally feeling unwell, flu-like symptoms
- increase in weight
- accidental injuries, such as broken bones, scratches or bruises
Uncommon (may affect up to 1 in 100 people):
- racing heartbeat
- unusually reduced or slow body movement
- swelling that may involve the trunk
- increase in liver enzymes and bilirubin seen in a blood test
- fall
- difficulty with thinking
- high blood sugar (most often seen in patients with diabetes)
- nettle rash or itchy rash
- agitation (a state of chronic restlessness and unintentional and purposeless motions) • difficulty swallowing
Rare (may affect up to 1 in 1,000 people):
- low blood sugar (most often seen in patients with diabetes)
- loss of consciousness
- trouble breathing, shallow breaths (respiratory depression)
Not known (frequency cannot be estimated from the available data):
- suicidal thoughts
- sensing things that are not real (hallucinations)
- ringing in the ears
- problems with abnormal movements such as writhing, jerking movements and stiffness affecting the eyes, head, neck and body
- hair loss
- uncontrolled passing of urine
- increased breast tissue, breast enlargement in males
- problems with sexual functioning including changes in sex drive, inability to reach a sexual climax, delayed ejaculation
- signs of withdrawal (such as anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
- increase in creatine phosphokinase seen in a blood test
- low levels of sodium in the blood
- Worsening of myasthenia gravis (a disease causing muscle weakness) • becoming dependent on Gabapentin (‘ dependence and addiction, see section “How do I know if I am tolerant or addicted?”)
Drug Withdrawal
When you stop taking Neurontin or after reducing your dose, 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 Neurontin, 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
Additional side effects in children
Aggressive behaviour was commonly reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the label, carton or bottle after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25 °C.
HDPE bottle: Keep the bottle tightly closed.
PVC/Alu blister: 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 contains
The active substance is gabapentin.
Each hard capsule contains either 100 mg, 300 mg or 400 mg gabapentin.
The other ingredients are:
Capsule contents: lactose anhydrous (see section 2, ‘Gabapentin contains lactose’), maize starch and talc.
Capsule shell: gelatin, sodium lauryl sulphate.
The 100mg capsules contain the colouring titanium dioxide (E171); the 300mg capsules contain the colourings: titanium dioxide (E171) and iron oxide yellow (E172) and the 400mg capsules contain the colourings titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
What Gabapentin looks like and contents of the pack
Each hard gelatin capsule contains a white powder.
Capsule, hard body and cap: the 100 mg capsules are white, the 300 mg capsules are yellow and the 400 mg capsules are orange.
Gabapentin is available in:
Blister packs of 10, 20, 30, 50, 90, 100 or 250 capsules,
Blister multipacks of 2 cartons, each containing 100 capsules,
Blister hospital multipacks of 5 or 10 cartons, each containing 100 capsules, Unit dose blisters of 20, 60 or 100, each containing 1 capsule or
Bottles of 50, 100, 200 or 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary