GABAPENTIN 100 mg Hard Capsules

Зміст інструкції

1. Gabapentin Aurobindo 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules
   1. What is Gabapentin Aurobindo and what it is used for
   2. Before taking Gabapentin Aurobindo
   3. How to take Gabapentin Aurobindo
   4. POSSIBLE SIDE EFFECTS
   5. How to store Gabapentin Aurobindo capsules
   6. Other information
2. Gabapentin 100 mg capsule with “D” imprinted on the white cap and “02” on the white body,

Gabapentin Aurobindo 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Equivalent Medicinal Product
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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet:

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

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

Gabapentin Aurobindo belongs to a group of medicines used for the treatment
of epilepsy and peripheral neuropathic pain (chronic long-term pain caused
by nerve damage).
The active substance of Gabapentin Aurobindo is gabapentin.
Gabapentin Aurobindo 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).
The doctor will prescribe Gabapentin Aurobindo as support in the treatment of epilepsy
when the treatment you are already following does not fully control your condition.
You should take Gabapentin Aurobindo in addition to the ongoing treatment unless
you receive other instructions. Gabapentin Aurobindo 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 pain). Several
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, cramping pains, suffering, tingling, numbness, pins and needles etc.

2. Before taking Gabapentin Aurobindo

Do not take Gabapentin Aurobindo

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Gabapentin Aurobindo

• 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 muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, nausea and vomiting, contact your doctor immediately, as these pains 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. *

In post-marketing experience, cases of abuse and
dependence have been reported for gabapentin. Talk to your doctor if you have a history of abuse or dependence.
A small number of people treated with antiepileptics like gabapentin have had
thoughts of self-harm or suicide. Whenever you have these thoughts, contact
your doctor immediately.

Important information about potentially serious reactions
A limited number of patients treated with Gabapentin Aurobindo have experienced an
allergic reaction or potentially serious skin reactions which, if left untreated,
can develop into more serious problems. You need to know these symptoms so you can
recognize them while taking Gabapentin Aurobindo.
“Contact your doctor immediately if you experience any of the following symptoms after taking
this medicine, as they may be serious.”
Muscle weakness, tenderness or pain, and especially if you do not feel well or have a high
temperature at the same time, may be caused by an abnormal breakdown of
muscles which can be life-threatening and lead to kidney problems. You may also
experience urine of altered color and changes in blood test results (in
particular increased creatine phosphokinase in the blood). If you experience any of these
signs and symptoms, contact your doctor immediately.
Caution: The HDPE bottle contains a desiccant. Do not ingest.

Other medicines and Gabapentin Aurobindo
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 that contain 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. In addition,
the combination of gabapentin with opioids can cause symptoms such as drowsiness and/or
reduced breathing.

Antacids for indigestion
If Gabapentin Aurobindo and antacids containing aluminum and magnesium are taken
together, the absorption of Gabapentin Aurobindo from the stomach may
be reduced. It is therefore recommended to take Gabapentin Aurobindo at least 2
hours after taking the antacid.
Gabapentin Aurobindo:
* Is not expected to interact with other antiepileptic drugs or with oral contraceptives.

*May interfere with some laboratory tests; if you need a urine test, inform
your doctor or hospital of what you are taking.

Gabapentin Aurobindo with food, beverages and alcohol
Gabapentin Aurobindo can be taken with or without food.

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

Pregnancy
Gabapentin Aurobindo should not be taken during pregnancy unless your doctor
tells 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 other medicines used to treat seizures have
reported an increased risk of harm to fetal development, especially when
taking more than one medicine for seizures simultaneously. Therefore,
when possible, and only on medical advice, you should try to take only one
medicine for seizures during pregnancy.
Contact your doctor immediately if you are pregnant, think you may be or are
planning a pregnancy while taking Gabapentin Aurobindo.
Do not suddenly stop taking this medicine as this can cause
sudden seizures which can have serious consequences for you and the baby.

Breastfeeding
Gabapentin, the active ingredient of Gabapentin Aurobindo, is excreted in breast milk. As
the effect on the infant is unknown, breastfeeding during treatment with
gabapentin is not recommended.

Fertility
Animal studies have shown no effects on fertility.

