NEURONTIN 100 mg Hard Capsules

Зміст інструкції

1. Neurontin 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is Neurontin and what is it 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. Package Contents and Other Information

Neurontin 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

gabapentin

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Neurontin and what is it used for

Neurontin belongs to a group of medicines used for the treatment of epilepsy and
peripheral neuropathic pain (long-lasting pain caused by damage to the
nerves).
The active ingredient of Neurontin is gabapentin.

Neurontin is used to treat:

• Various forms of epilepsy (seizures initially limited to certain areas of the brain, whether the seizures spread to other parts of the brain or not). The doctor treating you or your child aged 6 years or older will prescribe Neurontin as an adjunct to epilepsy treatment when current treatment does not fully control the condition. You or your child aged 6 years or older must take Neurontin in addition to ongoing treatment unless otherwise instructed. Neurontin can also be used alone for the treatment of 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 (occurs mainly in the legs and/or arms), such as diabetes or herpes zoster. The

pain sensations can be described as heat, burning, throbbing, shooting pains, stabbing pains, sharp pains, cramping pains, suffering, tingling,
numbness, pricking pains, etc.

2. What you need to know before taking Neurontin

Do not take Neurontin

• 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 dosage
• if you are undergoing hemodialysis (to remove waste products due to kidney failure) tell 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 suffer from neurological/respiratory system diseases or are over 65 years of age, your doctor may prescribe different doses.
• before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs or illegal drugs; this may mean that you are at a higher risk of developing a dependence on Neurontin.

Dependence
Some people may become dependent on Neurontin (need to continue taking the medicine). They may experience withdrawal effects when they stop using Neurontin (see section 3, "How to take Neurontin" and "If you stop taking Neurontin"). If you are afraid of developing a dependence on Neurontin, it is important that you consult your doctor.
If while taking Neurontin you notice any of the following signals, this could mean that you have become dependent:

• you feel the need to take the medicine for a longer period 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 the use of the medicine, without success
• if you feel sick after stopping taking 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 therapy for you, including when to stop it and how to do it safely.

A small number of patients treated with antiepileptic medicines like gabapentin have developed thoughts of suicide 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 reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with gabapentin. If you notice the appearance of signs and symptoms related to the serious skin reactions described in section 4, stop treatment with gabapentin and contact your doctor immediately.

“contact your doctor immediately if you experience any of the following symptoms after taking

this medicine, as they may be serious”
Muscle weakness, soreness or pain and especially if at the same time you do not feel well and have a fever, may be caused by a muscle injury that can be life-threatening and can lead to kidney problems. Discoloration of the urine and abnormalities in blood tests (in particular increased creatine phosphokinase) may also occur. If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Neurontin
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 medicines for seizures, sleep disorders, depression, anxiety or other neurological or psychiatric problems.
Medicines containing opioids such as morphine
If you are taking medicines that contain opioids (such as morphine), tell your doctor or pharmacist because opioids can increase the effect of Neurontin. In addition, the combination of Neurontin with opioids can cause drowsiness, sedation, decreased breathing or death.
Antacids for indigestion
If Neurontin and antacids containing aluminum and magnesium are taken together, the absorption of Neurontin from the stomach may be reduced. It is therefore recommended to take Neurontin no earlier than two hours after taking the antacid.
Neurontin:

• Is not expected to interact with other antiepileptic medicines or with the contraceptive pill.
• May interfere with some laboratory tests; if you need a urine test, tell your doctor or hospital what you are taking.

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

Pregnancy, breastfeeding and fertility

• If you are pregnant, if you suspect you are pregnant, you should inform your doctor immediately and discuss the possible risks that the medicine you are taking may entail for the unborn child.
• You should not stop treatment without discussing it with your doctor.
• If you are planning a pregnancy, you should discuss the treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or planning to do so, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Neurontin can be used during the first trimester of pregnancy, if necessary.
If you are planning a pregnancy, if you are pregnant or if you think you may be pregnant, contact your doctor immediately.
If you are pregnant and suffer from epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen the disease. Worsening of epilepsy could put you and your unborn child at risk.
In a study that examined data on women in the Nordic countries who took gabapentin in the first 3 months of pregnancy, no increase in the risk of birth defects or problems in the development of brain functions (neurodevelopmental disorders) was found. However, children of women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm delivery.
If used during pregnancy, gabapentin can cause withdrawal symptoms in newborns.
This risk may increase when gabapentin is taken together with opioid pain relievers (medicines for the treatment of severe pain).
Contact your doctor immediately if you are pregnant, if you think you may be pregnant or if you are planning a pregnancy while being treated with Neurontin. Do not suddenly stop taking this medicine as this may cause the sudden onset of seizures which may have serious consequences for you and the child.
Breastfeeding
Gabapentin, the active ingredient of Neurontin, passes into breast milk. As the effect on the baby is unknown, it is recommended not to breastfeed during treatment with Neurontin.
Fertility
Studies in animals have not shown any effect on fertility.

