Leaflet: information for the user

Gabapentin Aurovitas 800 mg film-coated tablets EFG

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Gabapentina Aurovitas belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).

The active ingredient of Gabapentina Aurovitas is gabapentin.

Gabapentin 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). Your doctor who treated you or your child aged 6 years or older will prescribe gabapentin to help treat epilepsy when the current treatment does not fully control the disease.You or your child aged 6 years or oldermust take gabapentin in combination with the current treatment unless otherwise instructed. Gabapentin can also be administered as a single medication in the treatment of adults and children aged 12 years or older.
• 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, tingling, numbness, and pins and needles, etc.

Do not take Gabapentina Aurovitas:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take gabapentin:

• if you have kidney problems, your doctor may prescribe a different dosing regimen,
• if you are undergoing hemodialysis (for removing waste products due to renal insufficiency), inform your doctor if you develop muscle pain and/or weakness;
• if you develop persistent stomach pain, feel dizzy or nauseous, inform your doctor immediately, as these symptoms may correspond to acute pancreatitis (inflamed pancreas),
• ifyou 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.

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 Aurovitas" and "If you interrupt treatment with Gabapentina Aurovitas"). 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 your 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.

A small number of people treated with antiepileptic drugs such as gabapentin have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.

Important information about potentially serious adverse reactions

Severe skin reactions associated with the use of gabapentin 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 severe symptoms in section 4 of this leaflet“Contact your doctor immediately ifyou experience any of the following symptoms after takingthis medicine, as they may be serious”.

Muscle weakness, sensitivity, or pain, and especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle fibers that can 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 the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Aurovitas

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 that contains opioids (such as morphine), inform your doctor or pharmacist, as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion:

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

Gabapentin:

• it 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 that you are taking gabapentin.

Taking Gabapentina Aurovitas with food, drinks, and alcohol

Gabapentin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, you must inform your doctor immediately to analyze the possible risks that the medicine you are taking may represent for the fetus.
• You should not interrupt your treatment without consulting your doctor first.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or are planning to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin can be used during the first trimester of pregnancy if necessary.

If you plan to become pregnant or are pregnant or think you may be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is essential not to stop taking your medicine without consulting your doctor first, as this may worsen your condition. Worsening of your epilepsy may put both you and your unborn baby at risk.

In a study that reviewed data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies of women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

Gabapentin taken during pregnancy 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 gabapentin. Do not stop taking this medicine abruptly, as this may cause an anticipation of seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient of gabapentin, passes into breast milk. It is not recommended to breastfeed while taking gabapentin, as its effect on the baby is unknown.

Fertility

No effects on fertility were found 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.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Do not take a dose 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 tablets as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be between 300 mg and 900 mg per day. From there, the dose may be increased as indicated by your doctor up to a maximum dose of 3,600 mg per day, and the total daily dose will be divided into three equal doses, for example, one in the morning, one in the middle of the day, 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 three days. The normal dose for controlling epilepsy is 25-35 mg per kg per day. The dose is usually administered by taking the tablets, divided into three equal doses per day, normally one in the morning, one in the middle of the day, and one at night.

Gabapentin is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of tablets as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be between 300 mg and 900 mg per day. From there, the dose may be increased up to a maximum dose of 3,600 mg per day, and will be divided into three equal doses, for example, one in the morning, one in the middle of the day, and one at night.

If you have kidney problems or are being hemodialyzed

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

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

You should take gabapentin as usual, except if you have kidney problems. Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.If you consider that the effect of gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin is administered orally. Swallow the tablets with a sufficient amount of water.

The tablet can be divided into two equal doses.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentina Aurovitas 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 915620420), indicating the medication and the amount ingested. Bring any remaining tablets, along with the packaging and label, so that the hospital can easily identify the medication taken.

If you forgot to take Gabapentina Aurovitas

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 treatment with Gabapentina Aurovitas

Do not stop taking gabapentin suddenly. If you want to stop taking gabapentin, 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 gabapentin. These include seizures, anxiety, difficulty sleeping, 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 gabapentin treatment. If you experience this withdrawal syndrome, contact your doctor.

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

Like all medications, this medication may have adverse effects, although not all people may 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 or circular shape 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).
• 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 medication, as they may be severe:

• Persistent stomach pain, vomiting, and nausea, which may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin 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. You may or may not have a rash when this type of reaction occurs. This may require stopping gabapentin or even hospitalization.
• Difficulty breathing, which, if severe, may require emergency medical attention to breathe normally.

Contact your doctor immediately if you have any of the following symptoms:

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 adverse 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 infections, urinary tract infections, ear inflammation, or other infections.
• Low white blood cell count.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, coordination difficulties, 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, cough, dry nose.
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence.
• Swelling of the face, hives, acne.
• Joint pain, muscle pain, back pain, spasms.
• Difficulty achieving an erection (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental injuries, fractures, bruises.

Additionally, in clinical trials in children, frequent adverse effects included aggressive behavior and spasmodic movements.

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

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

Adverse effects reported after gabapentin's commercialization:

• Decreased platelet count (blood clotting cells).
• Thoughts of suicide, hallucinations.
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity.
• Tinnitus (ringing in the ears).
• Yellow discoloration of the skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increased breast tissue, breast growth.
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Muscle fiber rupture (rhabdomyolysis).
• Changes in blood test results (elevated creatine phosphokinase).
• Sexual activity problems, 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 requiring urgent treatment).
• Developing dependence on gabapentin ("drug dependence").

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

Reporting adverse effects

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

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 collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Gabapentina Aurovitas

• The active ingredient is gabapentin.

Each film-coated tablet contains 800 mg of gabapentin.

• The other components (excipients) are:Maize starch, crospovidone (type A), copovidone (VA 64), microcrystalline cellulose (KG-1000), microcrystalline cellulose (PH-102), magnesium stearate.

Coating:Hydroxypropylcellulose, talc.

Appearance of the product and content of the container

Film-coated tablet.

Gabapentina Aurovitas 800 mg film-coated tablets EFG are film-coated tablets, white in color, eliptical in shape, biconvex, with a deep groove on both faces, with the letter “D” and the number “25” printed on one face on both sides of the groove and not printed on the other face.

Gabapentina Aurovitas 800 mg film-coated tablets EFG is available in a polyamide/aluminum/PVC blister with an aluminum foil containing 20, 60, and 90 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Gabapentina Aurovitas 800 mg film-coated tablets EFG

Last review date of this leaflet: January 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)