Gabapentin Kern Pharma 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Kern Pharma 600 mg film-coated tablets EFG

Gabapentin Kern Pharma 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; 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Gabapentin Kern Pharma is and what it is used for
2. What you need to know before taking Gabapentin Kern Pharma
3. How to take Gabapentin Kern Pharma
4. Possible side effects
5. How to store Gabapentin Kern Pharma
6. Contents of the pack and other information

1. What Gabapentin Kern Pharma is and what it is used for

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

Gabapentin Kern Pharma is used to treat

• Certain types of epilepsy (seizures that initially affect specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor may prescribe Gabapentin Kern Pharma to help treat epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take this medicine 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 diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or shingles. The pain sensation may be described as warmth, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, spasms, continuous pain, tingling, numbness, and pins-and-needles sensations, etc.

2. What you need to know before taking Gabapentin Kern Pharma

Do not take Gabapentin Kern Pharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Kern Pharma.

• if you have kidney problems, your doctor may prescribe a different dosage regimen
• if you are undergoing 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 signs 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
• if you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may have an increased risk of developing dependence on Gabapentina Kern Pharma

Dependence

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

If you experience any of the following signs while taking Gabapentina Kern Pharma, 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, 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 with your doctor to determine the best course of treatment for you, including when it is appropriate to discontinue treatment and how to do so safely.

A small number of people taking antiepileptic medicines such as Gabapentina Kern Pharma have had thoughts of harming themselves or of suicide. If at any time you experience 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 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 on palpation—and 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 the urine and changes in blood test results (a significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Kern Pharma

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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 enhance the effect of Gabapentina Kern Pharma. In addition, combining this medicine with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

If you take Gabapentina at the same time as antacids containing aluminum or magnesium, the absorption of Gabapentina in the stomach may be reduced. It is therefore recommended that this medicine be taken at least two hours after taking an antacid.

Gabapentina Kern Pharma

• No interaction between Gabapentin and other antiepileptic medicines or oral contraceptive pills is expected.

• 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 Gabapentina Kern Pharma with food, drinks, and alcohol

This medicine can 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 so that the possible risks of the medicine you are taking for the fetus can be evaluated.
• You should not stop your treatment without first consulting 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

Gabapentina Kern Pharma may be used during the first trimester of pregnancy if necessary.

If you are planning to become pregnant, are pregnant, or think you might be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important not to stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening epilepsy may 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 born to women who took gabapentin during pregnancy had a higher risk of low birth weight and premature delivery.

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 Gabapentina Kern Pharma. 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 substance in Gabapentina Kern Pharma, is excreted in breast milk. Breastfeeding is not recommended while taking this medicine, as the effect on infants is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and use of machines

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

Gabapentina Kern Pharma contains castor oil

This medicine may cause stomach discomfort and diarrhea because it contains castor oil.

3. How to take Gabapentina Kern Pharma

Follow exactly the administration instructions for Gabapentin as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medication than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of tablets prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. The dose may then be increased 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 or 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/kg/day. This dose is normally administered in three divided doses per day, usually one in the morning, one at midday, and one at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of tablets 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 undergoing hemodialysis

Your doctor may prescribe a different dosing regimen 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 the normal dose of Gabapentina Kern Pharma, unless you have kidney problems.

Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.

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

Method of administration

Gabapentina Kern Pharma is administered orally. Always swallow the tablets with sufficient water. The tablets may be divided into two equal halves.

Continue taking this medicine until your doctor tells you to stop.

If you take more Gabapentina Kern Pharma 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 at 91 562 04 20 immediately, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department if you have taken more Gabapentina Kern Pharma than prescribed. Bring any tablets you have not taken, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Kern Pharma

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 a missed dose.

If you stop taking Gabapentina Kern Pharma

Do not stop taking Gabapentina Kern Pharma suddenly, nor reduce the dose. If you wish to stop taking Gabapentina Kern Pharma, 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 Gabapentina Kern Pharma 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 treatment with Gabapentina Kern Pharma 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 experiences them.

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

• red, flat, target-shaped 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 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)
• Gabapentina Kern Pharma 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 this medicine or even hospitalization.
• breathing difficulties, 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. Your doctor will 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
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasmodic movements, 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, swollen 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 difficulties (impotence)
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased leukocytes, weight gain.
• Accidental injuries, fractures, abrasions.

Uncommon: (may affect between 1 and 10 in 1,000 people)

• Agitation (a state of chronic restlessness and involuntary, purposeless movements).
• Difficulty swallowing

Rare: (may affect fewer than 1 in 1,000 people)

• Decrease in platelets (blood clotting cells).
• Allergic reactions such as hives.
• Hallucinations.
• Abnormal movement problems such as twisting movements, jerking, and stiffness.
• Ringing in the ears.
• Increased heart rate.
• Inflammation of the pancreas.
• Liver inflammation, yellowing of the skin and eyes.
• Severe skin reactions requiring immediate medical attention, swelling of lips and face, skin rash and redness, hair loss.
• Acute kidney failure.
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Blood glucose fluctuations in diabetic patients, abnormal blood test results that may indicate liver problems.
• Breathing difficulties, shallow breathing (respiratory depression).

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
• Increased heart rate
• Difficulty swallowing
• Swelling that may affect 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 diabetic patients)

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

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

Following the marketing of Gabapentina Kern Pharma, the following adverse effects have been reported:

• • Decrease in platelets (blood clotting cells)
  • Suicidal thoughts, hallucinations
  • Abnormal movement problems such as twisting, spasmodic movements, and stiffness
  • Ringing in the ears
  • Yellowing of the skin and eyes (jaundice), liver inflammation
  • Acute renal failure, incontinence
  • Increase in 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)
  • Changes in blood test results (elevated creatine phosphokinase)
  • Sexual function problems, such as inability to achieve 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)
  • Development of dependence on Gabapentina Kern Pharma ("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 Gabapentina Kern Pharma or after reducing the dose (see "If you stop taking Gabapentina Kern Pharma").

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Kern Pharma

Keep out of the sight and reach of children.

Do not use Gabapentin Kern Pharma 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 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Kern Pharma

The active substance is gabapentin.

Each film-coated tablet contains 600 mg or 800 mg of gabapentin.

The other components of this medicine are: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose LH-21, hydrogenated castor oil, magnesium stearate, sodium lauryl sulfate, and Opadry II 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol, and talc).

Appearance of the product and contents of the pack

Film-coated tablets.

Gabapentin Kern Pharma 600 mg tablets

The tablets are oval (10 mm x 19 mm), white in colour, scored on one side and engraved with "600" on the other. The score line is intended to divide the tablet into equal halves.

Gabapentin Kern Pharma 800 mg tablets

The tablets are oval (10 mm x 19 mm), white in colour, scored on one side and engraved with "800" on the other. The score line is intended to divide the tablet into equal halves.

Each pack contains 90 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: January 2026.

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