100 mg, 300 mg, 400 mg hard capsules or 600 mg, 800 mg film-coated tablets
gabapentin
What Neurontin is and what it is used for
Neurontin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (prolonged pain caused by nerve damage).
The active substance in Neurontin is gabapentin.
Neurontin is used to treat
- Various forms of epilepsy (seizures that are initially limited to certain parts of the brain, with or without spread to other parts of the brain). The doctor treating you or your child aged 6 years or older may prescribe Neurontin to treat epilepsy if the current treatment does not provide sufficient effect. You or your child 6 years of age or older should take Neurontin as a supplement to the current treatment, unless your doctor tells you otherwise. Neurontin can also be used as the only drug for adults and children from 12 years.
- Peripheral neuropathic pain (prolonged pain caused by nerve damage). A number of different diseases can cause peripheral neuropathic pain (mainly in the legs and / or arms), such as diabetes or shingles . The pain can be described as a hot, burning, throbbing, flashing, stinging, sharp, cramping, aching, stinging, paralyzing sensation or as ant crawling.
Gabapentin contained in Neurontin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Neurontin
Do not use Neurontin
- if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Neurontin
- if you have kidney problems. Your doctor may then prescribe a different dosing schedule.
- if you are undergoing hemodialysis (treatment method for renal impairment where waste products are removed). Tell your doctor if you get muscle pain and / or muscle weakness.
- if you get symptoms such as persistent abdominal pain, nausea and vomiting. In this case, contact your doctor immediately as this may be a symptom of acute pancreatitis (inflammation of the pancreas).
- if you have nervous system disorders, respiratory diseases or if you are older than 65 years, your doctor may prescribe you a different dosage .
Cases of abuse and dependence have been reported for gabapentin since its introduction. Talk to your doctor if you have a history of substance abuse or addiction.
A small number of people who are treated with antiepileptic drugs such as gabapentin have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
Important information about potentially serious reactions
A few patients taking Neurontin have a severe reaction or potentially severe skin reaction, which can develop into more serious problems if left untreated. You need to know the symptoms you need to be aware of when taking Neurontin.
Read the description of these symptoms in section 4 of this leaflet under “Contact your doctor immediately if you get any of the following symptoms after taking this medicine as they may be serious.”
Muscle weakness, soreness, or pain, especially if you also feel unwell or have a high fever, maybe due to an abnormal muscle breakdown that can be life-threatening and lead to kidney problems. You may also have discolored urine and altered blood test results (especially elevated blood creatine phosphokinase). Contact your doctor immediately if you experience any of these symptoms.
Other drugs and Neurontin
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 recently taken medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or mental problems.
Drugs that contain opioids such as morphine
If you are taking any medicines that contain opioids (such as morphine), tell your doctor or pharmacist, as opioids may increase the effect of Neurontin. In addition, a combination of Neurontin and opioids can cause drowsiness, sedation, difficulty breathing, or death.
Antacids for stomach problems
If Neurontin is taken together with antacids that contain aluminum and magnesium, the uptake of Neurontin from the stomach may decrease. Neurontin should therefore be taken no earlier than two hours after taking the antacid.
Neurontin:
- is not expected to affect or be affected by other antiepileptic drugs or birth control pills .
- may interfere with certain laboratory tests. If you need to take a urine sample, tell your doctor or hospital staff what you are taking.
Neurontin with food, drink and alcohol
Neurontin can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Neurontin should not be taken during pregnancy unless your doctor tells you otherwise. An effective contraceptive must be used by women of childbearing potential.
No studies have been performed to specifically investigate the use of gabapentin in pregnant women, but the use of other epilepsy medicines has been reported to increase the risk of birth defects, especially when more than one such medicine is taken at the same time. As far as possible, you should try not to take more than one epilepsy medicine during pregnancy, and only in consultation with a doctor.
Contact your doctor immediately if you become pregnant, if you think you may be pregnant or if you are planning to become pregnant while taking Neurontin. Do not abruptly stop taking this medicine. This can lead to a breakthrough spasm and have serious consequences for you and your child.
Breast-feeding
Gabapentin, the active substance in Neurontin, passes into breast milk. As the effect on the baby is unknown, you should not breastfeed while being treated with Neurontin.
Fertility
No effect on fertility has been observed in animal studies.
Driving and using machines
Neurontin can cause dizziness, drowsiness, and fatigue. You should not drive, use advanced machines or engage in any other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Read all information in this leaflet for guidance. Ask your doctor or pharmacist if you are unsure.
