GABAPENTINA KERN PHARMA 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gabapentina Kern Pharma 600 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

1. What is Gabapentina Kern Pharma 600 mg and what is it used for
2. Before taking Gabapentina Kern Pharma 600 mg
3. How to take Gabapentina Kern Pharma 600 mg
4. Possible side effects
5. Storage of Gabapentina Kern Pharma 600 mg
6. Contents of the pack and further information

1. What is Gabapentina Kern Pharma 600 mg and what is it used for

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

Epilepsy: Gabapentina Kern Pharma 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 Gabapentina Kern Pharma to help treat your epilepsy when your current treatment does not fully control the disease. You should take Gabapentina Kern Pharma in addition to your current treatment unless otherwise indicated.

Gabapentina Kern Pharma can also be administered as a single drug in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain: Gabapentina Kern Pharma 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, shooting pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and sensation of pins and needles, etc.

2. Before taking Gabapentina Kern Pharma 600 mg

Do not take Gabapentina Kern Pharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Severe skin reactions have been reported with the use of gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina 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 leaflet under "Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as it may be serious".

Be particularly careful with this medicine if:

• If you have kidney problems.
• If you develop symptoms such as persistent stomach pain, feel dizzy or dizzy, inform your doctor.
• 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 medicine, 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 Gabapentina Kern Pharma.

Dependence

Some people may develop dependence (need to continue taking the medicine) on Gabapentina Kern Pharma. They may experience withdrawal syndrome when they stop taking Gabapentina Kern Pharma (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 essential that you 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 that you need to take the medicine for a longer period than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medicine for reasons other than your prescription.
• 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, 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 Gabapentina have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor immediately.

Other medicines and Gabapentina Kern Pharma

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. 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 problem.

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

No interaction is expected between this medicine and other antiepileptic medicines or oral contraceptives.

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

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

Taking Gabapentina Kern Pharma with food and drinks

This medicine 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 this medicine.

Do not take Gabapentina Kern Pharma 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 gabapentina in pregnant women, but in the case of other medicines used to treat seizures, an increased risk of fetal damage has been reported, particularly when more than one medicine 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 medicine for seizures during pregnancy.

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

If you take gabapentina during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (drugs for treating intense pain).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Kern Pharma.

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

Driving and using machines

Gabapentina 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 medicine.

Gabapentina Kern Pharma contains castor oil

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

3. How to take Gabapentina Kern Pharma 600 mg

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

Your doctor will determine the dose that is right for you.

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

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

Your doctor may prescribe a different dosage 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 Gabapentina Kern Pharma until your doctor tells you to stop.

Peripheral neuropathic pain:

Take the number of tablets that your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will generally 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 that your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will generally 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 of age or 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 Gabapentina Kern Pharma 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. Take any remaining tablets with you, along with the packaging and the package leaflet, so that the hospital can easily identify the medicine 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 the forgotten doses.

If you stop taking 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, 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 further 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 syndrome 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.

Immediately inform your doctor 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. Your doctor will examine you to decide if you should continue taking gabapentina.

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.

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.
• Difficulty breathing, 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.

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.

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- 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 common 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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 600 mg film-coated tablets

Keep out of sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Gabapentina Kern Pharma composition 600 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).

Product appearance and packaging contents

Film-coated tablets. The tablets are oval (10 mm x 19 mm), white, scored on one side, and "600" 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 leaflet was revised in January 2023

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