Neurontin

Patient Information Leaflet
Neurontin 100 mg hard capsules
Neurontin 300 mg hard capsules
Neurontin 400 mg hard capsules
gabapentin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Neurontin is gabapentin.
Neurontin is used to treat:

• Various forms of epilepsy (seizures initially affecting only certain areas of the brain, whether or not they spread to other parts of the brain). Your doctor may prescribe Neurontin as an add-on treatment for you or your child aged 6 years or older when current treatment does not fully control the condition. You or your child aged 6 years or older should take Neurontin in addition to your current treatment, unless otherwise instructed. Neurontin may also be used alone to treat adults and children over 12 years of age.
• Peripheral neuropathic pain (long-lasting pain caused by nerve damage). A variety of different diseases can cause peripheral neuropathic pain (which occurs mainly in the legs and/or arms), such as diabetes or shingles.

Pain sensations may be described as warmth, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, prickling, etc.

2. What you should know before taking Neurontin

Do not take Neurontin

• if you are allergic (hypersensitive) to gabapentin or to 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 dosage
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or muscle weakness
• if you develop signs such as persistent stomach pain, nausea, and vomiting, contact your doctor immediately, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• if you have neurological/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you are at higher risk of becoming dependent on Neurontin.

Dependence
Some people may become dependent on Neurontin (a need to keep taking the medicine). They may experience withdrawal symptoms when they stop using Neurontin (see section 3, "How to take Neurontin" and "If you stop taking Neurontin"). If you are concerned about becoming dependent on Neurontin, it is important to consult your doctor.
If while taking Neurontin you notice any of the following signs, this could mean you have become dependent:

• you feel the need to take the medicine for longer than recommended by your doctor
• you feel the need to take a higher dose than recommended
• you use the medicine for reasons other than those prescribed
• you have repeatedly tried to stop or control your use of the medicine but failed
• you feel unwell after stopping the medicine and feel better when you start taking it again. If you notice any of these situations, talk to your doctor to discuss the best treatment for you, including when and how to stop safely.

A small number of patients treated with antiepileptic medicines such as gabapentin have experienced suicidal thoughts or self-harm. If at any time you have thoughts of this kind, contact your doctor immediately.
Important information about potentially serious reactions
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in association with gabapentin treatment. If you notice the onset of signs and symptoms related to the serious skin reactions described in section 4, stop treatment with gabapentin and contact your doctor immediately.
Read the description of serious symptoms in section 4 of this package leaflet under
"contact your doctor immediately if any of the following symptoms occur after taking this
medicine, as they may be serious".
Muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell and fever, may be caused by muscle injury that can be life-threatening and may lead to kidney problems. You may also notice discolored urine and abnormalities in blood tests (particularly increased creatine phosphokinase). If any of these signs or symptoms occur, please contact your doctor immediately.
Other medicines and Neurontin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety, or other neurological or psychiatric conditions.
Medicines containing opioids such as morphine
If you are taking medicines containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Neurontin. In addition, combining Neurontin with opioids may cause drowsiness, sedation, reduced breathing, or death.
Antacids for indigestion
If Neurontin and antacids containing aluminium and magnesium are taken together, the absorption of Neurontin from the stomach may be reduced. It is therefore recommended to take Neurontin no sooner than two hours after taking an antacid.
Neurontin:

• is not expected to interact with other antiepileptic medicines or with oral contraceptives
• may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Neurontin with food
Neurontin may be taken with or without food.
Pregnancy, breastfeeding, and fertility

• If you are pregnant, think you may be pregnant, you should inform your doctor immediately and discuss the possible risks the medicine you are taking may pose to your unborn child.
• Do not stop treatment without discussing it with your doctor.
• If you are planning a pregnancy, you should discuss your treatment with your doctor or pharmacist as early as possible before becoming pregnant.
• If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Neurontin may be used during the first trimester of pregnancy, if necessary.
If you are planning a pregnancy, are pregnant, or think you may be pregnant, contact your doctor immediately.
If you are pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen your condition. Worsening epilepsy could endanger both you and your unborn child.
In a study examining data from women in Nordic countries who took gabapentin during the first three months of pregnancy, no increased risk of birth defects or problems in brain function development (neurodevelopmental disorders) was observed. However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm delivery.
When used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken together with opioid analgesics (medicines for the treatment of severe pain).
Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy while being treated with Neurontin. Do not suddenly stop taking this medicine, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your baby.
Breastfeeding
Gabapentin, the active substance in Neurontin, passes into breast milk. Since the effect on the infant is unknown, breastfeeding is not recommended during treatment with Neurontin.
Fertility
Animal studies have shown no effect on fertility.
Driving and using machines
Neurontin may cause dizziness, drowsiness, and fatigue. Do not drive, operate complex machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.
Neurontin contains lactose
Neurontin hard capsules contain lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Neurontin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 100 mg, 300 mg, and 400 mg hard capsule, i.e., it is essentially "sodium-free".

3. How to take Neurontin

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. 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 capsules prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally between 300 mg and 900 mg per day. Subsequently, the dose may be increased, as directed by your doctor, up to a maximum of 3600 mg per day, which should be taken in three separate doses—once in the morning, once in the afternoon, and once in the evening.

Children aged 6 years and older:
The dose for the child will be determined by the doctor based on the child's weight. Treatment is started with a low initial dose, which is gradually increased over approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg/kg per day, typically administered in three separate doses—taken daily, usually once in the morning, once in the afternoon, and once 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. Usually, your doctor will gradually increase your dose. The initial dose is generally between 300 mg and 900 mg per day. Subsequently, the dose may be increased, as directed by your doctor, up to a maximum of 3600 mg per day, to be taken in three separate doses—once in the morning, once in the afternoon, and once in the evening.

