Gabapentin Aurovitas 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Aurovitas 800 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Gabapentin Aurovitas

3. How to take Gabapentin Aurovitas

4. Possible side effects

5. How to store Gabapentin Aurovitas

6. Contents of the pack and other information

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

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

The active substance in Gabapentin Aurovitas is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures initially limited to specific parts of the brain, whether or not they spread to other parts of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe gabapentin to help manage epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with current treatment unless otherwise instructed. Gabapentin may also be given as monotherapy in the treatment of adults and children over 12 years of age.
• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles. The pain may be described as heat, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and prickling sensations, among others.

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

Do not take Gabapentin Aurovitas:

• if you are allergic to gabapentin or to 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 you a different dosing regimen,
• if you are undergoing haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or muscle weakness;
• if you develop symptoms such as persistent stomach pain, feel dizzy or experience dizziness, inform your doctor immediately, as these symptoms may indicate acute pancreatitis (inflamed pancreas),
• if you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms,
• if you have a nervous system disorder or a respiratory disorder or if you are over 65 years of age, your doctor may prescribe you a different dose,
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescribed medicines or illegal drugs; you may be at higher risk of developing dependence on gabapentin.

Dependence

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

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

• You feel you need to take the medicine for longer than prescribed.
• You feel you need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• 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 start taking it again.

If you notice any of the above, speak to your doctor to decide on the best treatment approach for you, including when it is appropriate to stop treatment and how to do so safely.

A small number of people treated with antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you have these thoughts, contact your doctor immediately.

Important information about potentially serious adverse reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention 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, tenderness or pain, especially if you also feel unwell or have a fever, could be due to abnormal breakdown of muscle fibres, which can lead to kidney problems and may be life-threatening. You may also experience discoloration of urine and changes in blood test results (significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentin Aurovitas

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine. In particular, inform 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 condition.

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 gabapentin. In addition, the combination of gabapentin with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion:

If you take gabapentin at the same time as antacids containing aluminium or magnesium, the absorption of gabapentin in the stomach may be reduced. It is therefore 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, inform your doctor or hospital that you are taking gabapentin.

Taking Gabapentin Aurovitas with food, drinks and alcohol

Gabapentin may be taken with or without food.

Pregnancy, breastfeeding and fertility

• If you are pregnant or think you might be pregnant, you must inform your doctor immediately to discuss the possible risks that the medicine you are taking may pose to the unborn baby.
• You should not stop your treatment without first discussing it with your doctor.
• If you are planning to become pregnant, you should review your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

If you are planning to become pregnant or if you are pregnant or think you might 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 could worsen your condition. Worsening of your epilepsy could endanger both you and your unborn baby.

In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to 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 concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking gabapentin. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient in gabapentin, passes into breast milk. Breastfeeding is not recommended while you are taking gabapentin, as the effect on the baby is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and use of machines

Gabapentin 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 Gabapentin Aurovitas

Follow exactly the instructions your doctor has given you for taking this medicine. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is:

Adults and adolescents:

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

Children aged 6 years or older:

Your doctor will decide the dose to give your child, based on the child's weight. Treatment will start with a low initial dose, which 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. This dose is normally administered by taking the tablets, divided into three equal doses per day, usually one in the morning, one at midday, and one at night.

The use of gabapentin is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of tablets your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 mg to 900 mg per day. Subsequently, the dose may be increased up to a maximum of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

If you have kidney problems or are undergoing hemodialysis

Your doctor may prescribe a different dosing schedule and/or different doses if you have kidney problems or are undergoing hemodialysis.

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

You should take gabapentin normally unless you have kidney problems. Your doctor may prescribe a different dosing schedule or different doses if you have kidney disorders. If you think 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. Always swallow the tablets with a sufficient amount of water.

The tablet may be divided into two equal doses.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentin Aurovitas than you should

Doses higher than recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service (telephone 915620420) immediately, stating the medicine and the amount ingested. Take any remaining tablets with you, along with the packaging and label, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Aurovitas

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentin Aurovitas

Do not stop taking gabapentin suddenly or reduce the dose. If you wish to stop taking gabapentin or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a minimum of one week. Be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with gabapentin or after reducing the dose. These may include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping gabapentin or reducing the dose. If you experience this withdrawal syndrome, 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 everyone will experience them.

Stop taking gabapentin and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-raised, target-shaped or circular patches on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes 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 medicine, as they may be serious:

• Persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body, such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may require discontinuation of gabapentin or even hospitalization.
• Difficulty breathing, which, if severe, may require emergency medical treatment to maintain normal breathing.

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

• Skin rash, redness, and/or hair loss
• Hives
• Fever
• Swollen glands that do not go away
• Swelling of the lips, face, and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections

These symptoms may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking gabapentin.

If you are on hemodialysis, inform your doctor if you begin to experience muscle pain and/or weakness.

Other adverse effects include:

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, 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
• Irritability, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), coordination problems, 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
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, jerking movements
• Difficulty with erection (impotence)
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

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

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

• Agitation (a state of chronic restlessness and involuntary purposeless movements)
• Allergic reactions such as hives
• Decreased movement
• Rapid heartbeat
• Difficulty swallowing
• Swelling that may affect the face, trunk, and limbs
• Abnormal blood test results that may indicate liver problems
• Progressive mental impairment
• Falls

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 problems, shallow breathing (respiratory depression)

Following the marketing of gabapentin, the following adverse effects have been reported:

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears
• Yellow appearance of skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rupture of muscle fibers (rhabdomyolysis)
• Worsening of myasthenia gravis (a disease causing muscle weakness)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual function problems, such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
• Development of dependence on gabapentin ("drug dependence")

You should be aware that you may experience certain adverse effects called withdrawal syndrome after stopping short- or long-term treatment with gabapentin or after reducing the dose (see "If you stop taking gabapentin").

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Aurovitas

• The active substance 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 contents of the pack

Film-coated tablet.

Gabapentin Aurovitas 800 mg film-coated tablets EFG are white, elliptical, biconvex, film-coated tablets with a deep score on both sides, marked with the letter “D” and the number “25” on one side of the score on one face, and unmarked on the other face.

Gabapentin Aurovitas 800 mg film-coated tablets EFG are available in blisters made of polyamide/aluminum/PVC and aluminum foil, containing 20, 60, and 90 film-coated tablets.

Only some pack 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Gabapentin Aurovitas 800 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: March 2026

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