Information for the user

Gabapentina Tevagen 300 mg hard capsules EFG

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

2. What you need to know before taking Gabapentina Tevagen.

3. How to take Gabapentina Tevagen.

4. Possible side effects

5. Storage of Gabapentina Tevagen

6. Contents of the pack and additional information

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

The active ingredient of Gabapentina Tevagen is gabapentin.

Gabapentina Tevagen 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 Tevagen 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, acute pain, spasms, continuous pain, numbness, tingling, and pins and needles etc.

Do not take Gabapentina Tevagen:

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

Warnings and precautions

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

?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 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.
• Before taking this medicine, 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 gabapentin dependence.

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 who were treated with antiepileptic drugs such as gabapentin have had thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Tevagen" and "If you interrupt treatment with Gabapentina Tevagen"). 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 medicine for a longer time than prescribed.

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

- You are taking the medicine for reasons other than its prescription.

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

- When you stop taking the medicine, 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

There have been reports of severe skin reactions associated with gabapentin use, 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 leaflet “Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, 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 muscle fiber rupture 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 Tevagen with other medicines

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

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist as opioids may increase the effect of Gabapentina Tevagen. Additionally, the combination of Gabapentina Tevagen 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 Gabapentina Tevagen in the stomach may be reduced. It is recommended that Gabapentina Tevagen be taken at least two hours after taking an antacid.

Gabapentina Tevagen

• Gabapentina Tevagen is not expected to interact with other antiepileptic drugs or with the oral contraceptive pill.
• 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 Tevagen with food, drinks, and alcohol

Foods do not affect the absorption of Gabapentina Tevagen.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

You should not take Gabapentina Tevagen during pregnancy, unless your doctor has told you to. You should use an effective contraceptive method in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medicines used to treat seizures, there have been reports of an increased risk of damage to the developing fetus, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible, you should try to take only one medicine for seizures during pregnancy 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, if you think you may be pregnant, or if you plan to become pregnant while taking Gabapentina Tevagen. Do not stop taking this medicine 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 Tevagen, passes into breast milk. It is not recommended to breastfeed while taking Gabapentina Tevagen, as its effect on the baby is unknown.

Fertility

There are no effects on fertility 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 medicine affects your ability to perform these activities.

Gabapentina Tevagen 300 mg capsules contain yellow-orange S.

This medicine may cause allergic reactions because it contains yellow-orange S. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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 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 can be increased, as indicated by your doctor, up to a maximum dose of 3,600 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, which will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg per kg per day. The dose is normally administered by ingesting the capsules, divided into 3 equal doses per day,usually, one in the morning, one at noon, and one at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsulesindicated by your doctor. Normally, your doctor will gradually increase the dose. The initial dose will generally be between 300 to 900 mg per day. From there, the dose can be increased, as indicated by your doctor, up to a maximum dose of 3,600mg 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 if you are receiving hemodialysis treatment

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or if you are receiving hemodialysis treatment.

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

You should take the normal dose ofGabapentina Tevagen, 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 ofGabapentina Tevagenis too strong or too weak, inform your doctor or pharmacist as soon as possible.

Administration method

Gabapentina Tevagenis administered orally.Swallow the capsules whole with a sufficient amount of water.

Continue takingGabapentina Tevagenuntil your doctor tells you to stop.

If you take moreGabapentina Tevagen 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, orcall the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested,orgo to the emergency department of the nearest hospital.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 takeGabapentina Tevagen

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 withGabapentina Tevagen

Do not stop taking Gabapentina Tevagen suddenly. If you want to stop taking Gabapentina Tevagen, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, this should be done gradually over a minimum period 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 Tevagen. These include seizures, anxiety, difficulty sleeping, feeling of discomfort (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of discomfort. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Tevagen. 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 with a target-like appearance or circular patches 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 severe:

• severe skin reactions that require immediate attention, lip and face inflammation, skin rash, and/or 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 Tevagen 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. There may or may not be a rash when this type of reaction occurs. This may require discontinuing Gabapentin Tevagen 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

?skin rash.

?hives

?fever

?swollen lymph nodes.

?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 (may affect more than 1 in 10 people)

?viral infection,

?drowsiness, dizziness, discoordination,

?feeling tired, fever.

Common (may affect up to 1 in 10 people)

?pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation, or other infections,

?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,

?dizziness,

?increased blood pressure, redness or dilation of blood vessels,

?difficulty breathing, bronchitis, sore throat, dry nose,

?vomiting, nausea, dental problems, gum inflammation

diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence,

?swelling of the face, hives, rash, itching, acne,

?joint pain, muscle pain, back pain, tremors,

?erectile dysfunction,

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

?low white blood cell count,

?weight gain,

?accidents, fractures, bruises.

Additionally, in clinical trials in children, aggressive behavior and seizures were reported as common side effects.

Uncommon (may affect up to 1 in 100 people)

?agitation (a chronic state of restlessness and involuntary, purposeless movements),

• allergic reactions such as hives
• decreased movement
• accelerated heart rate

?difficulty swallowing,

• swelling that can affect the face, trunk, and limbs
• abnormal blood test results that may indicate liver problems

?falls

?progressive mental damage?

• increased blood sugar levels (observed more frequently in patients with diabetes)

Rare (may affect up to 1 in 1000 people)

• loss of consciousness
• low blood sugar levels (observed more frequently in patients with diabetes)
• 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 know that you may experience certain side effects, called withdrawal syndrome, after interrupting a short or long-term treatment with Gabapentin Tevagen (see "If you stop taking Gabapentin Tevagen").

After the marketing of Gabapentin Tevagen, the following side effects have been reported:

?low platelet count (blood clotting cells),

?hallucinations,

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

?ringing in the ears,?

• yellow discoloration of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• breast enlargement, breast enlargement
• side effects after sudden discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• muscle fiber rupture (rhabdomyolysis)
• abnormal blood test results (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 Pharmacovigilance 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.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gabapentina Tevagen

The active ingredient is gabapentin. Each capsule contains 300 mg of gabapentin.

The other components (excipients) are: Talc, pregelatinized cornstarch.

The excipients of the cap/ body are: Titanium dioxide (E171), erythrosine (E127), yellow-orange S (E110) and gelatin.

Printing ink: shellac, iron oxide black (E 172) and propylene glycol.

Appearance of the product and content of the packaging

Gabapentina Tevagen 300 mg is presented in the form of hard capsules with orange body and cap,

containing a white to off-white powder with small aggregates.

The cap and body of the capsule are marked with the numbers '93' and '39'.

Each package contains 30 or 90 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B, 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 of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/