NEURONTIN 300 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. NEURONTIN 100, 100 mg, hard capsules
3. NEURONTIN 300, 300 mg, hard capsules
4. NEURONTIN 400, 400 mg, hard capsules
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
5. What Neurontin is and what it is used for
   1. Neurontin is used to treat:
6. What you need to know before you take Neurontin
   1. Do not take Neurontin:
   2. Warnings and precautions
   3. Neurontin and other medicines
   4. Neurontin with food
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Neurontin contains lactose
   8. Neurontin contains sodium
7. How to take Neurontin
   1. Epilepsy - recommended dose
   2. Peripheral neuropathic pain - recommended dose
   3. Use in patients with kidney problems or those undergoing hemodialysis
   4. Elderly patients (over 65 years of age)
   5. Method of administration
   6. Taking a higher dose of Neurontin than recommended
   7. Missing a dose of Neurontin
   8. Stopping Neurontin
8. Possible side effects
   1. Stop taking Neurontin and contact your doctor immediately if you experience any of the following symptoms:
   2. Due to possible serious health consequences, you should immediately contact your doctor if you experience any of the following symptoms:
   3. In such a reaction, a rash may occur. This reaction may require hospitalization or stopping Neurontin. You should immediately contact your doctor if you experience any of the following symptoms:
   4. These symptoms may be the first sign of a serious reaction. Your doctor should examine you and decide whether to continue taking Neurontin.
   5. Very common: (may affect more than 1 in 10 people)
   6. Common: (may affect up to 1 in 10 people)
   7. Uncommon: (may affect up to 1 in 100 people)
   8. Rare: (may affect up to 1 in 1000 people)
   9. After Neurontin has been marketed, the following side effects have been reported:
   10. Reporting side effects
9. How to store Neurontin
10. Contents of the pack and other information
    1. What Neurontin contains
    2. What Neurontin looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder:
    5. Manufacturer:
    6. Country
    7. Product name
    8. Viatris Healthcare Sp. z o.o.

Package Leaflet: Information for the User

NEURONTIN 100, 100 mg, hard capsules

NEURONTIN 300, 300 mg, hard capsules

NEURONTIN 400, 400 mg, hard capsules

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. What you need to know 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 specific areas 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 to treat epilepsy when the current treatment does not fully prevent seizures. Neurontin should be taken as an adjunctive therapy in the treatment of epilepsy in adults or children aged 6 years and older, unless otherwise advised by the doctor. 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 neuropathic pain is a type of pain that occurs when nerves in the body are damaged, such as in diabetes or shingles. Patients describe the pain as burning, tingling, pulsating, piercing, stabbing, sharp, similar to cramp, as aching, tingling, numbness, etc.

2. What you need to know before you take Neurontin

Do not take Neurontin:

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

Warnings and precautions

Before taking Neurontin, discuss with 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 immediately contact your doctor, 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
Some people may become dependent on Neurontin (need to continuously take the medicine). After stopping Neurontin, they may experience withdrawal effects (see section 3, "How to take Neurontin" and "Stopping Neurontin"). If you are concerned that you may become dependent on Neurontin, it is essential 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 longer than prescribed by your doctor
• 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 notice any of these, you should talk to your doctor to discuss the best treatment plan for you, 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 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 reaction with eosinophilia and systemic symptoms (DRESS). You should stop taking gabapentin and immediately contact your doctor if you experience any symptoms related to severe skin reactions described in section 4.
Read the description of serious symptoms in section 4"Due to possible serious health consequences, you should immediately contact your doctor 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 breakdown of muscle fibers, 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 immediately contact your doctor.

Neurontin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially those used to treat:

• seizures
• sleep disorders
• depression
• anxiety disorders
• other neurological or psychiatric disorders

Medicines containing opioids, such as morphine
Patient taking opioid-containing medicines (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effects of Neurontin.
Additionally, concomitant use of Neurontin and opioids may cause drowsiness, sedation, respiratory depression, or death.
Antacids containing aluminum or magnesium
When Neurontin is taken with antacids containing aluminum or magnesium, the absorption of Neurontin from the stomach may be reduced. Therefore, it is recommended to take Neurontin at least 2 hours after taking an antacid.

