Gabapentin Aurobindo

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

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

Generic Medicine
Read this entire leaflet carefully before 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, inform 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 taking 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 Gabapentin Aurobindo is and what it is used for

Gabapentin Aurobindo belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-term chronic pain caused by nerve damage).
The active substance of Gabapentin Aurobindo is gabapentin.
Gabapentin Aurobindo 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 Aurobindo as an add-on treatment for epilepsy when your current therapy does not fully control your condition.
You must take Gabapentin Aurobindo in addition to your ongoing treatment unless otherwise instructed. Gabapentin Aurobindo may also be used as monotherapy for the treatment of adults and children aged over 12 years.
Peripheral neuropathic pain (long-lasting pain caused by nerve damage). Various 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, pulsing, shooting pains, stabbing pains, sharp pains, cramping pains, aching, 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 you a different dosage
• if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor
• if you develop muscle pain and/or weakness
• if you experience symptoms such as persistent stomach pain, nausea and vomiting, contact your doctor immediately, as these symptoms may indicate acute pancreatitis (inflammation of the pancreas).
• if you have neurological/respiratory disorders or are over 65 years of age, your doctor may prescribe different doses.*

Post-marketing experience with gabapentin has shown cases of abuse and dependence. Speak with your doctor if you have a history of substance abuse or dependence.
A small number of patients treated with antiepileptic medicines such as gabapentin have had suicidal thoughts or actions. If you experience any such thoughts, contact your doctor immediately.
Important information about potentially serious reactions
A limited number of patients treated with Gabapentin Aurobindo have experienced allergic reactions or potentially serious skin reactions which, if not treated, may progress to more severe problems. You should be aware of these symptoms so that you can recognize them while taking Gabapentin Aurobindo.
Please 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 may be serious.”
Muscle weakness, tenderness or pain, especially if accompanied by feeling unwell or having a fever, may be due to abnormal breakdown of muscle tissue, which can be life-threatening and lead to kidney problems. You may also notice discoloured urine and changes in blood test results (particularly increased creatine phosphokinase in the blood). If you experience any of these signs or symptoms, contact your doctor immediately.
Warning: 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, 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 enhance the effect of gabapentin. In addition, combining gabapentin with opioids may cause symptoms such as drowsiness and/or reduced breathing.

Antacids for indigestion
If Gabapentin Aurobindo and antacids containing aluminium and magnesium are taken at the same time, 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 an antacid.

Gabapentin Aurobindo:
* Is not expected to interact with other antiepileptic drugs or with oral contraceptives.
* May interfere with certain laboratory tests; if you require a urine test, inform your doctor or hospital about the medicines you are taking.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Gabapentin Aurobindo should not be taken during pregnancy unless your doctor has advised you 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, other medicines used to treat epileptic seizures have been associated with an increased risk of fetal developmental harm, particularly when more than one antiepileptic medicine is taken at the same time. Therefore, whenever possible and only under medical advice, you should try to use a single antiepileptic medicine during pregnancy.
Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning a pregnancy while taking Gabapentin Aurobindo.
Do not stop taking this medicine suddenly, as this may cause sudden epileptic seizures which could have serious consequences for you and your baby.

Breastfeeding
Gabapentin, the active substance of Gabapentin Aurobindo, is excreted in breast milk. Since 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 may cause dizziness, drowsiness and fatigue. Do 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.

3. How to take Gabapentin Aurobindo

Take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
Epilepsy, recommended dose:
Adults and adolescents:
Take the number of capsules prescribed for you. 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 by your doctor up to a
maximum of 3600 mg per day, which should be taken in 3 doses, for example one in the morning, one in the afternoon and one in the evening.
Children aged 6 years and older:
The dose for your child will be decided by the doctor, as it is calculated based on the child's weight. Treatment starts 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 6 years of age.
Peripheral neuropathic pain, recommended dose:
Adults:
Take the number of capsules prescribed by your doctor. Usually, your doctor will gradually
increase your 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 instruct you to take this dose in 3
doses, for example one in the morning, one in the afternoon and one in the evening.
If you have kidney problems or are undergoing 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 (aged over 65 years)
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 dosing schedule 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 a generous amount 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 may cause side effects including loss of
consciousness, dizziness, double vision, speech difficulties, drowsiness and diarrhoea. If
you take more Gabapentin Aurobindo than prescribed by your doctor, contact your doctor or go immediately to the nearest hospital emergency department. Take with you any unused capsules or tablets, together with the container and the label, so that the hospital can easily identify 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 almost time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking Gabapentin Aurobindo
Do not stop treatment with Gabapentin Aurobindo unless your doctor tells you to. Discontinuation of treatment should be done gradually over at least 1 week. If you stop treatment with gabapentin suddenly, or stop before your doctor has instructed you to do so, your risk of epileptic seizures increases.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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, life-threatening allergic reaction including difficulty breathing, swelling of the 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 may cause a severe or life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood. You may or may not have a skin rash with this type of reaction. This may require hospitalization or discontinuation of treatment with Gabapentin Aurobindo. Call your doctor immediately if you experience any of the following symptoms:

