Gabapentin Teva 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Teva 800 mg film-coated tablets EFG

Contents of the package leaflet

1. What Gabapentin Teva is and what it is used for
2. What you need to know 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 Gabapentin Teva is and what it is used for

Gabapentin Teva belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active substance in Gabapentin Teva is gabapentin.

Gabapentin Teva is used to treat:

• Certain types of epilepsy (seizures that initially begin in specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor (aged 6 years or older) may prescribe Gabapentin Teva to help manage epilepsy when current treatment does not fully control the condition. You or your child (aged 6 years or older) should take gabapentin in combination with current treatment, unless otherwise instructed by your doctor. Gabapentin may also be used as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various medical conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles (herpes). The sensation of pain may be described as heat, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, or pins and needles, among others.

2. What you need to know before taking Gabapentina Teva

Do not take Gabapentina Teva:

? If you are allergic (hypersensitive) to gabapentin or to any of the components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentina Teva:

• if you have kidney problems, your doctor may prescribe a different dosing regimen.
• if you are undergoing haemodialysis (to remove waste products due to kidney failure), inform your doctor immediately if you start experiencing muscle pain and/or weakness.

? if you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately, as these may be symptoms of acute pancreatitis (inflamed pancreas).

• if you have a nervous system disorder or a respiratory disorder, or if you are over 65 years old, your doctor may prescribe a different dose.
• if you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on gabapentin.

Cases of abuse and dependence on gabapentin have been reported from post-marketing experience. Speak with your doctor if you have a history of substance abuse or dependence.

A small number of people being treated with antiepileptic medicines such as gabapentin have had suicidal thoughts or thoughts about harming themselves. If at any time you experience such thoughts, contact your doctor immediately.

Dependence

Some people may develop dependence (a need to continue taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin or reduce the dose (see section 3, "How to take Gabapentina Teva" and "If you stop taking Gabapentina Teva"). If you are concerned about developing dependence on gabapentin, it is important to consult your doctor.

If you experience any of the following signs while taking gabapentin, it may indicate that you have developed dependence:

• You feel you need to take the medicine for longer than prescribed.
• You feel you need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• You have tried several times to stop taking the medicine or control how you take it, but have been unsuccessful.
• When you stop taking the medicine, you feel unwell and feel better when you start taking it again.

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

Important information about potentially serious reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

Read the description of these symptoms in section 4 of this leaflet: “Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as it could be serious.”

Muscle weakness, tenderness, or pain on palpation—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibres, which may lead to kidney problems and be life-threatening. You may also experience discolouration of the urine and changes in blood test results (a significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Taking Gabapentina Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric condition.

Medicines containing opioids such as morphine

If you are taking a medicine containing opioids (such as morphine), inform your doctor or pharmacist, as morphine may increase the effect of Gabapentina Teva.

In addition, the combination of gabapentin with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

If you take gabapentin at the same time as antacids containing aluminium and magnesium, the absorption of gabapentin in the stomach may be reduced. Therefore, it is recommended that you take gabapentin at least two hours after taking an antacid.

Gabapentina Teva:

• is not expected to interact with other antiepileptic medicines or with oral contraceptive pills.
• may interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Gabapentina Teva with food, drinks, and alcohol

Gabapentina Teva can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should not take Gabapentina Teva during pregnancy unless your doctor has specifically instructed you to do so. An effective method of contraception should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but with other medicines used to treat seizures, an increased risk of fetal harm has been reported, particularly when more than one medicine is used simultaneously to treat seizures.

Therefore, whenever possible, only one seizure medicine should be used during pregnancy, and only under the advice of your doctor.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking Gabapentina Teva. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient in Gabapentina Teva, is excreted in breast milk. Breastfeeding is not recommended while taking Gabapentina Teva 800 mg tablets, as the effect on infants is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these tasks.

3. How to take Gabapentina Teva

Follow exactly the dosing instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is:

Adults and adolescents

Take the number of tablets prescribed by your doctor. Your doctor will usually gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

Children aged 6 years or older

Your doctor will decide the dose for your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg/kg/day. The dose is usually administered by taking the tablets, divided into three equal doses per day, typically one in the morning, one at midday, and one at night.