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 immediately consult 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 plan 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 consult 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 immediately contact your doctor.
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. The 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 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. 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 immediately contact your doctor. Do not suddenly stop taking Neurontin, as this may lead to withdrawal seizures, 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 breastfed infants, 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. Until you know how this medicine affects you, do not drive, operate complex machinery, or perform other potentially hazardous activities.

Neurontin contains lactose

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

Neurontin contains sodium

This 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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not take more medicine than prescribed.

Epilepsy - recommended dose

Adults and adolescents
Take the number of capsules as prescribed by your doctor. The dose is usually increased gradually. The usual starting dose is from 300 mg to 900 mg per day.
Then it may 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 approximately 3 days. The usual dose of Neurontin 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 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. The dose is usually increased gradually. The usual starting dose is from 300 mg to 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 kidney problems or those undergoing hemodialysis

Your doctor may prescribe a different dosing schedule and/or a different dose of Neurontin for patients with kidney problems or those 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 problems. For patients with kidney problems, 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 contact your doctor or pharmacist as soon as possible.

Method of administration

Neurontin is taken orally. The capsules should be swallowed whole with plenty of water.
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. Also, take all remaining capsules, packaging, and this leaflet with you so that the hospital staff can see what medicine you have taken.

Missing 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 missed 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 do this. 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 may occur, known as withdrawal effects. 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 after stopping Neurontin. If you experience withdrawal effects, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Neurontin and contact your doctor immediately if you experience any of the following symptoms:

• red, non-raised, round, or target-like spots on the torso, often with blisters in the center, peeling 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 immediately contact your doctor 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 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 a reaction, a rash may occur. This reaction may require hospitalization or stopping Neurontin. You should immediately contact your doctor 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 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.

• If you are undergoing 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 number of white blood cells
• Lack of appetite, increased appetite
• Irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking abnormalities
• Seizures, sudden muscle movements, speech problems, memory problems, tremors, sleep disturbances, headaches, increased sensitivity of the skin, numbness, coordination problems, abnormal eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing, vasodilation
• Shortness of breath, bronchitis, sore throat, cough, feeling of dryness in the nose
• Vomiting, nausea, dental problems, gum inflammation, 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 number of white blood cells, weight gain
• Accidental injuries, bone fractures, skin abrasions

In addition, in clinical studies in children, aggressive behavior and sudden muscle contractions were frequently reported.

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

• Restlessness (a state of constant restlessness and involuntary, aimless movements)
• Allergic reactions, such as hives
• Movement restrictions
• Palpitations
• Difficulty swallowing
• Swelling that includes 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 Neurontin has been marketed, the following side effects have been reported:

• Decreased number of platelets (blood cells responsible for blood clotting)
• Hallucinations
• Abnormal movements, such as twisting of limbs or sudden bending
• 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 suddenly stopping gabapentin (anxiety, sleep disturbances, 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
• Low sodium levels in the blood
• Anaphylactic reactions (severe, life-threatening allergic reactions that require immediate treatment, including difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure)
• 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 may occur, known as withdrawal effects (see "Stopping Neurontin").

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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 capsules above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Neurontin contains

The active substance is gabapentin. Each hard gelatin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.
Other ingredients in Neurontin hard capsules are:
Capsule content: 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 E 172 (iron oxide yellow), and the 400 mg hard capsules contain the colorant E 171 (titanium dioxide) and 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 printing "Neurontin 100 mg" and "VLE".
The 300 mg capsules are yellow, hard capsules with the printing "Neurontin 300 mg" and "VLE".
The 400 mg capsules are orange, hard capsules with the printing "Neurontin 400 mg" and "VLE".
Aluminum/PVC/PVDC blister packs contain: 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

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
For more detailed information on this medicine, 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