Leaflet: information for the user

Gabapentin Normon 600 mg film-coated tablets EFG

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Gabapentina Normonbelongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active ingredient of Gabapentina Normon is gabapentin.

Gabapentina Normon is 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). The doctor treating you or your child aged 6 years or older will prescribe GabapentinaNormonto help treat epilepsy when the current treatment does not fully control the disease. You or your child aged 6 years or older must take GabapentinaNormonin combination with the current treatment, unless otherwise indicated.

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

Peripheral neuropathic pain (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, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.

Do not take Gabapentina Normon:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Normon.

• If you have kidney problems, your doctor may prescribe a different dosing regimen.
• If you are on hemodialysis (for waste removal due to renal insufficiency), inform your doctor if you start feeling muscle pain and/or weakness.
• If you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately as they may be symptoms of acute pancreatitis (inflamed pancreas).
• 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 Normon.

There have been reports of gabapentin abuse and dependence from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

A small number of people taking antiepileptic medications such as gabapentin have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.

Dependence

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

If you experience any of the following signs while taking Gabapentina Normon, it may indicate that you have developed dependence:.

• You feel the need to take the medication for a longer period than prescribed.
• You feel the 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.
• 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.

Important information about potentially severe reactions

There have been reports of severe skin reactions associated with gabapentin use, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). 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

Contact your doctor immediately if you experience any of the following symptoms after taking this medication, as they may be severe:

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal rupture of muscle fibers that may lead to kidney problems and put your life at risk. You may also experience urine discoloration, and changes in blood test results (significant increase in creatine phosphokinase in the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Gabapentina Normon with other medications

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

Medications containing opioids such as morphine

If you are taking any medication containing opioids (such as morphine), inform your doctor or pharmacist as opioids may increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids may cause symptoms such as drowsiness and/or decreased breathing.

Antacids for indigestion

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

Gabapentina Normon

• No interaction is expected with other antiepileptic medications or with the oral contraceptive pill.

• It may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what you are taking.

Taking Gabapentina Normon with food

Gabapentin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should not take gabapentin during pregnancy, unless your doctor has indicated it. 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 damage to the developing fetus has been reported, particularly when more than one medication is used to treat seizures. Therefore, whenever possible, you should try to take only one medication for seizures and only under the advice of your doctor.

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

Breastfeeding

Gabapentin, the active ingredient in Gabapentina Normon, passes into breast milk. It is not recommended to breastfeed while taking Gabapentina Normon, as the effect on the baby is unknown.

Fertility

No effects on fertility have been reported in animal studies.

Driving and operating machinery:

Gabapentin may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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 suitable dose for you.

Epilepsy, the recommended dose is:

Adults and adolescents

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

Children 6 years or older

Your doctor will decide on the dose to be administered to your child based on the child's weight. The 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 normally administered by taking the capsules, divided into three equal doses per day, normally one in the morning, one at noon, and one at night.

It is not recommended to use Gabapentina Normon in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

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

If you have kidney problems or are being hemodialyzed

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or are being hemodialyzed.

If you are an elderly patient (over 65 years old)

You should take the normal dose of Gabapentina Normon, except if you have kidney problems.

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

If you consider that the effect of Gabapentina Normon is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina Normon is administered orally. Swallow the capsules with a sufficient amount of water. The capsule can be divided into equal doses.

Continue taking Gabapentina Normon until your doctor tells you to stop.

If you take more Gabapentina Normon than you should

Doses higher than recommended may cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospitalif you take more gabapentin than your doctor prescribed. Bring with you any capsules that you have not taken, along with the packaging and the leaflet so that the hospital can easily identify the medication you have taken.

