Prospect: Information for the User

Gabapentina Kern Pharma 400 mg Hard Capsules EFG

Read this entire prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Gabapentina Kern Pharma belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain.

Epilepsy:GabapentinaKern Pharmais used to treat certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). Your doctor will prescribe GabapentinaKern Pharmato help treat your epilepsy when your current treatment does not fully control the disease. You must take GabapentinaKern Pharmain addition to your current treatment unless otherwise instructed.

GabapentinaKern Pharmacan also be administered as a single medication in the treatment of adults and children over 12 years old.

Peripheral neuropathic pain:GabapentinaKern Pharmais used to treat chronic pain caused by nerve damage. There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.

Do not take Gabapentina Kern Pharma

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

Additional information about potentially serious reactions

Severe skin reactions associated with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. Stop taking gabapentin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Read the description of these symptoms in section 4 of this prospectus in “Call your doctor immediately if you experience any of the following symptoms after taking this medication, as they may be serious."

Warnings and precautions

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

• If you have kidney problems.
• If you develop persistent stomach pain, feel dizzy or nauseous, inform your doctor immediately.
• If you have a nervous system disorder or a respiratory disorder or if you are over 65 years old, your doctor may prescribe a different dose.
• Before taking this medication, inform your doctor if you have ever abused or had dependence on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina Kern Pharma.

Dependence

Some people may develop dependence (need to continue taking the medication) on Gabapentina Kern Pharma. They may experience withdrawal symptoms when they stop taking Gabapentina Kern Pharma (see section 3, "How to take Gabapentina Kern Pharma" and "If you interrupt treatment with Gabapentina Kern Pharma"). If you are concerned about developing dependence on Gabapentina Kern Pharma, it is essential 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 medication for a longer time than prescribed.
• You feel the need to take a higher dose than recommended.
• You are taking the medication for reasons other than your prescription.
• You have tried several times to stop taking the medication or control how you take it, without success.
• You feel unwell when you stop taking the medication and feel better when you take it again.

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

A small number of people who were treated with antiepileptic medications like Gabapentina Kern Pharma have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

Use of Gabapentina Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication. Especially, inform your doctor (or pharmacist) if you are taking or have recently taken any medication for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

If you are using any medication that contains morphine, inform your doctor or pharmacist as morphine may increase the effect of Gabapentina Kern Pharma.

No interaction is expected between Gabapentina Kern Pharma and other antiepileptic medications or oral contraceptive pills.

Gabapentina Kern Pharma may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital that you are taking Gabapentina Kern Pharma.

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 recommended that Gabapentina Kern Pharma be taken at least two hours after taking an antacid.

Use of Gabapentina Kern Pharma with food and drinks

Gabapentina Kern Pharma can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not take Gabapentina Kern Pharma during pregnancy, unless your doctor has told you to. You should use an effective contraceptive method in women of childbearing age.

No specific studies have been conducted on the use of gabapentin in pregnant women, but in the case of other medications used to treat seizures, an increased risk of fetal damage has been reported, particularly when more than one medication is used to treat seizures at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one medication for seizures during pregnancy.

Do not stop taking this medication abruptly as this may cause an anticipation of seizures, which could have serious consequences for you and your baby.

If you take gabapentin during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medications).

Gabapentin, the active ingredient in Gabapentina Kern Pharma, is excreted in breast milk. It is not recommended to breastfeed while taking Gabapentina Kern Pharma, as the effect on infants is unknown.

Driving and operating machinery

Gabapentina Kern Pharma may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Gabapentina Kern Pharma contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not take a higher dose of medication than prescribed.

Your doctor will determine the appropriate dose for you.

If you estimate that the effect of Gabapentina Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), take Gabapentina Kern Pharma normally, except if you have kidney problems.

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

Swallow the capsules whole with a sufficient amount of water.

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

Peripheral neuropathic pain:

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually be between 300 to 900 mg per day. Therefore, the dose can be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

Epilepsy:

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase the dose. The initial dose will usually be between 300 to 900 mg per day. Therefore, the dose can be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

Use in children and adolescents

Your doctor will decide on the dose to be administered to your child based on the child's weight. Treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually administered by taking the capsules in three equal doses per day, for example, one in the morning, one at noon, and one at night.

