Neurontin 400

Leaflet accompanying the packaging: information for the user

NEURONTIN 100, 100 mg, hard capsules

NEURONTIN 300, 300 mg, hard capsules

NEURONTIN 400, 400 mg, hard capsules

Gabapentin

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Neurontin is and what it is used for
• 2. Important information before taking Neurontin
• 3. How to take Neurontin
• 4. Possible side effects
• 5. How to store Neurontin
• 6. 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 (long-lasting pain caused by damage to the nerves).
The active substance of Neurontin is gabapentin.

Neurontin is indicated for the treatment of

• various forms of epilepsy (seizures that initially occur in specific areas of the brain and then spread to the rest of the brain or not). Neurontin is prescribed for adults and children aged 6 years and older as an adjunctive therapy for the treatment of epilepsy when the current treatment does not fully prevent seizures. Neurontin should be taken as an additional treatment for epilepsy in adults or children aged 6 years and older, unless the doctor advises otherwise. Neurontin can also be used as monotherapy in adults and children over 12 years of age;
• peripheral neuropathic pain (long-lasting pain caused by nerve damage). Peripheral (mainly occurring in the lower and/or upper limbs) neuropathic pain is caused by a variety of different diseases such as diabetes or shingles. Patients describe the pain they experience as burning, tingling, pulsating, piercing, stabbing, sharp, similar to that accompanying muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Neurontin

When not to take Neurontin

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Neurontin, you should discuss it with your doctor or pharmacist

• in case of kidney disease, the doctor may recommend a different dosing schedule,
• in case of hemodialysis treatment (to remove metabolic products due to kidney failure), you should inform your doctor about muscle pain and/or weakness,
• if symptoms such as persistent abdominal pain, nausea, vomiting occur, you should contact your doctor immediately, as they may be symptoms of acute pancreatitis,
• if the patient has neurological, respiratory, or is over 65 years of age; the doctor may recommend a different dosage,
• before starting to take this medicine, you should tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal addictive substances; this may mean that there is a greater risk of dependence on Neurontin.

Dependence
In some people, dependence on Neurontin (the need for continuous medication) may occur. After stopping the use of Neurontin, withdrawal effects may occur in them (see section 3, "How to take Neurontin" and "Stopping Neurontin"). If the patient is concerned that they may become dependent on Neurontin, it is essential to consult a doctor.
If, while taking Neurontin, the patient notices any of the following symptoms, it may be a sign of dependence.

• The feeling that the medicine needs to be taken longer than the doctor prescribed
• The feeling that a larger dose needs to be taken than prescribed
• Taking the medicine for purposes other than prescribed
• The patient has made multiple, unsuccessful attempts to stop or control the use of the medicine
• After stopping the medicine, the patient feels unwell, and after taking it again, they feel better

In case of noticing any of these, you should talk to your doctor to discuss the best treatment path for the patient, including when it is appropriate to stop taking the medicine and how to do it safely.
A small number of patients taking antiepileptic drugs, such as gabapentin, have had thoughts of self-harm or suicide. If such thoughts occur to the patient, they should contact their doctor immediately.

Important information about potentially serious reactions

In connection with the use of gabapentin, severe skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. You should stop taking gabapentin and immediately contact your doctor if you experience any symptoms related to severe skin reactions described in section 4.
You should read the description of serious symptoms in section 4"Due to possible serious health consequences, you should contact your doctor immediately if you experience any of the following symptoms after taking the medicine".
Muscle weakness, tenderness, or pain, especially if accompanied by malaise and high fever, may be caused by abnormal muscle fiber breakdown, which can be life-threatening and lead to kidney problems. There may be a change in urine color and changes in blood test results (significantly increased creatine phosphokinase levels in the blood). If such subjective and objective symptoms occur, you should contact your doctor immediately.

