NEURONTIN 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Neurontin 400mg Hard Capsules

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 pack and other information

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. Contents of the pack and other 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 in Neurontin is gabapentin.

Neurontin is used to treat

• Certain types of epilepsy (seizures that initially are 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 to help treat your epilepsy when your current treatment is no longer working fully. You should take Neurontin in addition to your current treatment unless told otherwise. Neurontin can also be used on its own to treat 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 legs and/or arms), such as diabetes or shingles. The sensation of pain can be described as burning, tingling, prickling, numbness, or aching 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

Talk to your doctor or pharmacist before taking Neurontin

• if you have kidney problems, your doctor may prescribe a different dosing schedule
• if you are on haemodialysis (to remove waste products due to renal 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 these 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 of age, your doctor may prescribe a different dose.
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescribed drugs, or illegal drugs; you may have a higher risk of developing dependence on Neurontin.

Dependence

Some people may develop dependence (need to keep taking the medicine) on Neurontin. They may have 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 talk to your doctor.

If you experience any of the following signs while taking Neurontin, it may be indicative of dependence.

• you feel that you need to take the medicine for longer than prescribed.
• you feel that you need to take a higher dose than recommended.
• you are taking the medicine for reasons other than prescribed.
• you have tried to stop taking the medicine or control how you take it, without success.
• when you stop taking the medicine, you feel unwell and feel better when you start taking 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 taking antiepileptics, such as Neurontin, have had thoughts of harming themselves or 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 serious 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 can be serious"

Muscle weakness, tenderness, or pain and especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle tissue that can lead to kidney problems and put your life at risk. You may also experience discoloration of the urine 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 taking, have recently taken, or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric disorder.

Medicines containing opioids such as morphine

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

Antacids for indigestion

If you take Neurontin at the same time as antacids containing aluminium and magnesium, the absorption of Neurontin in the stomach may be reduced. It is recommended that Neurontin be taken at least two 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, tell your doctor or hospital what you are taking.

TakingNeurontin with food

Neurontin can be taken with or without food.

Pregnancy, breast-feeding, and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Do not stop your treatment without first talking to your doctor.
• If you are planning to become pregnant, you should discuss your treatment with your doctor or pharmacist as soon as possible before you become pregnant.
• If you are breast-feeding or thinking of breast-feeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Neurontin can be used during the first trimester of pregnancy if necessary.

If you become pregnant or think you may be pregnant, consult your doctor immediately.

If you have epilepsy and are pregnant, it is important that you do not stop taking your medicine without first talking to your doctor, as this may cause your seizures to return. The return of your seizures 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 born to women who took gabapentin during pregnancy had a higher risk of being born with a low birth weight and preterm birth

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken with opioid painkillers (such as morphine).

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

Breast-feeding

Gabapentin, the active substance in 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. You should not drive, use machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Neurontin contains lactose

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

Neurontin contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this 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 than the recommended dose.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules as instructed by your doctor. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be between 300 and 900 mg per day. The dose may then be increased, as instructed by your doctor, up to a maximum dose of 3600 mg per day, divided into three equal doses, i.e., 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 be given to your child based on the child's weight. The treatment will start with a low initial dose, which will be gradually increased over approximately 3 days. The usual dose to control epilepsy is 25-35 mg per kg per day. The dose is usually given in three equal doses, i.e., one in the morning, one at noon, and one in the evening.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules as instructed by your doctor. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be between 300 and 900 mg per day. The dose may then be increased, as instructed by your doctor, up to a maximum dose of 3600 mg per day, divided into three equal doses, i.e., one in the morning, one at noon, and one in the evening.

If you have kidney problems or if you are on haemodialysis

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

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 dosing schedule or different doses if you have kidney problems.

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

Method of administration

Neurontin is taken by mouth. Always swallow the capsules whole with plenty of water.

Continue taking Neurontin until your doctor tells you to stop.

If you take moreNeurontinthan you should

Doses above the recommended dose may cause an increased risk of side effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, stating 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 capsules that you have not taken, along with the packaging and leaflet, so that the hospital can easily identify the medicine that you have taken.

If you forget to takeNeurontin

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.

If you stop takingNeurontin

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 stop taking Neurontin gradually over at least one week. You should know that you may experience certain side effects, called withdrawal symptoms, when you stop taking Neurontin after short-term or long-term treatment. These include seizures, anxiety, difficulty sleeping, feeling sick (nausea), pain, sweating, trembling, headache, depression, abnormal sensations, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping Neurontin treatment. If you experience any of these withdrawal symptoms, 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, 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 increased lymph node size (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. This reaction may or may not be accompanied by a rash. It may require discontinuing Neurontin or even hospitalization.
• Breathing problems 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 can 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 extremities

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

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

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

After Neurontin was marketed, the following adverse effects have been reported:

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity
• 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed 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. Storage of Neurontin

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging 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 hard gelatin capsule contains 400 mg of gabapentin.

The other ingredients of Neurontin 400 mg hard capsules are:

Capsule content: lactose monohydrate, cornstarch, and talc.

Capsule shell: gelatin, purified water, and sodium lauryl sulfate.

The 400 mg hard capsules contain the colorants E171 (titanium dioxide) and E172 (iron oxide red and yellow). The ink used for printing on all hard capsules contains shellac, E171 (titanium dioxide), and E132 (indigo carmine, aluminum salt).

Appearance of theproduct and package contents

The 400 mg capsules are hard, orange capsules with "Neurontin 400 mg" and "VLE" printed on them.

Available in PVC/PVDC/aluminum blisters included in packages of 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.

Only certain 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under 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/