GABAPENTIN 800 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Gabapentin Teva, 600 mg, coated tablets
3. Gabapentin Teva, 800 mg, coated tablets
   1. You should read the contents of the leaflet before taking the medicine because it contains important information for the patient:
   2. Table of contents of the leaflet:
4. What is Gabapentin Teva and what is it used for
5. 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
6. How to take Gabapentin Teva
   1. Epilepsy - recommended dose
   2. Peripheral neuropathic pain - recommended dose
   3. Use in patients with renal impairment or patients undergoing hemodialysis
   4. Method and route of administration
   5. Taking a higher dose of Gabapentin Teva than recommended
   6. Missing a dose of Gabapentin Teva
   7. Stopping Gabapentin Teva
7. Possible side effects
   1. Due to the possible serious health consequences, you should stop taking Gabapentin Teva and contact your doctor immediately if you experience any of the following symptoms after taking Gabapentin Teva:
   4. Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious:
   5. Very common (may affect more than 1 in 10 people):
   6. Common (may affect up to 1 in 10 people):
   7. Uncommon (may affect up to 1 in 100 people):
   8. Rare (may affect up to 1 in 1000 people):
   9. After the introduction of gabapentin to the market, the following side effects have been reported:
   10. Reporting side effects
8. How to store Gabapentin Teva
9. 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 attached to the packaging: information for the user

Gabapentin Teva, 600 mg, coated tablets

Gabapentin Teva, 800 mg, coated tablets

gabapentin

You should read the contents of the leaflet before taking the medicine because it contains important information for the patient:

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you need advice or additional information.
• 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 the previously used treatment does not provide complete control over seizures. Gabapentin Teva should be taken as an adjunctive therapy 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 you are 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, you should discuss it with your doctor or pharmacist

• if you have kidney disease, your doctor may prescribe a different dosing schedule,
• if you are undergoing hemodialysis (to remove metabolic products due to kidney failure), you should tell your doctor if you experience pain or muscle weakness,
• if you experience symptoms such as persistent abdominal pain, nausea, and vomiting, you should contact your doctor immediately, as they may be symptoms of acute pancreatitis,
• if you have neurological disorders, respiratory disorders, or are over 65 years of age; your doctor may prescribe a different dose,
• before starting to take this medicine, you should tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal addictive substances; this may mean that the risk of dependence on Gabapentin Teva is higher.

Dependence
Some people may develop dependence on Gabapentin Teva (the need for continuous taking of the medicine). 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 you are concerned that you may become dependent on Gabapentin Teva, it is essential to consult your doctor.
If, while taking Gabapentin Teva, you notice any of the following signs, it may indicate the development of dependence.

• You feel that you need to take the medicine for longer than your doctor prescribed
• You feel that you need to take a higher dose than prescribed
• You use the medicine for purposes other than prescribed
• You have made multiple, unsuccessful attempts to stop or control the use of the medicine
• After stopping the medicine, you feel unwell, and after taking it again, you feel better.

If you notice any of the above behaviors, you should talk to your doctor to discuss the best treatment option for you, 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 you have ever had such thoughts, you should contact your doctor immediately.

Important information about potential serious side effects

In connection with the use of gabapentin, severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred. If any of the symptoms associated with severe skin reactions described in section 4 occur, you should stop taking gabapentin and contact your doctor immediately.
You should 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 (a significant increase in creatine phosphokinase levels in the blood). If you experience such subjective and objective symptoms, you should contact your doctor immediately.

Gabapentin Teva and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should especially tell your doctor (or pharmacist) about all medicines you have recently taken or are currently taking to treat seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patients 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, 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. It is recommended to take Gabapentin Teva at least 2 hours after taking an 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, you should inform your doctor or hospital that you are taking Gabapentin Teva.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, you should contact your doctor immediately to discuss the potential risk to the unborn child associated with taking this medicine.
• You should not stop treatment without discussing it with your doctor.
• If you plan to have a child, you should discuss your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or plan to breastfeed, you should contact your doctor or pharmacist before starting to take this medicine.

Pregnancy
Gabapentin Teva can be used during the first trimester of pregnancy if necessary.
If you plan to become pregnant, are pregnant, or think you may be pregnant, you should contact your doctor immediately.
If you become pregnant and have epilepsy, it is essential not to stop taking your medicine without first consulting your doctor, as this may worsen your condition. The severity of epilepsy may pose a risk to you and your 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, children of women who took gabapentin during pregnancy were at increased risk of low birth weight and preterm birth.
Gabapentin may cause withdrawal symptoms in newborns. This risk may be increased if gabapentin is taken with opioid painkillers (medicines used to treat severe pain).
If you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentin Teva, you should contact your doctor immediately. You should not suddenly stop taking this medicine, as it may lead to withdrawal seizures, which can have serious consequences for both you and your 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 you start driving or operating complex machines, or performing other potentially hazardous activities, you should wait until you know how this medicine affects you.

