Neurontin 800

Package Leaflet: Information for the User

NEURONTIN 600, 600 mg, coated tablets

NEURONTIN 800, 800 mg, coated tablets

Gabapentin

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Neurontin is and what it is used for
• 2. Before you take 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 neuropathic pain (long-lasting pain caused by damage to the nerves).
The active substance in Neurontin is gabapentin.

Neurontin is used to treat:

• various forms of epilepsy (seizures that initially are localized to certain parts of the brain and may spread to other parts 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 currently used treatment does not fully prevent seizures. Neurontin should be taken as an adjunctive therapy for the treatment of 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 damage to the nerves). Peripheral (mainly occurring in the lower and/or upper limbs) neuropathic pain is caused by a variety of different diseases such as diabetes or herpes zoster. 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. Before you take Neurontin

Do not take Neurontin:

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

Warnings and precautions

Before taking Neurontin, tell your doctor or pharmacist:

• if you have kidney disease, your doctor may prescribe a different dosing schedule,
• if you are undergoing hemodialysis (to remove waste products from the blood due to kidney failure), you should inform your doctor about any muscle pain and/or weakness,
• if you experience symptoms such as persistent abdominal pain, nausea, vomiting, you should contact your doctor immediately, as these may be symptoms of acute pancreatitis,
• if you have neurological, respiratory, or are over 65 years of age; your doctor may prescribe a different dose,
• before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; this may indicate a higher risk of dependence on Neurontin.

Dependence
In some people, dependence on Neurontin (the need for continued use of the medicine) may occur.
After stopping Neurontin, withdrawal effects (see section 3, "How to take Neurontin" and "Stopping Neurontin") may occur in them.
If you are concerned that you may be dependent on Neurontin, it is important to consult your doctor.
If you experience any of the following symptoms while taking Neurontin, it may be a sign of dependence.

• Feeling that you need to take the medicine for longer than your doctor prescribed
• Feeling that you need to take a higher dose than prescribed
• Taking the medicine for purposes other than prescribed
• You have made multiple, unsuccessful attempts to stop or control the use of the medicine
• After stopping the medicine, you feel unwell, and after taking it again, you feel better

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

Important information about potentially serious reactions

Gabapentin has been associated with severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS).
You should stop taking gabapentin and contact your doctor immediately 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 fever, may be caused by abnormal muscle 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 elevated creatine phosphokinase levels in the blood).
If you experience such subjective and objective symptoms, you should contact your doctor immediately.

Neurontin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Particularly, tell your doctor if you are taking or have recently taken medicines for epilepsy, sleep disorders, depression, anxiety disorders, or other neurological or psychiatric disorders.
Opioid-containing medicines, such as morphine
If you are taking opioid-containing medicines (such as morphine), you should inform your doctor or pharmacist, as opioids may enhance the effects of Neurontin.
Additionally, taking Neurontin and opioids at the same time may cause drowsiness, sedation, shallow breathing, or death.
Antacids for indigestion
If you are taking antacids containing aluminum and magnesium, the absorption of Neurontin from the stomach may be reduced.
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, and if a urine test is performed, 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 you are pregnant or think you may be pregnant, you should contact your 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 you are planning to become pregnant, you should discuss your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or plan to breastfeed, you should contact your doctor or pharmacist before taking this medicine.

Pregnancy
Neurontin can be used during the first trimester of pregnancy if necessary.
If you are planning to become pregnant, are pregnant, or think you may be pregnant, you should contact 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 may worsen your condition.
Worsening of epilepsy may pose a risk to you and your unborn child.
In a study involving data from Scandinavian countries on 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 may cause withdrawal symptoms in newborns when used during pregnancy.
This risk may be increased when gabapentin is taken with opioid painkillers.
If you become pregnant or think you may be pregnant while taking Neurontin, you should contact your doctor immediately.
Do not stop taking Neurontin suddenly, as this may cause seizures or status epilepticus, which can have serious consequences for both you and your child.
Breastfeeding
Gabapentin, the active substance in Neurontin, passes into human milk.
Since it is not known what effect this has on the breastfed child, breastfeeding is not recommended during treatment with Neurontin.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Neurontin may cause dizziness, drowsiness, and fatigue.
Do not drive, use machines, or perform other potentially hazardous activities until you know how this medicine affects you.

