Gabapentin Aurovitas 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Aurovitas 400 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, since it may 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.

Leaflet contents

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 belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active substance in Gabapentin Aurovitas is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures that initially begin in specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor (6 years of age or older) may prescribe gabapentin to help manage epilepsy when current treatment does not fully control the condition. You or your child (6 years of age or older) should take gabapentin in combination with current treatment, unless otherwise instructed by your doctor. Gabapentin may also be used as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various medical conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles (herpes). The pain may be described as heat, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, muscle spasms, continuous pain, tingling, numbness, or prickling sensations, etc.

2. What you need to know before taking 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 Aurovitas.

• If you have kidney problems, your doctor may prescribe you a different dosing regimen.
• If you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor if you develop pain and/or weakness in your muscles.
• If you develop symptoms such as persistent stomach pain, vomiting, and nausea, tell your doctor immediately, as these may be symptoms of 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, prescription medicines, or illegal drugs; you may be at higher risk of developing dependence on gabapentin.

Dependence

Some people may develop dependence (a 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 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 longer than prescribed.
• You feel the 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, but have been unsuccessful.
• 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 with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you have such thoughts, contact your doctor as soon as possible.

Important information about potentially serious reactions

Serious skin rashes 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 immediate medical attention 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 leaflet under "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 on palpation—and 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 discolouration of the urine and changes in blood test results (a 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 Gabapentin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicines 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, combining 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 and 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 Aurovitas:

• Is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.
• May interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Gabapentin Aurovitas with food, drinks, and alcohol

Gabapentin 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 pose to the foetus.
• Do not stop 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 medicine.

Pregnancy

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

If you plan to become pregnant, or if you 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 could worsen your condition. Worsening of your epilepsy could put both you and your unborn baby at risk.

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 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 gabapentin. Do not stop taking this medicine abruptly, as this may trigger seizures, 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 (medicines for the treatment of severe pain).

Breastfeeding

Gabapentin, the active substance in Gabapentin Aurovitas, passes into breast milk. Breastfeeding is not recommended while taking gabapentin, as the effect on the infant is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using 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 such activities.

Gabapentin Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, essentially “sodium-free”.

3. How to take Gabapentin Aurovitas

Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. 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 capsules prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

Children aged 6 years and older

Your doctor will decide the dose for 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 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. This dose is usually administered by taking the capsules in three equal doses per day, typically 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 capsules prescribed by your doctor. Usually, your doctor will gradually increase the dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

If you have kidney problems or are receiving haemodialysis treatment

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

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

You should take the normal dose of gabapentin, unless you have kidney problems. Your doctor may prescribe a different dosing schedule or different doses if you have kidney problems.

If you think 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. Always swallow the capsules whole with sufficient water.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentin 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 diarrhoea. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91-562.04.20, stating the medicine and the amount ingested. Take any remaining capsules 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 forgotten doses.

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. You should 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 include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, 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, 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 everyone will experience them.

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

• Red, non-elevated circular patches or "target-like" rashes on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, or 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 swollen 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:

• Difficulty breathing, which, if severe, may require emergency medical treatment to maintain normal breathing
• Persistent stomach pain, nausea, and feeling unwell, as these 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. You may or may not develop a rash when this reaction occurs. This may lead to hospitalization or discontinuation of gabapentin treatment. Contact your doctor immediately if you experience 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 bruising or bleeding
  • 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 infection, urinary tract infection, ear inflammation, or other infections.
• Low white blood cell count.
• Anorexia, increased appetite.
• Feeling angry toward others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, decreased sensation (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, muscle pulls.
• Difficulty achieving erection (impotence).
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Decreased white blood cells, weight gain.
• Accidental overdose, fractures, abrasions.

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

Uncommon (may affect up to 1 in 100 people)

• Restlessness (a state of chronic lack of rest and involuntary, purposeless movements).
• Falls.
• Allergic reaction 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.
• 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).

The following adverse effects have been reported after the marketing of gabapentin:

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

• Decreased platelet count (blood clotting cells).
• Suicidal thoughts, hallucinations.
• Abnormal movement problems such as twisting movements, spasmodic movements, and rigidity.
• Ringing in the ears.
• Yellowish appearance of the 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.
• Muscle fiber breakdown (rhabdomyolysis).
• Worsening of myasthenia gravis (a disease causing muscle weakness).
• Changes in blood test results (elevated creatine phosphokinase).
• Problems with sexual function, such as inability to reach orgasm and delayed ejaculation.
• Low sodium levels in the blood.
• Anaphylaxis (a serious, potentially life-threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring urgent medical treatment).
• Development of dependence on gabapentin ("drug dependence").

You should 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 (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 through 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 the 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.

Store below 25°C.

Keep in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Aurovitas

• The active substance is gabapentin.

Each hard capsule contains 400 mg of gabapentin.

• The other components (excipients) are:

Capsule contents: maize starch and talc.

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

Printing ink: shellac, black iron oxide.

Appearance of the product and contents of the container

Hard capsules of size "0", with the letter "D" printed on the orange cap and "04" on the orange body, using edible black ink, containing white to almost white crystalline powder.

Gabapentin Aurovitas hard capsules are available in PVC/PVdC blister packs with aluminium foil.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Or

Generis Farmacêutica S.A.,

Rua João de Deus, no 19,

Venda Nova, 2700-487

Amadora

Portugal

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

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

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