GABAPENTIN 100 mg Hard Capsules

Зміст інструкції

1. GABAPENTIN EG 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is GABAPENTIN EG and what it is used for
   2. What you need to know before taking GABAPENTIN EG
   3. How to take GABAPENTIN EG
   4. Possible side effects
   5. How to store GABAPENTIN EG
   6. Contents of the pack and other information

GABAPENTIN EG 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 GABAPENTIN EG is and what it is used for
• 2. What you need to know before you take GABAPENTIN EG
• 3. How to take GABAPENTIN EG
• 4. Possible side effects
• 5. How to store GABAPENTIN EG
• 6. Contents of the pack and other information

1. What is GABAPENTIN EG and what it is used for

GABAPENTIN EG 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 substance of GABAPENTIN EG is gabapentin.
GABAPENTIN EG 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). Your doctor will prescribe GABAPENTIN EG as an adjunct to epilepsy treatment when the treatment you are already following does not fully control your condition. You should take GABAPENTIN EG in addition to the treatment you are already undergoing unless you receive other instructions. GABAPENTIN EG 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. 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 GABAPENTIN EG

Do not take GABAPENTIN EG

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

Warnings and precautions
Talk to your doctor or pharmacist before taking GABAPENTIN EG:

• 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 muscle pain and/or weakness;
• if you develop symptoms 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 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 substances, as this may indicate that you are at greater risk of developing a dependence on GABAPENTIN EG.

Cases of abuse and dependence have been reported for gabapentin from post-marketing experience.
Dependence
Some people may develop a dependence on GABAPENTIN EG (a need to continue taking the
medicine). They may experience withdrawal effects when they stop using GABAPENTIN EG
(see section 3, “How to take GABAPENTIN EG” and “If you stop taking GABAPENTIN EG”).
If you are concerned about the possibility of developing a dependence on GABAPENTIN EG, talk to your doctor.
If you notice any of the following signs while taking GABAPENTIN EG, you may have
developed a dependence on the medicine.

• You feel the need to take the medicine for longer than prescribed by your doctor
• You feel the need to take a higher dose than recommended
• You are using the medicine for reasons other than those for which it was prescribed
• You have made repeated and unsuccessful attempts to stop or control the use of the medicine
• When you stop taking the medicine you do not feel well and feel better when you take it again

If you notice any of these signs, talk to your doctor to discuss the best treatment plan for
you, including when it is appropriate to stop taking it and how to do so safely.
A small number of patients treated with antiepileptic drugs 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
Severe skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with
eosinophilia and systemic symptoms (DRESS) have been reported in association with gabapentin treatment. Stop taking gabapentin and contact a
doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

“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, and especially if you do not feel well and have
fever, may be caused by muscle injury that can be life-threatening and can lead to
kidney problems. You may also experience discoloration of the urine and abnormalities in blood tests (in
particular increased creatine phosphokinase). If you experience any of these signs or symptoms, please
contact your doctor immediately.

Other medicines and GABAPENTIN EG
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 GABAPENTIN EG. In addition, the combination of
GABAPENTIN EG with opioids can cause symptoms such as drowsiness and/or decreased
breathing.
Antacids for indigestion
If GABAPENTIN EG and antacids containing aluminum and magnesium are taken together,
the absorption of GABAPENTIN EG from the stomach may be reduced. It is therefore recommended to take
GABAPENTIN EG no sooner than two hours after taking the antacid.
GABAPENTIN EG:
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.

GABAPENTIN EG with food
GABAPENTIN EG can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
GABAPENTIN EG should not be taken during pregnancy unless your doctor has told you otherwise. Women of childbearing potential should use effective contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but an increased risk for the development of the baby has been reported for other medicines used for the treatment of seizures, especially when more than one medicine for seizures is taken at the same time. Therefore, if possible, during pregnancy you should try to take only one medicine for epilepsy and only on medical advice.
Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy while taking GABAPENTIN EG. Do not suddenly stop
taking this medicine as this may cause the sudden onset of seizures which
can have serious consequences for you and the baby.
If used during pregnancy, gabapentin can cause withdrawal symptoms in newborns. The risk may
be increased when gabapentin is taken together with opioid analgesics (pain medications).
Breastfeeding
Gabapentin, the active ingredient of GABAPENTIN EG, passes into breast milk. As the effect
on the baby is unknown, it is recommended not to breastfeed while taking GABAPENTIN EG.
Fertility
Animal studies have not shown any effect on fertility.

Driving and using machines
GABAPENTIN EG can cause dizziness, drowsiness and fatigue. Do not drive vehicles, use
complex machines or engage in other potentially dangerous activities until you know how
this medicine affects your ability to perform these activities.

GABAPENTIN EG contains lactose
The hard capsules of GABAPENTIN EG contain lactose (a type of sugar). If your doctor has
diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take GABAPENTIN EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist. Do not take more medicine than prescribed.
The doctor will establish the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules that your doctor has prescribed for you. Usually the doctor will gradually increase the dose
gradually. 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 the
doctor will tell you to take this dose in 3 separate administrations, that is, 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 approximately
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.
GABAPENTIN EG is not recommended in children under the age of 6 years.

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
gradually. 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 the
doctor will tell you to take the medicine in 3 separate doses, that is, once in the morning, once in the afternoon
and once in the evening.

