GABAPENTIN 300 mg Капсулы Твердые

Содержание инструкции

1. GABAPENTIN ALTER 300 mg hard capsules
   1. What is Gabapentin Alter and what it is used for
   2. What you need to know before taking Gabapentin Alter
2. Gabapentin Alter may cause dizziness, drowsiness and fatigue. Do not drive, use
   1. How to take Gabapentin Alter
   2. Possible side effects
   3. How to store Gabapentin Alter
   4. Contents of the pack and other information

GABAPENTIN ALTER 300 mg hard capsules

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

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

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

Do not take Gabapentin Alter

• 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 Alter.

• 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 substances, as this could
indicate that you are at a higher risk of developing a dependence on Gabapentin Alter.
Be careful with Gabapentin Alter especially:

• if you have kidney problems;
• if you develop signs such as persistent stomach pain, nausea and vomiting, contact your doctor immediately.

Be careful with Gabapentin especially:

• 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).

Dependence
Some people may develop a dependence on Gabapentin Alter (need to
continue taking the medicine). They may experience withdrawal effects when
stopping the use of Gabapentin Alter (see section 3, “How to take Gabapentin Alter” and
“If you stop taking Gabapentin Alter”).
If you are concerned about the possibility of developing a dependence on Gabapentin Alter, talk to
your doctor.
If you notice any of the following signs while taking Gabapentin Alter
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 you 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 such as gabapentin have
developed suicidal thoughts or self-harm. If you have ever had thoughts of this
kind, contact your doctor immediately.

Other medicines and Gabapentin Alter
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 morphine
If you are taking medicines that contain morphine, tell your doctor or pharmacist because
morphine can increase the effect of Gabapentin Alter.

Antacids for indigestion
If Gabapentin Alter and antacids containing aluminum and magnesium are taken together,
the absorption of Gabapentin from the stomach may be reduced. It is therefore recommended to
take Gabapentin Alter no earlier than two hours after taking the antacid.

Gabapentin Alter:
It is not expected to interact with other antiepileptic drugs or with the contraceptive pill.
It may interfere with some laboratory tests; if you need a urine test, inform your doctor or
hospital about what you are taking.

Gabapentin Alter with food and drink
Gabapentin Alter can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Gabapentin Alter should not be taken during pregnancy unless your doctor has told you to do so.
Women of childbearing potential should use effective contraception.
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).
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but an increased risk of harm to the fetus has been reported for other medicines used to treat seizures, especially when more than one medicine for seizures is taken at the same time. Therefore, if possible, and only on medical advice, during pregnancy you should try to take only one medicine for
epilepsy.
Do not suddenly stop taking this medicine as this can cause
the sudden onset of seizures which can have serious consequences for you and the
child.
Gabapentin, the active ingredient of Gabapentin Alter, is excreted in breast milk. As the effects of
breastfeeding on the infant are unknown, it is recommended not to
breastfeed during treatment with Gabapentin Alter.

Driving and using machines

Gabapentin Alter may cause dizziness, drowsiness and fatigue. Do not drive, use

complex machinery or undertake other potentially dangerous activities until you
understand whether this medicine may impair your ability to perform these activities.

Gabapentin Alter contains lactose
The hard capsules of Gabapentin Alter contain lactose (a type of sugar). If your doctor has
diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

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 using gabapentin and seek immediate medical attention if you notice any of the
symptoms related to these serious 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"

3. How to take Gabapentin Alter

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.
If you feel that the effect of Gabapentin Alter is too strong or too weak, inform your
doctor or pharmacist as soon as possible.

If you are elderly (over 65 years of age)you should take the normal dosage of Gabapentin Alter, 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.
Continue treatment with Gabapentin Alter until your doctor tells you to stop.

Method and route of administration
Gabapentin Alter is taken orally. Always swallow the capsules whole with plenty of
water.

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,
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 about 3 days. The usual dose for controlling epilepsy is 25-35 mg/kg
per day. The dose is usually administered in 3 separate doses, taking the capsule each
day generally once in the morning, once in the afternoon and once in the evening.

The use of Gabapentin Alter 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, 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 take more Gabapentin Alter than you should
A higher dose than recommended 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
Gabapentin Alter 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 Gabapentin Alter
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 Alter
Do not suddenly stop treatment with Gabapentin Alter. If you wish to stop the
treatment with Gabapentin Alter, 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 Alter, 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, tremors, headache, depression, feeling of abnormality, dizziness and
general malaise. These effects usually occur within 48 hours of
stopping Gabapentin Alter. If you experience withdrawal effects, you should contact your doctor.
If you have any doubts 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.

Contact your doctor immediately if any of the following symptoms occur after taking this medicine, as they could be serious:

• severe skin reactions requiring immediate medical attention, swelling of the lips and face, skin rash and redness, 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 Alter 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 skin rash. This may cause hospitalization or discontinuation of treatment with Gabapentin Alter.

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

• skin rashes
• hives
• fever
• swollen lymph nodes that do not tend to disappear
• 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 early signs of a severe allergic reaction. A doctor should examine you to decide whether to continue taking Gabapentin Alter.
Stop using Gabapentin Alter 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 you are on hemodialysis, inform your doctor if you experience pain and/or muscle weakness.
Other side effects include:

Very common side effects
(may affect more than 1 in 10 people):

• viral infections
• feeling sleepy, dizziness, lack of coordination
• feeling tired, fever

Common side effects
(may affect more than 1 in 100 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 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, skin 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 jerky movements have been commonly reported in clinical studies conducted in children.

Uncommon side effects
(may affect more than 1 in 1000 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
• falls
• difficulty thinking
• high blood glucose levels (more often observed in diabetic patients)
• difficulty swallowing

Rare side effects (may affect less than 1 in 1000 people):

• low blood glucose levels (more often observed in diabetic patients)
• loss of consciousness
• difficulty breathing, shortness of breath (respiratory depression)

The following side effects have been reported in the post-marketing phase:

• 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 renal failure, incontinence
• Breast tissue enlargement, breast enlargement
• adverse events that occur after the abrupt cessation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
• Stevens-Johnson syndrome, erythema multiforme
• hyponatremia

Side effects of unknown frequency (frequency cannot be estimated based on available data)

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

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

Reporting of side effects
If you get any side effects, even those 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 Alter

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 packaging. The expiry date refers to the last day of the month.
Do not store Gabapentin Alter hard capsules at a temperature above 30°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 Alter contains
The active ingredient is gabapentin. Each hard capsule contains 300 mg or 400 mg of gabapentin.
The other components of Gabapentin Alter capsules are:
corn starch, lactose monohydrate, talc, gelatin.
The 300 mg capsules contain the colorants E171 (titanium dioxide) and E172 (yellow iron oxide)
and the 400 mg capsules contain the colorant E171 (titanium dioxide).

Description of the appearance of Gabapentin Alter and contents of the pack
Hard capsules.
The 300 mg capsules are hard and yellow in color.
The 400 mg capsules are hard and white in color.
Packs in blisters of 50 hard capsules (300 mg) and 30 hard capsules (400 mg)
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratori Alter S.r.l. – Via Egadi 7- 20144 Milano

Manufacturer:
LABORATORIO FARMACEUTICO C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)

This leaflet was last updated on