Gabapentin ABC: detailed information

Package leaflet: Information for the user

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

gabapentin
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Gabapentin ABC is and what it is used for
What you need to know before taking Gabapentin ABC
How to take Gabapentin ABC
Possible side effects
How to store Gabapentin ABC
Contents of the pack and other information

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

Gabapentin ABC belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
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 or not they spread to other parts of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe Gabapentin ABC as an add-on treatment for epilepsy when the current therapy does not fully control the condition. You or your child aged 6 years or older should take Gabapentin ABC in addition to the ongoing treatment, unless otherwise instructed. Gabapentin ABC may 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 (which mainly occurs in the legs and/or arms), such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsations, shooting pains, stabbing pains, sharp pains, cramping pains, discomfort, 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 to any of the 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, inform 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 higher risk of developing dependence on Gabapentin ABC;
if you are undergoing haemodialysis (to remove waste due to kidney failure), inform 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)
if you suffer from nervous system/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses
if you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.

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

You feel the need to take the medicine longer than prescribed by your doctor
You feel the need to take a higher dose than recommended
You are using the medicine for reasons different from those for which it was prescribed
You have made repeated 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 and how to safely stop taking the medicine.
A small number of patients treated with antiepileptic medicines such as gabapentin have developed suicidal thoughts or self-harming behaviour. If at any time you have thoughts of this kind, contact your doctor immediately.
Important information about potentially serious reactions
Serious skin rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with gabapentin. Stop taking gabapentin and contact a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Read the description of serious symptoms in section 4 of this leaflet under “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, especially if you also feel unwell and have fever, may be caused by muscle injury which can be life-threatening and may lead to kidney problems. You may also experience discoloured urine and abnormalities in blood tests (particularly increased creatine phosphokinase). If any of these signs or symptoms occur, 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 medicine. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety, or other neurological or psychiatric conditions.
Medicines containing opioids such as morphine
If you are taking medicines containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin ABC. In addition, combining Gabapentin ABC with opioids may cause drowsiness, sedation, reduced breathing, or death.
Antacids for indigestion
If Gabapentin ABC and antacids containing aluminium and magnesium are taken together, the absorption of Gabapentin ABC from the stomach may be reduced. It is therefore recommended to take Gabapentin ABC no sooner than two hours after taking the antacid.
Gabapentin ABC:

is not expected to interact with other antiepileptic medicines or with oral contraceptives;
may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Gabapentin ABC with food
Gabapentin ABC may be taken with or without food.
Pregnancy, breastfeeding and fertility

If you are pregnant, suspect you may be pregnant, you must inform your doctor immediately and discuss the possible risks that the medicine you are taking may pose to the unborn child.
Do not stop treatment without discussing it with your doctor.
If you are planning a pregnancy, you should discuss your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Gabapentin ABC may be used during the first trimester of pregnancy, if necessary.
If you are planning a pregnancy, are pregnant, or think you may be pregnant, contact your doctor immediately.
If you are pregnant and have epilepsy, it is important not to stop taking the medicine without first consulting your doctor, as this could worsen your condition. Worsening of epilepsy could endanger both you and your unborn child.
In a study examining data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, no increased risk of birth defects or problems in brain function development (neurodevelopmental disorders) was observed. However, children born to women who took gabapentin during pregnancy had a higher risk of low birth weight and preterm delivery.
If used during pregnancy, gabapentin may cause withdrawal symptoms in newborns. The risk may be increased when gabapentin is taken together with opioid analgesics (medicines for the treatment of severe pain).
Contact your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy while being treated with Gabapentin ABC. Do not suddenly stop taking this medicine, as this may cause sudden onset of epileptic seizures, which could have serious consequences for you and your child.
Breastfeeding
Gabapentin, the active substance in Gabapentin ABC, passes into breast milk. As the effect on the infant is unknown, breastfeeding is not recommended during treatment with Gabapentin ABC.
Fertility
Animal studies have shown no effect on fertility.
Driving and using machines
Gabapentin ABC may cause dizziness, drowsiness and fatigue. Do not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know how this medicine affects your ability to perform these tasks.
Gabapentin ABC contains lactose
Gabapentin ABC hard capsules contain lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Gabapentin ABC

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is:
Adults and adolescents
Take the number of capsules prescribed by your doctor. Usually, your doctor will gradually increase your dose.
The initial dose is generally between 300 mg and 900 mg per day. Subsequently, the dose may be increased,
on the advice of your doctor, up to a maximum of 3600 mg per day, and your doctor will instruct you to take
this dose in three separate administrations: once in the morning, once in the afternoon, and once in the evening.

Children aged 6 years and older
The dose for the child will be determined by the doctor based on the child's body 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 three separate doses,
taking the capsule daily, 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 as directed by your doctor. Usually, your doctor will gradually increase your dose.
The initial dose is generally between 300 mg and 900 mg per day. Subsequently, the dose may be increased,
on the advice of your doctor, up to a maximum of 3600 mg per day, and your doctor will instruct you to take
the medicine in three separate doses: once in the morning, once in the afternoon, and once in the evening.

If you have kidney problems or are on haemodialysis
If you have kidney problems or are undergoing haemodialysis, your doctor may prescribe a different dosing schedule 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 schedule 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 a generous amount of water.
Continue treatment with Gabapentin ABC until your doctor tells you to stop.

