GABAPENTINE NORMON 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gabapentina Normon 600 mg Film-Coated Tablets EFG

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

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Gabapentina Normon belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

The active substance of Gabapentina Normon is gabapentin.

Gabapentina Normon 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 Normon for you or your child aged 6 years or older to help treat epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take Gabapentina Normon in combination with your current treatment, unless otherwise advised.

Gabapentina Normon can also be given as the only medicine in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain (long-lasting pain caused by damage to the nerves). 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, shooting, stabbing, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

2. What you need to know before you take Gabapentina Normon

Do not take Gabapentina Normon:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Gabapentina Normon.

• If you have kidney problems, your doctor may prescribe a different dosage regimen.
• If you are on hemodialysis (to remove waste products due to kidney failure), 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 been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina 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 being treated with antiepileptics such as gabapentin have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (need to continue 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 becoming dependent 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 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 its 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.

Important information about potentially serious reactions

Severe skin reactions have been reported with the use of gabapentin, 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 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, and especially if you feel unwell or have a fever, could be due to abnormal breakdown of muscle fibers, which can lead to kidney problems and put your life at risk. You may also experience discoloration of the urine 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.

Using Gabapentina Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. 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.

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids can increase the effect of gabapentin. Additionally, the combination of Gabapentina with opioids can 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 2 hours after taking an antacid.

Gabapentina Normon

• It is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.

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

Taking Gabapentina Normon with food

Gabapentina 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 medicine.

Pregnancy

Do not take gabapentin during pregnancy, unless your doctor has told you to. 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 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 to treat seizures. Therefore, whenever possible, you should try to take only one medicine for seizures during pregnancy 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 medicine suddenly, as this may cause seizures to return, which could have serious consequences for you and your baby.

If you take gabapentin during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken with opioid painkillers.

Breastfeeding

Gabapentin, the active substance of Gabapentina Normon, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Normon, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines:

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

3. How to take Gabapentina Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

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

Epilepsy, the recommended dose is:

Adults and adolescents

Take the number of tablets that your doctor has told you to. 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 in the evening.

Children aged 6 years and older

Your doctor will decide the dose to be given 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 usual dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually given by taking the tablets, divided into 3 equal doses per day, usually one in the morning, one at noon, and one in the evening.

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

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of tablets that your doctor has told you to. 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 in the evening.

If you have kidney problems or are on hemodialysis

Your doctor may prescribe a different dosage regimen and/or different doses if you have kidney problems or are on hemodialysis.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of Gabapentina Normon unless you have kidney problems.

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

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

Method of administration

Gabapentina Normon is administered orally. Always swallow the tablets with a sufficient amount of water. The tablet 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 side 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital if you take more gabapentina than your doctor prescribed. Bring any tablets you have not taken, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Normon

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

If you stop taking 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 tell you how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week. You should be aware that you may experience certain side effects, called withdrawal symptoms, after stopping treatment with Gabapentina Normon after short or long-term use. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Normon. 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 all people suffer from them.

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

• Red patches without relief with a target or circular shape 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 increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome).

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious:

• Severe skin reactions that require immediate attention, inflammation of the lips and face, skin rash, and redness, and/or hair loss (can be symptoms of a severe allergic reaction).
• Persistent stomach pain, vomiting, and nausea, as they can 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. This reaction may or may not have been preceded by a rash. It may require discontinuing gabapentina or even hospitalization.
• Breathing difficulties that, if severe, may require urgent medical attention to breathe normally.

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

• Skin rash.
• Hives.
• Fever.
• Inflammation of the glands that does not disappear.
• Swelling of the lips and tongue.
• Yellowish color of the skin or whites of the eyes.
• 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 be examined by a doctor to decide if you should continue taking Gabapentina Normon.

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

Other adverse effects include:

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

• Viral infection.
• Sleepiness, dizziness, lack of coordination.
• Feeling of tiredness, 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.
• Anorexia, increased appetite.
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), 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, 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, tremors.
• Difficulty with erection (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.
• Decreased leukocytes, weight gain.
• Accidental injuries, fractures, abrasions.

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

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

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

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

• Loss of consciousness.
• Decreased glucose levels in the blood (observed more frequently in patients with diabetes).
• Breathing difficulties, shallow breathing (respiratory depression).

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

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

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

After the marketing of Gabapentina, the following adverse effects have been reported:

• Decrease in platelets (blood clotting cells).
• Hallucinations.
• Problems with abnormal movements, such as contortions, spasmodic movements, and stiffness.
• Ringing in the ears.
• Yellowish appearance of the skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increased breast tissue, breast enlargement.
• Adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain.
• Rupture of muscle fibers (rhabdomyolysis).
• Changes in blood test results (elevated creatine phosphokinase).
• Problems with sexual activity, such as inability to reach orgasm and delayed ejaculation.
• Low sodium levels in the blood.
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).

Reporting of adverse effects

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

5. Storage of Gabapentina Normon 600 mg tablets

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

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

Do not store above 25°C. Store in the original packaging, tightly closed.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina Normon

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

The other components (excipients) are:

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

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

Appearance of the product and package contents

Gabapentina Normon is presented in the form of film-coated tablets. The tablets are white, biconvex, elliptical in shape, with a break line and engraved "600" on one face.

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

Each package contains 90 film-coated tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this leaflet: March 2023

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