GABAPENTINA 400 mg Hard Capsules

Contents of the leaflet

1. Introduction
2. What is gabapentina cinfa and what is it used for
3. What you need to know before taking gabapentina cinfa
4. How to take gabapentina cinfa
5. Possible Adverse Effects
6. Storage of Gabapentina Cinfa
7. Package Contents and Additional Information

Introduction

Package Leaflet: Information for the User

gabapentina cinfa 400 mg hard capsules EFG

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is gabapentina cinfa and what is it used for
2. What you need to know before taking gabapentina cinfa
3. How to take gabapentina cinfa
4. Possible side effects
5. Storage of gabapentina cinfa

Contents of the pack and further information

1. What is gabapentina cinfa and what is it used for

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

The active substance of gabapentina cinfa is gabapentina.

gabapentina cinfa 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). The doctor treating you or your child aged 6 years or older will prescribe gabapentina cinfa to help treat your epilepsy when your current treatment does not fully control the disease. You or your child aged 6 years or older should take gabapentina cinfa in combination with your current treatment unless otherwise indicated. 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 sensation of pain can be described as heat, burning, throbbing pain, shooting pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pinching sensation, etc.

2. What you need to know before taking gabapentina cinfa

Do not take gabapentina cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take gabapentina cinfa:

• 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 medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; you may have a higher risk of developing dependence on gabapentina.

There have been reports of abuse and dependence on gabapentina 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 gabapentina have had thoughts of harming themselves or committing 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 medication) on gabapentina cinfa. They may experience withdrawal symptoms when they stop taking gabapentina cinfa (see section 3, "How to take gabapentina cinfa" and "If you stop taking gabapentina cinfa"). If you are concerned about developing dependence on gabapentina cinfa, it is essential that you consult your doctor.

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

• You feel that you need to take the medication for a longer period than prescribed.
• You feel that you 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.
• When you stop taking the medication, 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 gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina 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 package leaflet"Contact your doctor immediately if you experience any of the following symptoms after taking this medication, as they may be serious".

Muscle weakness, sensitivity, or pain on palpation, and especially if you feel unwell or have a fever, could be due to abnormal muscle fiber breakdown, which can 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.

Other medications and gabapentina cinfa

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In particular, inform your doctor (or pharmacist) if you are taking or have recently taken 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 can increase the effect of gabapentina. Additionally, the combination of gabapentina with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

gabapentina cinfa:

It is not expected to interact 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 hospital about what you are taking.

Taking gabapentina cinfa 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 medication.

Pregnancy

Do not take gabapentina during pregnancy, unless your doctor has indicated it. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies on the use of gabapentina in pregnant women, but in the case of other medications used to treat seizures, an increased risk of fetal damage 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 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 gabapentina. Do not stop taking this medication abruptly, as this may cause a seizure, which could have serious consequences for you and your baby.

If taken during pregnancy, gabapentina may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (medications for intense pain treatment).

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina may cause symptoms such as drowsiness, dizziness, or vision changes, and may decrease reaction ability. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

gabapentina cinfa contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take gabapentina cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take a higher dose of the 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 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 at noon, and one at night.

Children 6 years or older:

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

gabapentina cinfa is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules 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 at noon, and one at night.

If you have kidney problems or if you are on hemodialysis

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

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

You should take the normal dose of gabapentina, except if you have kidney problems. Your doctor may prescribe a different dosage regimen or different doses if you have kidney problems.

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

Method of administration

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

Continue taking gabapentina until your doctor tells you to stop.

If you take more gabapentina cinfa 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 or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

Bring any unused capsules, along with the packaging and package leaflet, so that the hospital can easily identify the medication you have taken.

If you forget to take gabapentina cinfa

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 forgotten doses.

If you stop taking gabapentina cinfa

Do not stop taking gabapentina cinfa abruptly. If you want to stop taking gabapentina cinfa, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should be aware that you may experience certain side effects, called withdrawal syndrome, after interrupting short- or long-term treatment with gabapentina cinfa. These include seizures, anxiety, difficulty sleeping, feeling unwell (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 cinfa. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any other questions about the use of this medication, 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.

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)
• Gabapentin 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. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing gabapentin or even hospitalization
• Breathing difficulties that, if severe, may require urgent medical attention to continue breathing 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
• 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 gabapentin.

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

Other adverse effects include:

Very Common Adverse Effects(may affect more than 1 in 10 patients):

• Viral infection.
• Feeling of drowsiness, dizziness, discoordination.
• Feeling of fatigue, fever.

Common Adverse Effects(may affect up to 1 in 10 patients):

• Pneumonia, respiratory infection, urinary tract infection, ear inflammation, or other infections.
• Low white blood cell count.
• Anorexia, 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, decreased sensitivity (numbness), difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes.
• Blurred vision, double vision.
• Vertigo.
• Increased blood pressure, redness, or dilation of blood vessels.
• Difficulty breathing, bronchitis, sore throat, cough, dry nasal passages.
• 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 the pediatric population, aggressive behavior and spasmodic movements were reported as common adverse effects.

Uncommon Adverse Effects(may affect up to 1 in 100 patients):

• Difficulty swallowing.
• 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).

Rare Adverse Effects(may affect up to 1 in 1,000 patients):

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

Unknown Frequency(cannot be estimated from the available data):

• Developing dependence on gabapentin cinfa ("drug dependence").

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

Stop taking gabapentin cinfa 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

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

• Decrease in platelets (blood clotting cells).
• Hallucinations.
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity.
• 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 gabapentin 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 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 prospectus. 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 Cinfa

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. 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 Cinfa

• The active ingredient is gabapentin. Each capsule contains 400 mg of gabapentin.
• The other components are

• Capsule content: anhydrous lactose, cornstarch, and talc.
• Hard gelatin capsule: gelatin, yellow iron oxide (E-172), red iron oxide (E-172), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Gabapentina Cinfa is presented in the form of hard gelatin capsules with an orange opaque body and cap that contain white powder.

It is presented in PVC/Aluminum blisters and is available in packages containing 30, 90, or 500 (clinical package) capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:January 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/

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67969/P_67969.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67969/P_67969.html