Prospect: information for the user

Gabapentina Teva 800 mg film-coated tablets EFG

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

2. What you need to know before starting to take Gabapentina Teva

3. How to take Gabapentina Teva

4. Possible adverse effects

5. Storage of Gabapentina Teva

6. Contents of the package and additional information

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

The active ingredient of Gabapentina Teva is gabapentin.

Gabapentina Teva is used to treat:

• Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child aged 6 years or older will prescribe Gabapentina Teva to help treat epilepsy when the current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentin in combination with the current treatment unless otherwise indicated. Gabapentin can also be administered as a single medication in the treatment of adults and children over 12 years.

• Peripheral neuropathic pain(chronic pain caused by nerve damage). There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles etc.

Do not take Gabapentina Teva:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Teva:

• If you have kidney problems, your doctor may prescribe a different dosing regimen.
• If you are on hemodialysis (for waste removal due to renal insufficiency), inform your doctor if you start feeling muscle pain and/or weakness.

?If you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately as they 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.
• Before taking this medication, inform your doctor if you have ever abused or had dependence on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing dependence on gabapentin.

There have been reports of gabapentin abuse and dependence from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

A small number of people taking antiepileptic medications such as gabapentin have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (need to continue taking the medication) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Teva" and "If you interrupt treatment with Gabapentina Teva"). If you are concerned about developing dependence on gabapentin, it is essential 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 the need to take the medication for a longer time than prescribed.

- You feel the need to take a higher dose than recommended.

- You are taking the medication for reasons other than your prescription.

- You have tried several times to stop taking the medication or control how you take it, without success.

- When you stop taking the medication, you feel unwell and feel better when you take it again.

If you notice any of the above, talk to your doctor to decide on the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

Important information about potentially serious reactions

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

Read the description of these symptoms in section 4 of this prospectus “Contact your doctor immediately if you experience any of the following symptoms after taking this medication, as they may be serious”.

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal rupture of muscle fibers that may lead to kidney problems and put your life at risk. You may also experience urine discoloration, and changes in blood test results (significant increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal rupture of muscle fibers that may lead to kidney problems and put your life at risk. You may also experience urine discoloration, and changes in blood test results (significant increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Gabapentina Teva with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Especially, inform your doctor (or pharmacist) if you are taking or have taken recently any medication for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medications containing opioids such as morphine

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

Additionally, the combination of gabapentin with opioids may cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentina Teva:

• It is not expected to interact with other antiepileptic medications or with oral contraceptive pills.
• It may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Gabapentina Teva during pregnancy, unless your doctor has indicated otherwise. A reliable contraceptive method should be used in women of childbearing age.

No specific studies have been conducted on the use of gabapentin in pregnant women, but in the case of other medications used to treat seizures, an increased risk of fetal damage has been reported, particularly when multiple medications are used to treat seizures.

Therefore, whenever possible, you should only take one medication for seizures and only under the advice of your doctor.

If you take gabapentin during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medications).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Teva.Do not stop taking this medication abruptly as this may cause an anticipation of seizures, which could have serious consequences for you and your baby.

Breastfeeding

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

Fertility

No effects on fertility have been reported in animal studies.

Driving and operating machinery

Gabapentin may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Do not take a quantity of medication higher than the prescribed one.

Your doctor will determine what dose is suitable for you.

Epilepsy, the recommended dose is:

Adults and adolescents

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be between 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 noon, and one at night.

Children 6 years or older

Your doctor will decide on the dose to be administered to your child based on the child's weight. The treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg/kg/day. The dose is normally administered by taking the capsules, divided into three equal doses per day, usually one in the morning, one at noon, and one at night.

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

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be between 300 to 900 mg per day. From there, the dose may be increased as indicated 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 noon, and one at night.

If you have kidney problems or are being hemodialyzed

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or are being hemodialyzed.

If you are an elderly patient (over 65 years old)

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

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

If you consider that 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. Swallow the capsules whole with a sufficient amount of 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 cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospital if you have taken more gabapentin than your doctor prescribed. Bring with you any capsules that you have not taken, along with the packaging and the leaflet so that the hospital can easily identify the medication you have taken.

