Gabapentin EG

Package leaflet: Information for the user

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

Equivalent medicinal product
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Gabapentin EG and what is it used for?

Gabapentin EG 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 EG is gabapentin.
Gabapentin EG is used to treat:

• various forms of epilepsy (epileptic seizures initially limited to certain areas of the brain, whether or not they spread to other parts of the brain). Your doctor will prescribe Gabapentin EG as an add-on treatment for epilepsy when your current treatment does not fully control your condition. You must take Gabapentin EG in addition to your ongoing treatment unless otherwise instructed. Gabapentin EG 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 (occurring mainly 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, prickling pains, etc.

2. What you should know before taking Gabapentin EG

Do not take Gabapentin EG

• if you are allergic to the active substance 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 EG:

• if you have kidney problems; your doctor may prescribe a different dosage;
• if you are undergoing haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop muscle pain and/or weakness;
• if you experience 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 neurological/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 its symptoms;
• 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 have a higher risk of developing dependence on Gabapentin EG.

Cases of abuse and dependence have been reported for gabapentin from post-marketing experience.
Dependence
Some people may develop dependence on Gabapentin EG (a need to continue taking the medicine). They may experience withdrawal symptoms when they stop or reduce the dose of Gabapentin EG (see section 3, “How to take Gabapentin EG” and “If you stop treatment with Gabapentin EG”).
If you are concerned about the possibility of developing dependence on Gabapentin EG, talk to your doctor.
If you notice any of the following signs while taking Gabapentin EG, 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 feel unwell 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-harm. If at any time you have thoughts of this kind, contact your doctor immediately.
Important information about potentially serious reactions
Serious skin rashes 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 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 these symptoms in section 4 of this patient information 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, particularly 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 notice 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 EG
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 EG. In addition, the combination of Gabapentin EG with opioids may cause drowsiness, sedation, reduced breathing or death.
Antacids for indigestion
If Gabapentin EG and antacids containing aluminium and magnesium are taken together, the absorption of Gabapentin EG from the stomach may be reduced. Therefore, it is recommended to take Gabapentin EG no earlier than two hours after taking the antacid.
Gabapentin EG:
No interaction with other antiepileptic medicines or with oral contraceptives is expected.
It may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital about what you are taking.
Gabapentin EG with food
Gabapentin EG can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Gabapentin EG should not be taken during pregnancy unless your doctor has advised otherwise. Women of childbearing potential should use an effective method of contraception.
Specific studies to evaluate the use of gabapentin in pregnant women have not been conducted, but for other medicines used to treat epileptic seizures, an increased risk to the developing baby has been reported, particularly when taking more than one medicine for epileptic seizures at the same time. Therefore, whenever possible, during pregnancy you should try to take only one medicine for epilepsy and only under medical advice.
Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning a pregnancy while being treated with Gabapentin EG. Do not stop taking this medicine suddenly, as this may cause sudden onset of epileptic seizures which may have serious consequences for you and your baby.
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).
Breast-feeding
Gabapentin, the active substance of Gabapentin EG, passes into breast milk. As the effect on the infant is unknown, it is recommended not to breast-feed during treatment with Gabapentin EG.
Fertility
Animal studies have shown no effect on fertility.
Driving and using machines
Gabapentin EG may cause dizziness, drowsiness and fatigue. Do not drive, operate complex machinery or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these activities.
Gabapentin EG contains lactose
Gabapentin EG hard capsules contain lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Gabapentin EG

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, as directed by your doctor, up to a maximum of 3,600 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 a 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 typically administered in three separate doses, taking the capsule once daily in the morning, once in the afternoon, and once in the evening.

Gabapentin EG is not recommended for children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:
Adults
Take the number of capsules as instructed 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, as directed by your doctor, up to a maximum of 3,600 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 undergoing haemodialysis
If you have kidney problems or are on haemodialysis, your doctor may prescribe a different dosing schedule and/or a different dose.

If you are an elderly patient (aged over 65 years), you should take the normal dose of Gabapentin EG 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 EG is too strong or too weak, inform your doctor or pharmacist as soon as possible.

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

Continue treatment with Gabapentin EG until your doctor tells you to stop.

If you take more Gabapentin EG 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 EG than prescribed. Bring with you any unused capsules, the packaging, and the patient information leaflet so that hospital staff can quickly determine how much medicine you have taken.

If you forget to take Gabapentin EG
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 a missed dose.

If you stop taking Gabapentin EG
Do not stop treatment with Gabapentin EG suddenly or reduce your dose without consulting your doctor. If you wish to stop treatment with Gabapentin EG or reduce the dose, discuss this with your doctor first, who will explain how to do so safely. Stopping treatment or reducing the dose should be done gradually over a period of at least 1 week.