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

3. How to take Gabapentin Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have
doubts, consult your doctor or pharmacist.
The doctor will establish the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents:
Take the number of capsules that have been prescribed to you. Usually the doctor will gradually increase the
dose. The initial dose is generally between 300 mg and 900 mg per
day. Subsequently, the dose may be gradually increased by your doctor up to a
maximum of 3600 mg per day which they will tell you to take in 3 administrations, for example
one in the morning, one in the afternoon and one in the evening.

Children aged 6 years and over
The dose to give to your child will be decided by the doctor as it is calculated based on the weight of the
child. Treatment begins with a low initial dose which is gradually
increased over approximately 3 days. The usual dose for controlling epilepsy is 25-35
mg per kg per day. It is generally administered in 3 separate doses, taking the capsules
every day, once in the morning, once in the afternoon and once in the evening.

Gabapentin Aurobindo is not recommended in children under the age of 6 years.
Peripheral neuropathic pain, the recommended dose is:
Adults:
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 prescribed by the doctor up to a
maximum of 3600 mg per day and the doctor will tell you to take this dose in 3
administrations, for example one in the morning, one in the afternoon and one in the evening.

If you have kidney problems or if you are undergoing hemodialysis
If you have kidney problems or if you are undergoing hemodialysis, your doctor may prescribe a different
dosage regimen and/or a different dose.

If you are an elderly patient (over 65 years of age)
you should take the normal dose of Gabapentin Aurobindo, unless you have kidney problems.
If you have kidney problems, your doctor may prescribe a different dosage regimen and/or a
different dose.
If you feel that the effect of Gabapentin Aurobindo is too strong or too weak,
inform your doctor or pharmacist as soon as possible.

Method and route of administration
Gabapentin Aurobindo is for oral use. The capsules must always be swallowed whole
with plenty of water.
Continue taking Gabapentin Aurobindo until your doctor tells you to
stop.

If you take more Gabapentin Aurobindo than you should
Doses higher than those recommended can cause side effects including
loss of consciousness, dizziness, double vision, speech disorders, drowsiness and diarrhea. If
you take more Gabapentin Aurobindo than prescribed by your doctor, contact your doctor or
go immediately to the emergency room of the nearest hospital. Bring with you the capsules or
tablets you have not taken, together with the container and label so that the hospital
can easily understand which medicine you have taken.

If you forget to take Gabapentin Aurobindo
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
forgotten one.

If you stop taking Gabapentin Aurobindo
Do not stop treatment with Gabapentin Aurobindo unless your
doctor has told you to. Discontinuation of treatment must occur gradually over at least
1 week. If you suddenly stop treatment with gabapentin or if you
stop it before it has been prescribed by your doctor, the risk of seizures increases.
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.
Contact your doctor immediately if you experience any of the following symptoms after
taking this medicine, as they may be serious:

• Anaphylaxis [(a severe allergic reaction, life-threatening that includes difficulty breathing, swelling of lips, throat and tongue and hypotension requiring emergency treatment) frequency not known]
• Persistent stomach pain, nausea and vomiting, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• Gabapentin Aurobindo 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 cause hospitalization or discontinuation of treatment with Gabapentin Aurobindo. Call your doctor immediately if you experience any of the following symptoms:

o rash
o hives
o fever
o swollen lymph nodes that tend not to go away
o swelling of the lips and tongue
o yellowing of the skin or the whites of the eyes
o unusual bleeding or bruising
o severe fatigue or weakness
o sudden muscle pain
o frequent infections may require emergency and intensive care to
continue to breathe normally.
These symptoms may be the first signs of a serious allergic reaction. A doctor
should examine you to decide if you should continue to take Gabapentin Aurobindo.
If you are on hemodialysis, tell your doctor if you develop muscle pain and/or 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
• Anorexia, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Convulsions, spasms, 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, flushing or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting (feeling sick), nausea (feeling unwell), 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, spasm
• 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 jerky movements have been reported in clinical studies conducted in children.

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

• Agitation (a state of chronic restlessness and purposeless, involuntary movements)
• Allergic reaction such as hives
• Reduced movements
• Fast heartbeat
• Swelling that can involve the face, trunk and limbs
• Abnormal blood test results suggesting liver problems.
• Mental impairment
• Falls.
• Increased blood glucose levels (observed more often in diabetic patients).

