GABAPENTINA 400 mg Hard Capsules

Contents of the leaflet

1. Introduction
2. What is Gabapentina Viso Farmacéutica and what is it used for
3. What you need to know before you take Gabapentina Viso Farmacéutica
4. How to take Gabapentina Viso Farmacéutica
5. Possible Adverse Effects
6. Storage of Gabapentina Viso Farmacéutica
7. Package contents and additional information

Introduction

Package Leaflet: Information for the User

Gabapentina Viso Farmacéutica 400 mg Hard Capsules 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 signs of illness 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 pack

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

1. What is Gabapentina Viso Farmacéutica and what is it used for

Gabapentina Viso Farmacéutica belongs to a group of medicines used to treat epilepsy and neuropathic pain (persistent pain caused by nerve damage).

The active substance of Gabapentina Viso Farmacéutica is gabapentin.

Gabapentina Viso Farmacéutica is indicated for the treatment of:

• Various forms of epilepsy(seizures that are initially limited to certain areas of the brain, whether or not the seizure spreads to other areas of the brain). The doctor treating you or your child aged 6 years or older will prescribe Gabapentina Viso Farmacéutica to help treat epilepsy when current treatment does not fully control the disease. You or your child aged 6 years or older should take Gabapentina Viso Farmacéutica in combination with current treatment unless otherwise indicated. Gabapentina Viso Farmacéutica can also be administered as a single drug in the treatment of adults and children over 12 years.

Peripheral neuropathic pain (persistent neuropathic pain caused by nerve damage). Peripheral neuropathic pain can be caused by various diseases (mainly in the legs and/or arms), such as diabetes or herpes zoster. Painful sensations can be described as heat, burning, pulsating pain, flashing, stabbing, acute, cramps, pain, tingling, numbness, aches, etc.

2. What you need to know before you take Gabapentina Viso Farmacéutica

Do not take Gabapentina Viso Farmacéutica:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina.

• if you have kidney problems, your doctor may prescribe different dosing schedules
• if you are undergoing hemodialysis (removal of waste products due to kidney failure), inform your doctor if you develop muscle pain and/or weakness
• if you experience signs such as persistent stomach pain, vomiting, and nausea, contact your doctor immediately, as these symptoms may be indicative of acute pancreatitis (inflammation of the pancreas).
• if you have nervous system disorders, respiratory disorders, or if you are over 65 years old, your doctor may prescribe a different dosing regimen. before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; you may be at greater risk of developing dependence on Gabapentina Viso Farmacéutica.

There have been reports of abuse and dependence on gabapentin after its marketing. Talk to your doctor if you have a history of abuse or dependence.

A small number of patients being treated with antiepileptics such as gabapentin have thoughts of self-harm or suicidal ideas. If you ever have these thoughts, contact your doctor immediately.

Dependence

Some people may develop dependence (need to continue taking the medicine) on Gabapentina Viso Farmacéutica. They may experience withdrawal syndrome when they stop taking Gabapentina Viso Farmacéutica (see section 3, "How to take Gabapentina Viso Farmacéutica" and "If you stop taking Gabapentina Viso Farmacéutica"). If you are concerned about developing dependence on Gabapentina Viso Farmacéutica, it is essential that you consult your doctor.

If you experience any of the following signs while taking Gabapentina Viso Farmacéutica, it may indicate that you have developed dependence.

• You feel that you need to take the medicine for longer 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 possible serious reactions

Severe skin reactions have been reported in association 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 serious symptoms that appear in section 4 of this leaflet, following `If you experience any of the following symptoms after taking this medicine, contact your doctor immediately, as they may be serious´.

Muscle weakness, sensitivity, or painand particularly, if at the same time, you feel unwell or have a fever, may be caused by abnormal muscle breakdown that can put your life at risk and cause kidney problems. You may also experience urine discolorationand 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 medicines and Gabapentina Viso Farmacéutica

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 to treat 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 Gabapentina. Additionally, the combination of Gabapentina with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

When Gabapentina is taken at the same time as antacids with aluminum and magnesium, the absorption of Gabapentina in the stomach may be reduced. Therefore, it is recommended to take Gabapentina at least two hours after taking an antacid.

Gabapentina Viso Farmacéutica:

• is not expected to interact with other antiepileptic medicinesor the oral contraceptive pill.
• may interfere with some laboratory tests, so if you need a urine analysis, inform your doctor or hospital what you are taking.

Taking Gabapentina Viso Farmacéutica with food

Gabapentina can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, you must inform your doctor immediately to analyze the possible risks that the medicine you are taking may represent for the fetus.
• Do not interrupt your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentina Viso Farmacéutica can be used during the first trimester of pregnancy if necessary.

If you plan to become pregnant or are pregnant or think you may be pregnant, consult your doctor immediately.

If you have become pregnant and have epilepsy, it is essential that you do not stop taking your medicine without first consulting your doctor, as this may worsen your disease. The worsening of your epilepsy can put both you and your unborn baby at risk.

