GABAPENTINA AUROVITAS 600 mg FILM-COATED TABLETS

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

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

Talk to your doctor or pharmacist before taking gabapentin:

• 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), tell your doctor if you develop pain and/or weakness in your muscles;
• if you develop symptoms such as persistent stomach pain, feel dizzy or faint, tell your doctor immediately, as these symptoms may correspond to 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, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of becoming dependent on gabapentin.

Dependence

Some people may become dependent on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Aurovitas" and "If you stop taking Gabapentina Aurovitas"). If you are concerned about becoming dependent on gabapentin, it is important that you talk to your doctor.

If you experience any of the following signs while taking gabapentin, it may indicate that you have become dependent.

• 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 to stop taking the medicine or control how you take it several times 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 the best course of treatment is for you, including when it is appropriate to stop treatment and how to do it safely.

A small number of people treated with antiepileptics 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 side effects

Severe skin reactions have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin 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 serious 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, and especially if you feel unwell or have a fever, could 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 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 using, have recently used, or might use 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), tell 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 that contain aluminum or magnesium, the absorption of gabapentin in the stomach may be reduced. Therefore, it is recommended that gabapentin be taken at least two hours after taking an antacid.

Gabapentin:

• is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill,
• may interfere with some laboratory tests, so if you need a urine test, tell your doctor or hospital that you are taking gabapentin.

Taking Gabapentina Aurovitas with food, drinks, and alcohol

Gabapentina can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, you must tell your doctor immediately to assess the possible risks that the medicine you are taking may pose to the fetus.
• Do not stop your treatment without first consulting your doctor.
• 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 planning 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. Worsening of your epilepsy may pose a risk to both you and your unborn baby.

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 development (neurodevelopmental disorders). However, babies of women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

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

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 a seizure, which could have serious consequences for both you and your baby.

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

3. How to take Gabapentina Aurovitas

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. 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 tablets that your doctor has told you to. Your doctor will usually gradually increase your dose. The initial dose will generally be between 300 mg and 900 mg per day. From there, the dose may be increased as directed by your doctor up to a maximum dose of 3600 mg per day, and the total daily dose will be divided into three equal doses, for example, one in the morning, one at noon, and one at night.

Children aged 6 years and older:

Your doctor will decide the dose to be given 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 usual dose for controlling epilepsy is 25-35 mg per kg per day. The usual dose is given by taking the tablets, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

Gabapentina is not recommended for use in children below 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of tablets that your doctor has told you to. Your doctor will usually gradually increase your dose. The initial dose will generally be between 300 mg and 900 mg per day. From there, the dose may be increased as directed by your doctor up to a maximum dose of 3600 mg per day, and the total daily dose will be 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 on hemodialysis

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

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

You should take gabapentina normally except if you have kidney problems. Your doctor may prescribe a different dosage regimen or different doses if you have kidney disorders. If you consider 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 administered orally. Always swallow the tablets with a sufficient amount of water.

The tablet can be divided into two equal doses.

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, pharmacist, or call the Toxicology Information Service (telephone 915620420), indicating the medicine and the amount taken. Bring any remaining tablets, 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 your 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 short-term or long-term treatment with gabapentina. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of being unwell. These effects usually occur within the first 48 hours after stopping gabapentina treatment. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have 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-shaped or circular patches on the torso, 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 swollen lymph nodes (DRESS 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:

• Persistent stomach pain, vomiting, and nausea, 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. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization.
• Breathing difficulties that, if severe, may require urgent medical attention to breathe normally.

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

• skin rash and redness and/or hair loss
• hives
• fever
• gland inflammation that does not disappear
• swelling of the lips, face, and tongue
• yellowish color of the skin or the whites 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 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, discoordination.
• Feeling of fatigue, fever.

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

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections.
• Low white blood cell count.
• Anorexia, 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, decreased sensitivity (numbness), difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes.
• Blurred vision, double vision.
• Vertigo.
• 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, tremors.
• Difficulty with erection (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.
• Decreased leukocytes, weight gain.
• Accidental injuries, fractures, abrasions.

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent adverse effects.

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

• Agitation (a state of chronic restlessness and purposeless movements).
• Allergic reactions 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.
• Fall.
• Increased blood glucose levels (observed more frequently in patients with diabetes).

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

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

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

• Decrease in platelets (blood clotting cells).
• Suicidal thoughts, hallucinations.
• Problems with abnormal movements such as contortions, spasmodic movements, and stiffness.
• Ringing in the ears.
• Yellowish appearance of skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increase in breast tissue, breast growth.
• Adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain.
• Muscle fiber rupture (rhabdomyolysis).
• Changes in blood test results (elevated creatine phosphokinase).
• Problems with sexual activity, 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 treatment).
• Developing dependence on gabapentina ("drug dependence").

You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting short- 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. Conservation 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.

Do not store at a temperature above 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 film-coated tablet contains 600 mg of gabapentina.

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

Coating:Hydroxypropylcellulose, talc.

Appearance of the Product and Package Contents

Film-coated tablet.

Gabapentina Aurovitas 600 mg film-coated tablets EFG are film-coated tablets, white in color, elliptical in shape, biconvex, with a deep score on both faces, with the letter "D" and the number "24" printed on one face on either side of the score and without printing on the other face.

Gabapentina Aurovitas 600 mg film-coated tablets EFG are available in poliamide/aluminum/PVC and aluminum foil blisters containing 20, 60, and 90 film-coated tablets.

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

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

Spain: Gabapentina Aurovitas 600 mg film-coated tablets EFG

Date of the last revision of this prospectus: January 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/)