GABAPENTIN 100 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Gabapentin Teva, 100 mg, hard capsules
3. Gabapentin Teva, 300 mg, hard capsules
4. Gabapentin Teva, 400 mg, hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Gabapentin Teva and what is it used for
6. Important information before taking Gabapentin Teva
   1. When not to take Gabapentin Teva
   2. Warnings and precautions
   3. Important information about potential serious side effects
   4. Gabapentin Teva and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Gabapentin Teva, 300 mg, hard capsules contain orange yellow FCF (E110)
7. How to take Gabapentin Teva
   1. Epilepsy - recommended dose
   2. Peripheral neuropathic pain - recommended dose
   3. Use in patients with renal impairment or in patients undergoing hemodialysis
   4. Method of administration
   5. Taking a higher dose of Gabapentin Teva than recommended
   6. Missing a dose of Gabapentin Teva
   7. Stopping Gabapentin Teva
8. Possible side effects
   1. Due to the possible serious health consequences, the patient should stop taking Gabapentin Teva and contact their doctor immediately if they experience any of the following symptoms after taking Gabapentin Teva:
   4. The patient should contact their doctor immediately if they experience any of the following symptoms after taking this medicine, as they may be serious:
   5. The above symptoms may be the first signs of a serious reaction. The doctor should decide whether to continue treatment with Gabapentin Teva.
   6. Very common (may affect more than 1 in 10 people):
   7. Common (may affect up to 1 in 10 people):
   8. Uncommon (may affect up to 1 in 100 people):
   9. Rare (may affect up to 1 in 1000 people):
   10. After the introduction of gabapentin to the market, the following side effects have been reported:
   11. Reporting side effects
9. How to store Gabapentin Teva
10. Contents of the pack and other information
    1. What Gabapentin Teva contains
    2. What Gabapentin Teva looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet: June 2024

Leaflet accompanying the packaging: patient information

Gabapentin Teva, 100 mg, hard capsules

Gabapentin Teva, 300 mg, hard capsules

Gabapentin Teva, 400 mg, hard capsules

Gabapentinum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

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

• -various forms of epilepsy (seizures initially limited to specific areas of the brain, which spread to the rest of the brain or not). Gabapentin Teva is prescribed to adults and children aged 6 years and older as an adjunctive therapy for epilepsy, when previous treatments have not provided complete control of seizures. Gabapentin Teva should be taken as an additional treatment for epilepsy in adults and children aged 6 years and older, unless the doctor advises otherwise. Gabapentin Teva can also be used as monotherapy in adults and children over 12 years of age.
• peripheral neuropathic pain (long-lasting pain caused by nerve damage). Peripheral (mainly occurring in the lower and/or upper limbs) neuropathic pain is caused by many different diseases, such as diabetes or shingles. Patients describe the pain they feel as burning, tingling, pulsating, piercing, stabbing, sharp, similar to that accompanying muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Gabapentin Teva

When not to take Gabapentin Teva

Warnings and precautions

Before starting treatment with Gabapentin Teva, the patient should discuss it with their doctor or pharmacist.

• before starting this medicine, the patient should tell their doctor if they have ever abused or been dependent on alcohol, prescription drugs, or illegal substances; this may mean that the risk of dependence on Gabapentin Teva is higher.

Dependence
In some people, dependence on Gabapentin Teva (the need for continuous taking of the medicine) may develop. After stopping the use of Gabapentin Teva, they may experience withdrawal symptoms (see section 3, "How to take Gabapentin Teva" and "Stopping Gabapentin Teva"). If the patient is concerned that they may become dependent on Gabapentin Teva, it is essential to consult a doctor.
If, while taking Gabapentin Teva, the patient notices any of the following signs, it may indicate the development of dependence.

• Feels that they need to take the medicine for longer than their doctor prescribed
• Feels that they need to take a higher dose than prescribed
• Takes the medicine for purposes other than prescribed
• Has made multiple, unsuccessful attempts to stop or control the use of the medicine
• Feels unwell after stopping the medicine and feels better after taking it again

If the patient notices any of the above behaviors, they should talk to their doctor to discuss the best course of treatment, including determining when it is appropriate to stop taking the medicine and how to do it safely.
A small number of people taking antiepileptic drugs containing gabapentin have thought about harming themselves or committing suicide. If the patient ever has such thoughts, they should contact their doctor immediately.