Neurontin capsules contain lactose
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 medicine.
Neurontin capsules contain sodium
This medicine contains less than 1 mmol (23 mg) sodium per 100 mg, 300 mg, and 400 mg hard capsules, ie essentially ‘sodium-free’.
How to use Neurontin
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide which dose is right for you.
Epilepsy, the recommended dose is:
Adults and young people
Take the number of capsules or tablets that your doctor has prescribed. Your doctor may increase the dose one by one. The usual starting dose is between 300 mg and 900 mg daily. Then the dose can be increased up to a maximum of 3,600 mg daily, according to your doctor’s instructions, divided into 3 separate occasions, ie. once in the morning, once in the afternoon, and once in the evening.
Children from 6 years
The doctor will decide which dose to give to your child, as it is calculated taking into account the child’s weight. The treatment begins with a low starting dose, which is then gradually increased over about 3 days. The usual dose for epilepsy treatment is 25–35 mg per kg per day. The capsules or tablets are usually taken in 3 separate doses every day, once in the morning, once in the afternoon, and once in the evening.
Neurontin is not recommended for children under 6 years of age.
Peripheral neuropathic pain, recommended dose is:
Adults
Take the number of capsules or tablets that your doctor has prescribed. Your doctor may increase the dose one by one. The usual starting dose is between 300 mg and 900 mg daily. Then the dose can be increased up to a maximum of 3,600 mg daily, according to your doctor’s instructions, divided into 3 separate occasions, ie. once in the morning, once in the afternoon, and once in the evening.
If you have kidney problems or go for hemodialysis
Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems or are on hemodialysis.
If you are older (over 65 years), you should take the normal dose of Neurontin, unless you have kidney problems. Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems.
If you have the impression that the dose is too strong or too weak, talk to your doctor or pharmacist as soon as possible.
How Neurontin is taken
Neurontin should be swallowed. Always swallow the capsules or tablets together with plenty of water. The tablet can be divided into two equal doses.
Keep taking Neurontin until your doctor tells you to stop.
If you use more Neurontin than you should
Higher doses than recommended can lead to increased side effects including unconsciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Take the capsules or tablets that you have not taken with you, along with the packaging and label, so that the staff can easily see which medicine you have taken.
If you forget to use 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 using Neurontin
Do not stop taking Neurontin unless your doctor tells you to. If treatment is stopped, this should be done gradually for at least 1 week. If you stop taking Neurontin suddenly or before your doctor tells you to, there is an increased risk of seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you get any of the following symptoms after taking this medicine as they may be serious:
- severe skin reactions that require immediate care, such as swollen lips and face, skin rash and redness and / or hair loss (this may be a symptom of a severe allergic reaction)
- persistent abdominal pain, nausea and vomiting as this may be a symptom of acute pancreatitis (inflammation of the pancreas)
- breathing problems, where in severe cases you may need emergency and intensive care to continue breathing normally
- Neurontin can cause a serious or life-threatening allergic reaction that can affect your skin or other parts of your body such as your liver or blood cells. When you get such a reaction, you can either get a rash or not. You may need to be hospitalized or stop taking Neurontin.
Contact your doctor immediately if you have any of the following symptoms:
- rash
- hives
- fever
- swollen glands that do not disappear
- swelling of the lip or tongue
- yellow skin or whites of the eyes
- unusual bruising or bleeding
- severe fatigue or weakness
- unexpected muscle pain
- frequent infection is
These symptoms may be the first signs of a severe reaction. A doctor should examine you to decide if you should continue to take Neurontin.
If you go for hemodialysis, tell your doctor if you get muscle pain and/or muscle weakness
Other side effects include:
Very common (may affect more than 1 user in 10):
- Virus infection
- Feeling drowsy, dizzy, uncoordinated muscle movements
- Feeling tired, fever
Common (may affect up to 1 in 10 people) :
- Pneumonia , respiratory tract infection, urinary tract infection, ear infection or other infection
- Decreased white blood cell count
- Anorexia , increased appetite
- Aggression against others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking clearly
- Seizures, jerky movements, speech difficulties, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensation (numbness), coordination difficulties, abnormal eye movements, increased / decreased or absence of reflexes
- Blurred vision, double vision
- Dizziness
- High blood pressure , redness / dilation of blood vessels
- Difficulty breathing, bronchitis , sore throat, cough, nasal congestion
- Vomiting, nausea, teeth problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth and throat, gas
- Facial swelling, bruising, rash, itching , acne
- Joint pain, muscle aches, back pain, twitching
- Erectile Dysfunction ( Impotence )
- Swollen legs and arms, difficulty walking, weakness, aches, malaise, flu-like symptoms
- Weight gain
- Accidents, fractures , abrasions
In addition, aggressive behavior and jerky movements have been reported as common side effects in clinical trials in children.
