NEURONTIN 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Neurontin 800mg Film-Coated Tablets

Gabapentin

Read all of this leaflet carefully before you start 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 Package Leaflet

1. What is Neurontin and what is it used for
2. What you need to know before you take Neurontin
3. How to take Neurontin
4. Possible side effects
5. Storing Neurontin
6. Package Contents and Further Information

1. What is Neurontin and what is it used for

Neurontin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

The active substance of Neurontin is gabapentin.

Neurontin is used to treat

• Certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe Neurontin for you or your child aged 6 years or older to help treat epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take Neurontin in combination with your current treatment unless otherwise directed by your doctor. Neurontin can also be given as the only medicine in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (long-lasting pain caused by damage to the nerves). There are various diseases that can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing, stabbing, shooting, aching, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

2. What you need to know before you take Neurontin

Do not takeNeurontin

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

Warnings and Precautions

Consult your doctor or pharmacist before starting Neurontin

• if you have kidney problems, your doctor may prescribe a different dosage regimen
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you start to feel muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately as they may be symptoms of acute pancreatitis (inflamed pancreas).
• if you have a nervous system disorder or a respiratory disorder or if you are over 65 years old, your doctor may prescribe a different dose.
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of developing dependence on Neurontin.

Dependence

Some people may develop dependence (need to continue taking the medicine) on Neurontin. They may experience withdrawal symptoms when they stop taking Neurontin (see section 3, "How to take Neurontin" and "If you stop taking Neurontin"). If you are concerned about developing dependence on Neurontin, it is important that you consult your doctor.

If you experience any of the following signs while taking Neurontin, it may indicate that you have developed dependence.

• you feel that you need to take the medicine for a longer period than prescribed.
• you feel that you need to take a higher dose than recommended.
• you are taking the medicine for reasons other than its prescription.
• you have tried to stop taking the medicine or control how you take it several times without success.
• when you stop taking the medicine, you feel unwell and feel better when you take it again.

If you notice any of the above, talk to your doctor to decide on the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

A small number of people being treated with antiepileptics such as Neurontin have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

Important information about potentially serious reactions

Severe skin reactions have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Read the description of serious symptoms in section 4 of this leaflet"Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious".

Muscle weakness, sensitivity, or pain on palpation, and especially if you feel unwell or have a fever, could be due to abnormal muscle fiber breakdown, which can lead to kidney problems and put your life at risk. You may also experience urine discoloration and changes in blood test results (significant increase in creatine phosphokinase in the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Using Neurontin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids can increase the effect of Neurontin. Additionally, the combination of Neurontin with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

If you take Neurontin at the same time as antacids containing aluminum and magnesium, the absorption of Neurontin in the stomach may be reduced. Therefore, it is recommended that Neurontin be taken at least 2 hours after taking an antacid.

Neurontin

• is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.

• may interfere with some laboratory tests, so if you need a urine test, inform your doctor or hospital about what you are taking.

Taking Neurontin with food

Neurontin can be taken with or without food.

Pregnancy, Breast-feeding, and Fertility

• If you are pregnant or think you may be pregnant, you must inform your doctor to assess the possible risks that the medicine you are taking may have for the fetus.
• Do not stop your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breast-feeding or planning to breast-feed, 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 or are pregnant or think you may be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your condition. The worsening of your epilepsy may put both you and your unborn baby at risk.

In a study that reviewed data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain development (neurodevelopmental disorders). However, babies of women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken with opioid analgesics (drugs for treating intense pain).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Neurontin. Do not stop taking this medicine abruptly, as this may cause a seizure, which could have serious consequences for both you and your baby.

Breast-feeding

Gabapentin, the active substance of Neurontin, passes into breast milk. Breast-feeding is not recommended while taking Neurontin, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and Using Machines

Neurontin may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.

3. How to take Neurontin

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 than the prescribed dose.

Your doctor will determine the dose that is right for you.

Epilepsy, the recommended dose is

Adults and Adolescents

Take the number of tablets that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be 300 to 900 mg per day. From then on, the dose may be increased as directed by your doctor up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one in the evening.

Children aged 6 years and older

Your doctor will decide the dose to give to your child based on the child's weight. The treatment will start with a low initial dose that will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25-35 mg per kg per day. The dose is usually given by taking the tablets, divided into 3 equal doses per day, normally one in the morning, one at noon, and one in the evening.