Important information about potential serious side effects

In connection with the use of gabapentin, serious skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have occurred. If any of the symptoms associated with serious skin reactions described in section 4 occur, the patient should stop taking gabapentin and contact their doctor immediately.
Read the description of serious symptoms in section 4"You should 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, especially if accompanied by malaise and high fever, may be caused by abnormal muscle fiber breakdown, which can be life-threatening and lead to kidney problems. There may be a change in urine color and changes in blood test results (significantly elevated creatine phosphokinase levels in the blood). If such subjective and objective symptoms occur, the patient should contact their doctor immediately.

Gabapentin Teva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should tell their doctor (or pharmacist) about all medicines recently or currently used to treat seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.
Opioid-containing medicines, such as morphine
Patient taking opioid-containing medicines (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Gabapentin Teva.
Additionally, concomitant use of Gabapentin Teva and opioids may cause drowsiness, sedation, shallow breathing, or death.
Antacids for heartburn
In the case of concomitant use of Gabapentin Teva and antacids containing aluminum and magnesium, the absorption of Gabapentin Teva from the stomach may be limited. Therefore, it is recommended to take Gabapentin Teva at least 2 hours after taking the antacid.

• Gabapentin Teva is not expected to interact with other antiepileptic medicines or oral contraceptives.
• it may affect the results of some laboratory tests; if a urine test is to be performed, the patient should inform their doctor or hospital about the use of Gabapentin Teva.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or thinks they may be pregnant, they should consult their doctor to discuss the potential risk to the unborn child associated with taking this medicine.
• Do not stop treatment without discussing it with your doctor.
• If the patient plans to have a child, they should discuss their treatment with their doctor or pharmacist as soon as possible before becoming pregnant.
• If the patient is breastfeeding or plans to breastfeed, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy
Gabapentin Teva can be used during the first trimester of pregnancy if necessary.
If the patient plans to become pregnant, is pregnant, or thinks they may be pregnant, they should contact their doctor immediately.
If the patient becomes pregnant and has epilepsy, it is essential not to stop taking the medicine without first consulting their doctor, as this may worsen the course of the disease. The severity of epilepsy may pose a risk to the patient and their unborn child.
In a study involving data from Scandinavian women who took gabapentin during the first 3 months of pregnancy, no increased risk of birth defects or developmental problems (neurodevelopmental disorders) was found. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and preterm birth.
Gabapentin may cause withdrawal symptoms in newborns. This risk may be increased when gabapentin is taken with opioid painkillers (medicines used to treat severe pain).
In the event of pregnancy, suspected pregnancy, or planning pregnancy while taking Gabapentin Teva, the patient should contact their doctor immediately. Do not stop taking this medicine abruptly, as this may lead to withdrawal seizures, which can have serious consequences for both the pregnant woman and her child.
Breastfeeding
Gabapentin, the active substance of Gabapentin Teva, passes into breast milk. Since it is not known what effect it has on the breastfed child, breastfeeding is not recommended while taking Gabapentin Teva.
Fertility
In animal studies, no effect on fertility has been found.

Driving and using machines

Gabapentin Teva may cause dizziness, drowsiness, and fatigue. Before the patient is sure how this medicine affects their ability to drive, use complex machines, or perform other potentially hazardous activities, they should refrain from doing so.

Gabapentin Teva, 300 mg, hard capsules contain orange yellow FCF (E110)

The medicine may cause allergic reactions.

3. How to take Gabapentin Teva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Do not take more medicine than prescribed.
The dose suitable for the individual patient is determined by the doctor.

