GABAPENTINE KERN PHARMA 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gabapentin Kern Pharma 800 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

1. What is Gabapentin Kern Pharma 800 mg and what is it used for
2. Before taking Gabapentin Kern Pharma 800 mg
3. How to take Gabapentin Kern Pharma 800 mg
4. Possible side effects
5. Storage of Gabapentin Kern Pharma 800 mg
6. Contents of the pack and further information

1. What is Gabapentin Kern Pharma 800 mg and what is it used for

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

Epilepsy: Gabapentin is used to treat certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe this medication to help treat your epilepsy when your current treatment does not fully control the disease. You should take Gabapentin in addition to your current treatment unless otherwise indicated.

Gabapentin can also be administered as a single medication in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain: Gabapentin is 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 sensation of pain can be described as heat, burning, throbbing pain, flashing pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pinching sensation, etc.

2. Before taking Gabapentin Kern Pharma 800 mg

Do not take Gabapentin Kern Pharma

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

Warnings and precautions

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

Severe skin reactions associated with the use of gabapentin have been reported, 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 severe skin reactions described in section 4.

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

Be particularly careful with Gabapentin Kern Pharma:

• If you have kidney problems.
• If you develop symptoms such as persistent stomach pain, feel dizzy or dizzy, 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 been dependent on alcohol, prescription medications, or illegal drugs; you may have a higher risk of developing dependence on Gabapentin Kern Pharma.

Dependence

Some people may develop dependence (need to continue taking the medication) on Gabapentin Kern Pharma. They may experience withdrawal syndrome when they stop taking Gabapentin Kern Pharma (see section 3, "How to take Gabapentin Kern Pharma" and "If you interrupt treatment with Gabapentin Kern Pharma"). If you are concerned about developing dependence on Gabapentin Kern Pharma, it is essential that you consult your doctor.

If you experience any of the following signs while taking Gabapentin Kern Pharma, it may indicate that you have developed dependence.

• You feel that you need to take the medication for a longer period than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medication for reasons other than its prescription.
• You have tried several times to stop taking the medication or control how you take it, without success.
• When you stop taking the medication, you feel unwell 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 being treated with antiepileptics like Gabapentin have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.

Other medications and Gabapentin Kern Pharma

Inform your doctor or pharmacist if you are using, have recently used, or may need to take any other medication, including those purchased without a prescription.

In particular, 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 Gabapentin.

It is not expected that Gabapentin will interact with other antiepileptic medications or oral contraceptives.

Gabapentin may interfere with some laboratory tests, so if you need a urine test, inform your doctor or hospital that you are taking this medication.

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

Taking Gabapentin Kern Pharma with food and drinks

This medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

You should not take Gabapentin during pregnancy, unless your doctor has indicated it. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies 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 a seizure to occur, which could have serious consequences for both 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 with opioid analgesics (medications for treating intense pain).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking this medication.

Gabapentin, the active ingredient of Gabapentina Kern Pharma, is excreted in breast milk. Breastfeeding is not recommended while taking this medication, as its effect on infants is unknown.

Driving and using machines

Gabapentin may cause symptoms such as drowsiness, dizziness, or vision changes, and may reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Gabapentina Kern Pharma contains castor oil

This medication may cause stomach upset and diarrhea because it contains castor oil.

3. How to take Gabapentina Kern Pharma 800 mg

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

Your doctor will determine the appropriate dose for you.

If you think the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take Gabapentina in the normal way, unless you have kidney problems.

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

Always swallow the tablets with a sufficient amount of water. The tablets can be divided into two equal halves.

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

Peripheral neuropathic pain:

Take the number of tablets your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. Therefore, the dose may 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:

Adults and adolescents:

Take the number of tablets your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. Therefore, the dose may 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.

Children 6 years and older:

Your doctor will decide the dose to be administered to your child based on the child's weight. The treatment will start 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 normal dose is usually administered by taking the tablets, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

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

If you take more Gabapentina Kern Pharma than you should

Consult your doctor immediately or go to the emergency department of the nearest hospital. Bring any remaining tablets, along with the packaging and package leaflet, so that the hospital can easily identify the medication you have taken.

You can also call the Toxicology Information Service, phone: 91 562 04 20.

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 the next dose.

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Gabapentina Kern Pharma

Do not stop taking Gabapentina Kern Pharma abruptly. If you want to stop taking Gabapentina Kern Pharma, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should be aware that you may experience certain side effects, called withdrawal syndrome, after interrupting 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 discomfort. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Kern Pharma. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible Adverse Effects

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

• Red, target-like 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 can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Expanded rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Like all medicines, gabapentina can cause adverse effects, although not all people suffer from them.

Gabapentina may 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. If this type of allergic reaction appears, you may need to be hospitalized or stop taking this medication.

Inform your doctor immediately if you have any of the following symptoms:

• skin rashes,
• hives,
• fever,
• inflammation of the glands that does not disappear,
• swelling of the lips and tongue,
• yellowish color of the skin or the whites of the eyes,
• unusual bleeding or bruising,
• severe fatigue or weakness,
• unexpected muscle pain,
• frequent infections,
• breathing problems that, if severe, may require urgent medical attention to breathe normally.

These symptoms may be the first signs of a severe reaction. The doctor will examine you to decide if you should continue taking gabapentina.

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

• Viral infection.
• Feeling of drowsiness, dizziness, discoordination.
• Feeling of fatigue, fever.

The common adverse 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.
• Anorexia, increased appetite.
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, tremors, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensations, difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes.
• Blurred vision, double vision.
• Dizziness.
• Increased blood pressure, redness or dilation of blood vessels.
• Breathing difficulties, bronchitis, sore throat, cough, nasal dryness.
• Vomiting (feeling nauseous), nausea (feeling dizzy), tooth 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, spasms.
• Incontinence.
• Difficulty with erections.
• Swelling in the legs and arms or swelling that can affect the face, trunk, and extremities, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.
• Decreased white blood cells, weight gain.
• Accidental injuries, fractures, abrasions.

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

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

The rare adverse effects that may affect less than 1 in 1,000 people are:

• Decreased platelet count (blood clotting cells).
• Allergic reaction such as hives.
• Hallucinations.
• Abnormal movement problems such as contortions, tremors, and stiffness.
• Ringing in the ears.
• Accelerated heart rate.
• Pancreatitis.
• Liver inflammation, yellowish appearance of the skin and eyes.
• Severe skin reactions that require immediate medical attention, lip and face swelling, skin rash and redness, hair loss.
• Acute kidney failure.
• Adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, feeling dizzy, pain, and sweating), chest pain.
• Fluctuations in blood glucose levels in patients with diabetes, abnormal blood test results that may indicate liver problems.
• Breathing problems, shallow breathing (respiratory depression).

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

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

You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting short-term 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 tremors were reported as frequent adverse effects.

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaram.es) By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gabapentina Kern Pharma 800 mg

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Kern Pharma 800 mg tablets

• The active ingredient is gabapentina. Each film-coated tablet contains 800 mg of gabapentina.
• The other components of this medication 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 Package Contents

Film-coated tablets. The tablets are oval (10 mm x 19 mm), white, scored on one side, and "800" engraved on the other. The score line serves to divide the tablet into two equal halves.

Each package contains 90 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This prospectus was revised in January 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/