  o skin rash
  o hives
  o fever
  o persistent swelling of lymph glands
  o swelling of the lips and tongue
  o yellowing of the skin or whites of the eyes
  o unusual bleeding or bruising
  o severe fatigue or weakness
  o sudden muscle pain
  o frequent infections—these may require emergency and intensive care to maintain normal breathing.
  These symptoms may be early signs of a serious allergic reaction. A doctor should examine you to determine whether you should continue taking Gabapentin Aurobindo.
  If you are on hemodialysis, inform your doctor if you develop muscle pain and/or weakness.

Other adverse reactions 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
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasms, 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, hot flushes or blood vessel dilation
• Breathing difficulties, bronchitis, sore throat, cough, nasal dryness
• Vomiting (feeling unwell), nausea (feeling sick), dental problems, inflamed gums, diarrhea, stomach ache, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, skin rash, itching, acne
• Joint pain, muscle pain, back pain, spasms
• Erectile dysfunction (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 behavior and jerky movements have been 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
• Rapid heartbeat
• Swelling that may affect the face, trunk and limbs
• Abnormal blood test results suggesting liver problems
• Mental impairment
• Falls
• Increased blood glucose levels (observed more frequently in diabetic patients)

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

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

Following marketing, the following adverse reactions have been reported:

• Reduced platelet count (cells responsible for blood clotting)
• Hallucinations
• Movement disorders such as convulsive agitation, jerky movements and rigidity
• Ringing in the ears
• A group of side effects occurring together, including swollen lymph nodes (small isolated swellings visible under the skin), fever, skin rash and liver inflammation
• 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 fiber breakdown (rhabdomyolysis)
• Changes in blood tests (increased creatine phosphokinase)
• Sexual function problems including inability to reach orgasm, delayed ejaculation
• Low sodium levels in the blood

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting adverse reactions, 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 stated on the carton/labelling/bottle after EXP. The expiry date refers to the last day of that month.
Store below 25 °C.
Blister: store in the original packaging.
HDPE bottle: store in the original container.
Use within 12 months after first opening the HDPE bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Other information

What Gabapentin Aurobindo contains
* The active substance 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 components are:
Capsule contents: maize starch and talc.
Capsule shell:
100 mg: Titanium dioxide (E171), sodium lauryl sulfate, gelatin.
300 mg: Yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, gelatin.
400 mg: 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 capsules with "D" printed on the white cap and "02" on the white body, containing white to off-white crystalline powder.
Gabapentin 300 mg capsules with "D" printed on the yellow cap and "03" on the yellow body, containing white to off-white crystalline powder.
Gabapentin 400 mg capsules with "D" printed on the orange cap and "04" on the orange body, containing white to off-white crystalline powder.

Gabapentin 100 mg capsules are available in:
* PVC/PVDC-Aluminum blisters in packs of 10, 20, 30, 50, 60, 90, 100 and 200 hard capsules
* HDPE bottles with polypropylene closure containing silica gel desiccant: 100, 200 and 1000 hard capsules

Gabapentin 300 mg capsules are available in:
* PVC/PVDC-Aluminum blisters in packs of 10, 20, 30, 50, 60, 90, 100 and 200 hard capsules
* HDPE bottles with polypropylene closure containing silica gel desiccant: 100, 200 and 1000 hard capsules

Gabapentin 400 mg capsules are available in:
* PVC/PVDC-Aluminum blisters in packs of 10, 20, 30, 50, 60, 90, 100, 200 and 300 hard capsules
* HDPE bottles with polypropylene closure containing silica gel desiccant: 100, 200, 300 and 500 hard capsules

Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in EEA Member States under the following names:
Czech Republic Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg tvrdé tobolky
Denmark Gabapentin Aurobindo
France Gabapentine Arrow Génériques 100 mg/ 300 mg/ 400 mg, gélules
Germany Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg Hartkapseln
Ireland Gabin 100 mg/ 300 mg/ 400 mg capsules, hard
Italy Gabapentin Aurobindo
Latvia Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg cietās kapsulas
Lithuania Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg kietos kapsulės
Netherlands Gabapentine Aurobindo 100 mg/ 300 mg/ 400 mg, capsules, hard
Portugal Gabapentina Aurobindo
Romania Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg capsule
Slovakia Gabapentin Vipharma 100 mg/ 300 mg/ 400 mg tvrdé kapsuly
Spain Gabapentina Aurobindo 100 mg/ 300 mg/ 400 mg cápsulas duras
Sweden Gabapentin Aurobindo 100 mg/ 300 mg/ 400 mg kapslar, hårda
United Kingdom Gabapentin Milpharm 100 mg/ 300 mg/ 400 mg capsules, hard

This summary of product characteristics was last approved on