Neurontin 100

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 damaged 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 previous therapy has not fully controlled seizures. Neurontin should be taken as an adjunctive therapy in the treatment of epilepsy in adults and 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 damaged nerves). Peripheral neuropathic pain is a type of pain that occurs on the surface of or inside the body, often described as hot, burning, throbbing, shooting, stabbing, or painful. It may be caused by a variety of diseases such as diabetes or shingles.

2. What you need to know before you take Neurontin

Do not take Neurontin:

• if you are allergic to gabapentin 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 problems, your doctor may prescribe a different dosing schedule;
• are undergoing haemodialysis (to remove waste products from your blood due to kidney failure), tell your doctor if you experience muscle pain and/or weakness;
• experience persistent stomach pain, nausea, vomiting, as these may be symptoms of acute pancreatitis;
• have nervous system, respiratory, or cardiovascular disorders, or are over 65 years old; your doctor may prescribe a different dose;
• have ever abused or been dependent on drugs or alcohol; this may increase the risk of dependence on Neurontin.

Dependence
Some people taking Neurontin may become dependent on it (need to continue taking it). If you are concerned that you may become dependent on Neurontin, talk to 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 prescribed
• Feeling that you need to take a higher dose than prescribed
• Taking the medicine for reasons other than prescribed
• Having made multiple, unsuccessful attempts to stop or control the use of the medicine
• Feeling unwell or experiencing withdrawal symptoms when the medicine is stopped or the dose is reduced

If you experience any of these symptoms, talk to your doctor to discuss the best course of treatment, including when it is appropriate to stop taking the medicine and how to do so safely.
A small number of people taking antiepileptic medicines, such as gabapentin, have had thoughts of harming or killing themselves. If you experience any such thoughts, contact your doctor immediately.

Important information about potentially serious reactions

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported with gabapentin use. Stop taking gabapentin and contact your doctor immediately if you experience any symptoms of severe skin reactions, as described in section 4.
Read the description of the serious symptoms in section 4, "Because of the possible serious health consequences, 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 fever and malaise, may be signs of a condition called rhabdomyolysis, which can be life-threatening and lead to kidney problems. Changes in urine color and blood test results (elevated creatine phosphokinase levels) may also occur. If you experience any of these symptoms, 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, including those for epilepsy, sleep disorders, depression, anxiety disorders, or other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patients taking opioid-containing medicines (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effects of Neurontin.
Additionally, taking Neurontin and opioids together may cause drowsiness, sedation, respiratory depression, or death.
Antacids containing aluminium or magnesium
When taking Neurontin and antacids containing aluminium or 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.
• Neurontin may affect the results of some laboratory tests, so inform your doctor or hospital that you are taking Neurontin if you have a urine test.

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, consult your doctor before taking Neurontin.
• Do not stop taking Neurontin without consulting your doctor.
• If you are planning to become pregnant, consult your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking Neurontin.

Pregnancy
Neurontin can be used during the first trimester of pregnancy if necessary.
If you are pregnant or think you may be pregnant, contact your doctor immediately.
If you become pregnant while taking Neurontin for epilepsy, do not stop taking Neurontin without 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 of women from Scandinavian countries who took gabapentin during the first 3 months of pregnancy, no increased risk of birth defects or developmental problems was found. However, children born to mothers who took gabapentin during pregnancy had a higher risk of low birth weight and preterm birth.
Gabapentin use during pregnancy may cause withdrawal symptoms in newborns. This risk may be increased if gabapentin is taken with opioid pain medicines (used to treat severe pain).
If you become pregnant or think you may be pregnant while taking Neurontin, contact your doctor immediately. Do not stop taking Neurontin suddenly, as this may cause seizures or status epilepticus, which can have serious consequences for you and your unborn child.
Breastfeeding
Gabapentin, the active substance in Neurontin, passes into breast milk. As the effect of this on the breastfed infant is unknown, breastfeeding is not recommended during treatment with Neurontin.
Fertility
In animal studies, Neurontin did not affect fertility.

Driving and using machines

Neurontin may cause dizziness, drowsiness, and fatigue. Do not drive, operate complex machinery, or perform other potentially hazardous activities until you know how Neurontin affects you.

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, contact your doctor before taking Neurontin.

Neurontin contains sodium

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

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.
The dose will be determined by your doctor.

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 will be determined by your doctor based on the child's weight. Treatment starts with a low starting dose, which is gradually increased over approximately 3 days. The usual dose to control epilepsy is 25-35 mg/kg body weight per day. This dose is usually divided into 3 separate doses, given at morning, afternoon, and evening.

