GABAPENTIN 100 mg Жесткие Капсулы

Содержание инструкции

1. GABAPENTIN DOC Generici 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is GABAPENTIN DOC Generici and what it is used for
   2. What you need to know before taking GABAPENTIN DOC Generici
   3. How to take GABAPENTIN DOC Generici
   4. Possible side effects
   5. How to store GABAPENTIN DOC Generici
   6. Package Contents and Other Information

GABAPENTIN DOC Generici 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 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 DOC Generici is and what it is used for
• 2. What you need to know before you take GABAPENTIN DOC Generici
• 3. How to take GABAPENTIN DOC Generici
• 4. Possible side effects
• 5. How to store GABAPENTIN DOC Generici
• 6. Contents of the pack and other information

1. What is GABAPENTIN DOC Generici and what it is used for

GABAPENTIN DOC Generici 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).

Epilepsy:GABAPENTIN DOC Generici is used for the treatment of 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 DOC Generici
as an adjunct to the treatment of epilepsy when the treatment you are already following does not
fully control your condition. You must take GABAPENTIN DOC Generici in addition to
ongoing treatment unless you receive other instructions. GABAPENTIN DOC Generici can
also be used alone for the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain:GABAPENTIN DOC Generici is used for the treatment of
long-lasting pain caused by damage to the nerves. 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 DOC Generici

Do not take GABAPENTIN DOC Generici

• if you are allergic 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 DOC Generici.

• 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 DOC Generici.

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

Be careful with GABAPENTIN DOC Generici especially

• 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) 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).

A small number of patients treated with antiepileptic drugs such as GABAPENTIN DOC
Generici have developed thoughts of self-harm or suicide. If thoughts of this kind emerge at any time, contact your doctor immediately.

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

symptoms after taking this medicine, as they may be serious"

Other medicines and GABAPENTIN DOC Generici
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.
If you are taking medicines that contain morphine, tell your doctor or pharmacist because
morphine can increase the effect of GABAPENTIN DOC Generici.
GABAPENTIN DOC Generici is not expected to interact with other antiepileptic medicines or with
the contraceptive pill.
GABAPENTIN DOC Generici may interfere with some laboratory tests; if you need a urine test tell your doctor or the hospital that you are taking GABAPENTIN DOC Generici.
If GABAPENTIN DOC Generici and antacids containing aluminum and magnesium are taken
together, the absorption of GABAPENTIN DOC Generici from the stomach may be reduced. It is
therefore recommended to take GABAPENTIN DOC Generici at least two hours after
taking the antacid.

GABAPENTIN DOC Generici with food and drink
GABAPENTIN DOC Generici can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
GABAPENTIN DOC Generici 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 of fetal harm has been reported for other medicines used to treat seizures, particularly when taken
simultaneously with more than one anti-seizure medicine. Therefore, if possible, and
only on medical advice, during pregnancy you should try to take only one medicine for
epilepsy.
Contact your doctor immediately if you are pregnant, think you may be pregnant or
are planning to become pregnant while taking GABAPENTIN DOC Generici.
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
(drugs for the treatment of severe pain).

Breastfeeding
Gabapentin, the active ingredient of GABAPENTIN DOC Generici, is excreted in breast milk.
As the effects on the breastfed baby are unknown, it is
recommended not to breastfeed during treatment with GABAPENTIN DOC Generici.

Driving and using machines
GABAPENTIN DOC Generici can cause dizziness, drowsiness and fatigue. Do not drive,
use complex machinery or engage in other potentially dangerous activities until you
understand if this medicine may impair your ability to perform these activities.

GABAPENTIN DOC Generici contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take GABAPENTIN DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will establish the appropriate dose for you.
If you feel that the effect of GABAPENTIN DOC Generici is too strong or too weak,
inform your doctor or pharmacist.

If you are elderly (over 65 years of age)you should take the normal dosage of GABAPENTIN DOC
Generici, unless you have kidney problems.

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.
The capsules should always be swallowed whole with plenty of water.
Continue treatment with GABAPENTIN DOC Generici until your doctor tells you to
stop.

Peripheral Neuropathic Pain:
Take the number of capsules following your doctor's instructions. Usually your 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 gradually increased up to a maximum of 3600 mg per
day and your doctor will tell you to take this dose in 3 administrations (once in the morning,
once in the afternoon and once in the evening).

Epilepsy:
Adults and adolescents:
Take the number of capsules that your doctor has prescribed for you. Usually your 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 gradually increased up to a maximum of 3600 mg per
day and your doctor will tell you to take this dose in 3 administrations (once in the morning,
once in the afternoon and once in the evening).

Use in children and adolescents
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. The dose is usually administered divided into 3 doses, taking the capsule
every day generally once in the morning, once in the afternoon and once in the evening.

The use of GABAPENTIN DOC Generici is not recommended in children under 6 years of age.
If you take more GABAPENTIN DOC Generici than you should
If you (or someone else) have accidentally taken too many capsules or if you think a child has
ingested them, contact your doctor immediately or go to the nearest emergency room. Since
GABAPENTIN DOC Generici capsules can cause drowsiness, it is advisable to ask
someone else to drive you to the doctor or hospital, or to call an ambulance. Easily carry with you the medicine you have taken.
Overdoses of gabapentin, especially if associated with the use of other medicines that depress
the CNS, can lead to coma.
A higher than recommended dose may result in an increase in side
effects; symptoms of an overdose are loss of consciousness, dizziness, double vision,
difficulty speaking, drowsiness and diarrhea.

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

• circular or target-shaped, reddish, non-raised patches on the trunk, often with central blisters, 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).

