Label: information for the user

Neurontin 400mg hard capsules

Gabapentin

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What is Neurontin and how is it used

2.What you need to know before starting to take Neurontin

3.How to take Neurontin

4.Possible adverse effects

5.Storage of Neurontin

6.Contents of the package and additional information

Neurontin belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active ingredient of Neurontin is gabapentin.

Neurontin is used to treat

- Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizures spread to other parts of the brain or not). Your doctor will prescribe Neurontin to help treat epilepsy when current treatment does not fully control the disease. You or your child aged 6 years or older must take Neurontin in combination with current treatment unless otherwise instructed.Neurontin can also be administered as a single medication in the treatment of adults and children over 12 years.

- Peripheral neuropathic pain(chronic pain caused by nerve damage). There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles etc.

Do not takeNeurontin

• if you are allergic (hypersensitive) to gabapentin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Neurontin.

• if you have kidney problems, your doctor may prescribe a different dosing regimen.
• if you are on haemodialysis (for the removal of waste products due to renal insufficiency), inform your doctor if you start to feel muscle pain and/or weakness.
• if you develop persistent stomach pain, vomiting, and nausea, inform your doctor immediately as these may be symptoms of acute pancreatitis (inflamed pancreas).
• if you have a nervous system disorder or a respiratory disorder or if you are over 65 years old, your doctor may prescribe a different dose.
• before taking this medicine, inform your doctor if you have ever abused or had dependence on alcohol, prescribed medicines, or illegal drugs; you may have a higher risk of developing dependence on Neurontin.

Dependence

Some people may develop dependence (need to continue 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 interrupt treatment with Neurontin"). If you are concerned about developing dependence on Neurontin, it is essential to consult your doctor.

If you experience any of the following signs while taking Neurontin, it may be indicative that you have developed dependence.

- you feel the need to take the medicine for longer than prescribed.

- you feel the need to take a higher dose than recommended.

- you are taking the medicine for reasons other than your prescription.

- 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 take it again.

If you notice any of the above, speak with your doctor to decide on the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

A small number of people taking antiepileptic medicines such as Neurontin have had thoughts of harming themselves or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.

Important information about potentially serious reactions

Severe skin reactions associated with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. Stop taking gabapentin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Read the description of severe 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, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle fibers, which may lead to kidney problems and put your life at risk. You may also experience urine discoloration, and changes in blood test results (significant increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Neurontin with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. In particular, inform your doctor (or pharmacist) if you are taking or have taken recently any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

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. Additionally, the combination of Neurontin with opioids may cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

If you take Neurontin at the same time as antacids containing aluminium and magnesium, the absorption of Neurontin in the stomach may be reduced. It is recommended that Neurontin be taken at least two hours after taking an antacid.

Neurontin

- no interaction is expected with other antiepileptic medicines or with the oral contraceptive pill.

- it may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what 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, you must inform your doctor immediately to assess the potential risks the medicine you are taking may pose to the foetus.
• You should not stop your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or are planning to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Neurontin can be used during the first trimester of pregnancy if necessary.

If you plan to become pregnant or are pregnant or think you may be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is essential not to stop taking your medicine without first consulting your doctor, as this may worsen your condition. Worsening of your epilepsy may put both you and your unborn baby 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 brain development (neurodevelopmental disorders). However, babies of 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 (pain medicines).

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 cause an anticipation of seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient in Neurontin, passes into breast milk. It is not recommended to breastfeed while taking Neurontin, as the effect on the baby is unknown.

Fertility

No effects on fertility have been observed in animal studies.

Driving and operating machines

Neurontin may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medicine affects your ability to perform other activities.

Neurontin contains lactose

Neurontin hard capsules contain lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Neurontin contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Do not take a quantity of medication higher than the prescribed one.

Your doctor will determine what dose is suitable for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, up to a maximum dose of 3,600 mg per day, divided into three equal doses, i.e., one in the morning, one at noon, and one at night.

Children 6 years or older

Your doctor will decide on the dose to be administered to your child based on the child's weight.The treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg per kg per day. The dose is normally administered by taking the capsules, divided into 3 equal doses per day,usually, one in the morning, one at noon, and one at night.

Neurontin is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsulesindicated by your doctor. Normally, your doctor will gradually increase the dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as indicated 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 noon, and one at night.

If you have kidney problems or if you are receiving hemodialysis treatment

Your doctor may prescribe a different dosing regimen and/or dose if you have kidney problems or if you are receiving hemodialysis treatment.

If you are an elderly patient (over 65 years of age)

You should take the normal dose ofNeurontin, except if you have kidney problems.Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

If you consider that the effect ofNeurontinis too strong or too weak, inform your doctor or pharmacist as soon as possible.