Neurontin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should especially tell your doctor (or pharmacist) about all medicines recently or currently used to treat seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patient taking medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Neurontin.
Additionally, taking Neurontin and opioids at the same time may cause drowsiness, sedation, shallow breathing, or death.
Antacids for heartburn
In case of concurrent use of Neurontin and antacids containing aluminum and magnesium, the absorption of Neurontin from the stomach may be limited. Therefore, it is recommended to take Neurontin at least 2 hours after taking the antacid.

• Neurontin does not interact with other antiepileptic medicines or oral contraceptives.
• it may affect the results of some laboratory tests; in case of a urine test, you should inform your doctor or hospital about the medicines you are currently taking.

Neurontin with food

Neurontin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or thinks she may be pregnant, she should contact her doctor immediately to discuss the potential risk to the unborn child associated with taking this medicine.
• Do not stop treatment without discussing it with your doctor.
• If the patient plans to become pregnant, she should discuss her treatment with her doctor or pharmacist as soon as possible before becoming pregnant.
• If the patient is breastfeeding or plans to breastfeed, she should contact her doctor or pharmacist before starting to take this medicine.

Pregnancy
Neurontin can be used during the first trimester of pregnancy if necessary.
If the patient plans to become pregnant, is pregnant, or thinks she may be pregnant, she should contact her doctor immediately.
If the patient becomes pregnant and has epilepsy, it is essential not to stop taking the medicine without prior consultation with the doctor, as this may worsen the course of the disease. The severity of epilepsy may pose a risk to the patient and her unborn child.
In a study involving data from Scandinavian women who took gabapentin during the first 3 months of pregnancy, no increased risk of congenital malformations or neurodevelopmental disorders was found. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and preterm birth.
Gabapentin may cause withdrawal symptoms in newborns when used during pregnancy. This risk may be increased when gabapentin is taken with opioid painkillers.
In case of pregnancy, suspected pregnancy, or planning pregnancy while taking Neurontin, you should contact your doctor immediately. Do not stop taking Neurontin suddenly, as this may lead to withdrawal seizures, which can have serious consequences for both the pregnant woman and her child.
Breastfeeding
Gabapentin, the active substance of Neurontin, passes into human milk. Since it is not known what effect it has on the breastfed child, breastfeeding is not recommended while taking Neurontin.
Fertility
In animal studies, no effect on fertility has been found.

Driving and using machines

Neurontin may cause dizziness, drowsiness, and fatigue. Until you know how this medicine affects your ability to drive, use complex machines, or perform other potentially hazardous activities, you should avoid them.

Neurontin contains lactose

Neurontin hard capsules contain lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Neurontin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 100 mg, 300 mg, and 400 mg hard capsule, which means it is essentially 'sodium-free'.

3. How to take Neurontin

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. Do not take more medicine than prescribed. The dose is determined by the doctor.

Epilepsy - recommended dose

Adults and adolescents
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually. The most commonly used initial dose is from 300 mg to 900 mg per day.
Then it can be gradually increased according to the doctor's instructions to a maximum dose of 3600 mg per day divided into 3 separate doses (one in the morning, one in the afternoon, and one in the evening).
Children aged 6 years and older
The dose to be given to the child is determined by the doctor based on the child's body weight. Treatment starts with a small initial dose, which is increased gradually over a period of about 3 days. The commonly used dose of Neurontin that controls epilepsy is from 25 to 35 mg/kg body weight per day. This dose is usually given in three separate doses, which means giving the child a capsule (or capsules) daily, 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 - recommended dose

Adults
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually. The most commonly used initial dose is from 300 mg to 900 mg per day.
Then it can be gradually increased to a maximum dose of 3600 mg per day divided into 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or patients undergoing hemodialysis

The doctor may recommend a different dosing schedule and/or a different dose of Neurontin for patients with renal impairment or patients undergoing hemodialysis.

