Gabapentin Teva

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gabapentin Teva (Gabapentine Teva), 400 mg, hard capsules

Gabapentinum
Gabapentin Teva and Gabapentine Teva are different trade names for the same drug.

The patient should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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. Package contents 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 treatment for epilepsy when the current treatment does not provide complete control of seizures. Gabapentin Teva should be taken as an adjunctive 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 experience 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

• if the patient is allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• if the patient has kidney disease, the doctor may recommend a different dosing schedule,
• if the patient is undergoing hemodialysis (to remove metabolic products due to kidney failure), they should tell their doctor if they experience pain and/or muscle weakness,
• if the patient experiences symptoms such as persistent abdominal pain, nausea, and vomiting, they should contact their doctor immediately, as these may be symptoms of acute pancreatitis,
• if the patient has neurological disorders, respiratory disorders, or is over 65 years of age; the doctor may recommend a different dosage,
• before starting to take 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.

There have been reports of abuse and dependence associated with the use of gabapentin after its introduction to the market. If the patient has a history of drug abuse or dependence, they should tell their doctor.
Dependence
In some people, dependence on Gabapentin Teva (the need for continuous use 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 prescribed by the doctor
• 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 for them, 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

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with the use of gabapentin. If any of the symptoms of serious skin reactions described in section 4 occur, the patient should stop taking gabapentin and contact their doctor immediately.
The patient should read the description of the above symptoms in section 4 of this leaflet"The patient should contact their doctor immediately if any of the following symptoms occur after taking this medicine, as it may be serious".
Muscle weakness, tenderness, or pain, especially if accompanied by malaise and 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 (a significant increase in creatine phosphokinase levels in the blood). If such objective and subjective 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, the patient 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.
Medicines containing opioids, such as morphine
The patient taking medicines containing opioids (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, respiratory depression, 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 reduced. 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.
• may affect the results of some laboratory tests; if a urine test is 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 breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Gabapentin Teva should not be taken during pregnancy, unless the doctor advises otherwise. Women of childbearing age must use effective contraception.
Although no studies have been conducted to evaluate the use of gabapentin in pregnant women, other antiepileptic drugs have been reported to increase the risk of harm to the developing child, especially when multiple antiepileptic drugs are used concomitantly. Whenever possible, but only in consultation with the doctor, pregnant women should take only one antiepileptic drug.
The patient should not stop taking this medicine suddenly, as it may cause seizure breakthrough, which can lead to serious consequences for both the pregnant woman and her child.
In the event of pregnancy, suspected pregnancy, or planning pregnancy while taking Gabapentin Teva, the patient should contact their doctor immediately.
The patient should not stop taking this medicine suddenly, as it may lead to the occurrence of withdrawal seizures, which can lead to serious consequences for both the pregnant woman and her child.
The use of gabapentin during pregnancy may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken with opioid painkillers (drugs used to treat severe pain).
Breastfeeding
Gabapentin, the active substance of Gabapentin Teva, passes into breast milk. Since it is not known what effect this has on the breastfed child, breastfeeding is not recommended during treatment with Gabapentin Teva.
Fertility
In animal studies, no effect on fertility has been observed.

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 avoid them.

3. How to take Gabapentin Teva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The patient should not take more medicine than prescribed.
Gabapentin Teva is available in the following strengths: 100 mg, 300 mg, 400 mg.
The doctor will determine the dose suitable for the individual patient.

Epilepsy - recommended dose

Adults and adolescents
The patient should take the number of capsules prescribed by their doctor. The dose is usually increased gradually. The most commonly used initial 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 a period of 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
The patient should take the number of capsules prescribed by their doctor. The doctor will gradually increase the dose.
The usual initial 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 the case of patients with kidney disease or patients undergoing hemodialysis, the doctor may recommend a different dosing schedule and/or a different dose.
Patients over 65 years of ageshould take Gabapentin Teva according to the normally recommended dosing schedule, unless they have kidney disease. In the case of 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.
The patient should not stop taking Gabapentin Teva until their doctor advises them to do so.

Overdose of Gabapentin Teva

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 more Gabapentin Teva than recommended, they should contact their doctor or go to the nearest hospital emergency department immediately.
The patient should take the remaining capsules, packaging, and leaflet with them so that the hospital staff can immediately see what medicine has been taken.

Missed dose of Gabapentin Teva

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

Stopping Gabapentin Teva

The patient should not stop taking Gabapentin Teva suddenly. If the patient wants to stop taking the medicine, they should first discuss it with their doctor. The doctor will tell them how to do it. The medicine should be stopped gradually, over a minimum period of 1 week. After stopping short-term or long-term treatment with Gabapentin Teva, the patient should be aware that certain side effects, called withdrawal symptoms, may occur. These symptoms may include seizures, anxiety, difficulty sleeping, 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 the use of 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.

The patient should stop taking Gabapentin Teva and contact their doctor immediately if they experience any of the following symptoms:

as they can be serious:

• red, non-raised, patchy, or circular 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 reactions 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 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:

• serious skin reactions requiring immediate medical attention, swelling around the mouth, and swelling of the face, skin rash, and redness, and (or) hair loss (these may be symptoms of a severe allergic reaction)
• 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 be the reason for 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
• hives
• fever
• swollen lymph nodes that do not go away
• swelling of the lips and tongue
• yellowing of the skin or the whites of the eyes (jaundice)
• unusual bruising or bleeding
• severe fatigue or weakness
• unusual muscle pains
• frequent infections.

The above symptoms may be the first signs of a serious reaction. The doctor will 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):

• lung infections, respiratory tract infections, urinary tract infections, infections, ear infections, or other infections
• decreased white blood cell count
• loss of appetite, increased appetite
• aggression 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 disorders, 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
• vomiting, nausea, dental problems, gum inflammation, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• facial swelling, bruising, skin rash, itching, acne
• 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 continuous 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
• increased 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).

Frequency not known: frequency cannot be estimated from the available data

• development of dependence on the medicine ("medicine dependence").

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

The following side effects have been reported after Gabapentin Teva was introduced to the market:

• 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), liver inflammation
• 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 (increased 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).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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
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.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should not be stored at temperatures above 25°C. It should be stored in the original packaging.
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. Package contents and other information

What Gabapentin Teva contains

The active substance of the medicine is gabapentin.
Each hard capsule contains 400 mg of gabapentin.
The other ingredients are:
Core of the capsule: talc, gelatinized starch.
Capsule shell and body: gelatin, iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171)
Printing ink: shellac (E 904), iron oxide black (E 172), propylene glycol.

What Gabapentin Teva looks like and what the package contains

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 package contains 10, 20, 30, 50, 90, 100, 200, 500, or 1000 hard capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Teva BV, Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands marketing authorization number: RVG 31982

Parallel import authorization number: 233/24

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

Norway
Gatonin 400 mg hard capsules
Germany
GABAPENTIN-TEVA 400 mg hard capsules
Czech Republic
Gabapentin-Teva 400 mg
Poland
Gabapentin Teva
Portugal
Gabapentina Teva 400 mg capsules
Slovakia
Gabapentin-Teva 400 mg

Date of leaflet approval: 10.06.2024

[Information about the trademark]