Gabapentin Doc Generici

Package leaflet: Information for the user

GABAPENTIN DOC Generici 100 mg hard capsules, 300 mg hard capsules, 400 mg hard capsules

Equivalent 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 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 DOC Generici is 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. Contents of the pack and other information

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

GABAPENTIN DOC Generici belongs to a group of medicines used in the treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
Epilepsy: GABAPENTIN DOC Generici 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 will prescribe GABAPENTIN DOC Generici as an add-on treatment for epilepsy when your current treatment does not fully control your condition. You must take GABAPENTIN DOC Generici in addition to your ongoing treatment unless otherwise instructed. GABAPENTIN DOC Generici may also be used as monotherapy for the treatment of adults and children over 12 years of age.
Peripheral neuropathic pain: GABAPENTIN DOC Generici is used to treat 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 warmth, burning, pulsing, shooting pain, stabbing pain, sharp pain, cramping pain, discomfort, tingling, numbness, pricking pain, etc.

2. What you should know before taking GABAPENTIN DOC Generici

Do not take GABAPENTIN DOC Generici

• 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 DOC Generici.

• 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 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 DOC Generici.

Dependence
Some people may develop dependence on GABAPENTIN DOC Generici (a need to continue taking the medicine). They may experience withdrawal symptoms when they stop using GABAPENTIN DOC Generici or reduce the dose (see section 3, “How to take GABAPENTIN DOC Generici” and “If you stop treatment with GABAPENTIN DOC Generici”).
If you are concerned about the possibility of developing 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 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 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.
Be especially careful with GABAPENTIN DOC Generici

• if you have kidney problems, your doctor may prescribe a different dosage;
• if you are on hemodialysis (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).

A small number of patients treated with antiepileptic medicines such as GABAPENTIN DOC Generici have developed suicidal thoughts or self-harming thoughts. If such thoughts occur at any time, 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 gabapentin treatment. Stop taking gabapentin and seek immediate medical advice 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 leaflet under "contact your doctor immediately if any of the following symptoms occur after taking this medicine, as they could be serious"
Other medicines and GABAPENTIN DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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.
If you are taking medicines containing morphine, inform your doctor or pharmacist, as morphine may increase the effect of GABAPENTIN DOC Generici.
No interaction is expected between GABAPENTIN DOC Generici and other antiepileptic medicines or oral contraceptives.
GABAPENTIN DOC Generici may interfere with certain laboratory tests; if you need a urine test, inform your doctor or hospital that you are taking GABAPENTIN DOC Generici.
If GABAPENTIN DOC Generici and antacids containing aluminium 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 an 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, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
GABAPENTIN DOC Generici 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. However, for other medicines used to treat epileptic seizures, an increased risk of fetal harm has been reported, particularly when more than one antiepileptic medicine is taken simultaneously. Therefore, whenever possible and only on medical advice, you should try to take only one antiepileptic medicine during pregnancy.
Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning a pregnancy while being treated with GABAPENTIN DOC Generici.
Do not stop taking this medicine suddenly, as this may cause sudden onset of epileptic seizures, which could 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).
Breastfeeding
Gabapentin, the active substance in GABAPENTIN DOC Generici, is excreted in breast milk. Since the effects of breastfeeding on the infant are unknown, it is recommended not to breastfeed during treatment with GABAPENTIN DOC Generici.
Driving and using machines
GABAPENTIN DOC Generici may cause dizziness, drowsiness, and fatigue. You must not drive, operate complex machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform these tasks.
GABAPENTIN DOC Generici contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take GABAPENTIN DOC Generici

Take this medicine exactly as directed by your doctor. 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.
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 (age over 65) you should take the normal dosage of GABAPENTIN DOC Generici, unless you have kidney problems.

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.

The capsules must 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 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 gradually increased up to a maximum of 3600 mg per day, which your doctor will advise you to take in three divided doses (once in the morning, once in the afternoon, and once in the evening).

Epilepsy:
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 gradually increased up to a maximum of 3600 mg per day, which your doctor will advise you to take in three divided doses (once in the morning, once in the afternoon, and once in the evening).

Use in children and adolescents
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. This dose is usually administered in three divided doses, taken every day—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 any, contact your doctor immediately or go to the nearest emergency department. Since GABAPENTIN DOC Generici capsules may cause drowsiness, it is advisable to ask someone else to drive you to the doctor or hospital, or to call an ambulance. Bring any remaining capsules, the packaging, and the leaflet with you so that hospital staff can easily identify the medicine you have taken.

