Neurontin 400 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Neurontin 400mg hard capsules
Gabapentin
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Neurontin is and what it is used for
- What you need to know before taking Neurontin
- How to take Neurontin
- Possible adverse effects
- How to store Neurontin
- Contents of the pack and other 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 (chronic pain caused by nerve damage).
The active substance in Neurontin is gabapentin.
Neurontin is used to treat
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Certain types of epilepsy (seizures that initially affect only certain parts of the brain, whether or not they spread to other parts of the brain). Your doctor or your child's doctor (for children aged 6 years or older) may prescribe Neurontin to help treat epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take Neurontin in combination with current treatment, unless otherwise instructed by your doctor. Neurontin may also be used as monotherapy in the treatment of adults and children over 12 years of age.
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Peripheral neuropathic pain (chronic pain caused by nerve damage). Various conditions can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or shingles. The pain may be described as burning, shooting, stabbing, sharp, continuous, tingling, numbness, pins and needles, or electric shock-like sensations, among others.
2. What you need to know before taking Neurontin
Do not take Neurontin
- if you are allergic (hypersensitive) to gabapentin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Neurontin
- if you have kidney problems, your doctor may prescribe a different dosing regimen
- if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience muscle pain and/or weakness
- if you develop symptoms such as persistent stomach pain, vomiting, and nausea, notify your doctor immediately, as these may be symptoms of acute pancreatitis (inflamed pancreas)
- if you have a disorder of the nervous system or a respiratory disorder, or if you are over 65 years of age, your doctor may prescribe a different dose
- before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on Neurontin.
Dependence
Some people may develop dependence (a need to keep taking the medicine) on Neurontin. They may experience withdrawal symptoms when they stop taking Neurontin (see section 3, "How to take Neurontin" and "If you stop taking Neurontin"). If you are concerned about developing dependence on Neurontin, it is important to consult your doctor.
If you experience any of the following signs while taking Neurontin, it may indicate that you have developed dependence:
- you feel the need to take the medicine longer than prescribed
- you feel the need to take a higher dose than recommended
- you are taking the medicine for reasons different from those for which it was prescribed
- you have tried several times to stop taking the medicine or control how you take it, without success
- when you stop taking the medicine, you feel unwell and feel better when you start taking it again
If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.
A small number of people taking antiepileptic medicines such as Neurontin have had thoughts of harming themselves or of suicide. If you have such thoughts at any time, contact your doctor as soon as possible.
Important information about potentially serious reactions
Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of serious symptoms in section 4 of this leaflet "Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious"
Muscle weakness, tenderness, or pain on palpation, especially if accompanied by feeling unwell or fever, could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and may be life-threatening. You may also experience discoloration of the urine and changes in blood test results (significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.
Taking Neurontin with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric conditions.
Medicines containing opioids such as morphine
If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Neurontin. In addition, combining Neurontin with opioids may cause drowsiness, sedation, reduced breathing, or death.
Antacids for indigestion
If you take Neurontin at the same time as antacids containing aluminum and magnesium, the absorption of Neurontin in the stomach may be reduced. It is therefore recommended that Neurontin be taken at least two hours after taking an antacid.
Neurontin
- is not expected to interact with other antiepileptic medicines or with oral contraceptive pills
- may interfere with certain laboratory tests, so if you need a urine test, inform your doctor or hospital about the medicines you are taking
Taking Neurontin with food
Neurontin can be taken with or without food.
Pregnancy, breastfeeding, and fertility
- If you are pregnant or think you may be pregnant, tell your doctor immediately so they can assess any possible risks the medicine you are taking may pose to the fetus.
- You should not stop your treatment without first discussing it with your doctor.
- If you are planning to become pregnant, you should review your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
- If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Neurontin may be used during the first trimester of pregnancy if necessary.
If you are planning to become pregnant, or if you are pregnant or think you may be pregnant, consult your doctor immediately.
If you become pregnant and have epilepsy, it is important not to stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening of your epilepsy could endanger both you and your unborn baby.
In a study reviewing data from women in Nordic countries who took gabapentin during the first three months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.
If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).
Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Neurontin. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.
Breastfeeding
Gabapentin, the active substance in Neurontin, passes into breast milk. Breastfeeding is not recommended while taking Neurontin, as the effect on the infant is unknown.
