GABAPENTINA AUROVITAS 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina Aurovitas 300 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Gabapentina Aurovitas and what is it used for
2. What you need to know before you take Gabapentina Aurovitas
3. How to take Gabapentina Aurovitas
4. Possible side effects
5. Storage of Gabapentina Aurovitas
6. Contents of the pack and other information

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

Gabapentina belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

The active substance of Gabapentina Aurovitas is gabapentina.

Gabapentina is used to treat:

• Certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe gabapentina for you or your child aged 6 years or older to help treat your epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentina in combination with your current treatment unless otherwise indicated by your doctor. Gabapentina can also be given as the only medicine in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (long-lasting pain caused by damage to the nerves). There are various diseases that can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing pain, shooting pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and a feeling of pins and needles, etc.

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

Do not take Gabapentina Aurovitas:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Gabapentina Aurovitas.

• If you have kidney problems, your doctor may prescribe a different dosage regimen.
• If you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or weakness in the muscles.
• 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 medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of developing dependence on gabapentina.

Dependence

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

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

• You feel that you need to take the medicine for a longer period than prescribed.
• You feel that you 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 what is 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 being treated with antiepileptics such as gabapentina have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

Important information about potentially serious reactions

Severe skin reactions have been reported associated with the use of gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina and seek medical attention immediately 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 leafletin "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 on palpation, and especially if you feel unwell or have a fever, may be due to abnormal muscle fiber breakdown, which 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell 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 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 gabapentina. Additionally, the combination of gabapentina with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

If you take gabapentina at the same time as antacids that contain aluminum and magnesium, the absorption of gabapentina in the stomach may be reduced. Therefore, it is recommended that gabapentina be taken at least 2 hours after taking an antacid.

Gabapentina Aurovitas:

• It is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.
• It may interfere with some laboratory tests, so if you need a urine test, inform your doctor or 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, you must inform your doctor immediately and discuss the possible risks that the medicine you are taking may have for the fetus.
• Do not stop your treatment without consulting your doctor.
• If you plan to become pregnant, you should 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 medicine.

Pregnancy

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

If you are planning 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 important that you do not stop taking your medicine without first 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 that reviewed data from women in Nordic countries who took gabapentina in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain development (neurodevelopmental disorders). However, babies of women who took gabapentina 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 medicine abruptly, as this may cause a seizure, which could have serious consequences for both you and your baby.

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

Breastfeeding

Gabapentina, the active substance of Gabapentina Aurovitas, passes into breast milk. Breastfeeding is not recommended while taking gabapentina, as its effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina can cause dizziness, drowsiness, and fatigue. You should 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 Aurovitas contains sodium

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

3. How to take Gabapentina Aurovitas

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. Do not take more than the prescribed dose.

Your doctor will determine the dose that is right for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules that your doctor has told you to. Your doctor will usually 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 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one in the evening.

Children aged 6 years and over

Your doctor will decide the dose to be given to your child based on the child's weight. Treatment will begin 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 per kg per day. The usual dose is given by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentina 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 that your doctor has told you to. Your doctor will usually 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 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one in the evening.

If you have kidney problems or if you are on hemodialysis

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

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

You should take the normal dose of gabapentina, unless you have kidney problems. Your doctor may prescribe a different dosage regimen or different doses if you have kidney problems.

If you think that the effect of gabapentina is too strong or too weak, tell your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina is given orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking gabapentina 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 side 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 Toxicology Information Service, phone 91-562.04.20, indicating the medicine and the amount taken. Bring any remaining capsules, along with the packaging and label, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Aurovitas

If you forget 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 make up for forgotten doses.

If you stop taking Gabapentina Aurovitas

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

Stop taking gabapentina and seek immediate medical attention if you notice any of these symptoms:

• Red, target-like or circular patches on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can 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 can be serious:

• Breathing problems that, if severe, may require urgent medical attention to breathe normally
• Persistent stomach pain, feeling unwell, and a feeling of discomfort, as they can be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentina can 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 can lead to hospitalization or discontinuation of treatment with gabapentina. Contact your doctor immediately if you have any of the following symptoms:
• • skin rash and redness and/or hair loss
  • hives
  • fever
  • inflammation of the glands that does not disappear
  • inflammation of the lips, face, and tongue
  • yellowing of the skin or whites of the eyes
  • unusual bruising or bleeding
  • severe fatigue or weakness
  • unexpected muscle pain
  • frequent infections

These symptoms may be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking gabapentina.

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

Other adverse effects include:

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

• Viral infection.
• Feeling of drowsiness, dizziness, lack of coordination.
• Feeling of fatigue, 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 of anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensitivity (numbness), difficulty with coordination, 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, bruising, rash, itching, acne.
• Joint pain, muscle pain, back pain, muscle spasms.
• Difficulty with erection (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental overdoses, fractures, abrasions.

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

Uncommon (may affect up to 1 in 100 people)

• Agitation (state of chronic restlessness and involuntary movements without apparent purpose).
• Falling.
• Allergic reaction such as hives.
• Decreased movement.
• Accelerated heart rate.
• Difficulty swallowing.
• Swelling that can affect the face, trunk, and extremities.
• Abnormal blood test results that may indicate liver problems.
• Progressive mental damage.
• Increased blood glucose levels (observed more frequently in patients with diabetes).

Rare (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).

After the marketing of gabapentina, the following adverse effects have been reported:

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

• Decrease in platelet count (blood clotting cells).
• Suicidal thoughts, hallucinations.
• Abnormal movement problems such as contortions, spasmodic movements, and stiffness.
• Ringing in the ears.
• Yellowing of the skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increased breast tissue, breast growth.
• Adverse effects after sudden discontinuation of treatment with gabapentina (anxiety, difficulty sleeping, feeling of 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 reach orgasm and delayed ejaculation.
• Low sodium levels in the blood.
• Anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent medical treatment).
• Developing dependence on gabapentina ("drug dependence").

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

Reporting of adverse effects

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

5. Storage of Gabapentina Aurovitas

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

Do not use this medicine 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.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Aurovitas

• The active ingredient is gabapentina.

Each hard capsule contains 300 mg of gabapentina.

• The other components (excipients) are:

Capsule content:cornstarch and talc.

Capsule:yellow iron oxide (E-172), titanium dioxide (E-171), sodium lauryl sulfate, and gelatin.

Printing ink:shellac, black iron oxide.

Appearance of the Product and Package Contents

Hard capsules of size "1", marked with the letter "D" on the yellow cap and with "03" on the yellow body, printed with edible black ink, containing crystalline powder of white to off-white color.

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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, no 19,

Venda Nova, 2700-487

Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: March 2024

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