Prospect: information for the user

Gabapentin Normon 300 mg hard capsules EFG

Gabapentin

Read this prospect carefully before starting to take this medicine, 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 medicine has been prescribed only for you, and you must not give it to others even if they 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.

1.What is Gabapentin Normon and for what it is used

2.What you need to know before starting to take Gabapentin Normon

3.How to take Gabapentin Normon

4.Possible adverse effects

5.Storage of Gabapentin Normon

6.Contents of the package and additional information

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

The active ingredient is gabapentin.

Gabapentin 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). Your doctor will prescribe Gabapentina to help treat your epilepsy when your current treatment does not fully control the disease. You must take Gabapentina in combination with your current treatment unless otherwise instructed.Gabapentina 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 takeGabapentin:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentin:

• If you have kidney problems, your doctor may prescribe a different dosing regimen.
• If you are on haemodialysis (for removing waste products due to renal insufficiency), inform your doctor if you start to feel 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 medicine, inform your doctor if you have ever abused or had dependence on alcohol, prescribed medicines, or illegal drugs; you may have a higher risk of developing dependence on Gabapentin Normon.

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

A small number of people taking antiepileptic medicines such as Gabapentin have had thoughts of harming themselves or suicide. If you ever experience these thoughts, contact your doctor as soon as possible.

Dependence

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

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

• You feel the need to take the medicine for longer than prescribed.
• You feel the 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.
• You feel unwell when you stop taking the medicine 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 serious reactions

Severe skin reactions associated with the use of gabapentin have been reported, 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 leaflet“Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they may be serious”

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal breakdown 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 blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Gabapentin with other medicines

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

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 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 Gabapentin be taken at least two hours after taking an antacid.

Gabapentin:

- Gabapentin is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.

- Gabapentin 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 Gabapentin with food

Gabapentin 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 medicine.

Pregnancy

You should not take Gabapentin during pregnancy, unless your doctor has told you to.,Effective contraception should be used 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 medicines used to treat seizures, an increased risk of damage to the developing fetus has been reported, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible, you should try to take only one medicine for seizures and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, if you think you may be pregnant, or if you plan to become pregnant while taking Gabapentin.,Do not stop taking this medicine 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 medicines).

Breastfeeding

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

Fertility

No effects on fertility have been observed 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 medicine affects your ability to perform other tasks.

Gabapentin Normon 300 mg hard capsules EFG contain lactose

Gabapentin Normon 300 mg hard capsules EFG contain lactose (a type of sugar). If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medicine.

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 appropriate 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 can be increased, as indicated 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 noon, 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, which will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg per kg per day. The dose is normally administered by ingesting the capsules, divided into 3 equal doses per day,usually, one in the morning, one at noon, and one at night.

Do not recommend the use ofGabapentina in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults:

Take the number of capsulesas indicated by your doctor. Normally, your doctor will gradually increase the dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose can be increased, as indicated by your doctor, up to a maximum dose of 3,600mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

If you have kidney problems or if you are receiving hemodialysis treatment

Your doctor may prescribe a different dosing regimen and/or dose if you have kidney problems or if you are receiving hemodialysis treatment.

If you are an elderly patient (over 65 years of age),you should take the normal dose ofGabapentina, except if you have kidney problems.Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

If you consider that the effect ofGabapentinais too strong or too weak, inform your doctor or pharmacist as soon as possible.

Administration form

Gabapentinais administered orally.Swallow the capsules whole with a sufficient amount of water.

Continue takingGabapentina until your doctor tells you to stop.

If you take moreGabapentinathan 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, orcall the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested,orgo to the emergency department of the nearest hospital.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 takeGabapentina

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 the treatment withGabapentina

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 period 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 serious:

• 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 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. It may or may not be accompanied by a rash. This may require discontinuing Gabapentina or even hospitalization. Contact 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.
• Respiratory problems that, if severe, may require emergency medical attention to breathe normally.

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.

• 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, lack of coordination.
• 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, headaches, sensitive skin, numbness, 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, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence.
• Swelling of the face, hives, rash, itching, acne.
• Joint pain, muscle pain, back pain, tremors.
• Difficulty achieving orgasm and delayed ejaculation.
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Low 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.

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions such as hives.
• Decreased movement.
• Increased heart rate.
• Swelling that may 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).
• Restlessness (a chronic state of anxiety and involuntary, purposeless movements).
• Difficulty swallowing.

Rare (may affect up to 1 in 1000 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):

• 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 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 platelets (blood clotting cells).
• Hallucinations.
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity.
• Tinnitus (ringing in the ears).
• Yellowing of the skin and eyes (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).
• Changes in blood test results (elevated creatine phosphokinase).
• Sexual activity problems, such as inability to achieve orgasm and delayed ejaculation.
• Low sodium levels in the blood.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines 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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Gabapentina Normon 300 mg hard capsules EFG

The active ingredient is gabapentin. Each hard gelatin capsule contains 300 mg of gabapentin.

The other components of Gabapentina Normon 300 mg hard capsules EFG are: lactose monohydrate, cornstarch, and talc. The gelatin capsule is composed of: gelatin, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Gabapentina Normon 300 mg hard capsules EFG are presented in the form of hard gelatin capsules of size 0 and yellow color. Each package contains 90 capsules.

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