Gabapentin Normon 400 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gabapentin Normon 400 mg hard capsules EFG

Gabapentin

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Gabapentin Normon is and what it is used for
2. What you need to know before taking Gabapentin Normon
3. How to take Gabapentin Normon
4. Possible side effects
5. How to store Gabapentin Normon
6. Contents of the pack and other information

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

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

The active substance is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures that initially affect only specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor will prescribe Gabapentin to help manage your epilepsy when your current treatment does not fully control the condition. You should take Gabapentin in combination with your current treatment unless otherwise instructed. Gabapentin may also be given as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various diseases can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles (herpes). The pain sensation may be described as warmth, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and prickling sensations, etc.

2. What you need to know before taking Gabapentina Normon

Do not take Gabapentin:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Gabapentin:

• If you have kidney problems, your doctor may prescribe you a different dosing regimen.
• If you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience muscle pain and/or weakness.
• If you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately, as these may be symptoms of acute pancreatitis (inflamed pancreas).
• If you have a disorder of the nervous system or a respiratory disorder, or if you are over 65 years of age, your doctor may prescribe you a different dose.
• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on Gabapentina Normon.
• If you have myasthenia gravis (a disease causing muscle weakness), as this

medicine may worsen your symptoms.

Cases of abuse and dependence on gabapentin have been reported from post-marketing experience. Speak with your doctor if you have a history of substance abuse or dependence.

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

Dependence

Some people may develop dependence (a need to keep taking the medicine) 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 stop taking Gabapentina Normon"). If you are concerned about developing dependence on Gabapentina Normon, it is important that you 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 you need to take the medicine for longer than prescribed.
• You feel you need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• 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 start taking it again.

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

Important information about potentially serious reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention if you notice any of the symptoms related to these serious 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, tenderness, or pain on palpation—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and may be life-threatening. You may also experience discoloration of the urine and changes in blood test results (a significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Taking Gabapentin with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric conditions.

Medicines containing opioids such as morphine

If you are taking a medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin. In addition, combining Gabapentin with opioids may cause symptoms such as drowsiness and/or reduced 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 therefore recommended that Gabapentin be taken at least two hours after taking an antacid.

Gabapentin:

• No interaction with other antiepileptic medicines or with oral contraceptive pills is expected.
• May interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Gabapentin with food

Gabapentin can be taken with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take Gabapentin during pregnancy unless your doctor has instructed you to do so. An effective method of contraception 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 medicines used to treat seizures, an increased risk of harm to the developing baby has been reported, particularly when more than one medicine is used simultaneously to treat seizures. Therefore, whenever possible, you should try to take only one seizure medicine during pregnancy, and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking Gabapentin. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Breast-feeding

Gabapentin, the active substance in Gabapentina Normon, passes into breast milk. Breast-feeding is not recommended while taking Gabapentin, as the effect on the infant is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform such activities.

Gabapentina Normon 400 mg hard capsules EFG contains lactose

Gabapentina Normon 400 mg hard capsules EFG contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gabapentina Normon

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is

Adults and adolescents:

Take the number of capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

Children aged 6 years or older:

Your doctor will decide the dose to administer to your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. This dose is usually administered by taking the capsules, divided into three equal doses per day, typically one in the morning, one at midday, and one at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults:

Take the number of capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

If you have kidney problems or are receiving hemodialysis treatment

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

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

If you think the effect of Gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin is administered orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking Gabapentin until your doctor tells you to stop.

If you take more Gabapentin 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital emergency unit. Bring any unused capsules, together with the packaging and the package leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for missed doses.

If you stop taking Gabapentin

Do not stop taking Gabapentina Normon suddenly or reduce the dose without consulting your doctor. If you wish to stop taking Gabapentina Normon or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentina Normon or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Normon or reducing the dose. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible adverse effects

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

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

• Red, non-raised patches with a target-like or circular shape on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These serious skin rashes 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 requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a serious allergic reaction).
• Persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. A rash may or may not be present with this type of reaction. This may require discontinuation of Gabapentin or even hospitalization. Contact your doctor immediately if you have any of the following symptoms:
  • Skin rash.
  • Hives.
  • Fever.
  • Swollen glands that do not go away.
  • Swelling of the lips and tongue.
  • Yellowing of the skin or whites of the eyes.
  • Unusual bleeding or bruising.
  • Severe fatigue or weakness.
  • Unexpected muscle pain.
  • Frequent infections.
• Breathing difficulties that, if severe, may require urgent medical care to maintain normal breathing.

These symptoms may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking Gabapentin.

• If you are on hemodialysis, inform your doctor if you begin to experience muscle pain and/or weakness.

Other adverse 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 infection, ear inflammation, or other infections.
• Low white blood cell count.
• Loss of appetite, increased appetite.
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), coordination problems, 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 or throat, flatulence.
• Facial swelling, bruising, rash, itching, acne.
• Joint pain, muscle pain, back pain, jerking movements.
• Erectile difficulties (impotence).
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Decreased white blood cells, weight gain.
• Accidental injuries, fractures, abrasions.

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

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

• Allergic reactions such as hives.

• Reduced movement.

• Increased heart rate.

• Swelling that may affect the face, trunk, and limbs.

• Abnormal blood test results that may indicate liver problems.

• Progressive mental impairment.

• Fall.

• Increased blood glucose levels (observed more frequently in diabetic patients).

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

• Difficulty swallowing.

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

• Loss of consciousness.
• Decreased blood glucose levels (observed more frequently in diabetic patients).
• Breathing problems, shallow breathing (respiratory depression).

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

• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment).
• Suicidal thoughts.
• Development of dependence on Gabapentina Normon ("drug dependence").

You should be aware that you may experience certain adverse effects called withdrawal syndrome after stopping short- or long-term treatment with Gabapentina Normon or after reducing the dose (see "If you stop taking Gabapentina Normon").

Following the marketing of Gabapentin, the following adverse effects have been reported:

• Decreased platelet count (blood clotting cells).
• Hallucinations.
• Abnormal movement problems such as dystonia, spasmodic movements, and rigidity.
• Ringing in the ears.
• Yellow appearance of the skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increase in breast tissue, breast enlargement.
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Muscle fiber breakdown (rhabdomyolysis).
• Changes in blood test results (elevated creatine phosphokinase).
• Problems with sexual function, such as inability to reach orgasm and delayed ejaculation.
• Low sodium levels in the blood.
• Worsening of myasthenia gravis (a disease causing muscle weakness).
• (Frequency not known)
• Worsening of myasthenia gravis (a disease causing muscle weakness). (Frequency not known).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Normon 400 mg hard capsules EFG

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

The other components of Gabapentin Normon 400 mg hard capsules EFG are: monohydrate lactose, corn starch and talc. The gelatin capsule consists of: gelatin, quinoline yellow (E-104), iron oxide red (E-172) and titanium dioxide (E-171).

Appearance of the product and contents of the container

Gabapentin Normon 400 mg hard capsules EFG are presented as hard gelatin capsules of size 0L and orange-yellow in colour. Each pack contains 30, 90 or 500 capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this leaflet: April 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/