Driving and using machines
Neurontin can cause dizziness, drowsiness and fatigue. You should not drive vehicles, use complex machinery or engage in other potentially dangerous activities until you understand if this medicine can alter your ability to perform these activities.

Neurontin contains lactose
Neurontin hard capsules contain lactose (a type of sugar). If your doctor has diagnosed you with intolerance to some sugars, contact them 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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Do not take a quantity of medicine higher than that prescribed.
The doctor will establish the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules prescribed by your doctor. Usually the doctor will gradually increase the dose. The initial dose will generally be 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 and your doctor will tell you to take this dose in 3 separate administrations, namely once in the morning, once in the afternoon and once in the evening.
Children aged 6 years and over:
The dose to be administered to the child will be established by the doctor because it is calculated based on the child's weight. Treatment is started with a low initial dose which is gradually increased over about 3 days. The usual dose for controlling epilepsy is 25-35 mg/kg per day. It is usually administered in 3 separate doses, taking the capsule every day generally once in the morning, once in the afternoon and once in the evening.
Neurontin is not recommended in children under 6 years of age .
Peripheral neuropathic pain, the recommended dose is:
Adults:
Take the number of capsules following your doctor's instructions. Usually the doctor will gradually increase the dose. The initial dose will generally be 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 and your doctor will tell you to take the medicine in 3 separate doses, namely once in the morning, once in the afternoon and once in the evening.

If you have kidney problems or if you are on hemodialysis
If you have kidney problems or are on hemodialysis, your doctor may prescribe a different dosing schedule for the medicine and/or a different dose.

If you are an elderly patient (over 65 years of age)
You should take the normal dose of Neurontin, unless you have kidney problems. If you have kidney problems, your doctor may prescribe a different dosing schedule for the medicine and/or a different dose.
If you feel 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 orally. Always swallow the capsules whole with plenty of water.
Continue treatment with Neurontin until your doctor tells you to stop.

If you take more Neurontin than you should
A dose higher than the recommended one may lead to an increase in side effects including loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness and diarrhea.
Contact your doctor immediately or go to the nearest emergency room if you take more Neurontin than prescribed by your doctor. Bring with you the capsules you have not taken together with 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 to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Neurontin
Do not suddenly stop treatment with Neurontin. If you wish to stop treatment with Neurontin, talk to your doctor first. The latter will tell you how to do it. If you decide to stop treatment, this must be done gradually over at least 1 week. After stopping short- or long-term treatment with Neurontin, you should know that you may experience some side effects, so-called withdrawal effects. These may include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling of abnormality, dizziness and feeling generally unwell. These effects usually occur within 48 hours of stopping Neurontin. If you experience withdrawal symptoms, contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Not everyone will experience them.

Stop using Neurontin and contact your doctor immediately if you notice any of the
following symptoms:

• Reddish-purple, non-raised patches on the trunk, shaped like targets or circles, oftenwith blisters in the center, skin peeling, ulcers of the mouth, throat, nose,genitals, and eyes. These severe skin rashes may be preceded byfever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermalnecrosis).
• Widespread rash, high body temperature, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).

You should contact your doctor immediately if you notice any of the following symptoms after taking this
medicine because they may be serious:

• Persistent stomach pain, nausea, and vomiting because these may besymptoms of acute pancreatitis (inflammation of the pancreas).
• Breathing problems that, if severe, may require emergency and intensivecare to allow you to continue breathing normally
• Neurontin can cause a severe or life-threatening allergic reaction, which canaffect the skin or any other part of the body such as the liver or blood. When you areaffected by this type of reaction you may or may not have skin rashes. This maycause hospitalization or discontinuation of treatment with Neurontin.Call your doctor immediately if you experience any of the following symptoms:
• Skin rashes and skin 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 the whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Sudden muscle pain
• Frequent infections

These symptoms may be the first signs of a serious reaction. Your doctor needs to
examine you to decide whether to continue taking Neurontin.

• If you are on hemodialysis, tell 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
• Feeling sleepy, 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
• Loss of appetite, increased appetite
• Anger towards other people, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Convulsions, jerky movements, difficulty speaking, memory loss, tremors, sleep disturbances, headache, skin sensitivity, reduced sensation (numbness), difficulty coordinating, abnormal eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, facial flushing, or widening 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, muscle contractions
• Erectile dysfunction (impotence)
• Swelling of the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

In addition, aggressive behavior and convulsive movements have been commonly reported in clinical studies conducted in children.