Epilepsy - recommended dose

Adults and adolescents
Take the number of capsules as prescribed by the doctor. Doses are usually increased gradually.
The usual starting dose is 300-900 mg per day. It can then be gradually increased to a maximum dose of 3600 mg per day, divided into 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).
Children aged 6 years and older:
The dose to be given to the child is determined by the doctor based on the child's body weight.
Treatment starts with a small initial dose, which is gradually increased over 3 days.
The usual dose of the medicine that ensures control of epilepsy is 25-35 mg/kg body weight per day. The medicine is usually taken in three divided doses, one capsule (or capsules) in the morning, one in the afternoon, and one in the evening.
Gabapentin Teva is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults
Take the number of capsules as prescribed by the doctor. The doctor will gradually increase the dose.
The usual starting dose is 300-900 mg per day. It can then be gradually increased to a maximum dose of 3600 mg per day, taken as prescribed by the doctor, in 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or in patients undergoing hemodialysis

In patients with kidney disease or undergoing hemodialysis, the doctor may recommend a different dosing schedule and/or a different dose.
Elderly patients (over 65 years)should take Gabapentin Teva according to the normally recommended dosing schedule, unless they have kidney disease. In patients with kidney disease, the doctor may recommend a different dosing schedule and/or a different dose.
If the patient feels that the effect of Gabapentin Teva is too strong or too weak, they should consult their doctor or pharmacist.

Method of administration

Gabapentin Teva should be taken orally. The capsules should always be swallowed whole, with a large amount of water.
Gabapentin Teva can be taken with or without food.
Do not stop taking Gabapentin Teva until the doctor advises it.

Taking a higher dose of Gabapentin Teva than recommended

Taking higher doses than recommended may cause an increased number of side effects, including loss of consciousness, dizziness, double vision, blurred speech, drowsiness, and diarrhea. If the patient has taken a higher dose of Gabapentin Teva than recommended, they should contact their doctor or go to the nearest hospital emergency department immediately. They should take the remaining capsules, packaging, and leaflet with them, so that the hospital staff knows which medicine was taken.

Missing a dose of Gabapentin Teva

If a dose is missed, the patient should take it as soon as they remember, unless it is time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping Gabapentin Teva

Do not stop taking Gabapentin Teva abruptly. If the patient wants to stop taking the medicine, they should first discuss it with their doctor. The doctor will advise them on how to do it. The medicine should be stopped gradually, over a minimum of 1 week. After stopping short-term or long-term treatment with Gabapentin Teva, the patient should be aware that certain side effects, known as withdrawal symptoms, may occur. These symptoms may include seizures, anxiety, difficulty sleeping, nausea (nausea), pain, sweating, tremors, headache, depression, feeling abnormal, dizziness, and general malaise. These symptoms usually occur within 48 hours of stopping Gabapentin Teva. If withdrawal symptoms occur, the patient should contact their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gabapentin Teva can cause side effects, although not everybody gets them.

Due to the possible serious health consequences, the patient should stop taking Gabapentin Teva and contact their doctor immediately if they experience any of the following symptoms after taking Gabapentin Teva:

• red, non-raised, plate-like or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. 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 or hypersensitivity syndrome).

The patient should contact their doctor immediately if they experience any of the following symptoms after taking this medicine, as they may be serious:

• persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• breathing difficulties, which may require immediate and intensive medical attention to restore normal breathing
• Gabapentin Teva may cause serious or life-threatening allergic reactions that can affect the skin or other parts of the body, such as the liver or blood cells. During the occurrence of this type of reaction, a rash may or may not occur. The above symptoms may result in hospitalization or the need to stop taking Gabapentin Teva. The patient should contact their doctor if they experience any of the following symptoms:
• skin rash and redness, and/or hair loss
• hives
• fever
• swollen lymph nodes that do not go away
• swelling of the lips, face, and tongue
• yellowing of the skin and whites of the eyes (jaundice)
• abnormal bruising or bleeding
• severe fatigue or weakness
• unusual muscle pain
• frequent infections

The above symptoms may be the first signs of a serious reaction. The doctor should decide whether to continue treatment with Gabapentin Teva.

If the patient is undergoing hemodialysis, they should tell their doctor if they experience 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
• fatigue, fever

Common (may affect up to 1 in 10 people):

• pneumonia, respiratory tract infections, urinary tract infections, infection, ear infection, or other infections
• decreased white blood cell count
• loss of appetite, increased appetite
• anger towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
• seizures, sudden muscle movements, speech problems, memory loss, tremors, sleep disturbances, headaches, increased skin sensitivity, numbness, coordination problems, abnormal eye movements, exaggerated, weakened, or absent reflexes
• blurred vision, double vision
• dizziness
• high blood pressure, flushing, or vasodilation
• shortness of breath, bronchitis, sore throat, cough, dryness in the nose
• facial swelling, bruising, rash, itching
• joint pain, muscle pain, back pain, muscle tremors
• erectile dysfunction (impotence)
• swelling of the feet and hands, difficulty walking, weakness, pain, malaise, flu-like symptoms
• decreased white blood cell count, weight gain
• accidental injuries, bone fractures, skin abrasions

In addition, aggressive behavior and sudden limb movements have been commonly reported in children in clinical trials.