Fertility
No effects on fertility were observed in animal studies.
Driving and using machines
Neurontin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or perform other potentially hazardous activities until you know whether this medicine affects your ability to perform such activities.
Neurontin contains lactose
Neurontin hard capsules contain lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Neurontin contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free.”
3. How to take Neurontin
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.
Epilepsy, the recommended dose is
Adults and adolescents
Take the number of capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed by your doctor, up to a maximum dose of 3,600 mg per day, divided into three equal doses, that is, one in the morning, one at midday, and one at night.
Children aged 6 years and older
Your doctor will decide the dose to give your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. This dose is usually administered by taking the capsules, divided into three equal doses per day, typically one in the morning, one at midday, and one at night.
The use of Neurontin is not recommended in children under 6 years of age.
Peripheral neuropathic pain, the recommended dose is
Adults
Take the number of capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed by your doctor, up to a maximum dose of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.
If you have kidney problems or are receiving haemodialysis treatment
Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems or are receiving haemodialysis treatment.
If you are an elderly patient (over 65 years of age)
You should take the normal dose of Neurontin, unless you have kidney problems. Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.
If you think that the effect of Neurontin is too strong or too weak, tell your doctor or pharmacist as soon as possible.
Method of administration
Neurontin is taken orally. Always swallow the capsules whole with sufficient water.
Continue taking Neurontin until your doctor tells you to stop.
If you take more Neurontin than you should
Doses higher than those recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhoea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department if you have taken more Neurontin than your doctor prescribed. Take any unused capsules with you, together with the packaging and the package leaflet, so that the hospital can easily identify the 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 almost time for your next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Neurontin
Do not stop taking Neurontin suddenly. If you wish to stop taking Neurontin, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week. You should know that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Neurontin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping Neurontin treatment. If you experience this withdrawal syndrome, contact your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking Neurontin and seek immediate medical attention if you notice any of the following symptoms:
- Raised red circular rash, often with blisters in the center, typically on the trunk; skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may 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 may be serious:
- Persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
- Neurontin may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may require discontinuation of Neurontin or even hospitalization.
- Difficulty breathing, which, if severe, may require emergency medical treatment to maintain normal breathing.
Contact your doctor immediately 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 the lips, face, and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
These symptoms may be early signs of a serious reaction. A doctor should examine you to determine whether you should continue taking Neurontin.
- If you are on hemodialysis, inform your doctor if you begin to experience muscle pain and/or weakness.
Other adverse effects include:
Very common: (may affect more than 1 in 10 people)
- Viral infection
- Drowsiness, dizziness, lack of coordination
- Feeling tired, fever
Common: (may affect up to 1 in 10 people)
- Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections
- Low white blood cell count
- Anorexia, increased appetite
- Irritability, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
- Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, unusual eye movements, increased, decreased, or absent reflexes
- Blurred vision, double vision
- Dizziness
- Increased blood pressure, redness or dilation of blood vessels
- Difficulty breathing, bronchitis, sore throat, cough, dry nose
- Vomiting, nausea, dental problems, swollen gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
- Facial swelling, bruising, rash, itching, acne
- Joint pain, muscle pain, back pain, jerking
- Erectile dysfunction (impotence)
- Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
- Decreased leukocytes, weight gain
- Accidental injuries, fractures, abrasions
Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common adverse effects.
Uncommon: (may affect up to 1 in 100 people)
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Agitation (a state of chronic restlessness and involuntary, purposeless movements)
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Allergic reactions such as hives
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Decreased movement
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Rapid heartbeat
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Difficulty swallowing
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Swelling that may affect the face, trunk, and limbs
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Abnormal blood test results that may indicate liver problems.
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Progressive mental impairment
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Falls
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Increased blood glucose levels (observed more frequently in patients with diabetes)
Rare: (may affect up to 1 in 1000 people)
- Loss of consciousness
- Decreased blood glucose levels (observed more frequently in patients with diabetes)
- Breathing difficulties, shallow breathing (respiratory depression)
Following the marketing of Neurontin, the following adverse effects have been reported:
- Decreased platelets (blood clotting cells)
- Suicidal thoughts, hallucinations
- Abnormal movement problems such as twisting movements, spasmodic movements, and rigidity
- Ringing in the ears
- Yellow appearance of the skin and eyes (jaundice), liver inflammation
- Acute kidney failure, incontinence
- Increase in breast tissue, breast enlargement
- Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
- Muscle fiber breakdown (rhabdomyolysis)
- Changes in blood test results (elevated creatine phosphokinase)
- Sexual function problems, such as inability to reach orgasm and delayed ejaculation
- Low sodium levels in blood
- Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
- Development of dependence on Neurontin ("drug dependence")
You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with Neurontin (see "If you stop taking Neurontin").