If you have kidney problems or are undergoing hemodialysis
If you have kidney problems or are undergoing 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 GABAPENTIN EG, 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 GABAPENTIN EG is too strong or too weak, tell your doctor or
pharmacist as soon as possible.

Method of administration
GABAPENTIN EG is taken orally. Always swallow the capsules whole with plenty of
water.
Continue treatment with GABAPENTIN EG until your doctor tells you to stop.

If you take more GABAPENTIN EG than you should
A dose higher than the recommended one may lead to an increase in undesirable 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 GABAPENTIN
EG than prescribed by your doctor. Bring with you the capsules you have not taken together with the packaging and the

If you forget to take GABAPENTIN EG
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 GABAPENTIN EG
Do not suddenly stop treatment with GABAPENTIN EG. If you want to stop
treatment with GABAPENTIN EG, talk to your doctor first, who will explain how to do it. If the
treatment is stopped, this must happen gradually over at least 1 week.
After stopping short- or long-term treatment with GABAPENTIN EG, you should know that
you may experience some undesirable effects, called withdrawal effects. These effects may include
seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors,
headache, depression, feeling abnormal, dizziness and general malaise. These
effects usually occur within 48 hours of stopping GABAPENTIN EG. If you experience withdrawal effects, you should 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.
Stop using GABAPENTIN EG and contact your doctor immediately if you notice any of the following symptoms:

• circular or target-shaped, reddish, flat patches on the trunk, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes. 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).

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

• severe skin reactions requiring immediate attention, swelling of the lips and face, rash and redness of the skin, and/or hair loss (these may be symptoms of a severe allergic reaction);
• persistent stomach pain, nausea, and vomiting because these may be symptoms of acute pancreatitis (inflammation of the pancreas);
• breathing problems that, if severe, may require emergency and intensive care to allow you to continue breathing normally;
• GABAPENTIN EG can cause a severe or life-threatening allergic reaction, which can affect the skin or any other part of the body such as the liver or blood; When affected by this type of reaction, you may or may not have a rash. This may require hospitalization or discontinuation of treatment with GABAPENTIN EG. Call your doctor immediately if you experience any of the following symptoms:
• rashes;
• hives;
• fever;
• swollen lymph glands that do not tend to go away;
• swelling of the lips 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 GABAPENTIN EG.

• If you are on hemodialysis, 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;
• feeling sleepy, 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;
• 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 disorders, headache, skin sensitivity, reduced sensation (numbness), difficulty with coordination, abnormal eye movements, increased, decreased, or absent reflexes;
• blurred vision, double vision;
• dizziness;
• high blood pressure, facial flushing, or dilated 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, muscle contractions;
• erection problems (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):

• allergic reaction such as hives;
• reduced movement;
• increased heart rate;
• 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);
• difficulty thinking;
• difficulty swallowing.

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

• loss of consciousness;
• decreased blood glucose levels (observed more often in patients with diabetes);
• difficulty breathing, shortness of breath (respiratory depression).

Not known (frequency cannot be estimated from available data)

• anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure requiring emergency treatment);
• agitation (a state of chronic restlessness and involuntary and aimless movements);
• suicidal thoughts;
• becoming dependent on GABAPENTIN EG (“drug dependence”). After stopping short- or long-term treatment with GABAPENTIN EG, you should know that you may experience some side effects, called withdrawal effects (see “If you stop taking GABAPENTIN EG”).

The following side effects have been reported after marketing authorization:

• decreased platelets (cells that coagulate blood);
• hallucinations;
• problems with abnormal movements such as convulsive jerks, jerky movements, and rigidity;
• 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 fiber injury (rhabdomyolysis);
• abnormal blood test results (increased creatine phosphokinase);
• sexual dysfunction including inability to achieve orgasm, delayed ejaculation;
• low sodium levels in the blood.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 GABAPENTIN EG

Keep this medicine out of the sight and reach of children.
Do not use GABAPENTIN EG after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of package deterioration.
Do not store at a temperature above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GABAPENTIN EG contains
GABAPENTIN EG 100 mg hard capsules
One hard capsule contains:
the active ingredient is:
gabapentin 100 mg
The other ingredients are:
Corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E 171)
GABAPENTIN EG 300 mg hard capsules
One hard capsule contains:
the active ingredient is:
gabapentin 300 mg
The other ingredients are:
Corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E 171), erythrosine, yellow iron oxide
(E 172)
GABAPENTIN EG 400 mg hard capsules
One hard capsule contains:
the active ingredient is:
gabapentin 400 mg
The other ingredients are:
Corn starch, lactose monohydrate, talc, gelatin, titanium dioxide (E 171), red iron oxide, iron oxide
yellow (E 172)

Description of the appearance of GABAPENTIN EG and contents of the pack
Hard capsules
Blister pack of 50 capsules of 100 mg
Blister pack of 50 capsules of 300 mg
Blister pack of 30 capsules of 400 mg

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturer
COSMO S.p.A., Via C. Colombo, 1 - 20045 Lainate (MI)
VAMFARMA S.r.l., Via Kennedy, 5 - 26833 Comazzo (LO)
Fulton Medicinali S.p.A., Via Marconi 28/9 - 20020 Arese (MI)