Neurontin is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of tablets that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be 300 to 900 mg per day. From then on, the dose may be increased as directed by your doctor up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one in the evening.

If you have kidney problems or are on hemodialysis

Your doctor may prescribe a different dosage regimen and/or different doses if you have kidney problems or are on hemodialysis.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of Neurontin, unless you have kidney problems.

Your doctor may prescribe a different dosage regimen or different doses if you have kidney problems.

If you think that the effect of Neurontin is too strong or too weak, tell your doctor or pharmacist as soon as possible.

Method of Administration

Neurontin is taken by mouth. Always swallow the tablets with a sufficient amount of water. The tablet can be divided into two equal halves.

Continue taking Neurontin until your doctor tells you to stop.

If you take more Neurontin than you should

Doses higher than recommended may cause an increase in side effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital if you take more Neurontin than your doctor prescribed. Bring any remaining tablets, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Neurontin

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 forgotten doses.

If you stop taking Neurontin

Do not stop taking Neurontin suddenly. If you want to stop taking Neurontin, talk to your doctor first. Your doctor will tell you how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should know that you may experience certain side effects, called withdrawal syndrome, after stopping short-term or long-term treatment with Neurontin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with Neurontin. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Neurontin and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief and with a target or circular shape on the torso, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Expanded rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious:

• persistent stomach pain, vomiting, and nausea, as they can be symptoms of acute pancreatitis (inflammation of the pancreas)

• Neurontin can cause a severe or potentially life-threatening allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing Neurontin or even hospitalization.
• breathing difficulties that, if severe, may require urgent medical attention to breathe normally.

Contact your doctor immediately if you have any of the following symptoms:• skin rash and redness and/or hair loss• hives• fever• swelling of the glands that does not disappear• swelling of the lips, face, and tongue• yellowish color of the skin or whites of the eyes• unusual bleeding or bruising• severe fatigue or weakness• unexpected muscle pain• Frequent infections

These symptoms may be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking Neurontin.

• If you are on hemodialysis, inform your doctor if you start to feel muscle pain and/or weakness.

Other adverse effects include:

Very common: (may affect more than 1 in 10 people)

• Viral infection
• Feeling of drowsiness, dizziness, discoordination
• Feeling of fatigue, fever

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

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections
• Low white blood cell count
• Anorexia, increased appetite
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Vertigo
• Increased blood pressure, redness, or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, tremors
• Difficulty with erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms
• Decreased leukocytes, weight gain
• Accidental injuries, fractures, abrasions

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent adverse effects.

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

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Allergic reactions such as hives
• Decreased movement
• Accelerated heart rate
• Difficulty swallowing
• Swelling that can affect the face, torso, and limbs

• Abnormal blood test results that may indicate liver problems.
• Progressive mental damage
• Falling
• Increased blood glucose levels (more frequently observed in patients with diabetes)

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

• Loss of consciousness
• Decreased blood glucose levels (more frequently observed in patients with diabetes)
• Breathing difficulties, shallow breathing (respiratory depression)

After the marketing of Neurontin, the following adverse effects have been reported:

• Decrease in platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and stiffness
• Ringing in the ears
• Yellowish appearance of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse effects after sudden discontinuation of gabapentin treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual activity problems, such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment)
• Developing dependence on Neurontin ("drug dependence")

You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting short-term or long-term treatment with Neurontin (see "If you stop taking Neurontin").

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Neurontin

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Neurontin

The active ingredient is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.

The other components of Neurontin 800 mg film-coated tablets are: poloxamer 407 (ethylene oxide and propylene oxide), copovidone, cornstarch, and magnesium stearate.

Coating: Opadry White YS-1-18111 (hydroxypropylcellulose, talc).

Polishing agent: candelilla wax.

Appearance of the product and package contents

The 800 mg tablets are white, elliptical, film-coated tablets with a score on both sides and engraved with "NT" on one half and "26" on the other.

They are available in PVC/PE/PVDC/aluminum or PVC/PVDC/aluminum blisters included in packages of 20, 30, 45, 50, 60, 84, 90, 100, 200, and 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

MEDIS INTERNATIONAL a.s., výrobní závod Bolatice

Prumyslová 961/16

747 23 Bolatice

Czech Republic

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the following European Economic Area member states and in the United Kingdom (Northern Ireland) with the following name: Neurontin

Date of the last revision of this prospectus: July 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/