Overdoses of gabapentin, particularly when associated with other medicines that depress the central nervous system (CNS), may lead to coma.
Taking more than the recommended dose may increase the risk of adverse effects; symptoms of overdose include loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, and diarrhoea.

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 almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking GABAPENTIN DOC Generici
Do not stop treatment with GABAPENTIN DOC Generici suddenly or reduce the dose abruptly. If you wish to stop treatment or reduce the dose, speak to your doctor first, who will advise you on how to do so safely. Stopping treatment or reducing the dose should be done gradually over a period of at least one week. After stopping short- or long-term treatment with GABAPENTIN DOC Generici, or after reducing the dose, you should be aware that you may experience certain adverse effects known as withdrawal symptoms. 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 DOC Generici. 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 DOC Generici and contact a 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 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 experience any of the following symptoms after taking the medicine, contact your doctor immediately,
as they may be signs of serious conditions:

• Breathing problems, which, if severe, may require emergency and intensive care to allow you to continue breathing normally.
• GABAPENTIN DOC Generici may cause a serious or life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood. When experiencing this type of reaction, you may or may not develop a skin 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 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 allergic reaction. A doctor should examine you to determine whether you should continue taking GABAPENTIN DOC Generici.
The following are very common side effects (may affect more than 1 in 10 people):

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

The following are common side effects (may affect more than 1 in 100 people):

• Pneumonia, respiratory infections, urinary tract infections, infections, ear inflammation,
• Low white blood cell count,
• Anorexia, increased appetite,
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking,
• Seizures, convulsive movements, difficulty speaking, memory loss, tremors, sleep disturbances, headache, skin sensitivity, reduced sensation, coordination difficulties, 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, diarrhea, stomach ache, indigestion, constipation, dry mouth or throat, intestinal gas (flatulence),
• Facial swelling, bruising, rash, itching, acne,
• Joint pain, muscle pain, back pain, muscle cramps,
• Erectile dysfunction,
• 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.

The following are uncommon side effects (may affect more than 1 in 1,000 people):

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

The following are rare side effects (may affect less than 1 in 1,000 people):

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

The following side effects have unknown frequency (cannot be estimated from available data):

• Reduced platelet count (blood cells responsible for clotting),
• Hypersensitivity syndrome, a systemic reaction with variable manifestations including fever, rash, hepatitis, lymphadenopathy (swollen lymph nodes; small isolated nodules under the skin), eosinophilia and sometimes other signs and symptoms,
• Anaphylaxis (severe, potentially fatal allergic reaction including breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring emergency treatment),
• Hallucinations,
• Movement disorders such as convulsive restlessness, convulsive movements and stiffness,
• Ringing in the ears (tinnitus),
• 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 lips and face, skin rash and redness, hair loss, drug rash with eosinophilia and systemic symptoms (DRESS),
• Myoclonus, muscle breakdown (rhabdomyolysis),
• 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, sudden death (no causal relationship with gabapentin treatment established),
• Changes in glucose levels in diabetic patients, abnormal blood test results suggesting liver problems,
• Hyponatremia,
• Suicidal thoughts,
• Becoming dependent on GABAPENTIN DOC Generici (“drug dependence”),
• Worsening of myasthenia gravis (a disease causing muscle weakness).

After stopping short- or long-term treatment with GABAPENTIN DOC Generici or after reducing the dose,
you should be aware that you may experience certain side effects known as withdrawal effects (see “If you
stop taking GABAPENTIN DOC Generici”).
Additionally, in clinical studies conducted in children, aggressive behaviour, convulsive movements, respiratory
infections, otitis media and bronchitis were commonly reported.
In patients undergoing hemodialysis, myopathy and elevated creatine kinase levels have been reported due
to end-stage renal disease.
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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine 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 DOC Generici contains
The active substance 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: monohydrate lactose, maize starch, talc, gelatin, titanium dioxide (E 171).
• GABAPENTIN DOC Generici 300 mg hard capsules: monohydrate lactose, maize starch, talc, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), erythrosine.
• GABAPENTIN DOC Generici 400 mg hard capsules: monohydrate lactose, maize 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 white hard capsules.
The 300 mg capsules are yellow hard capsules.
The 400 mg capsules are orange hard capsules.
Pack sizes:
GABAPENTIN DOC Generici 100 mg hard capsules are available in packs of 50 capsules in PVC/PVDC/Al blisters.
GABAPENTIN DOC Generici 300 mg hard capsules are available in packs of 50 capsules in PVC/PVDC/Al blisters.
GABAPENTIN DOC Generici 400 mg hard capsules are available in packs of 30 capsules in PVC/PVDC/Al blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Manufacturers:
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.