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

• Agitation (state of chronic restlessness and unintentional and aimless movements)
• Allergic reaction such as hives
• Reduced movement
• Increased heart rate
• Difficulty swallowing
• Swelling that can affect the face, trunk, and limbs
• Altered blood test values suggesting liver problems.
• Mental impairment
• Falls
• Increased blood glucose levels (observed more often in patients with diabetes)

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

• Decreased blood glucose levels (observed more often in patients with diabetes)
• Loss of consciousness
• Difficulty breathing, shortness of breath (respiratory depression)

The following side effects have been reported after marketing authorization:

• Decreased platelets (cells that coagulate blood)
• Suicidal thoughts, hallucinations
• Problems with abnormal movements such as convulsive agitations, jerky movements, and rigidity
• Tinnitus
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events that occur after sudden discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
• Muscle fiber injury (rhabdomyolysis)
• Blood test abnormalities (increased creatine phosphokinase)
• Sexual dysfunction including inability to reach orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe allergic reaction potentially fatal including difficulty breathing, swelling of lips, throat, and tongue and hypotension requiring emergency treatment)
• Dependence on Neurontin (drug dependence)

After stopping short- or long-term treatment with Neurontin, you should know
that you may experience some side effects, so-called withdrawal effects (see
“If you stop taking Neurontin”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you 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 which is stated on the pack. The expiry date refers to the last day of that month.
Do not store Neurontin hard capsules at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 ingredient is gabapentin. Each hard gelatin capsule contains 100 mg, 300 mg or
400 mg of gabapentin.
The other components of Neurontin capsules are:
Capsule content: lactose monohydrate, corn starch and talc.
Capsule shell: gelatin, purified water and sodium lauryl sulfate.
The 100 mg capsules contain the coloring agent E171 (titanium dioxide), the 300 mg capsules
contain the coloring agents E171 (titanium dioxide) and E172 (yellow iron oxide) and the 400
mg capsules contain the coloring agents E171 (titanium dioxide) and E172 (red and yellow iron oxide).
The ink used in all capsules contains shellac, E171 (titanium dioxide) and E132
(aluminum salt of indigo carmine).

Description of Neurontin’s appearance and package contents
The 100 mg capsules are rigid and white in color with “Neurontin 100 mg” and
“VLE” imprinted on them.
The 300 mg capsules are rigid and yellow in color with “Neurontin 300 mg” and
“VLE” imprinted on them.
The 400 mg capsules are rigid and orange in color with “Neurontin 400 mg” and
“VLE” imprinted on them.
Blister packs in PVC/PVDC/aluminum containing 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000
capsules.
Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan

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 Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following name: Neurontin.
Member State
Name
Medicinal product name
Austria Neurontin 300 mg – Hard capsules,
Neurontin 400 mg – Hard capsules
Belgium/Luxembourg Neurontin 100 mg capsules/hard capsules/Hartkapseln, Neurontin
300 mg capsules/hard capsules/Hartkapseln, Neurontin 400 mg
capsules/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 capsules, hard, Neurontin 400 mg capsules, hard
France Neurontin 100 mg capsule, Neurontin 300 mg capsule, Neurontin 400
mg capsule,
Germany Neurontin 100 mg Hard capsules, Neurontin 300 mg Hard capsules,
Neurontin 400 mg Hard capsules
Greece Neurontin 300 mg hard capsule, Neurontin 400 mg hard capsule
Hungary Neurontin 100 mg hard capsule
Neurontin 300 mg hard capsule
Neurontin 400 mg hard capsule
Iceland Neurontin
Ireland Neurontin 100 mg hard capsules, Neurontin 300mg hard capsules,
Neurontin 400mg hard capsules
Italy Neurontin 100 mg Rigid Capsules, Neurontin 300 mg Rigid
Capsules, Neurontin 400 mg Rigid Capsules
Latvia Neurontin 100 mg hard capsules, Neurontin 300 mg hard
capsules, Neurontin 400 mg hard capsules
Netherlands Neurontin 100, harde Capsules 100 mg, Neurontin 300, harde
Capsules 300 mg, Neurontin 400, harde Capsules 400 mg
Norway Neurontin 100 mg capsules, hard, Neurontin 300 mg capsules,
hard, Neurontin 400 mg capsules, hard
Poland Neurontin 100, Neurontin 300, Neurontin 400
Portugal Neurontin