GABAPENTINA NORMON 800 mg FILM-COATED TABLETS

2. What you need to know before taking 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

Talk to 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), tell your doctor if you start to feel muscle pain and/or weakness.
• If you develop symptoms such as persistent stomach pain, vomiting, and nausea, tell 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, tell 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 have 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 talk to your doctor.

If you experience any of the following signs while taking Gabapentina Normon, it may be indicative of 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 what is 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 medical attention immediately 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 taking, have recently taken, or might take any other medicines. In particular, tell 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), tell 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, tell your doctor or hospital 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 think you may be pregnant, or if you 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 other medicines used to treat seizures have been reported to increase the risk of harm to the developing baby, particularly when used at the same time as more than one medicine 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, it 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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. Do not take more than the prescribed dose.

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 directed 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 at noon, and one in the evening.

Children aged 6 years and over

Your doctor will decide the dose to be given to your child based on the child's weight. Treatment will begin 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 directed 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 at noon, 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 taken by mouth. 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 gabapentin than your doctor prescribed. Bring any remaining tablets, 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 forgotten doses.

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 on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Gabapentina Normon 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, 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).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Contact your doctor immediately if you experience any of the following symptoms after taking this medication, 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 Normon 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. This reaction may or may not be accompanied by a rash. It may require discontinuing gabapentina or even hospitalization.
• Breathing difficulties that, if severe, may require urgent medical attention to maintain normal breathing.

Contact your doctor immediately if you have 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 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.
• Drowsiness, dizziness, lack of coordination.
• Fatigue, 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, 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, reddening, or dilation of blood vessels.
• Breathing difficulties, 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 unwell, 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 blood glucose levels (observed more frequently in patients with diabetes).
• Difficulty swallowing.

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

• Loss of consciousness.

• Decreased blood glucose levels (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 taking Gabapentina Normon").

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

• Decrease in platelets (blood clotting cells).
• Hallucinations.
• Abnormal movement problems, such as contortions, spasmodic movements, and stiffness.
• Ringing in the ears.
• Yellowing 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, dizziness, pain, and sweating), chest pain.
• Rupture of muscle fibers (rhabdomyolysis).
• Changes in blood test results (elevated creatine phosphokinase).
• Sexual activity problems, 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 medication.

5. Storage of Gabapentina Normon

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated 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 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. Additional Information

Composition of Gabapentina Normon

The active ingredient is gabapentina. Each film-coated tablet contains 800 mg of gabapentina.

The other ingredients (excipients) are:

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

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

Appearance of the product and packaging content

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 with "800" 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 thisleaflet: March 2023

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