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

• restlessness (a state of constant restlessness and unintentional, purposeless movements)
• allergic reactions, such as hives
• decreased mobility
• rapid heartbeat
• difficulty swallowing
• swelling, which may include the face, torso, and limbs
• abnormal blood test results suggesting liver problems
• psychiatric disorders
• falls
• elevated blood glucose levels (most commonly observed in patients with diabetes)

Rare (may affect up to 1 in 1000 people):

• low blood glucose levels (most commonly observed in patients with diabetes)
• loss of consciousness
• breathing difficulties, shallow breathing (respiratory depression)

After the introduction of gabapentin to the market, the following side effects have been reported:

• decreased platelet count (cells responsible for blood clotting)
• suicidal thoughts, hallucinations
• abnormal movements, such as twisting of limbs or sudden jerking and stiffness
• ringing in the ears
• yellowing of the skin and eyes (jaundice), hepatitis
• acute kidney failure, urinary incontinence
• breast tissue enlargement, breast enlargement
• side effects after sudden stopping of gabapentin (anxiety, sleep problems, nausea, pain, excessive sweating), chest pain
• changes in blood glucose levels in patients with diabetes
• muscle fiber breakdown (rhabdomyolysis)
• changes in blood test results (elevated creatine phosphokinase levels)
• sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• low sodium levels in the blood
• anaphylactic reactions (severe, potentially life-threatening reactions involving difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure requiring immediate treatment)
• risk of developing dependence on Gabapentin Teva ("drug dependence").

After stopping short-term or long-term treatment with Gabapentin Teva, the patient should be aware that certain side effects, known as withdrawal symptoms, may occur (see "Stopping Gabapentin Teva").

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gabapentin Teva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date:" or "EXP:". The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package.
Blisters should be stored in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Gabapentin Teva contains

The active substance of the medicine is gabapentin.
Each hard capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.
The other ingredients are:
Gabapentin Teva, 100 mg hard capsules
Core: talc, maize starch, cornstarch
Capsule cap and body: gelatin, iron oxide black (E172), titanium dioxide (E171)
Printing ink: shellac, iron oxide black (E172), propylene glycol
Gabapentin Teva, 300 mg, hard capsules
Core: talc, maize starch, cornstarch
Capsule cap and body: gelatin, erythrosine (E127), orange yellow FCF (E110), titanium dioxide (E171)
Printing ink: shellac, iron oxide black (E172), propylene glycol
Gabapentin Teva, 400 mg, hard capsules
Core: talc, maize starch, cornstarch
Capsule cap and body: gelatin, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171)
Printing ink: shellac, iron oxide black (E172), propylene glycol

What Gabapentin Teva looks like and contents of the pack

Gabapentin Teva, 100 mg, hard capsules
Hard gelatin capsule with a gray cap and body, filled with a white or off-white powder in small aggregates. The cap and body are printed with the numbers "93" and "38".
The pack contains 10, 20, 28, 50, 90, 100, 200, 500, or 1000 hard capsules.
Gabapentin Teva, 300 mg, hard capsules
Hard gelatin capsule with an orange cap and body, filled with a white or off-white powder in small aggregates. The cap and body are printed with the numbers "93" and "39".
The pack contains 10, 20, 28, 50, 90, 100, 200, 500, or 1000 hard capsules.
Gabapentin Teva, 400 mg, hard capsules
Hard gelatin capsule with a brown cap and body, filled with a white or off-white powder in small aggregates. The cap and body are printed with the numbers "93" and "40".
The pack contains 10, 20, 28, 30, 50, 90, 100, 200, 500, or 1000 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw

Manufacturer

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Krakow

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: June 2024