Neurontin 600

Patient Information Leaflet

NEURONTIN 600, 600 mg, film-coated tablets
NEURONTIN 800, 800 mg, film-coated tablets
Gabapentinum
Please 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Neurontin is and what it is used for
2. What you need to know 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 in the treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Neurontin is gabapentin.
Neurontin is indicated for the treatment of

• various forms of epilepsy (seizures that start in a specific part of the brain and may or may not spread to the rest of the brain). Neurontin is prescribed for adults and children aged 6 years and older as an add-on therapy for epilepsy when current treatment does not fully prevent seizures. Neurontin should be taken as an additional medicine in the treatment of epilepsy in adults or children aged 6 years and older, unless otherwise directed by a doctor. Neurontin may 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 pain (occurring mainly in the lower and/or upper limbs) is caused by a variety of different diseases such as diabetes or shingles. Patients describe the pain they feel as burning, stinging, pulsating, shooting, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important information before using Neurontin

When not to use Neurontin

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

Warnings and precautions
Before starting to take Neurontin, discuss this with your doctor or pharmacist:

• if the patient has kidney disease, the doctor may recommend a different dosing regimen;
• if the patient is undergoing haemodialysis (to remove metabolic waste products due to kidney failure), inform the doctor about any muscle pain and/or weakness;
• if symptoms such as persistent abdominal pain, nausea, or vomiting occur, contact the doctor immediately, as these may be signs of acute pancreatitis;
• if the patient has neurological or respiratory disorders or is over 65 years of age; the doctor may recommend a different dosage;
• before starting treatment with this medicine, inform the doctor if the patient has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean there is an increased risk of becoming dependent on Neurontin.

Dependence
Some individuals may develop dependence on Neurontin (a need to continue taking the medicine). After stopping Neurontin, withdrawal effects may occur (see section 3, "How to take Neurontin" and "Stopping Neurontin"). If the patient is concerned about possibly becoming dependent on Neurontin, it is important to consult the doctor.
If, while taking Neurontin, the patient notices any of the following symptoms, this may be a sign of dependence:

• Feeling the need to take the medicine longer than prescribed by the doctor
• Feeling the need to take a higher dose than prescribed
• Using the medicine for purposes other than those prescribed
• The patient has made multiple unsuccessful attempts to stop or control use of the medicine
• The patient feels unwell after stopping the medicine, but feels better after taking it again

If any of these are noticed, the patient should talk to the doctor to discuss the best treatment approach, including when and how to safely stop taking the medicine.
A small number of patients taking antiepileptic medicines such as gabapentin have had thoughts of self-harm or suicide. If such thoughts occur at any time, the patient should contact the doctor immediately.
Important information about potentially serious reactions
Serious skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of gabapentin. Gabapentin should be discontinued and medical advice sought immediately if any symptoms related to serious skin reactions described in section 4 occur.
Please read the description of serious symptoms in section 4 – "Due to possible serious health consequences, contact your doctor immediately if any of the following symptoms occur after taking the medicine."
Muscle weakness, tenderness, or pain, especially when accompanied by malaise and high fever, may be due to abnormal breakdown of muscle fibres, which can be life-threatening and lead to kidney problems. Changes in urine colour and blood test results (markedly increased levels of creatine kinase in the blood) may occur. If such symptoms occur, contact the doctor immediately.

Neurontin and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor (or pharmacist) about all medicines currently or recently used to treat seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric disorders.

Medicines containing opioids, such as morphine
Patients taking medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effects of Neurontin.
Additionally, taking Neurontin together with opioids may cause drowsiness, sedation, respiratory depression, or death.

Antacids for indigestion
When Neurontin is taken at the same time as antacids containing aluminium and magnesium, absorption of Neurontin from the stomach may be reduced. Therefore, Neurontin should be taken at least two hours after taking an antacid.

Neurontin:

• does not interact with other antiepileptic medicines or with oral contraceptives;
• may affect the results of certain laboratory tests; if undergoing urine testing, inform the doctor or hospital about all medicines currently being taken.

