Gabapentin Teva

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Gabapentin Teva(Gabapentina Teva)

800 mg, coated tablets

Gabapentinum
Gabapentin Teva and Gabapentina Teva are different trade names for the same medicine.

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

There have been reports of abuse and dependence associated with the use of gabapentin after it was introduced 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.

• Feeling that they need to take the medicine for longer than their doctor recommended
• Feeling that they need to take a higher dose than prescribed
• Taking the medicine for purposes other than prescribed
• Making repeated, unsuccessful attempts to stop or control the use of the medicine
• Feeling unwell after stopping the medicine and feeling 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

Severe 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 severe 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 after:"The patient should contact their doctor immediately if they 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 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 the patient experiences such subjective and objective symptoms, they 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, shallow breathing, or death.
Antacids for heartburn
If Gabapentin Teva is taken with 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 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, the patient should inform their doctor or hospital that they are taking 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 recommends it. Women of childbearing age must use effective contraception.
Although there are no studies evaluating 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. Whenever possible, but only in consultation with their doctor, pregnant women should take only one antiepileptic drug.
If the patient becomes pregnant, suspects they are pregnant, or plans to become pregnant while taking Gabapentin Teva, they should contact their doctor immediately.
The patient should not stop taking this medicine suddenly, as it may cause breakthrough seizures, which can have serious consequences for both the pregnant woman and her child.
Taking gabapentin during pregnancy may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken with opioid painkillers (medicines used to treat severe pain).
Breastfeeding
Gabapentin, the active substance of Gabapentin Teva, passes into human 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 doing so.

3. How to take Gabapentin Teva

This medicine should always be taken exactly as the doctor or pharmacist has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
The patient should not take more medicine than prescribed.
The doctor will determine the dose that is right for the patient.
Gabapentin Teva is available in the following doses: 600 mg and 800 mg.

Epilepsy - recommended dose

Adults and adolescents
The patient should take the number of tablets their doctor recommends. The dose is usually increased gradually. The most commonly used initial dose is from 300 to 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 will be determined by their doctor based on the child's weight.
Treatment starts with a small initial dose, which is gradually increased over a period of 3 days. The commonly used dose of the medicine that controls epilepsy is from 25 to 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
The patient should take the number of tablets their doctor recommends. The doctor will gradually increase the dose.
The commonly used initial dose is from 300 to 900 mg per day. It can then be gradually increased to a maximum dose of 3600 mg per day, taken as recommended by the doctor, in 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).
In case a lower dose is recommended, for which these strengths cannot be used, other strengths and pharmaceutical forms are available.

Use in patients with renal impairment or in patients undergoing hemodialysis

In patients with kidney disease or in patients undergoing hemodialysis, the doctor may recommend 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 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 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.
Gabapentin Teva should not be stopped unless the doctor recommends 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 any remaining tablets, packaging, and leaflet with them so that the hospital staff knows which medicine has been taken.

Missing a 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 a 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 the patient 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 may occur, known as withdrawal symptoms. 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.
If the patient has any doubts about taking this medicine, they 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:

after taking Gabapentin Teva, as they may be serious:

• 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 drug 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:

• severe skin reactions requiring immediate medical attention, swelling around the mouth and 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, 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 these reactions, a rash may or may not occur. The above symptoms may require hospitalization or discontinuation of Gabapentin Teva. The patient should contact their doctor if they experience any of the following symptoms:
• rash
• hives
• fever
• swollen lymph nodes that do not go away
• swelling of the lips and tongue
• yellowing of the skin or whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unusual muscle pains
• frequent infections.

The above symptoms may be the first signs of a severe 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):

• pneumonia, respiratory tract infections, urinary tract infections, ear infections, 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 sensitivity of the skin, decreased sensation (numbness), coordination disorders, abnormal eye movements, exaggerated, decreased, 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, 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):

• agitation (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
• 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 with Gabapentin Teva, the patient should be aware that certain side effects may occur, known as withdrawal symptoms (see "Stopping Gabapentin Teva").

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

• decreased platelet count (cells responsible for blood clotting)
• suicidal thoughts, hallucinations
• abnormal movements, such as twisting of the limbs or sudden, involuntary movements 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).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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

Keep 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 the month stated.
Do not store above 30°C.
Store in the original packaging. Blister packs 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gabapentin Teva contains

The active substance is gabapentin. Each coated tablet contains 800 mg of gabapentin.
The other ingredients are:
Tablet core: copovidone, microcrystalline cellulose, crospovidone, talc, magnesium stearate.
Coating: polyvinyl alcohol, talc, macrogol, titanium dioxide.

What Gabapentin Teva looks like and contents of the pack

Gabapentin Teva, coated tablets, is available in two strengths, which can be distinguished by the engraved numbers.
Gabapentin Teva, 800 mg, coated tablets, are white or almost white, oval, coated tablets with beveled edges. On one side, the number "7174" is engraved, and on the other side, "93".
The coated tablets are available in blister packs containing 100 tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Teva Pharma – Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5-A, Piso 2
2740-245 Porto Salvo
Portugal

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., ul. Mogilska 80, 31-546 Kraków

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number:5564588

Parallel import authorization number: 106/23

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

Date of leaflet approval: 07.06.2023