If you forgot to take Gabapentina Teva

If you forgot to take a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Gabapentina Teva

Do not stop taking Gabapentina Teva suddenly. If you want to stop taking Gabapentina Teva, talk to your doctor first. Your doctor will tell you how to proceed.If you are going to stop treatment, this should be done gradually over a minimum of one week.You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment with Gabapentina Teva. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of unwellness. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Teva. If you experience this withdrawal syndrome, contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

• flat red patches that are not raised, shaped like a target or circular on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• expanded 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 that require immediate attention, lip and face inflammation, skin rash and redness, and/or hair loss (may be symptoms of a severe allergic reaction).
• persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin Teva may cause a severe or potentially life-threatening allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. It may or may not have appeared as a rash when this type of reaction occurs. This may require stopping Gabapentin Teva or even hospitalization.
• breathing problems that, if severe, may require emergency medical attention to breathe normally.

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 lymph nodes that do not subside

?swelling of the lips and tongue

?yellow discoloration of the skin or white of the eyes

unusual bleeding or bruising

?severe fatigue or weakness

?unexpected muscle pain

?frequent infections

These symptoms may be the first signs of a severe reaction. You should have a doctor examine you to decide if you should continue taking gabapentin.

• If you are on hemodialysis, inform your doctor if you start feeling muscle pain and/or weakness.

Other side effects include:

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

• viral infection

• drowsiness, dizziness, discoordination

• feeling tired, fever

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

• pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation

• low white blood cell count

• loss of appetite, increased appetite

• irritability towards others, confusion, mood changes, depression, anxiety, nervousness,

difficulty thinking

• seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes

• blurred vision, double vision

• vertigo

• high blood pressure, redness or dilation of blood vessels

• difficulty breathing, bronchitis, sore throat, cough, nasal dryness

• vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence

• facial swelling, hives, rash, itching, acne,

• joint pain, muscle pain, back pain, twitching

• incontinence

• erectile dysfunction

• swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms

• low white blood cell count,

• weight gain,

• accidental injuries, fractures, bruises

In addition, in clinical trials in children, aggressive behavior and twitching were reported as common side effects.

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

• agitation (a chronic state of restlessness and involuntary, purposeless movements),
• allergic reaction such as hives.
• decreased movement.
• accelerated heart rate
• difficulty swallowing.
• swelling that may affect the face, trunk, and limbs
• abnormal results of blood tests suggesting liver problems
• progressive mental damage
• falls
• increased blood glucose levels (observed more frequently in patients with diabetes)

Rare side 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)

Unknown frequency (cannot be estimated from available data)

• suicidal thoughts
• developing dependence on gabapentin ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after stopping a short or long-term treatment with Gabapentin Teva (see "If you stop taking Gabapentin Teva").

After the commercialization of the medicine, the following side effects have been reported:

• decreased platelets (blood clotting cells)

• allergic reaction such as hives

• hallucinations

• abnormal movements such as contortions, spasmodic movements, and rigidity

• tinnitus (ringing in the ears)

•

• yellowish discoloration of the skin and eyes (jaundice), liver inflammation

• acute kidney failure, incontinence

• breast enlargement, breast enlargement

• muscle fiber rupture (rhabdomyolysis)

• abnormal results of blood tests (elevated creatine phosphokinase)

• sexual dysfunction, such as inability to achieve orgasm and delayed ejaculation

• low sodium levels in the blood

• anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight andreach of children.

Do not usethis medicationafter the expiration date that appears on the packagingafter CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Gabapentina Teva

The active ingredient 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.

Appearance of the product and contents of the packaging

Gabapentina Teva 800 mg is presented in the form of film-coated tablets, white or almost white in color, oval in shape, with beveled edges. Marked with “7174” on one face and “93” on the other.

Each package contains 90 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid Spain

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi Street 13.

Debrecen, H-4042

Hungary

Last review date of this leaflet:January 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/