Leaflet: information for the user

Gabapentina Aurovitas 400 mg hard capsules EFG

Read this leaflet carefully before you start taking 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.

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

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

3. How to take Gabapentina Aurovitas

4. Possible side effects

5. Storage of Gabapentina Aurovitas

6. Contents of the pack and additional informationadditional information

Gabapentina 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 Aurovitas is gabapentina.

Gabapentina 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 to help treat your epilepsy when your current treatment does not fully control the disease.You or your child aged 6 years or older must take gabapentina in combination with your current treatment unless otherwise instructed.Gabapentina can also be administered as a single medication in the treatment of adults and children over 12 years old.

• 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 Aurovitas:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Aurovitas.

• If you have kidney problems, your doctor may prescribe a different dosing regimen.
• If you are on 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, 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 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 gabapentin dependence.

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 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 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.

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

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 prospectusin “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, which 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.

Other medications and Gabapentina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 taking any medication containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of gabapentin. 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 gabapentin be taken at least two hours after taking an antacid.

Gabapentina Aurovitas:

• No interaction is expected with other antiepileptic medications or oral contraceptives.
• Gabapentina Aurovitas 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 Aurovitas with food, drinks, and alcohol

Gabapentina Aurovitas can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, inform your doctor immediately and discuss the possible risks that the medication you are taking may pose to the fetus.
• Do not interrupt your treatment without consulting your doctor.
• If you plan to become pregnant, discuss your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking this medication.

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

In a study reviewing 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.

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentina. Do not stop taking this medication abruptly, as this may cause a seizure, which could have serious consequences for both you and your baby.

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

Breastfeeding

Gabapentin, the active ingredient in Gabapentina Aurovitas, 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 medication affects your ability to perform other tasks.

Gabapentina Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

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 higher dose of medication than prescribed.

Your doctor will determine the suitable dose 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 300 to 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, 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, normally, one in the morning, one at noon, 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 capsules as indicated by your doctor. Normally, your doctor will gradually increase the dose. The initial dose will generally be 300 to 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, 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 a different dosing regimen and/or dose 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 of gabapentin, 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 capsules whole with a sufficient amount of water.

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 or pharmacist immediately or call the Toxicological Information Service, phone 91-562.04.20, indicating the medication and the amount ingested. Bring any remaining capsules, 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 indicate 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 interrupting treatment with gabapentin. 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 medications, this medication may 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).
• 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:

• Difficulty breathing that, if severe, may require emergency medical attention to breathe normally.
• Persistent stomach pain, feeling unwell, and discomfort, as they 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 develop a rash when you develop this reaction. This may require hospitalization or suspension of gabapentin treatment. Contact your doctor immediately if you experience any of the following symptoms:
• • skin rash and redness and/or hair loss
  • hives
  • fever
  • swollen glands that do not subside
  • inflammation of the lips, face, and tongue
  • yellow discoloration of the skin or white of the eyes
  • bruising or unusual bleeding
  • severe fatigue or weakness
  • unexplained 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, ear inflammation, or other infections.
• Low white blood cell count.
• Anorexia, increased appetite.
• Feeling angry towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, 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 or throat, flatulence.
• Swelling of the face, hives, rash, acne.
• Joint pain, muscle pain, back pain, muscle 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 overdoses, fractures, bruises.

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

Uncommon (may affect up to 1 in 100 people)

• Restlessness (chronic sleep deprivation and involuntary movements without apparent purpose).
• Fall.
• Allergic reaction such as hives.
• Decreased movement.
• Increased heart rate.
• Difficulty swallowing.
• Swelling that may affect the face, trunk, and limbs.
• Abnormal results in blood tests that may indicate liver problems.
• Progressive mental damage.
• Increased blood sugar levels (observed more frequently in patients with diabetes).

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

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

Adverse reactions reported after gabapentin marketing:

Unknown frequency: (cannot be estimated from available data)

• Decreased platelet count (blood clotting cells).
• Thoughts of suicide, hallucinations.
• Abnormal movements 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 reactions after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Muscle fiber rupture (rhabdomyolysis).
• Abnormal results in 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 medical treatment).
• 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 (see "If you stop taking gabapentin").

Reporting adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. 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 reactions, 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.

Store below 25°C.

Store in the original packaging to protect it from moisture.

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 hard capsule contains 400mg of gabapentin.

• The other components (excipients) are:

Hard capsule content:maize starch and talc.

Hard capsule:red iron oxide (E-172), yellow iron oxide (E-172), titanium dioxide (E-171), sodium lauryl sulfate, and gelatin

Printing ink:shellac, iron oxide black.

Appearance of the product and contents of the package

Hard capsules of size “0”, marked with the letter “D” on the orange cap and with “04” on the orange body, printed with edible black ink, containing white to off-white crystalline powder.

Gabapentina Aurovitas hard capsules are available in PVC/PVdC blister packs with aluminum foil.

Package sizes:20, 30, 60, 90, and 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica S.A.,

Rua João de Deus, no19,

Venda Nova, 2700-487

Amadora

Portugal

This medicinal product is authorized in the member states of the European Economic Area under the following names:

Last review date of this leaflet: March 2024

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