After stopping short- or long-term treatment with Gabapentin EG or after reducing the dose, you should be aware that you may experience certain side effects known as withdrawal effects. These may include epileptic 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 or reducing the dose of Gabapentin EG. If you experience withdrawal effects, 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 everybody gets them.
Stop using Gabapentin EG and contact a doctor immediately if you notice any of the following symptoms:

• circular or target-shaped reddish patches, flat on the trunk, 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).

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

• severe skin reactions requiring immediate 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, 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 EG may cause a severe or life-threatening allergic reaction, which may affect 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 skin rashes. This may lead to hospitalization or discontinuation of treatment with Gabapentin EG.
Call your doctor immediately if you experience any of the following symptoms:

• skin rashes;
• hives;
• fever;
• swollen lymph nodes that do not go away;
• swelling of the lips and tongue;
• yellowing of the skin or 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 serious reaction. Your doctor must examine you to decide whether to continue taking Gabapentin EG.

• If you are on haemodialysis, inform 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;
• 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;
• loss of appetite, increased appetite;
• anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty in thinking;
• seizures, jerky movements, difficulty speaking, memory loss, tremors, sleep disorders, headache, skin sensitivity, reduced sensation (numbness), coordination difficulties, abnormal eye movements, increased, decreased or absent reflexes;
• blurred vision, double vision;
• dizziness;
• high blood pressure, facial flushing or dilation of blood vessels;
• breathing difficulties, bronchitis, sore throat, cough, dry nose;
• vomiting, nausea, dental problems, inflamed gums, diarrhoea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence;
• facial swelling, bruising, skin rash, itching, acne;
• joint pain, muscle pain, back pain, muscle spasms;
• erection problems (impotence);
• swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms;
• reduced white blood cell count, weight gain;
• accidental injuries, fractures, abrasions.

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

• allergic reaction such as hives;
• reduced movement;
• increased heart rate;
• swelling affecting the face, trunk and limbs;
• abnormal blood test results suggesting liver problems;
• mental impairment;
• falls;
• increased blood glucose levels (observed more frequently in patients with diabetes);
• difficulty thinking;
• difficulty swallowing.

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

• loss of consciousness;
• decreased blood glucose levels (observed more frequently in patients with diabetes);
• breathing difficulties, shortness of breath (respiratory depression).

Not known (frequency cannot be estimated from the available data):

• anaphylaxis (severe, potentially life-threatening allergic reaction including breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring emergency treatment);
• agitation (a state of chronic restlessness and unintentional, purposeless movements);
• suicidal thoughts;
• becoming dependent on Gabapentin EG (“drug dependence”). After stopping short- or long-term treatment with Gabapentin EG or reducing the dose, you should be aware that you may experience certain side effects, known as withdrawal effects (see “If you stop taking Gabapentin EG”).

The following side effects have been reported during post-marketing experience:

• reduced platelet count (blood-clotting cells);
• hallucinations;
• movement disorders such as convulsive restlessness, jerky movements and stiffness;
• ringing in the ears;
• yellowing of the skin and eyes (jaundice), liver inflammation;
• acute kidney failure, incontinence;
• increased 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 (elevated creatine phosphokinase);
• sexual dysfunction including inability to reach orgasm, delayed ejaculation;
• low sodium levels in the blood;
• 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 EG

Keep this medicine out of the sight and reach of children.
Do not use Gabapentin EG after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration of the packaging.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gabapentin EG contains
Gabapentin EG 100 mg hard capsules
Each hard capsule contains:
the active substance is:
gabapentin 100 mg
The other components are:
Maize starch, monohydrate lactose, talc, gelatin, titanium dioxide (E 171)
Gabapentin EG 300 mg hard capsules
Each hard capsule contains:
the active substance is:
gabapentin 300 mg
The other components are:
Maize starch, monohydrate lactose, talc, gelatin, titanium dioxide (E 171), erythrosine, iron oxide yellow (E 172)
Gabapentin EG 400 mg hard capsules
Each hard capsule contains:
the active substance is:
gabapentin 400 mg
The other components are:
Maize starch, monohydrate lactose, talc, gelatin, titanium dioxide (E 171), iron oxide red, iron oxide yellow (E 172)

Description of the appearance of Gabapentin EG and contents of the pack
Hard capsules
Box containing 50 capsules of 100 mg
Box containing 50 capsules of 300 mg
Box containing 30 capsules of 400 mg

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturer
COSMO S.p.A., Via C. Colombo, 1 - 20045 Lainate (MI)
VAMFARMA S.r.l., Via Kennedy, 5 - 26833 Comazzo (LO)
Fulton Medicinali S.p.A., Via Marconi 28/9 - 20044 Arese (MI)