If you forgot to take Gabapentina Normon

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

If you interrupt the treatment with Gabapentina Normon

Do not stop taking Gabapentina Normon suddenly. If you want to stop taking Gabapentina Normon, talk to your doctor first. Your doctor will indicate 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 Normon. These include seizures, anxiety, difficulty sleeping, feeling of discomfort (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 Normon. 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Gabapentina Normon and seek medical attention immediately if you notice any of the following symptoms:

• Red, flat 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 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 severe:

• Severe skin reactions that require immediate attention, lip and face inflammation, skin rash, and/or redness, and/or hair loss (may be symptoms of a severe allergic reaction).
• Persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas).
• 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. It may or may not have appeared as a rash when this type of reaction occurs. This may require stopping gabapentina or even hospitalization.
• Respiratory problems that, if severe, may require emergency medical attention to breathe normally.

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

• Skin rash.
• Hives.
• Fever.
• Swollen glands that do not subside.
• Lip and tongue swelling.
• Yellowish skin or eye discoloration.
• Unusual bleeding or bruising.
• Severe fatigue or weakness.
• Unexpected muscle pain.
• Frequent infections.

These symptoms may be the first signs of a severe reaction. You should have a doctor examine you to decide if you should continue taking Gabapentina Normon.

• If you are on hemodialysis, inform your doctor if you start feeling muscle pain and/or weakness.

Other side effects include:

Very common (may affect more than 1 in 10 people):

• Viral infection.
• Drowsiness, dizziness, discoordination.
• Feeling tired, fever.

Common (may affect up to 1 in 10 people):

• Pneumonia, respiratory infections, urinary tract infections, ear inflammation, or other infections.
• Low white blood cell count.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, coordination difficulties, unusual eye movements, increased or decreased 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, flatulence.
• Swollen face, hives, rash, itching, acne.
• Joint pain, muscle pain, back pain, tremors.
• Difficulty achieving erection (impotence).
• Swollen legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental injuries, fractures, bruises.

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent side effects.

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

• Agitation (a chronic state of restlessness and involuntary, purposeless movements).
• Allergic reactions such as hives.
• Decreased movement.
• Increased heart rate.
• Swelling that can affect the face, trunk, and limbs.
• Abnormal results in blood tests that may indicate liver problems.
• Progressive mental damage.
• Falling.
• Increased blood sugar levels (observed more frequently in patients with diabetes).
• Difficulty swallowing.

Very rare (may affect up to 1 in 10,000 people):

• Loss of consciousness.
• Decreased blood sugar levels (observed more frequently in patients with diabetes).
• Respiratory problems, shallow breathing (respiratory depression).

Frequency not known (cannot be estimated from available data):

• Suicidal thoughts.
• Developing dependence on Gabapentina Normon ("drug dependence").

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

After the commercialization of Gabapentina, the following side effects have been reported:

• Decreased platelet count (blood clotting cells).
• Hallucinations.
• Abnormal movements, such as contortions, spasmodic movements, and rigidity.
• Tinnitus (ringing in the ears).
• Yellowish skin and eye discoloration (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Mammary gland enlargement, breast enlargement.
• Side effects after abrupt discontinuation of gabapentina treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Rhabdomyolysis (muscle fiber rupture).
• Abnormal results in blood tests (elevated creatine phosphokinase).
• Sexual activity problems, such as inability to achieve orgasm and delayed ejaculation.
• Low sodium levels in the blood.
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, lip, throat, and tongue swelling, and hypotension that require urgent treatment).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above25°C. Store in the original packaging well closed.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Gabapentina Normon

The active ingredient is gabapentin. Each film-coated tablet contains 600 mg of gabapentin.

The other components (excipients) are:

Core: Povidone K-90, crospovidone, Poloxamer 407, magnesium stearate.

Coating:(Opadry 20A28569): Hydroxypropylmethylcellulose, talc.

Appearance of the product and contents of the packaging

Gabapentina Normon is presented in the form of film-coated tablets. The tablets are white, biconvex, elliptical in shape, with a breaking bar and printed with “600” on one side.

The tablets are packaged in PVC+PVdC/Aluminum blisters.

Each package contains 90 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: March 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/