3. How to take Neurontin

Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Do not take more medicine than prescribed.

Epilepsy - recommended dose

Adults and adolescents
Take the number of tablets as prescribed by your doctor.
Doses are usually increased gradually.
The usual starting dose is from 300 mg to 900 mg per day.
Then it can be gradually increased as instructed by your doctor 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 gradually increased over a period of about 3 days.
The usual dose of the medicine that controls epilepsy is from 25 to 35 mg/kg body weight per day.
This dose is usually divided into 3 separate doses, which means giving the child a tablet (or tablets) 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 tablets as prescribed by your doctor.
Doses are usually increased gradually.
The usual starting 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 kidney failure or patients undergoing hemodialysis

Your doctor may prescribe a different dosing schedule and/or a different dose of Neurontin for patients with kidney failure 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 patients with kidney disease, the doctor may prescribe a different dosing schedule and/or a different dose.
If you feel 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.
Swallow the tablets with plenty of water.
The tablets can be divided into two halves.
Do not stop taking Neurontin unless 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 take more Neurontin than you should, contact your doctor or go to the nearest hospital emergency department immediately.
Take all remaining tablets, packaging, and this leaflet with you.

Forgetting to take a dose of Neurontin

If you miss 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.

Stopping Neurontin

Do not stop taking Neurontin suddenly.
If you want to stop taking Neurontin, you should first discuss this with your doctor.
Your doctor will tell you how to stop taking Neurontin safely.
Stopping Neurontin 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 (vomiting), pain, sweating, tremors, headache, depression, feeling abnormal, dizziness, and general malaise.
These effects usually occur within 48 hours after stopping Neurontin.
If you experience withdrawal effects, you should contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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:

• red, non-raised, target-like, or circular 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 reactions 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 reaction).

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

• 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 cases, a rash may occur. Such a reaction may require hospitalization or discontinuation of 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 swollen lymph nodes
• swelling of the lips, face, and tongue
• yellowing of the skin and whites of the eyes
• unusual bruising or bleeding
• extreme 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, you should inform your doctor about any 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 white blood cell count
• Lack of appetite, increased appetite
• Irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking abnormalities
• Seizures, sudden muscle movements, speech problems, memory loss, tremors, sleep disturbances, headaches, increased sensitivity of the skin, numbness (tingling), 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 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

In addition, in clinical trials 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, such as 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 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 medicine was placed on the market, the following side effects were observed:

• Decreased platelet count (blood cells responsible for blood clotting)
• Hallucinations
• Abnormal movements, such as twisting of limbs or sudden flexion
• Ringing in the ears
• Yellowing of the skin and whites of the eyes (jaundice), liver inflammation
• Acute kidney failure, urinary incontinence
• Breast tissue growth, breast enlargement
• Side effects after sudden discontinuation of gabapentin (anxiety, difficulty sleeping, nausea, pain, excessive sweating), chest pain
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase levels)
• Sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• Sodium deficiency in the blood
• Anaphylactic reactions (severe, life-threatening allergic reactions, including difficulty breathing, 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 (see "Stopping Neurontin"), may occur.

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, 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 provide more information on the safety of this medicine.

5. 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 expiry date refers to the last day of that month.
Do not store Neurontin tablets 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 protect the environment.

6. Contents of the pack and other information

What Neurontin contains

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

What Neurontin looks like and contents of the pack

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.
Aluminum/PVC/PE/PVDC blister or Aluminum/PVC/PVDC blister pack 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:

For more information, 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