Gabapentin Stada 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Gabapentin Stada 400 mg hard capsules 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Gabapentin Stada is and what it is used for
2. Before you take Gabapentin Stada
3. How to take Gabapentin Stada
4. Possible adverse effects
5. How to store Gabapentin Stada
6. Contents of the pack and other information

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

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

The active substance in Gabapentina Stada is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures that initially start in specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor 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 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. The pain may be described as warmth, burning, throbbing, shooting, stabbing, sharp, continuous pain, tingling, numbness, or pins and needles sensation, among others.

2. What you need to know before taking Gabapentina Stada

Do not take Gabapentina Stada:

• 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 Gabapentina Stada:

• if you have kidney problems, your doctor may prescribe a different dosing regimen
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, notify 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 of age, 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 medicines, or illegal drugs; you may be at increased risk of developing dependence on gabapentin
• if you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms

Cases of abuse and dependence on gabapentin have been reported from post-marketing experience. Speak with your doctor if you have a history of abuse or dependence.

A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If you ever have such thoughts, contact your doctor immediately.

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 Gabapentina Stada" and "If you stop taking Gabapentina Stada"). 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 you need to take the medicine 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, but failed.
• You feel unwell when you stop taking the medicine and feel better when you start again.

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

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 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 these symptoms in section 4 of this leaflet: "Stop taking gabapentin and seek immediate medical attention if you notice any of these symptoms."

Muscle weakness, tenderness, or pain on palpation—especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and could be life-threatening. You may also experience discoloration of urine and changes in blood test results (marked increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Taking Gabapentina Stada with other medicines

Inform 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 a 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 symptoms such as drowsiness and/or reduced breathing.

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. 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 oral contraceptive pills.
• may interfere with certain laboratory tests; therefore, if you require a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Gabapentina Stada with food, drinks and alcohol

Gabapentin can be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take gabapentin during pregnancy unless your doctor has specifically instructed you to do so. Women of childbearing age should use an effective method of contraception.

There are no specific studies on the use of gabapentin in pregnant women. However, with other medicines used to treat seizures, an increased risk of harm to the developing baby has been reported, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible, it is recommended to take only one seizure medicine during pregnancy, and only under the advice of your doctor.

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 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.

Breast-feeding

Gabapentin, the active substance in gabapentin, passes into breast milk. Breast-feeding is not recommended while taking gabapentin, as the effect on the baby is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform such tasks.

Gabapentina Stada contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Gabapentin Stada

Follow exactly the instructions for use of this medicine 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 your doctor has indicated. 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 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 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. The dose is usually administered by taking capsules, divided into 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 your doctor has indicated. 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.

If you have kidney problems or are receiving hemodialysis treatment

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

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 the effect of gabapentin is too strong or too weak, tell your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin is administered orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentin Stada 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital emergency unit. Take any unused capsules with you, along with the packaging and the leaflet, so the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Stada

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 Stada

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 treatment 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-itchy, flat or target-shaped (bull's-eye) rashes on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe 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)

• Severe skin reactions requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction)

• 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 and possibly hospitalization.

• Difficulty breathing, which, if severe, may require emergency medical treatment to maintain normal breathing.

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

• Skin rash
• Hives
• Fever
• Swollen glands that do not go away
• Swelling of the lips 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. A doctor should examine you 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, nervousness, difficulty thinking
• Seizures, spasms, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, 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, jerking movements
• Erectile dysfunction (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 spasms 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
• Reduced movement
• Increased heart rate
• Swelling affecting the face, trunk, and limbs
• Abnormal blood test results that may indicate liver problems
• Progressive mental impairment
• Falls
• Increased blood glucose levels (observed more frequently in patients with diabetes)
• Difficulty swallowing

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)

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

• Suicidal thoughts
• 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 Stada").

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

• Decreased platelet count (blood clotting cells)
• Hallucinations
• Abnormal movement problems such as twisting movements, spasms, and stiffness
• Ringing in the ears
• Yellowing 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)
• 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)
• Worsening of myasthenia gravis (a disease causing muscle weakness)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 Stada

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 refers to 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina Stada

• The active substance is gabapentin. Each hard capsule contains 400 mg of gabapentin.

• The other components are lactose, corn starch and talc. The capsule shell consists of titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) and gelatin.

Appearance of the product and pack sizes

Gabapentina Stada 400 mg are hard gelatin capsules with opaque orange body and cap, containing white powder.

Gabapentina Stada 400 mg hard capsules are available in blister packs containing 90 or 500 capsules (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Stada, S.L.
c/ Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

LAMP S. PROSPERO S.P.A.
Via Della Pace, 25/A
41030 San Prospero (Modena)
Italy

or

KERN PHARMA, S.L.
Polígono Ind. Colón II
c/ Venus, 72
08228 Terrassa (Barcelona)
Spain

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/