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

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

The following side effects have been reported after marketing authorization:

• Decreased platelets (cells that cause blood to clot)
• Hallucinations
• Problems with abnormal movements such as convulsive agitations, jerky movements and rigidity
• Ringing in the ears
• A group of side effects including enlarged lymph nodes (small swelling visible under the skin), fever, rash and liver inflammation that occur together
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse events that occur after the abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood tests (increased creatine phosphokinase)
• Problems with sexual function including inability to reach orgasm, delayed ejaculation
• Low sodium levels in the blood

Reporting of side effects
If you get any side effect, 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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Gabapentin Aurobindo capsules

Keep this medicine out of the sight and reach of children.
Do not use Gabapentin Aurobindo after the expiry date which is reported
on the package/label/bottle after EXP. The expiry date refers to the last
day of that month.
Store at a temperature below 25  C.
Blisters: store in the original packaging.
HDPE bottle: store in the original container.
Use within 12 months of the first opening of the HDPE bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What Gabapentin Aurobindo contains
* The active ingredient is gabapentin.
Each 100 mg hard capsule contains 100 mg of gabapentin.
Each 300 mg hard capsule contains 300 mg of gabapentin.
Each 400 mg hard capsule contains 400 mg of gabapentin.
* The other ingredients are:
The capsules contain: corn starch and talc
Capsule coating:
100mg: Titanium dioxide (E171), sodium lauryl sulfate, gelatin.
300mg: Yellow iron oxide (E172), Titanium dioxide (E171), Sodium lauryl sulfate, gelatin.
400mg: Red iron oxide (E172), Yellow iron oxide (E172), Titanium dioxide (E171),
Sodium lauryl sulfate, gelatin
Printing ink: shellac, propylene glycol, black iron oxide, potassium
hydroxide

Description of the appearance of Gabapentin Aurobindo and contents of the pack
Hard capsules.

Gabapentin 100 mg capsule with “D” imprinted on the white cap and “02” on the white body,

containing crystalline powder from white to off-white.
Gabapentin 300 mg capsule with “D” imprinted on the yellow cap and “03” on the yellow body,
containing crystalline powder from white to off-white.
Gabapentin 400 mg capsule with “D” imprinted on the orange cap and “04” on the orange body,
containing crystalline powder from white to off-white.
Gabapentin 100 mg capsules are available in:
* PVC/PVDC-Aluminum blister packs of 10, 20, 30, 50, 60, 90, 100 and 200 hard capsules
* HDPE bottle with polypropylene closure containing desiccant silica gel: 100, 200 and
1000 hard capsules
Gabapentin 300 mg capsules are available in:
* PVC/PVDC-Aluminum blister packs of 10, 20, 30, 50, 60, 90, 100 and 200 hard capsules
* HDPE bottle with polypropylene closure containing desiccant silica gel: 100, 200 and
1000 hard capsules.
Gabapentin 400 mg capsules are available in:
* PVC/PVDC-Aluminum blister packs of 10, 20, 30, 50, 60, 90, 100, 200 and 300 hard capsules
* HDPE bottle with polypropylene closure containing desiccant silica gel: 100, 200,
300 and 500 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe 102,
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the EEA with the following
denominations:
Czech Republic Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg hard capsules
Denmark Gabapentin Aurobindo
France Gabapentine Arrow Génériques 100 mg/ 300 mg/ 400mg, capsules
Germany Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg hard capsules
Ireland Gabin 100 mg/ 300 mg/ 400mg hard capsules
Italy Gabapentin Aurobindo
Latvia Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg cietās kapsulas
Lithuania Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg kietos kapsulės
Netherlands Gabapentine Aurobindo 100 mg/ 300 mg/ 400mg, hard capsules
Portugal Gabapentina Aurobindo
Romania Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg capsule
Slovak Republic Gabapentin Vipharma 100 mg/ 300 mg/ 400mg hard capsules
Spain Gabapentina Aurobindo 100 mg/ 300 mg/ 400mg hard capsules
Sweden Gabapentin Aurobindo 100 mg/ 300 mg/ 400mg hard capsules
United Kingdom Gabapentin Milpharm 100 mg/ 300 mg/ 400mg hard capsules