Elderly patients (over 65 years of age)

Elderly patients (over 65 years of age) should take the normally recommended dose of Neurontin, unless they have kidney disease. In the case of patients with kidney disease, the doctor may recommend a different dosing schedule and/or a different dose.
If it seems that the effect of Neurontin is too strong or too weak, you should consult your doctor or pharmacist as soon as possible.

Method of administration

Neurontin is taken orally. The capsules should be swallowed with a large amount of water.
Do not stop taking Neurontin until your doctor tells you to.

Taking a higher dose of Neurontin than recommended

Taking higher doses than recommended may cause an increased number of side effects, including loss of consciousness, dizziness, double vision, blurred speech, drowsiness, and diarrhea. If you have taken a higher dose of Neurontin than recommended, you should contact your doctor immediately or go to the nearest hospital emergency department (ER). In such a situation, you should also take all the remaining capsules, packaging, and leaflet with you, so that the hospital staff knows immediately which medicine was taken.

Missing a dose of Neurontin

If you miss a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to make up for the missed dose.

Stopping Neurontin

Do not stop taking Neurontin suddenly. If you want to stop taking Neurontin, you should first discuss it with your doctor. They will inform you how to do it.
Withdrawal should be done gradually, over a minimum period of 1 week. After stopping short-term or long-term treatment with Neurontin, you should be aware that certain side effects, so-called withdrawal effects, may occur. These effects may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headache, depression, feeling abnormal, dizziness, and general malaise. These effects usually occur within 48 hours of stopping Neurontin. If withdrawal effects occur, you should contact your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Neurontin can cause side effects, although not everybody gets them.

You should stop taking Neurontin and contact your doctor immediately if you experience any of the following symptoms after taking the medicine:

• red, non-raised, plate-like or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Due to possible serious health consequences, you should contact your doctor immediately if you experience any of the following symptoms after taking the medicine:

• persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• breathing difficulties, which may, especially if severe, require immediate and intensive medical care to restore normal breathing
• Neurontin may cause serious or life-threatening allergic reactions, which may affect the skin or other parts of the body, such as the liver or blood cells.

In such a reaction, a rash may occur. This reaction may require hospitalization or stopping Neurontin. You should contact your doctor immediately if you experience any of the following symptoms:

• skin rash and redness, and/or hair loss
• hives
• fever
• persistent swelling of lymph nodes
• swelling of lips, face, and tongue
• yellowing of the skin or whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unusual muscle pain
• frequent infections

These symptoms may be the first sign of a serious reaction. Your doctor should examine you and decide whether to continue taking Neurontin.

• In case of hemodialysis treatment, you should inform your doctor about muscle pain and/or weakness.

Other side effects include:

Very common: (may affect more than 1 in 10 people)

• Viral infections
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

Common: (may affect up to 1 in 10 people)

• Pneumonia, respiratory tract infections, urinary tract infections, ear infections, or other infections
• Decreased number of white blood cells
• Lack of appetite, increased appetite
• Irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking disorders
• Seizures, sudden muscle movements, speech problems, memory loss, tremors, sleep disorders, headaches, increased skin sensitivity, numbness, coordination disorders, abnormal eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing, or vasodilation
• Shortness of breath, bronchitis, sore throat, cough, feeling of dryness in the nose
• Vomiting, nausea, dental problems, gingivitis, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle tremors
• Erectile dysfunction (impotence)
• Swelling of feet and hands, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased number of white blood cells, weight gain
• Accidental injuries, bone fractures, skin abrasions

Additionally, in clinical studies in children, aggressive behavior and sudden limb flexion were frequently reported.

