GABAPENTIN 100 mg Kapsułka Twarda

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

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

gabapentin

Generic medicine

Read this leaflet carefully before you start 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 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 Gabapentin ABC is and what it is used for
• 2. What you need to know before you take Gabapentin ABC
• 3. How to take Gabapentin ABC
• 4. Possible side effects
• 5. How to store Gabapentin ABC
• 6. Contents of the pack and other information

1. What is Gabapentin ABC and what it is used for

Gabapentin ABC 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 ABC is gabapentin.
Gabapentin ABC 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 ABC as an adjunct to epilepsy treatment when the treatment you are already following does not fully control your condition. You should take Gabapentin ABC in addition to the ongoing treatment unless you receive other instructions. Gabapentin ABC 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 ABC

Do not take Gabapentin ABC

• 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 Gabapentin ABC:

• if you have kidney problems your doctor may prescribe a different dosage
• before taking this medicine, tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or illegal substances, as this may indicate that you are at greater risk of developing a dependence on Gabapentin ABC;
• if you are on 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

Cases of abuse and dependence have been reported for gabapentin from post-marketing experience. Tell your
doctor if you have a history of abuse or dependence.
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.

Dependence
Some people may develop a dependence on Gabapentin ABC (need to continue taking the
medicine). They may experience withdrawal effects when they stop using Gabapentin ABC
(see section 3, “How to take Gabapentin ABC” and “If you stop taking Gabapentin
ABC”).
If you are concerned about the possibility of developing a dependence on Gabapentin ABC, talk to your doctor.
If you notice any of the following signs while taking Gabapentin ABC, 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.

Important information about potentially serious reactions
Serious skin reactions have been reported in association with gabapentin treatment, including
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with
eosinophilia and systemic symptoms (DRESS). Stop using gabapentin and contact a
doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

immediately your doctor if you experience any of the following symptoms after taking this medicine, as

they can be serious”.
Muscle weakness, numbness or pain and especially if at the same time you do not feel well and have
a 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 ABC
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 convulsions, 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 ABC. In addition, the combination of Gabapentin
ABC with opioids can cause drowsiness, sedation, decreased breathing or death.
Antacids for indigestion
If Gabapentin ABC and antacids containing aluminum and magnesium are taken together, the absorption
of Gabapentin ABC from the stomach may be reduced. It is therefore recommended to take Gabapentin ABC
not before two hours after taking the antacid.
Gabapentin ABC:

• It 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 the hospital what you are taking.

Gabapentin ABC with food
Gabapentin ABC can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you might be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
Gabapentin ABC should not be taken during pregnancy unless your doctor has told you to do so.
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 to treat seizures, especially when taken together with more than one
medicine for seizures. 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 ABC. 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 (medicines for
treating severe pain).

Breastfeeding
Gabapentin, the active ingredient of Gabapentin ABC, passes into breast milk. As the effect
on the baby is unknown, it is recommended not to breastfeed while taking Gabapentin ABC.

Fertility
Animal studies have not shown any effect on fertility.

Driving and using machines
Gabapentin ABC 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 ABC contains lactose
The hard capsules of Gabapentin ABC contain lactose (a type of sugar). If your doctor has
diagnosed you as having intolerance to some sugars, contact him before taking this medicine.

3. How to take Gabapentin ABC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any 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 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 weight of the
child. 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 ABC is not recommended for 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 are undergoing hemodialysis
If you have kidney problems or are undergoing hemodialysis, your doctor may prescribe a different dosing regimen 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 ABC unless you have kidney problems. If you have kidney problems, your doctor may prescribe a different dosing regimen for
the medicine and/or a different dose.
If you feel that the effect of Gabapentin ABC is too strong or too weak, inform your doctor or
pharmacist as soon as possible.

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

If you take more Gabapentin ABC than you should
A dose higher than recommended 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 ABC than
prescribed by your doctor. Bring with you the capsules you have not taken together with the package and the leaflet
so that the hospital can easily understand how much medicine you have taken.

If you forget to take Gabapentin ABC
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 a missed dose.

If you stop taking Gabapentin ABC
Do not suddenly stop treatment with Gabapentin ABC. If you wish to stop
treatment with Gabapentin ABC, talk to your doctor first, who will explain how to do it. If the
treatment is stopped, this must be done gradually over at least 1 week. After
stopping short- or long-term treatment with Gabapentin ABC, 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,
tremor, headache, depression, feeling abnormal, dizziness and general malaise.
These effects usually occur within 48 hours of stopping Gabapentin ABC. 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 ABC 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 severeallergic reaction)
• persistent stomach pain, nausea, and vomiting because these may be symptoms ofacute pancreatitis (inflammation of the pancreas).
• Gabapentin ABC can cause a severe or life-threatening allergic reaction that can affect theskin or any other part of the body such as the liver or blood. When affected by this typeof reaction, you may or may not have a rash. This may require hospitalization or discontinuationof treatment with Gabapentin ABC.
• breathing problems that, if severe, may require emergency and intensive care toallow you to continue breathing normally

Call your doctor immediately if you experience any of the following symptoms:

• rashes
• hives
• fever
• swollen lymph glands that do not 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 if
you should continue taking Gabapentin ABC.

• 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 infections, ear inflammation, or other infections
• Low white blood cell count
• Loss of appetite, increased appetite
• Anger towards others, 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 coordinating, 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
• 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 (a 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)

• 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

• Becoming dependent on Gabapentin ABC (“drug dependence”)

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

The following side effects have been reported after marketing authorization:

• Decreased platelets (cells that clot blood)
• Suicidal thoughts, hallucinations
• Problems with abnormal movements such as convulsive agitations, jerky movements, and stiffness
• 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)
• Abnormalities in blood tests (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, emergency)

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 ABC

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

• swelling of lips, throat and tongue and hypotension with consequent need for treatment of Do not use this medicine after the expiry date which is reported on the pack after “Exp.”. The expiry date refers to the last day of that month.

Do not store Gabapentin ABC hard capsules at a temperature higher than 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gabapentin ABC contains
Gabapentin ABC 100 mg hard capsules
The active ingredient is gabapentin. Each hard capsule contains 100 mg of gabapentin.
The other ingredients are: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E171).
Gabapentin ABC 300 mg hard capsules
The active ingredient is gabapentin. Each hard capsule contains 300 mg of gabapentin.
The other ingredients are: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E171),
yellow iron oxide (E172).
Gabapentin ABC 400 mg hard capsules
The active ingredient is gabapentin. Each hard capsule contains 400 mg of gabapentin.
The other ingredients are: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E171).

Description of the appearance of Gabapentin ABC and contents of the pack
Pack of 50 hard capsules of 100 mg in blisters.
Pack of 50 hard capsules of 300 mg in blisters.
Pack of 30 hard capsules of 400 mg in blisters.

Marketing Authorisation Holder and Manufacturer
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – Turin

Manufacturers
LABORATORIO FARMACEUTICO C.T. S.r.l. – Via Dante Alighieri, 71 – Sanremo (IM)
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 S. Bernardo d’Ivrea (TO)