Gabapentin Kern Pharma 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Gabapentin Kern Pharma 300 mg hard capsules EFG

Gabapentin Kern Pharma 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 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 they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Gabapentin Kern Pharma
6. Contents of the pack and other information

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

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

Gabapentina Kern Pharma 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 (for children aged 6 years and older) will prescribe Gabapentina 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. Gabapentina Kern Pharma 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 sensation of pain may be described as heat, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and prickling sensations, etc.

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

Do not take Gabapentina 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

Talk to 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 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 signs of acute pancreatitis (inflamed pancreas)
• if you have a neurological 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 condition 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 be at increased risk of developing dependence on Gabapentina Kern Pharma.

Dependence

Some people may develop dependence (a need to continue 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 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 take 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 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 symptoms related to these serious skin reactions described in section 4.

Read the description of these 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 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.

Taking Gabapentina Kern Pharma with other medicines

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 conditions.

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 gabapentin with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

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

Gabapentina Kern Pharma

• no interaction between Gabapentina Kern Pharma 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 and drink

Gabapentina Kern Pharma may be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you might be pregnant, inform your doctor immediately so they can assess any possible risks the medicine you are taking may pose to the fetus.
• 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 planning to breastfeed, 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 may 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 three 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 may 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

Gabapentina Kern Pharma passes into breast milk. Breastfeeding is not recommended while taking this medicine, as the effect on the baby is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using 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 tasks.

Gabapentina Kern Pharma contains lactose.

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

3. How to take Gabapentin Kern Pharma

Follow exactly the instructions for administration 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, i.e., 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. This dose is normally administered by taking the capsules in three equal doses per day, usually one in the morning, one at midday, and one at night.

The use of Gabapentin Kern Pharma 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 haemodialysis treatment

Your doctor may prescribe a different dosing regimen 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 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 the effect of Gabapentin Kern Pharma is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin Kern Pharma is taken orally.

Always swallow the capsules whole with sufficient water.

Continue taking Gabapentin Kern Pharma until your doctor tells you to stop.

If you take more Gabapentin Kern Pharma than you should

Doses higher than those recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhoea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested, or go immediately to the nearest hospital emergency department if you take more Gabapentin Kern Pharma than prescribed. Bring any unused capsules, together with the packaging and the patient information leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Kern Pharma

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 Kern Pharma

Do not stop taking Gabapentin Kern Pharma suddenly or reduce the dose abruptly. If you wish to stop taking Gabapentin 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 Gabapentin 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 Gabapentin 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 or circular rash resembling a target or bullseye on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genitals, and eyes. 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)

• This medicine may cause a severe 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 with this type of reaction. This may require discontinuation of Gabapentina Kern Pharma or even 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, 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

• Fatigue or severe 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, 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, 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 leukocytes, 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
• Reduced 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 patients with diabetes)

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

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and rigidity
• Ringing in the ears
• Yellow appearance of the skin and eyes (jaundice), liver inflammation
• Acute kidney 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 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")

Frequency not known (cannot be estimated from available data)

• Worsening of myasthenia gravis (a disease causing muscle weakness)

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

Reporting of adverse effects:

If you experience any adverse effects, 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 (Website: www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentina Kern Pharma

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use Gabapentina Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Kern Pharma

The active substance is gabapentin.

Each hard capsule contains 300 mg or 400 mg of gabapentin.

The other components are anhydrous lactose, corn starch and talc. The components of the gelatin capsule are gelatin, yellow iron oxide (E-172), red iron oxide (E-172) (only in the 400 mg capsules) and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Gabapentin Kern Pharma 300 mg are yellow hard gelatin capsules.

Gabapentin Kern Pharma 400 mg are orange hard gelatin capsules.

Each standard pack contains 30 or 90 capsules. Each clinical pack contains 500 capsules.

Only certain pack sizes may be marketed.

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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/