Neurontin 800 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Neurontin 800mg Film-coated Tablets

Gabapentin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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 adverse 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 peripheral neuropathic pain (chronic pain caused by nerve damage).

The active substance in Neurontin is gabapentin.

Neurontin is used to treat

• Certain types of epilepsy (seizures that initially start in specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe Neurontin to help manage epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take Neurontin in combination with current treatment, unless otherwise instructed. Neurontin may also be given as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or shingles. The pain sensation may be described as warmth, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and prickling sensations, etc.

2. What you need to know before taking Neurontin

Do not take Neurontin

• if you are allergic (hypersensitive) to gabapentin or to any of the other components 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 regimen
• if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, notify 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, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on Neurontin.

Dependence

Some people may develop dependence (a need to keep 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 to consult your doctor.

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

• you feel you need to take the medicine for longer than prescribed
• you feel you need to take a higher dose than recommended
• you are taking the medicine for reasons different from those for which it was prescribed
• you have tried several times to stop taking the medicine or control how you take it, without success
• you feel unwell when you stop taking the medicine and feel better when you start taking it again

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

A small number of people taking antiepileptic medicines such as Neurontin have had thoughts of harming themselves or of suicide. If at any time you experience such thoughts, contact your doctor as soon as possible.

Important information about potentially serious reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention 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 may be serious".

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

Taking Neurontin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform 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 conditions.

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may enhance the effect of Neurontin. In addition, combining Neurontin with opioids may cause drowsiness, sedation, reduced 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 therefore 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 oral contraceptive pills.

• may interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Neurontin with food

Neurontin may be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, inform your doctor immediately so that the potential risks of the medicine to the unborn baby can be discussed.
• You should not stop your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should review your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Neurontin may 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, consult your doctor immediately.

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

In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to 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 concomitantly with opioid analgesics (medicines for the treatment of severe 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 trigger seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active substance in Neurontin, passes into breast milk. Breastfeeding is not recommended while taking Neurontin, as the effect on the infant is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Neurontin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform such tasks.

3. How to take Neurontin

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of tablets your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed by your doctor up to a maximum dose of 3,600 mg per day, which is divided into three equal doses, for example, one in the morning, one at midday, and one at night.

Children aged 6 years and older

Your doctor will decide the dose to give your child based on the child's weight. Treatment will start with a low initial dose, which 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. This dose is normally administered by taking tablets divided into three equal doses per day, usually one in the morning, one at midday, and one at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of tablets your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed by your doctor up to a maximum dose of 3,600 mg per day, which is divided into three equal doses, for example, one in the morning, one at midday, and one at night.

If you have kidney problems or are undergoing hemodialysis

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

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

Method of administration

Neurontin is administered orally. Always swallow the tablets with a sufficient amount of water. The tablet may 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 increase the risk of adverse 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 immediately at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested, or go to the nearest hospital emergency department if you have taken more Neurontin than prescribed. Bring any tablets not taken, together with the container and the package 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 almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Neurontin

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

If you have any further questions about 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 everyone will experience them.

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

• Red, non-elevated, target-shaped or circular rashes on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

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

• Neurontin may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may require stopping Neurontin or even hospitalization.

• Difficulty breathing, which, if severe, may require emergency medical treatment to maintain normal breathing.

Contact your doctor immediately if you have any of the following symptoms: • Skin rash and redness and/or hair loss • Hives • Fever • Swollen glands that do not go away • Swelling of the lips, face, and tongue • Yellowing 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 early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking Neurontin.

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

Other adverse effects include:

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, 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, restlessness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, 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
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, jerking movements
• Erectile difficulties (impotence)
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased leukocytes, weight gain
• Accidental injuries, fractures, abrasions

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common 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

• Rapid heartbeat

• Difficulty swallowing

• Swelling that may affect the face, trunk, and limbs

• Abnormal blood test results that may indicate liver problems.

• Progressive mental impairment

• Fall

• Increased blood glucose levels (observed more frequently in patients with diabetes)

Rare: (may affect up to 1 in 1,000 people)

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

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

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears
• Yellowish appearance of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increase in breast tissue, breast enlargement
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual function problems, such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in blood
• Anaphylaxis (serious, potentially life-threatening allergic reaction, including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
• Development of dependence on Neurontin ("drug dependence")

You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with Neurontin (see "If you stop taking Neurontin").

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Neurontin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Neurontin

The active substance 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, maize starch and magnesium stearate.

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

Polishing agent: candelilla wax.

Appearance of the product and contents of the pack

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

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

Only certain pack 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
Calle General Aranaz, 86
28027 Madrid
Spain

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

Date of last review of this leaflet: July 2023

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