Neurontin 600

Leaflet accompanying the packaging: information for the user

NEURONTIN 600, 600 mg, coated tablets

NEURONTIN 800, 800 mg, coated tablets

Gabapentin

You should carefully read the contents of the 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 nerve damage).
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 spread to the rest of the brain or not). Neurontin is prescribed to adults and children over 6 years of age as an adjunctive therapy for epilepsy when previous treatments have not fully prevented seizures. Neurontin should be taken as an adjunctive therapy for epilepsy in adults or children over 6 years of age, 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 diseases such as diabetes or shingles. Patients describe the pain they experience as burning, scorching, 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

Warnings and precautions

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

• 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, they may experience withdrawal effects (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 for longer than the doctor prescribed
• The feeling that a larger dose than prescribed needs to be taken
• 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 immediately contact their doctor.

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 rash with eosinophilia and systemic symptoms (DRESS), have been reported. You should stop taking gabapentin and immediately consult a doctor if any symptoms related to severe skin reactions described in section 4 occur.
You should read the description of serious symptoms in section 4"Due to possible serious health consequences, you should immediately contact a doctor if any of the following symptoms occur 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 immediately contact your doctor.

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
A 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 an 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 immediately consult a doctor 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 have a child, 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 consult a 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 immediately contact her doctor.
If the patient becomes pregnant and has epilepsy, it is essential not to stop taking the medicine without prior consultation with her 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 birth defects or developmental problems (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 use during pregnancy may lead to withdrawal symptoms in newborns. This risk may be increased when gabapentin is taken with opioid painkillers (medicines used to treat severe pain).
In case of pregnancy, suspected pregnancy, or planning pregnancy while taking Neurontin, you should immediately contact your doctor. Do not suddenly stop taking Neurontin, 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 a 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 you, you should avoid driving, operating complex machines, or performing other potentially hazardous activities.

3. How to take Neurontin

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist. Do not take more medicine than prescribed.
The dose is determined by your doctor.

Epilepsy - recommended dose

Adults and adolescents
You should take the number of tablets prescribed by your doctor. The doses are usually increased gradually. The most commonly used initial dose is between 300 mg and 900 mg per day.
Then it may 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 over 6 years of age
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 the medicine that controls epilepsy is between 25 and 35 mg/kg body weight per day. This dose is usually given in three separate doses, which means giving the child a tablet (or tablets) every day, usually once in the morning, once in the afternoon, and once in the evening.
Neurontin is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults
You should take the number of tablets prescribed by your doctor. The doses are usually increased gradually. The most commonly used initial dose is between 300 mg and 900 mg per day.
Then it may 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 in patients undergoing hemodialysis

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

Patients over 65 years of age

Patients over 65 years of age should take the normally recommended dose of Neurontin, unless they have kidney disease. In 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 tablets should be swallowed, washed down with a large amount of water. The tablets can be divided in half.
Do not stop taking Neurontin until your doctor advises you to do so.

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 immediately contact your doctor or go to the nearest hospital emergency department (ER). In such a situation, you should also take all the remaining tablets, 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, you should 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 suddenly stop taking Neurontin. 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 doubts about taking this medicine, you should consult 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 immediately contact your doctor if any of the following symptoms occur after taking the medicine:

• red, non-raised, plate-like or round patches 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 syndrome or drug hypersensitivity syndrome).

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

• persistent abdominal pain, nausea, and vomiting, as they may be symptoms of acute pancreatitis
• breathing difficulties, which may require immediate and intensive medical attention 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 cases, a rash may occur. Such a reaction may require hospitalization or discontinuation of Neurontin. You should immediately contact your doctor if any of the following symptoms occur:
• skin rash and redness, and/or hair loss
• hives
• fever
• persistent swollen lymph nodes
• swelling of the 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 occur in more than 1 in 10 people)

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

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

• Pneumonia, respiratory tract infections, urinary tract infections, ear infections, or other infections
• Decreased white blood cell count
• 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, 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 the feet and hands, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, bone fractures, skin abrasions

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

Uncommon: (may occur in 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
• Elevated blood glucose levels (most commonly observed in patients with diabetes)

Rare: (may occur in 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 platelet count (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 cessation of gabapentin (anxiety, sleep disorders, 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 the 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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.
Reporting side effects will help gather more information on the safety of the 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 packaging. The expiry date refers to the last day of the month stated.
Neurontin coated tablets should not be stored at a temperature above 25°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 packaging and other information

What Neurontin contains

The active substance of Neurontin is gabapentin. Each coated tablet contains 600 mg or 800 mg of gabapentin.
The other ingredients of Neurontin coated tablets are: poloxamer 407 (ethylene oxide and propylene oxide), copovidone, cornstarch, magnesium stearate.
Coating: Opadry White YS-1-18111 (hydroxypropyl cellulose, talc)
Lubricant: Candelilla wax.

What Neurontin looks like and what the packaging contains

Neurontin 600 mg coated tablets are white, elongated coated tablets with a dividing line on both sides and the inscription "NT" and "16" on one side.
Neurontin 800 mg coated tablets are white, elongated coated tablets with a dividing line on both sides and the inscription "NT" and "26" on one side.
The packaging is an Aluminium/PVC/PE/PVDC blister or Aluminium/PVC/PVDC blister and contains: 20, 30, 45, 50, 60, 84, 90, 100, 200, 500 tablets.
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:

To obtain more detailed information, 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