It is not recommended to use Gabapentina Kern Pharma in children under 6 years old.

If you take more Gabapentina Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Gabapentina Kern Pharma

If you forgot to take a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Gabapentina Kern Pharma

Do not stop taking Gabapentina Kern Pharma suddenly. If you want to stop taking Gabapentina Kern Pharma, talk to your doctor first. Your doctor will tell you how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week.You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment with Gabapentina Kern Pharma. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of unwellness. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Kern Pharma. If you experience this withdrawal syndrome, contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

• Flat, red patches with a target-like or circular shape on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions 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).

Like all medications, gabapentin may cause side effects, although not everyone will experience them.

Gabapentin can cause a severe or potentially life-threatening allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. When this type of reaction occurs, it may or may not be accompanied by a rash. In the event of this type of allergic reaction, you may need to be hospitalized or stop taking gabapentin.

Inform your doctor immediately if you experience any of the following symptoms.

- Skin rash

- Hives

- Fever

- Persistent swelling of the glands

- Swelling of the lips and tongue

- Yellowing of the skin or white of the eyes

- Unusual bleeding or bruising

- Severe fatigue or weakness

- Unexpected muscle pain

- Frequent infections

• Difficulty breathing, which may require emergency medical attention to breathe normally.

These symptoms may be the first signs of a severe reaction. Your doctor will examine you to decide whether you should continue taking gabapentin.

The very common side effects that may affect more than 1 in 10 people are:

• Viral infection.
• Drowsiness, dizziness, lack of coordination.
• Feeling tired, fever.

The common side effects that may affect more than 1 in 100 people are:

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation.
• Low white blood cell count.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, convulsions, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensations, coordination difficulties, 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 (feeling dizzy), nausea (feeling dizzy), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence.
• Swelling of the face, hives, rash, itching, acne.
• Muscle pain, muscle spasms, back pain, stiffness.
• Incontinence.
• Erectile dysfunction.
• Swelling in the legs and arms or swelling that can affect the face, trunk, and extremities, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Low white blood cell count, weight gain.
• Accidental injuries, fractures, bruises.

The uncommon side effects that may affect between 1 and 10 in every 1,000 patients are:

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

The rare side effects that may affect fewer than 1 in 1,000 people are:

• Decreased platelets (blood clotting cells).
• Allergic reaction such as hives.
• Hallucinations.
• Abnormal movement problems such as contortions, convulsions, and stiffness.
• Tinnitus (ringing in the ears).
• Increased heart rate.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver), yellowing of the skin and eyes.
• Severe skin reactions that require immediate medical attention, swelling of the lips and face, rash, and redness, hair loss.
• Acute kidney failure.
• Side effects after stopping gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Fluctuations in blood glucose in patients with diabetes, abnormal blood test results that may indicate liver problems.
• Difficulty breathing, shallow breathing (respiratory depression).

Other possible side effects: their frequency cannot be estimated from the available data:

• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).
• Suicidal thoughts.
• Developing dependence on Gabapentina Kern Pharma ("drug dependence").

You should know that you may experience certain side effects, called withdrawal syndrome, after stopping a short- or long-term treatment with Gabapentina Kern Pharma (see "If you stop taking Gabapentina Kern Pharma").

Additionally, in clinical trials in children, aggressive behavior and seizures were reported as common side effects.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (Website:www.notificaram.es)Reporting side effects can help provide more information on the safety of this medication.

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

Do not store at a temperature above25°C.

Do not use Gabapentina Kern Pharma after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medicines.By doing so, you will help protect the environment.

Composition of Gabapentina Kern Pharma

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

• The other components are anhydrous lactose, cornstarch, and talc. The components of the gelatin capsule are gelatin, yellow iron oxide (E-172), red iron oxide (E-172), and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Hard capsules. The gelatin hard capsules are orange in color.

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

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa -Barcelona

Spain

Last review date of this leaflet: January 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/