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

• Restlessness (a state of constant restlessness and unintentional, purposeless movements)
• Allergic reactions, e.g., hives
• Movement restrictions
• Palpitations
• Difficulty swallowing
• Swelling involving the face, torso, limbs
• Abnormal blood test results indicating liver function disorders
• Psychiatric disorders
• Falls
• Increased blood glucose levels (most commonly observed in patients with diabetes)

Rare: (may affect up to 1 in 1000 people)

• Decreased blood glucose levels (most commonly observed in patients with diabetes)
• Loss of consciousness
• Breathing difficulties, shallow breathing (respiratory depression)

After the introduction of Neurontin to the market, the following side effects have been observed:

• Decreased number of platelets (blood cells responsible for blood clotting)
• Hallucinations
• Abnormal movements, such as limb twisting or sudden flexion, muscle stiffness
• Ringing in the ears
• Yellowing of the skin and whites of the eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue growth, breast enlargement
• Side effects after sudden stopping of gabapentin (anxiety, difficulty sleeping, nausea, pain, excessive sweating), chest pain
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (increased creatine phosphokinase levels)
• Sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylactic reactions (severe, life-threatening allergic reactions, including breathing difficulties, swelling of lips, throat, and tongue, and low blood pressure requiring immediate treatment)
• Risk of developing dependence on Neurontin ("drug dependence")

After stopping short-term or long-term treatment with Neurontin, you should be aware that certain side effects, so-called withdrawal effects, may occur (see "Stopping Neurontin").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Neurontin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Neurontin capsules should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Neurontin contains

The active substance of Neurontin is gabapentin. Each hard gelatin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.
The other ingredients of Neurontin are:
Capsule contents: lactose monohydrate, cornstarch, and talc.
Capsule shell: gelatin, purified water, and sodium lauryl sulfate.
The 100 mg hard capsules contain the colorant E 171 (titanium dioxide), the 300 mg hard capsules contain the colorant E 171 (titanium dioxide) and the colorant E 172 (iron oxide yellow), and the 400 mg hard capsules contain the colorant E 171 (titanium dioxide) and the colorant E 172 (iron oxide red and yellow). The ink used for printing on all strengths of hard capsules contains shellac, E 171 (titanium dioxide), and E 132 (indigo carmine aluminum salt).

What Neurontin looks like and contents of the pack

The 100 mg capsules are white, hard capsules with the imprint "Neurontin 100 mg" and "VLE".
The 300 mg capsules are yellow, hard capsules with the imprint "Neurontin 300 mg" and "VLE".
The 400 mg capsules are orange, hard capsules with the imprint "Neurontin 400 mg" and "VLE".
The Aluminum/PVC/PVDC blister pack contains: 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Country

Medicinal product name

Austria
Neurontin 300 mg – Hartkapseln, Neurontin 400 mg – Hartkapseln
Belgium/Luxembourg
Neurontin 100 mg gélules/harde capsules/Hartkapseln, Neurontin 300 mg gélules/harde capsules/Hartkapseln, Neurontin 400 mg gélules/harde 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 kapseli, kova, Neurontin 400 mg kapseli, kova
France
Neurontin 100 mg gélule, Neurontin 300 mg gélule, Neurontin 400 mg gélule,
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 300mg hard capsules, Neurontin 400mg hard capsules
Italy
Neurontin 100 mg Capsule Rigide, Neurontin 300 mg Capsule Rigide, Neurontin 400 mg Capsule Rigide
Latvia
Neurontin 100 mg cietās kapsulas, Neurontin 300 mg cietās kapsulas, Neurontin 400 mg cietās kapsulas
Netherlands
Neurontin 100, harde Capsules 100 mg, Neurontin 300, harde Capsules 300 mg, Neurontin 400, harde Capsules 400 mg
Norway
Neurontin 100 mg kapsler, harde, Neurontin 300 mg kapsler, harde, Neurontin 400 mg kapsler, harde
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 capsulas duras, Neurontin 400 mg Capsulas Duras
Sweden
Neurontin
United Kingdom (Northern Ireland)
Neurontin 100 mg Hard Capsules, Neurontin 300 mg Hard Capsules, Neurontin 400 mg Hard Capsules
To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00
Date of last revision of the leaflet:01/2025