Uncommon (may affect up to 1 in 100 people):
- Agitation (a state of constant restlessness and involuntary, meaningless movements)
- Allergic reactions such as hives
- Reduced movements
- Palpitation
- Difficulty swallowing
- Swelling that may include face, torso and limbs
- Abnormal blood test results that indicate liver problems
- Psychological disorder
- Fall accidents
- Increased blood sugar level (most commonly seen in patients with diabetes )
Rare (may affect up to 1 in 1,000 people):
- Decreased blood sugar level (most commonly seen in patients with diabetes )
- Loss of consciousness
- Shortness of breath, shallow breathing ( respiratory depression )
Following the introduction of Neurontin on the market, the following side effects have been reported:
- Decreased platelet count (cells important for coagulation )
- Suicidal thoughts and hallucinations
- Abnormal movements, such as winding or jerky movements and stiffness
- Earrings
- A group of side effects that may include swollen lymph nodes (isolated, small, raised bumps under the skin), fever, rash and hepatitis occur simultaneously.
- Yellowing of the skin and eyes (jaundice), inflammation of the liver
- Acute renal failure , incontinence
- Increase in breast tissue, breast enlargement
- Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, nausea, aches, sweating), chest pain
- Degradation of muscle tissue ( rhabdomyolysis )
- Alteration of blood test results (elevated blood creatine phosphokinase)
- Sexual problems including inability to orgasm, delayed ejaculation
- Low sodium levels in the blood
- Anaphylactic reaction (severe allergic reaction that can be life-threatening, with symptoms such as difficulty breathing, swelling of the lips, throat and tongue and low blood pressure that requires emergency treatment)
How to store Neurontin
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. The expiration date is the last day of the specified month.
Neurontin capsules should not be stored above 30 ° C.
Neurontin tablets should not be stored above 25 ° C.
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.
Contents of the pack and other information
Content declaration
Neurontin capsules, hard
The active substance is gabapentin. Each hard gelatin capsule contains either 100 mg, 300 mg, or 400 mg of gabapentin.
Other ingredients are:
Capsule, content: lactose monohydrate, corn starch, and talc.
Capsule shell: gelatin, purified water, and sodium lauryl sulfate.
100 mg capsules contain the dye E171 (titanium dioxide), 300 mg capsules contain the dyes E171 (titanium dioxide) and E172 (yellow iron oxide) and 400 mg capsules contain the dyes E171 (titanium dioxide) and E172 (red and yellow iron oxide). The printing ink used on all capsules contains shellac, E171 (titanium dioxide), and E132 (indigo carmine aluminum salt).
Neurontin film-coated tablets
The active substance is gabapentin. Each film-coated tablet contains either 600 mg or 800 mg of gabapentin.
The other ingredients are Poloxamer 407 (ethylene oxide and propylene oxide), copovidone, corn starch, and magnesium stearate.
Film coating: Opadry White YS-1-18111 (hydroxypropyl cellulose, talc)
Polish: candelillavax
What the medicine looks like and contents of the pack
Capsules, hard
Neurontin 100 mg hard capsules are white and marked with “Neurontin 100 mg” and “PD”.
Neurontin 300 mg hard capsules are yellow and marked with “Neurontin 300 mg” and “PD”.
Neurontin 400 mg hard capsules are orange and marked with “Neurontin 400 mg” and “PD”.
Supplied as PVC / PVDC / aluminum foil blister pack of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
Not all pack sizes may be marketed.
Film-coated tablets
Neurontin 600 mg tablets are white, elliptical film-coated tablets with a scoreline on both sides and imprint “NT” and “16” on one side.
Neurontin 800 mg tablets are white, elliptical film-coated tablets with a scoreline on both sides and imprint “NT” and “26” on one side.
Supplied as PVC / PE / PVDC / aluminum foil blister pack or PVC / PVDC / aluminum foil blister pack of 20, 30, 45, 50, 60, 84, 90, 100, 200, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local representative
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Operating office Freiburg
Mooswaldallee 1
D-79090 Freiburg
Germany