If you take more Gabapentin ABC than you should
Taking more than the recommended dose may lead to an increase in side effects, including loss of consciousness,
dizziness, double vision, difficulty speaking, drowsiness, and diarrhoea. Contact your doctor immediately or go to the nearest emergency department
if you take more Gabapentin ABC than prescribed. Bring with you any unused capsules, the packaging, and the patient information leaflet
so that hospital staff can easily determine 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 almost time for your next dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Gabapentin ABC
Do not stop treatment with Gabapentin ABC suddenly or reduce your dose without medical advice.
If you wish to stop treatment with Gabapentin ABC or reduce the dose, discuss this first with your doctor, who will advise you on how to proceed.
Stopping treatment or reducing the dose should be done gradually over at least 1 week.
After stopping short- or long-term treatment with Gabapentin ABC or after reducing the dose, you should be aware that you may experience certain side effects known as withdrawal symptoms.
These may include epileptic seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremor, headache, depression, feeling of abnormality, dizziness, and general malaise.
These symptoms usually occur within 48 hours of stopping or reducing the dose of Gabapentin ABC.
If you experience withdrawal symptoms, contact your doctor.

If you have any questions 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.
Stop using Gabapentin ABC and contact your doctor immediately if you notice any of the following symptoms:

Circular or target-shaped, reddish, non-elevated skin patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 must contact your doctor immediately if you notice any of the following symptoms after taking this
medicine, as they may be serious:

persistent stomach pain, nausea and vomiting, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
breathing problems which, if severe, may require emergency and intensive care to allow you to continue breathing normally.
Gabapentin ABC may cause a serious or life-threatening allergic reaction affecting the skin or any other part of the body such as the liver or blood. When experiencing this type of reaction, you may or may not have a skin rash. This may lead to hospitalization or discontinuation of treatment with Gabapentin ABC.

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

skin rash and redness and/or hair loss
hives
fever
swollen lymph glands that do not go away
swelling of the lips, face and tongue
yellowing of the skin or whites of the eyes
unusual bleeding or bruising
severe tiredness or weakness
sudden muscle pain
frequent infections

These symptoms may be early signs of a serious reaction. Your doctor should examine you to decide whether
to continue taking Gabapentin ABC.

If you are on haemodialysis, inform your doctor if you develop pain and/or muscle weakness.

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

Viral infections
Drowsiness, 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
Aggression towards others, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking
Seizures, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation (numbness), coordination problems, eye movement abnormalities, increased, decreased or absent reflexes
Blurred vision, double vision
Dizziness
High blood pressure, facial flushing or blood vessel dilation
Breathing difficulties, bronchitis, sore throat, cough, dry nose
Vomiting, nausea, dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence
Swelling of the face, bruising, skin rash, itching, acne
Joint pain, muscle pain, back pain, muscle spasms
Problems with erection (impotence)
Swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
Decreased white blood cells, weight gain
Accidental injuries, fractures, abrasions

In addition, in clinical studies conducted in children, aggressive behaviour and convulsive movements were commonly reported.
Uncommon (may affect up to 1 in 100 people):

Agitation (a state of chronic restlessness and unintentional, purposeless movements)
Allergic reaction such as hives
Reduced movement
Increased heart rate
Difficulty swallowing
Swelling affecting the face, trunk and limbs
Abnormal blood test results suggesting liver problems
Mental impairment
Falls
Increased blood glucose levels (more frequently observed in patients with diabetes)

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

Decreased blood glucose levels (more frequently observed in patients with diabetes)
Loss of consciousness
Breathing difficulties, shortness of breath (respiratory depression)

Not known: frequency cannot be estimated from the available data

Becoming dependent on Gabapentin ABC (“drug dependence”)

After stopping short- or long-term treatment with Gabapentin ABC or after reducing the dose, you should be aware that you may experience some side effects known as withdrawal effects (see “If you stop taking Gabapentin ABC”).
The following side effects have been reported after marketing of the medicine:

Decreased platelet count (blood cells that help blood to clot)
Suicidal thoughts, hallucinations
Problems with abnormal movements such as convulsive restlessness, jerky movements and stiffness
Ringing in the ears (tinnitus)
Yellowing of the skin and eyes (jaundice), liver inflammation
Acute kidney failure, incontinence
Increase in breast tissue, breast enlargement
Adverse events occurring after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, feeling unwell, pain, sweating), chest pain
Muscle fibre damage (rhabdomyolysis)
Abnormalities in blood tests (increased creatine phosphokinase)
Sexual dysfunction including inability to reach orgasm, delayed ejaculation
Low sodium levels in the blood
Anaphylaxis (a severe, potentially fatal allergic reaction including difficulty breathing, swelling of lips, throat and tongue, and hypotension requiring emergency treatment)
Worsening of myasthenia gravis (a disease causing muscle weakness)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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.
Do not use this medicine after the expiry date stated on the container after "Exp.".
The expiry date refers to the last day of that month.
Do not store Gabapentin ABC hard capsules above 30 °C.
Do not dispose of medicines via wastewater 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 ABC contains
Gabapentin ABC 100 mg hard capsules
The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin.
The other components are: monohydrate lactose, maize starch, talc, gelatin, titanium dioxide (E171).
Gabapentin ABC 300 mg hard capsules
The active substance is gabapentin. Each hard capsule contains 300 mg of gabapentin.
The other components are: monohydrate lactose, maize starch, talc, gelatin, titanium dioxide (E171),
yellow iron oxide (E172).
Gabapentin ABC 400 mg hard capsules
The active substance is gabapentin. Each hard capsule contains 400 mg of gabapentin.
The other components are: monohydrate lactose, maize starch, talc, gelatin, titanium dioxide (E171).

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

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

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)