Neurontin 300mg Hard Capsules
Package Leaflet: Information for the User
Neurontin® 300mg Hard Capsules (gabapentin)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Neurontin 300mg Hard Capsules but will be referred to as Neurontin throughout this leaflet. Neurontin Hard Capsules are available in other strengths.
In this leaflet:
1) What Neurontin is and what it is used for
2) Before you take Neurontin
3) How to take Neurontin
4) Possible side effects
5) How to store Neurontin
6) Further information
1) WHAT NEURONTIN IS AND WHAT IT IS USED FOR
Neurontin 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 ingredient in Neurontin is gabapentin.
Neurontin 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 Neurontin for you to help treat your epilepsy when your current treatment is not fully controlling your condition. You should take Neurontin in addition to your current treatment unless told otherwise. Neurontin 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.
2) BEFORE YOU TAKE NEURONTIN Do not take Neurontin
• if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Neurontin
Take special care with Neurontin:
• 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)
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
A small number of people taking Neurontin get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. You need to know the symptoms to look out for while you are taking Neurontin.
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 discolouration 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Medicines containing morphine
If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of Neurontin.
Antacids for indigestion
If Neurontin and antacids containing aluminium and magnesium are taken at the same time, absorption of Neurontin from the stomach may be reduced. It is therefore recommended that Neurontin is taken at the earliest two hours after taking an antacid.
Neurontin:
• 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.
Taking Neurontin with food and drink
Neurontin can be taken with or without food.
Pregnancy
Neurontin 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 of your doctor.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking Neurontin. 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 Neurontin, is passed on through human milk. Because the effect on the baby is unknown, it is not recommended to breast-feed while using Neurontin.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Neurontin 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.
Important information about some of the ingredients of Neurontin
Neurontin 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.
3) HOW TO YOU TAKE NEURONTIN
Always take Neurontin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will determine what dose is appropriate for you.
If you have the impression that the effect of Neurontin is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
If you are an elderly patient (over 65 years of age), you should take the normal dose of Neurontin 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.
Continue taking Neurontin until your doctor tells you to stop.
Method and route of administration
Neurontin is for oral use. Always swallow the capsules or tablets with plenty of water. The tablet can be divided into equal halves.
Epilepsy, the usual dose is:
Adults and adolescents:
Take the number of capsules or tablets 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.
Children aged 6 years and above:
The dose to be given to your child will be decided by your doctor as it is calculated against your child's weight. The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days. The usual dose to control epilepsy is 25-35 mg per kg of body weight per day. It is usually given in 3 separate doses, by taking the capsule(s) or tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.
Neurontin is not recommended for use in children below 6 years of age.
Peripheral Neuropathic Pain, the usual dose is:
Adults:
Take the number of capsules or tablets as instructed by your doctor.
Your doctor will usually build up your dose gradually. The starting dose will generally be between 300 mg and 900 mg each day. Thereafter, the dose may be increased as instructed by your doctor, up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 separate doses, i.e. once in the morning, once in the afternoon and once in the evening.
POM
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 take more Neurontin 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 Neurontin than your doctor prescribed. Take along any capsules or tablets 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 Neurontin
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 Neurontin
Do not stop taking Neurontin unless your doctor tells you to. If your treatment is stopped it should be done gradually over a minimum of 1 week. If you stop taking Neurontin suddenly or before your doctor tells you, there is an increased risk of seizures.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Neurontin can cause side effects, although not everybody gets them:
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)
• Neurontin 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 Neurontin. 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 Neurontin.
If you are on haemodialysis, tell your doctor if you develop muscle pain and/or weakness.
Other side effects include:
Very common side-effects (which may affect more than 1 person in 10):
• Viral infection
• Feeling drowsy, dizziness, lack of coordination
• Feeling tired, fever
Common side-effects (which may affect more than 1 person in 100):
• 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 side effects (which may affect more than 1 person in a 1000):
• Allergic reactions such as hives
• Decreased movement
• Racing heartbeat
• Swelling that may involve the face, trunk and limbs
• Abnormal blood test results suggesting problems with the liver
Since introduction to the market the following side-effects have been reported:
• Decreased platelets (blood clotting cells)
• Hallucinations
• Problems with abnormal movements such as writhing, jerking movements and stiffness
• Ringing in the ears
• A group of side effects that could include swollen lymph nodes (isolated small raised lumps under the skin), fever, rash, and inflammation of liver occurring together
• 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
• Blood glucose fluctuations in patients with diabetes
• Breakdown of muscle fibers (rhabdomyolysis)
• Change in blood test results (creatine phosphokinase increased)
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE NEURONTIN
• Keep out of the sight and reach of children.
• Do not use Neurontin after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• If your capsules become discoloured or show any sign of deterioration, return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Neurontin contains
The active substance is gabapentin.
Each hard capsule contains 300 mg gabapentin.
The other ingredients in Neurontin capsules are:
Capsule contents: Lactose monohydrate, maize starch and talc. Capsule shell: gelatin, purified water, sodium lauryl sulphate, titanium dioxide (E171) and yellow iron oxide (E172).
The printing ink contains shellac, titanium dioxide (E171) and indigo carmine (E132).
What Neurontin looks like and contents of the pack
A two-piece, yellow opaque hard capsule, imprinted with ‘Neurontin 300mg' and ‘PD' and containing a white to off-white powder. Neurontin is available in blister packs of 50 and 100 capsules.
Manufacturer
Neurontin are manufactured by Goedecke GmbH, Mooswaldallee 1, D-79090 Freiburg, Germany.
They are procured from within the EU by the Product Licence holder: MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by: xxxxxxxxxxxxxxxxxxxxxxxxxxxxx PL: 33532/0106
Leaflet code: xxxxxx
Leaflet date: 06th February 2014
Neurontin® is a registered trademark of Warner-Lambert Company LLC