If you have kidney problems or are on haemodialysis
If you have kidney problems or are undergoing haemodialysis, your doctor may prescribe a different dosing schedule and/or a different dose.

If you are an elderly patient (aged over 65 years)
You should take the normal dose of Neurontin unless you have kidney problems. If you do have kidney problems, your doctor may prescribe a different dosing schedule and/or a different dose.

If you feel 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 taken orally. Always swallow the capsules whole with plenty of water.

Continue Neurontin treatment until your doctor tells you to stop.

If you take more Neurontin than you should
Taking more than the recommended dose may lead to an increase in adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, and diarrhoea.
Contact your doctor immediately or go to the nearest emergency department if you take more Neurontin than prescribed. Bring with you any unused capsules, the packaging, and the patient information leaflet so that hospital staff 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 the missed dose.

If you stop taking Neurontin
Do not stop Neurontin treatment suddenly. If you wish to discontinue treatment with Neurontin, speak to your doctor first. Your doctor will advise you on how to proceed. If stopping treatment, it should be done gradually over a period of at least 1 week.
After stopping short- or long-term treatment with Neurontin, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These may include epileptic seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling of abnormality, dizziness, and general malaise. These effects generally occur within 48 hours of stopping Neurontin. If you experience withdrawal symptoms, contact your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop using Neurontin and contact your doctor immediately if you notice any of the
following symptoms:

• Reddish, flat spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen 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, nausea and vomiting, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Breathing problems which, if severe, may require emergency and intensive care to allow you to continue breathing normally.
• Neurontin may cause a serious or life-threatening allergic reaction, affecting the skin or any other part of the body such as the liver or blood. When experiencing this type of reaction, you may or may not develop a skin rash. This may lead to hospitalization or discontinuation of Neurontin treatment. Call your doctor immediately if you experience any of the following symptoms:
• Skin rash and redness and/or hair loss
• Hives
• Fever
• Swollen lymph 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 tiredness or weakness
• Sudden muscle pain
• Frequent infections

These symptoms may be early signs of a serious reaction. Your doctor must examine you
to determine whether you should continue taking Neurontin.

• If you are on haemodialysis, inform your doctor if you experience pain and/or muscle 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 infections, urinary tract infections, 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, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation (numbness), coordination problems, abnormal eye movements, increased, decreased or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, facial flushing or dilation of blood vessels
• Breathing difficulties, bronchitis, sore throat, cough, dry nose
• Vomiting, nausea, dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle spasms
• Erectile dysfunction (impotence)
• Swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

In addition, in clinical studies conducted in children, aggressive behaviour and convulsive movements have been commonly reported.
Uncommon (may affect up to 1 in 100 people):

• Agitation (a state of chronic restlessness and unintentional, non-purposeful movements)
• Allergic reaction such as hives
• Reduced movement
• Increased heart rate
• Difficulty swallowing
• Swelling affecting the face, trunk and limbs
• Abnormal blood test results suggesting liver problems
• Impaired mental function
• Falls
• Increased blood glucose levels (more frequently observed in patients with diabetes)

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

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

After marketing authorization, the following side effects have been reported:

• Reduced platelet count (blood cells responsible for clotting)
• Suicidal thoughts, hallucinations
• Movement disorders such as convulsive agitation, jerky movements and stiffness
• Ringing in the ears
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
• Muscle fibre damage (rhabdomyolysis)
• Abnormal blood tests (elevated creatine phosphokinase)
• Sexual dysfunction including inability to reach orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction including breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring emergency treatment)
• Neurontin dependence (drug dependence)

After stopping short- or long-term treatment with Neurontin, you should be aware that you may experience certain side effects, known as withdrawal effects (see "If you stop taking Neurontin").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this 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 that month.
Do not store Neurontin hard capsules at temperatures above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Neurontin contains
The active substance is gabapentin. Each hard gelatin capsule contains 100 mg, 300 mg or
400 mg of gabapentin.
The other components of Neurontin capsules are:
Capsule contents: monohydrate lactose, maize starch and talc.
Capsule coating: gelatin, purified water and sodium lauryl sulfate.
The 100 mg capsules contain the colour E171 (titanium dioxide), the 300 mg capsules
contain the colours E171 (titanium dioxide) and E172 (yellow iron oxide), and the 400 mg
capsules contain the colours E171 (titanium dioxide) and E172 (red and yellow iron oxide).
The ink used on all capsules contains shellac, E171 (titanium dioxide) and E132
(aluminium salt of indigo carmine).

Description of the appearance of Neurontin and pack sizes
The 100 mg capsules are hard, white in colour, imprinted with “Neurontin 100 mg” and
“VLE”.
The 300 mg capsules are hard, yellow in colour, imprinted with “Neurontin 300 mg” and
“VLE”.
The 400 mg capsules are hard, orange in colour, imprinted with “Neurontin 400 mg” and
“VLE”.
Blister packs in PVC/PVDC/aluminium containing 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:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg Mooswaldallee, 1
D-79090 Freiburg
Germany
or
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

This medicinal product is authorised in the European Economic Area (EEA) and the United
Kingdom (Northern Ireland) under the following name: Neurontin.

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Austria | Neurontin 300 mg – Hartkapseln, Neurontin 400 mg – Hartkapseln | | Belgium/Luxembourg | Neurontin 100 mg gélules/hard capsules/Hartkapseln, Neurontin 300 mg gélules/hard capsules/Hartkapseln, Neurontin 400 mg gélules/hard 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 300 mg hard capsules, Neurontin 400 mg 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 |