Administration method

Neurontinis administered orally.Swallow the capsules whole with a sufficient amount of water.

Continue takingNeurontinuntil your doctor tells you to stop.

If you take moreNeurontinthan you should

Doses higher than recommended may cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20,indicating the medication and the amount ingested,or go to the emergency department of the nearest hospital if you take moreNeurontinthan your doctor prescribed.Bring any capsules you have not taken, along with the packaging and the leaflet, so that the hospital can easily identify the medication you have taken.

If you forget to takeNeurontin

If you forget to take a dose, take it as soon as you remember, unless it is time for the next dose.Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withNeurontin

Do not stop taking Neurontin suddenly. If you want to stop taking Neurontin, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, this should be done gradually over a minimum period of one week.You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment withNeurontin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of discomfort. These effects usually occur within the first 48 hours after stopping treatment with Neurontin. If you experience this withdrawal syndrome, contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Neurontin and seek medical attention immediately if you notice any of the following symptoms:

• flat red patches with a target-like appearance or circular patches on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Expanded 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, which may be symptoms of acute pancreatitis (inflammation of the pancreas)
• Neurontin can cause a severe or potentially life-threatening allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. It may or may not have appeared as a rash when this type of reaction occurs. This may require stopping Neurontin or even hospitalization.
• breathing problems that, if severe, may require emergency medical attention to breathe normally.

Contact your doctor immediately if you have any of the following symptoms:
• skin rash and redness and/or hair loss
• urticaria
• fever
• persistent swelling of the glands
• swelling of the lips, face, and tongue
• yellowing of the skin or white of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

These symptoms may be the first signs of a severe reaction. You should have a doctor examine you to decide if you should continue taking Neurontin.

• If you are on hemodialysis, inform your doctor if you start feeling muscle pain and/or weakness.

Other side 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 infections, ear inflammation, or other infections
• Low white blood cell count
• Loss of appetite, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, muscle spasms, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, coordination difficulties, unusual eye movements, increased or decreased 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, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence
• Swelling of the face, hives, rash, acne
• Joint pain, muscle pain, back pain, twitching
• Difficulty with erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Low white blood cell count, weight gain
• Accidental injuries, fractures, bruises

Additionally, in clinical trials in children, aggressive behavior and muscle spasms were reported as common side effects..

Uncommon: (may affect up to 1 in 100 people)

• Agitation (a chronic state of restlessness and involuntary, purposeless movements)
• Allergic reactions such as urticaria
• Decreased movement
• Increased heart rate
• Difficulty swallowing
• Swelling that may affect the face, trunk, and limbs

• Abnormal results in blood tests that may indicate liver problems.
• Progressive mental damage
• Falling
• Increased blood sugar levels (observed more frequently in patients with diabetes)

Rare: (may affect up to 1 in 1,000 people)

• Loss of consciousness
• Decreased blood sugar levels (observed more frequently in patients with diabetes)
• Difficulty breathing, shallow breathing (respiratory depression)

After the commercialization of Neurontin, the following side effects have been reported:

• Decreased platelet count (blood clotting cells)
• Thoughts of suicide, hallucinations
• Abnormal movements such as contortions, muscle spasms, and rigidity
• Tinnitus (ringing in the ears)
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Enlargement of breast tissue, breast enlargement
• Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rhabdomyolysis (muscle fiber rupture)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual dysfunction, such as inability to achieve orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment)
• Developing dependence on Neurontin ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after interrupting a short or long-term treatment with Neurontin (see "If you stop taking Neurontin").

Reporting of side effects

If you experience any type of side effect, consultyour doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sightandreachof children.

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C).

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Please ask your pharmacist how to dispose of packaging and medicationsyouno longer need.This will help protect the environment.

Composition of Neurontin

The active ingredient is gabapentin. Each hard gelatin capsule contains 400 mg of gabapentin.

The other components of Neurontin 400 mg hard capsules are:

Capsule content: lactose monohydrate, cornstarch and talc.

Capsule coating: gelatin, purified water and sodium lauryl sulfate.

The 400 mg hard capsules contain the colorants E171 (titanium dioxide) and E172 (iron oxide red and yellow). The printing ink used on all hard capsules contains shellac, E171 (titanium dioxide) and E132 (indigocarmine, aluminum salt).

Appearance of the product and contents of the package

The 400 mg capsules are hard orange capsules with "Neurontin 400 mg" and "VLE" printed on them.

Available in PVC/PVDC/aluminum blisters included in packs of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg im Breisgau

Germany

or

MEDIS INTERNATIONAL a.s., production plant Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following name: Neurontin.

Last review date of this leaflet: July 2023

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/