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Neurontin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging. The expiry date is the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Neurontin
The active substance is gabapentin. Each hard gelatin capsule contains 400 mg of gabapentin.
The other components of Neurontin 400 mg hard capsules are:
Capsule contents: lactose monohydrate, maize starch and talc.
Capsule shell: gelatin, purified water and sodium lauryl sulfate.
The 400 mg capsules contain the colouring agents E171 (titanium dioxide) and E172 (red and yellow iron oxide). The printing ink used on all hard capsules contains shellac, E171 (titanium dioxide) and E132 (indigo carmine, aluminium salt).
Appearance of the product and contents of the pack
The 400 mg capsules are orange-coloured hard capsules imprinted with “Neurontin 400 mg” and “VLE”.
Available in PVC/PVDC/aluminium blisters contained in packs of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany
or
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Prumyslová 961/16
747 23 Bolatice
Czech Republic
Further information on this medicinal product is available by contacting the local representative of the Marketing Authorisation Holder:
Viatris Pharmaceuticals, S.L.U.
Calle General Aranaz, 86
28027 Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name: Neurontin.
Member State | Medicinal Product Name |
Austria | Neurontin 300 mg – Hard Capsules, Neurontin 400 mg – Hard Capsules |
Belgium/Luxembourg | Neurontin 100 mg capsules/hard capsules/Hartkapseln, Neurontin 300 mg capsules/hard capsules/Hartkapseln, Neurontin 400 mg capsules/hard capsules/Hartkapseln |
Cyprus | Neurontin 300 mg hard capsule, Neurontin 400 mg hard capsule |
Czech Republic | Neurontin 100 mg, Neurontin 300 mg, Neurontin 400 mg |
Denmark | Neurontin |
Estonia | Neurontin |
Finland | Neurontin 300 mg capsule, hard, Neurontin 400 mg capsule, hard |
France | Neurontin 100 mg capsule, Neurontin 300 mg capsule, Neurontin 400 mg capsule, |
Germany | Neurontin 100 mg Hartkapseln, Neurontin 300 mg Hartkapseln, Neurontin 400 mg Hartkapseln |
Greece | Neurontin 300 mg hard capsule, Neurontin 400 mg hard capsule |
Hungary | Neurontin 100 mg kemény kapszula Neurontin 300 mg kemény kapszula Neurontin 400 mg kemény kapszula |
Iceland | Neurontin |
Ireland | Neurontin 100 mg hard capsules, Neurontin 300 mg hard capsules, Neurontin 400 mg hard capsules |
Italy | Neurontin 100 mg Capsule Rigide, Neurontin 300 mg Capsule Rigide, Neurontin 400 mg Capsule Rigide |
Latvia | Neurontin 100 mg cietas kapsulas, Neurontin 300 mg cietas kapsulas, Neurontin 400 mg cietas kapsulas |
Netherlands | Neurontin 100, harde Capsules 100 mg, Neurontin 300, harde Capsules 300 mg, Neurontin 400, harde Capsules 400 mg |
Norway | Neurontin 100 mg capsules, hard, Neurontin 300 mg capsules, hard, Neurontin 400 mg capsules, hard |
Poland | Neurontin 100, Neurontin 300, Neurontin 400 |
Portugal | Neurontin |
Slovenia | Neurontin 100 mg trde kapsule, Neurontin 300 mg trde kapsule, Neurontin 400 mg trde kapsule |
Spain | Neurontin 300 mg hard capsules, Neurontin 400 mg hard capsules |
Sweden | Neurontin |
United Kingdom (Northern Ireland) | Neurontin 100 mg Hard Capsules, Neurontin 300 mg Hard Capsules, Neurontin 400 mg Hard Capsules |
Date of the last revision of this leaflet: July 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/