3. How to take Gabapentin Teva

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. Do not take more medicine than prescribed.

Epilepsy - recommended dose

Adults and adolescents
You should take the number of tablets prescribed by your 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 increased gradually 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 tablet (or tablets) in the morning, one in the afternoon, and one in the evening.
Gabapentin Teva should not be used in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults
You should take the number of tablets prescribed by your doctor. Your 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 your doctor, in 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).
In case of a lower dose recommendation, for which these strengths cannot be used, other strengths and pharmaceutical forms are available.

Use in patients with renal impairment or patients undergoing hemodialysis

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

Method and route of administration

Gabapentin Teva should be taken orally. The tablets 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 your doctor tells you to do so.

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 you have taken a higher dose of Gabapentin Teva than recommended, you should contact your doctor or go to the nearest hospital emergency department immediately. You should take the remaining tablets, packaging, and leaflet with you so that the hospital staff knows which medicine you have taken.

Missing a dose of Gabapentin Teva

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

Stopping Gabapentin Teva

You should not suddenly stop taking Gabapentin Teva. If you want to stop taking the medicine, you should first discuss it with your doctor. They will tell you how to do it. The medicine should be discontinued gradually, over a minimum period of 1 week. After stopping short-term or long-term treatment with Gabapentin Teva, you should be aware that certain side effects may occur, known as withdrawal symptoms. These symptoms may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headaches, depression, feeling abnormal, dizziness, and general malaise. These symptoms usually occur within 48 hours of stopping Gabapentin Teva. If you experience withdrawal symptoms, you should contact your doctor.
If you have any doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to the possible serious health consequences, you should stop taking Gabapentin Teva and contact your doctor immediately if you 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 severe 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).

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

• persistent abdominal pain, nausea, and vomiting, as they may be symptoms of acute pancreatitis
• breathing problems, which may require immediate and intensive medical attention to restore normal breathing, especially in severe cases.
• Gabapentin Teva may cause severe 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 appear. The above symptoms may require hospitalization or discontinuation of Gabapentin Teva. You should contact your doctor if you experience any of the following symptoms:
• skin rash and redness, and/or hair loss
• hives
• fever
• swollen lymph nodes that do not subside
• swelling of the lips, face, and tongue
• yellowing of the skin and eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unusual muscle pain
• frequent infections

The above symptoms may be the first signs of a severe reaction. Your doctor will decide whether to continue treatment with Gabapentin Teva.
If you are undergoing hemodialysis, you should tell your doctor if you 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, ear infections, or other infections
• decreased white blood cell count
• loss of appetite, increased appetite
• irritability towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
• seizures, involuntary muscle movements, speech problems, memory loss, tremors, sleep disturbances, headaches, increased sensitivity of the skin, 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, gingivitis, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• facial swelling, bruising, 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, in clinical trials in children, aggressive behavior and sudden limb jerks were frequently reported.

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
• high blood sugar levels (most commonly observed in patients with diabetes)

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

• low blood sugar levels (most commonly observed in patients with diabetes)
• loss of consciousness
• breathing problems, 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 jerks 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
• 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)
• risk of developing dependence on Gabapentin Teva ("drug dependence").

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Gabapentin Teva

Keep out of the 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 that month.
Do not store above 30°C.
Store in the original package, keep blisters in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 is gabapentin.
Gabapentin Teva, 600 mg, coated tablets
Each coated tablet contains 600 mg of gabapentin.
Gabapentin Teva, 800 mg, coated tablets
Each coated tablet contains 800 mg of gabapentin.
Other ingredients are:
Tablet core: copovidone, microcrystalline cellulose, crospovidone type A, talc, magnesium stearate.
Coating: polyvinyl alcohol, talc, polyethylene glycol, titanium dioxide.

What Gabapentin Teva looks like and contents of the pack

Gabapentin Teva coated tablets are available in two strengths, which can be distinguished by the engraved numbers:
Gabapentin Teva, 600 mg, coated tablets:
white or off-white, oval, coated tablet with beveled edges. On one side, the number "7173" is engraved, and on the other side, "93".
Gabapentin Teva, 800 mg, coated tablets:
white or off-white, oval, coated tablet with beveled edges. On one side, the number "7174" is engraved, and on the other side, "93".
The coated tablets are available in blisters containing 30, 50, 90, 100, or 200 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o., 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