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 separate doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with kidney problems or patients undergoing haemodialysis

Your doctor may prescribe a different dose and/or dosing schedule if you have kidney problems or are undergoing haemodialysis.

Use in elderly patients (over 65 years of age)

Elderly patients (over 65 years of age) should take the normal recommended dose of Neurontin unless they have kidney problems. If you have kidney problems, your doctor may prescribe a different dose and/or dosing schedule.
If you think that the effect of Neurontin is too strong or too weak, talk to your doctor or pharmacist.

Method of administration

Neurontin is taken by mouth. Swallow the capsules with plenty of water.
Do not stop taking Neurontin unless your doctor tells you to.

Overdose

Taking more Neurontin than prescribed may increase the risk of side effects, including loss of consciousness, dizziness, double vision, blurred speech, drowsiness, and diarrhea. If you take more Neurontin than prescribed, contact your doctor or go to the nearest hospital emergency department immediately. Take the remaining capsules, packaging, and this leaflet with you.

Missed dose

If you forget to take 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, talk to your doctor first. They will tell you how to stop taking Neurontin safely.
Stopping Neurontin should be done gradually over a minimum of 1 week. After stopping short-term or long-term treatment with Neurontin, you may experience withdrawal symptoms, such as seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headache, depression, feeling abnormal, dizziness, and general feeling of being unwell. These symptoms usually occur within 48 hours after stopping Neurontin. If you experience any of these symptoms, 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, target-like, or circular patches on the trunk, 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 fever, and enlarged lymph nodes (DRESS syndrome or hypersensitivity reaction).

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

• persistent stomach pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• breathing difficulties, which may require immediate medical attention
• 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.

If you experience any of the following symptoms, contact your doctor immediately:

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

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

• If you are undergoing haemodialysis, tell 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
• Loss of appetite, increased appetite
• Irritability, confusion, mood changes, depression, anxiety, restlessness
• Seizures, sudden movements, speech problems, memory problems, tremors, sleep disturbances, headaches, increased sensitivity, numbness, coordination problems, abnormal eye movements, increased or decreased reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, flushing
• Shortness of breath, bronchitis, sore throat, coughing
• Nausea, vomiting, dental problems, gum inflammation, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, bloating
• Facial swelling, bruising, rash, itching
• Joint pain, muscle pain, back pain, muscle tremors
• Erectile dysfunction (impotence)
• Swelling of the feet and hands, difficulty walking, weakness, pain, general feeling of being unwell, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, bone fractures, skin abrasions

In addition, in clinical studies in children, aggressive behavior and sudden limb movements were commonly reported.

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

• Restlessness (a state of agitation and involuntary movements)
• Allergic reactions, such as hives
• Movement disorders
• Palpitations
• Difficulty swallowing
• Swelling, including face, trunk, and limbs
• Abnormal liver function test results
• Psychiatric disorders
• Falls
• Elevated blood glucose levels (most commonly observed in patients with diabetes)

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

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

After marketing, the following side effects have been reported:

• Decreased platelet count (blood cells responsible for blood clotting)
• Hallucinations
• Abnormal movements, such as twisting or jerking of the limbs, stiffness
• 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
• Withdrawal symptoms after stopping gabapentin (anxiety, difficulty sleeping, nausea, pain, excessive sweating), chest pain
• Muscle 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, including difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure, requiring immediate medical attention)
• Risk of developing dependence on Neurontin ("drug dependence")

After stopping short-term or long-term treatment with Neurontin, you may experience withdrawal symptoms (see "Stopping Neurontin").

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can be reported to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). You can also report side effects directly to the manufacturer.

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 after "EXP". The expiry date refers to the last day of that month.
Store Neurontin capsules below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Neurontin contains

The active substance is gabapentin. Each hard capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.
Other ingredients in Neurontin hard capsules are:
capsule contents: lactose monohydrate, maize starch, 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 colorants E 171 (titanium dioxide) and E 172 (yellow iron oxide), and the 400 mg hard capsules contain the colorants E 171 (titanium dioxide) and E 172 (red and yellow iron oxide). The ink used for printing on all strengths of hard capsules contains shellac, E 171 (titanium dioxide), and E 132 (indigo carmine aluminum lake).

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".
Aluminium/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 authorisation holder and manufacturer

Marketing authorisation 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 authorised 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 information on this medicine, contact the representative of the marketing authorisation holder:

Viatris Healthcare Sp. z o.o.

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