The use of Gabapentina Teva is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of tablets prescribed by your doctor. Your doctor will usually gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed by your doctor up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

If you have kidney problems or are undergoing hemodialysis

Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems or are undergoing hemodialysis.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of Gabapentina Teva, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.

If you think the effect of Gabapentina Teva is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina Teva is administered orally. Always swallow the tablets whole with sufficient water.

Continue taking Gabapentina Teva until your doctor tells you to stop.

If you take more Gabapentina Teva than you should

Doses higher than recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency unit if you have taken more gabapentin than prescribed by your doctor. Take with you any tablets not taken, along with the packaging and the patient information leaflet so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Teva

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentina Teva

Do not stop taking Gabapentina Teva suddenly or reduce the dose without consulting your doctor. If you wish to stop taking Gabapentina Teva or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentina Teva or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Teva or reducing the dose. If you experience this withdrawal syndrome, contact your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking gabapentin and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-raised, target-shaped or circular rashes on the trunk, often with blisters in the center; skin peeling, sores 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

• Severe skin reactions requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be signs of a severe allergic reaction)
• Persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• Gabapentin Teva may cause a severe or potentially life-threatening allergic reaction that may affect the skin or other parts of the body such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may require stopping Gabapentin Teva or even hospitalization
• Breathing difficulties which, if severe, may require emergency medical treatment to maintain normal breathing

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

? Skin rash

? Hives

? Fever

? Swollen glands that do not go away

? Swelling of the lips and tongue

? Yellowing of the skin or whites of the eyes

? Unusual bleeding or bruising

? Severe fatigue or weakness

? Unexpected muscle pain

? Frequent infections

These symptoms may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking gabapentin.

• If you are on hemodialysis, inform your doctor if you begin to experience muscle pain and/or weakness.

Other adverse effects include:

Very common adverse effects (may affect more than 1 in 10 people):

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

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

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation
• Low white blood cell count
• Anorexia, increased appetite
• Irritability, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Increased blood pressure, redness or dilation of blood vessels
• Breathing difficulty, bronchitis, sore throat, cough, dry nose
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, jerking movements
• Incontinence
• Erectile difficulties (impotence)
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cell count
• Weight gain
• Accidental injuries, fractures, abrasions

Additionally, in clinical trials in children, aggressive behavior and jerking movements were reported as common adverse effects.

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

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Allergic reaction such as hives
• Reduced movement
• Increased heart rate
• Difficulty swallowing
• Swelling that may affect face, trunk, and limbs
• Abnormal blood test results suggesting liver problems
• Progressive mental impairment
• Falls
• Increased blood glucose levels (observed more frequently in patients with diabetes)

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

• Decreased blood glucose levels (observed more frequently in patients with diabetes)
• Loss of consciousness
• Breathing problems, shallow breathing (respiratory depression)

Frequency not known (cannot be estimated from available data):

• Suicidal thoughts
• Developing dependence on gabapentin ("drug dependence")

You should be aware that you may experience certain adverse effects called withdrawal syndrome after stopping short- or long-term treatment with Gabapentin Teva or after reducing the dose (see "If you stop taking Gabapentin Teva").

The following adverse effects have been reported after marketing of the medicine:

• Decreased platelet count (blood clotting cells)
• Allergic reaction such as hives
• Hallucinations
• Movement disorders such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears

•

• Yellowish appearance of skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Breast tissue growth, breast enlargement
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual function problems such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat and tongue, and hypotension, requiring urgent treatment)
  • Worsening of myasthenia gravis (a disease causing muscle weakness)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Teva

The active substance is gabapentin. Each tablet contains 800 mg of gabapentin.

The other components (excipients) are: Copovidone, talc, crospovidone (type A), microcrystalline cellulose, isopropyl alcohol, magnesium stearate and in the tablet coating (Opadry II 85F18422 (white)): polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc.

Nature of the product and contents of the pack

Gabapentin Teva 800 mg is presented as film-coated tablets, white or almost white, oval-shaped, with bevelled edges. Marked with “7174” on one side and “93” on the other.

Each pack contains 90 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid, Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi Street 13.

Debrecen, H-4042

Hungary

Date of the most recent revision of this leaflet: April 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/