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

• Breathing problems that, if severe, may require emergency and intensive care to allow you to continue breathing normally
• GABAPENTIN DOC Generici 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 you have this type of reaction, you may or may not have a rash. This may lead to hospitalization or discontinuation of treatment with GABAPENTIN DOC Generici.

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

• hives,
• swelling of the lips and tongue,
• yellowing of the skin or the white of the eyes,
• unusual bleeding or bruising,
• severe fatigue or weakness,
• sudden muscle pain,
• frequent infections.

These symptoms may be early signs of a serious allergic reaction. A doctor
should examine you to decide whether to continue taking GABAPENTIN DOC Generici.

Very common side effects that can occur in more than 1 in 10 people are
listed below:

• Viral infections,
• Feeling sleepy, dizziness, lack of coordination,
• Feeling tired, fever.

Common side effects that can occur in more than 1 in 100 people are listed below:

• Pneumonia, respiratory infections, urinary tract infections, infections, ear inflammation,
• 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 sensitivity, difficulty coordinating, abnormal eye movements, increased, decreased or absent reflexes,
• Blurred vision, double vision,
• Dizziness,
• High blood pressure, flushing of the face 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, intestinal gas (flatulence),
• Facial swelling, bruising, rash, itching, acne,
• Joint pain, muscle pain, back pain, muscle contractions,
• Erectile dysfunction,
• 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.

Uncommon side effects that can occur in more than 1 in 1,000 people are listed below:

• Allergic reactions (e.g. hives),
• Falls,
• Difficulty thinking,
• Agitation (chronic state of restlessness and unintentional and aimless movements),
• High blood sugar levels (observed more frequently in diabetic patients),
• Hypokinesia,
• Fast heartbeat (palpitations),
• Generalized edema (swelling that can affect the face, trunk and limbs),
• Increased creatine phosphokinase, abnormal blood test results suggesting liver problems (increased liver function indices (SGOT, AST, SGPT, ALT) and bilirubin),
• Difficulty swallowing.

Rare side effects that can occur in less than 1 in 1,000 people are listed below:

• Difficulty breathing, shortness of breath (respiratory depression),
• Low blood sugar levels (observed more frequently in diabetic patients),
• Loss of consciousness.

Side effects with unknown frequency (cannot be defined based on available data) are listed below:

• Decreased platelets (cells that coagulate blood),
• Hypersensitivity syndrome, a systemic reaction with a variable manifestation that can include fever, rash, hepatitis, lymphadenopathy (swollen lymph nodes; small isolated nodules under the skin), eosinophilia and sometimes other signs and symptoms,
• Anaphylaxis (severe allergic reaction potentially fatal including difficulty breathing, swelling of lips, throat and tongue and hypotension with resulting need for emergency treatment),
• Hallucinations,
• Problems with abnormal movements such as jerky movements, convulsive movements and rigidity,
• Tinnitus (ringing in the ears),
• Pancreatitis (inflammation of the pancreas),
• Liver inflammation, yellowing of the skin and eyes (jaundice),
• Severe skin reactions (Stevens-Johnson Syndrome) requiring immediate medical attention, swelling of the lips and face, rash and redness of the skin, hair loss, drug eruption with eosinophilia and systemic symptoms (DRESS),
• Myoclonus, muscle destruction (rhabdomyolysis),
• Acute renal failure, incontinence,
• Increased breast tissue, breast enlargement,
• Adverse events that occur after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain, sudden death for which a relationship with gabapentin treatment has not been established,
• Changes in glucose levels in patients with diabetes, abnormal blood test results suggesting liver problems,
• Hyponatremia,
• Suicidal thoughts
• Becoming dependent on GABAPENTIN DOC Generici (“drug dependence”).

After stopping short- or long-term treatment with GABAPENTIN DOC Generici,
you should know that you may experience some side effects, called withdrawal effects
(see “If you stop taking GABAPENTIN DOC Generici”).
In addition, in clinical studies conducted in children, aggressive behavior and jerky movements, respiratory tract infections, otitis media and bronchitis have been commonly reported.
In patients undergoing hemodialysis, myopathy and high levels of creatine kinase have been reported
due to end-stage renal disease.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. 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 DOC Generici

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 at a temperature above 25°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 GABAPENTIN DOC Generici contains
The active ingredient is gabapentin. Each hard capsule contains 100 mg, 300 mg or 400 mg of
gabapentin.
The other components of GABAPENTIN DOC Generici capsules are:

• GABAPENTIN DOC Generici 100 mg hard capsules: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E 171).
• GABAPENTIN DOC Generici 300 mg hard capsules: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), erythrosine.
• GABAPENTIN DOC Generici 400 mg hard capsules: lactose monohydrate, corn starch, talc, gelatin, titanium dioxide (E 171), red iron oxide and yellow iron oxide (E 172).

Description of the appearance of GABAPENTIN DOC Generici and package contents
Hard capsules.
The 100 mg capsules are hard and white in color.
The 300 mg capsules are hard and yellow in color.
The 400 mg capsules are hard and orange in color.
Packs:
GABAPENTIN DOC Generici 100 mg hard capsules is available in packs of 50 capsules in
PVC/PVDC/Al blisters.
GABAPENTIN DOC Generici 300 mg hard capsules is available in packs of 50 capsules in
PVC/PVDC/Al blisters.
GABAPENTIN DOC Generici 400 mg hard capsules is available in packs of 30 capsules in
PVC/PVDC/Al blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.
Manufacturer:
Vamfarma S.r.l. - Via Kennedy 5 - 26833 Comazzo (Lodi) – Italy.
Lachifarma S.r.l Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona industriale - Zollino
(Lecce) – Italy.