Neurontin and food
Neurontin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or suspects she may be pregnant, she should contact her doctor immediately to discuss the potential risks to the unborn child associated with taking this medicine.
• Do not stop treatment without discussing it with the doctor.
• If the patient plans to become pregnant, she should discuss treatment with her doctor or pharmacist as early as possible before conception.
• If the patient is breastfeeding or planning to breastfeed, she should consult her doctor or pharmacist before starting this medicine.

Pregnancy
Neurontin may be used during the first trimester of pregnancy if necessary.
If the patient plans to become pregnant, is pregnant, or suspects she may be pregnant, she should contact her doctor immediately.
If the patient becomes pregnant and has epilepsy, it is important not to stop taking the medicine without first consulting her doctor, as this could worsen the condition. Worsening of epilepsy may pose a risk to both the pregnant woman and her unborn child.
In a study involving data from women in Scandinavian countries who took gabapentin during the first three months of pregnancy, no increased risk of congenital malformations or brain development problems (neurodevelopmental disorders) was observed. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and premature birth.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be increased if gabapentin is taken together with opioid pain medicines (medicines used to treat severe pain).
If pregnancy occurs, is suspected, or is planned while taking Neurontin, contact the doctor immediately. Do not suddenly stop taking Neurontin, as this may lead to withdrawal seizures, which could have serious consequences for both the pregnant woman and her child.

Breastfeeding
Gabapentin, the active substance in Neurontin, passes into human milk. As it is not known what effect it may have on a breastfed infant, breastfeeding is not recommended during treatment with Neurontin.

Fertility
No effect of the medicine on fertility was observed in animal studies.

Driving and operating machinery
Neurontin may cause dizziness, drowsiness, and fatigue. Until the patient knows how this medicine affects their ability to drive, operate complex machinery, or perform other potentially hazardous activities, such activities should be avoided.

3. How to use Neurontin

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a 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 tablets as prescribed by your doctor. Doses are usually increased gradually.
The most commonly used starting dose ranges from 300 mg to 900 mg per day.
This dose may then be gradually increased, as directed by the physician, up 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 administered to a child is determined by the doctor based on the child's body weight.
Treatment starts with a low initial dose, which is gradually increased over a period of approximately 3 days.
The usual effective dose for controlling seizures ranges from 25 to 35 mg/kg body weight/day.
This dose is usually given in three separate doses, meaning the child takes a tablet (or tablets) daily,
typically 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
Take the number of tablets as prescribed by your doctor. Doses are usually increased gradually.
The most commonly used starting dose ranges from 300 mg to 900 mg per day.
This dose may then be gradually increased up 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 prescribe a different dosing regimen 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 patients with kidney disease, the doctor may prescribe a different
dosing regimen and/or a different dose.
If the effect of Neurontin appears too strong or too weak, consult your doctor or pharmacist promptly.
Method of administration
Neurontin is administered orally. Tablets should be swallowed with plenty of water. Tablets may be
split in half.
Neurontin treatment should only be discontinued when instructed by a doctor.
Taking more Neurontin than prescribed
Taking higher than recommended doses may increase the risk of adverse effects, including loss of
consciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. If you take more
Neurontin than prescribed, seek immediate medical help by contacting a doctor or going to the
nearest hospital emergency department. In such cases, bring any remaining tablets, the packaging,
and the leaflet with you so that hospital staff can immediately identify the medicine taken.
Missing a dose of Neurontin
If you miss a dose, take it as soon as you remember, unless it is almost time for the 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 wish to discontinue Neurontin, discuss this first with your
doctor. The doctor will advise you on how to proceed. Discontinuation should be done gradually over
a period of at least 1 week. After stopping short-term or long-term treatment with Neurontin, be aware
that certain adverse effects, known as withdrawal effects, may occur. These may include seizures,
anxiety, difficulty sleeping, nausea, pain, sweating, tremor, headache, depression, feelings of
abnormality, dizziness, and general malaise. These effects usually occur within 48 hours after
stopping Neurontin. If withdrawal effects occur, contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Neurontin and contact your doctor immediately if any of the following symptoms occur after taking the medicine:

• Red, non-raised, flat or round spots on the trunk, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genital organs, or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Due to possible serious health consequences, you should contact your doctor immediately if any of the following symptoms occur 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 affecting the skin or other parts of the body, such as the liver or blood cells. Such reactions may include a rash. These reactions may require hospitalization or discontinuation of Neurontin. Contact your doctor immediately if any of the following symptoms occur:
• Skin rash and redness of the skin, and/or hair loss
• Hives (urticaria)
• Fever
• Persistent swelling of lymph nodes
• Swelling of lips, face, and tongue
• Yellowing of the skin or whites of the eyes (jaundice)
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections

These symptoms may be the first signs of a serious reaction. The doctor should examine the patient and decide whether Neurontin should be continued.

• In patients undergoing hemodialysis, inform the doctor about any muscle pain and/or weakness.

Other adverse reactions include:
Very common: (may affect more than 1 in 10 people)

• Viral infections
• Drowsiness, dizziness, lack of coordination
• Feeling of fatigue, 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
• Hostility towards others, disorientation, mood changes, depression, anxiety, restlessness, thinking disturbances
• Seizures, sudden muscle movements, speech problems, memory loss, tremor, sleep disorders, headache, increased skin sensitivity, reduced sensation (numbness), coordination problems, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, redness or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dry 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 twitching
• Erectile dysfunction (impotence)
• Swelling of hands and feet, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, bone fractures, skin abrasions

Additionally, in clinical studies, aggressive behavior and sudden bending of limbs were commonly reported in children.
Uncommon: (may affect up to 1 in 100 people)

• Agitation (a state of constant restlessness and unintentional, purposeless movements)
• Allergic reactions, e.g., hives
• Restricted movement
• Palpitations
• Difficulty swallowing
• Swelling affecting face, trunk, limbs
• Abnormal blood test results indicating liver function abnormalities
• 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 Neurontin was introduced to the market, the following adverse reactions have been observed:

• Decreased platelet count (blood cells responsible for blood clotting)
• Hallucinations
• Abnormal movements, such as twisting of limbs or sudden bending, muscle stiffness
• Tinnitus (ringing in the ears)
• Yellowing of the skin and whites of the eyes (jaundice), hepatitis (liver inflammation)
• Acute kidney failure, urinary incontinence
• Tissue overgrowth in the breast area, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep difficulties, nausea, pain, excessive sweating), chest pain
• Rhabdomyolysis (breakdown of muscle fibers)
• Changes in blood test results (elevated creatine phosphokinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Hyponatremia (low sodium levels in the blood)
• Anaphylactic reactions (severe, potentially life-threatening allergic reactions involving breathing difficulties, swelling of lips, throat, and tongue, and hypotension requiring immediate treatment)
• Risk of developing dependence on Neurontin ("drug dependence")

After stopping short-term or long-term treatment with Neurontin, it should be recognized that certain adverse reactions, known as withdrawal effects, may occur (see "Stopping Neurontin").
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the carton. The expiry date refers to the last day of the stated month.
Do not store Neurontin coated tablets above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
Other ingredients of Neurontin coated tablets are: poloxamer 407 (ethylene oxide and propylene oxide), copovidone, maize starch, magnesium stearate.
Coating composition: Opadry White YS-1-18111 (hydroxypropyl cellulose, talc)
Glidant: Candelilla wax.

What Neurontin looks like and contents of the pack
Neurontin 600 mg coated tablets are white, elongated, film-coated tablets with a central breakline on both sides and embossed with the characters "NT" and "16" on one side.
Neurontin 800 mg coated tablets are white, elongated, film-coated tablets with a central breakline on both sides and embossed with the characters "NT" and "26" on one side.
Packaging: Aluminium/PVC/PE/PVDC blisters or Aluminium/PVC/PVDC blisters containing 20, 30, 45, 50, 60, 84, 90, 100, 200, 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

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 name: Neurontin:
Country Name of the medicinal product
Austria Neurontin 600 mg Filmtabletten
Neurontin 800 mg Filmtabletten

For more detailed information, please contact the representative of the responsible entity:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00