In a study that reviewed data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies of women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

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

Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning to become pregnant while being treated with Gabapentina. Do not stop treatment with this medicine abruptly, as it may cause recurrent seizures, which can have serious consequences for you and your child.

Breastfeeding

Gabapentin, the active substance of Gabapentina Viso Farmacéutica, is excreted in breast milk. Since the effect on newborns is unknown, Gabapentina is not recommended for use during breastfeeding.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina may cause dizziness, drowsiness, and fatigue. You should not drive, operate complex machinery, or engage in activities that may be dangerous until you know if this medicine affects your ability to perform these activities.

Gabapentina contains lactose.

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

3. How to take Gabapentina Viso Farmacéutica

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not take a larger amount of medicine than prescribed.

Your doctor will determine the indicated dose for you.

Epilepsy, the recommended dose is

Use in children and adolescents:

Take the number of capsules that your doctor has prescribed. Normally, your doctor will gradually increase the dose. The initial dose is usually 300 to 900 mg per day. From then on, the dose can be increased to a maximum daily dose of 3600 mg/day, and your doctor will indicate that you take this amount divided into three separate doses, i.e., once in the morning, once in the afternoon, and once at night.

Children aged 6 years or older:

Your doctor will decide the dose to be administered to your child, calculated based on their weight. Treatment is started with a low initial dose, which is gradually increased over a period of about 3 days. The usual dose for regulating epilepsy is 25 to 35 mg/kg/day. It is usually administered divided into three doses, normally once in the morning, once in the afternoon, and once at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules that your doctor has prescribed. Normally, your doctor will gradually increase the dose. The initial dose is usually 300 to 900 mg per day. From then on, the dose can be increased, as indicated by your doctor, to a maximum daily dose of 3600 mg/day, and your doctor will indicate that you take this amount divided into three separate doses, i.e., once in the morning, once in the afternoon, and once at night.

If you have kidney problems or are undergoing hemodialysis

If you have kidney problems or are undergoing hemodialysis, your doctor will prescribe a different dosing schedule and/or dose.

Elderly patients (over 65 years old)

You should take the normal dose of Gabapentina, unless you have kidney problems. Your doctor may prescribe a different dosing schedule and/or dose if you have kidney problems.

If you feel that the effect of Gabapentina is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina is for oral use. Always swallow the capsules with plenty of water.

Continue taking Gabapentina until your doctor tells you to stop.

If you take more Gabapentina Viso Farmacéutica than you should

Doses higher than recommended may cause an increase in side effects, including loss of consciousness, dizziness, double vision, slurred speech, drowsiness, 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 ingested, or go to the emergency department of the nearest hospital if you take more Gabapentina than your doctor prescribed. Bring any unused capsules, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Viso Farmacéutica

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 Viso Farmacéutica

Do not stop taking Gabapentina Viso Farmacéutica suddenly. If you want to stop taking Gabapentina Viso Farmacéutica, 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 know that you may experience certain side effects, called withdrawal syndrome, after interrupting short- or long-term treatment with Gabapentina Viso Farmacéutica. 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 Viso Farmacéutica. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible Adverse Effects

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

• Red, target-like or circular patches on the torso, 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Like all medicines, this medicine can cause side effects, although not everyone may experience them.

If you experience any of the following symptoms after taking this medicine, contact your doctor immediately,as they may be serious:

• Persistent stomach pain, feeling of dizziness and dizziness, as these symptoms may be indicative of acute pancreatitis (inflammation of the pancreas).
• Breathing difficulties, which, if severe, may require emergency attention and intensive care to continue breathing normally.
• It can cause a severe allergic reactionthat can affect the skin or other parts of the body, such as the liver or blood cells. A rash does not always appear when this type of reaction occurs. This reaction may require hospitalization or discontinuation of treatment with Gabapentina. Contact your doctor immediately if you experience any of the following symptoms:
• • skin rash and redness and/or hair loss
  • hives
  • fever
  • persistent swelling of the lymph nodes
  • swelling of the lips, face, and tongue
  • yellowing of the skin or whites of the eyes
  • unexplained bruising or bleeding
  • severe fatigue or weakness
  • unexplained muscle pain
  • frequent infections

These symptoms could be the first signs of a severe reaction. Your doctor will examine you and determine if you should continue treatment with Gabapentina.

• If you are undergoing hemodialysis, inform your doctor of any muscle pain or weakness you experience.

Other adverse effects are:

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

• Viral infections
• Drowsiness, feeling of dizziness, lack of coordination
• Fatigue, fever

Common(may affect more than 1 in 10 people):

• Pneumonia, respiratory infections, urinary tract infections, otitis, or other infections
• Low white blood cell count
• Anorexia, increased appetite
• Irritability, confusion, mood changes, depression, anxiety, nervousness, difficulty reasoning
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty falling asleep, headache, skin sensitivity, decreased sensitivity (numbness), difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, flushing, or dilation of blood vessels
• Breathing difficulties, bronchitis, sore throat, cough, dry nose
• Vomiting (nausea), nausea (feeling of dizziness), changes in dental pieces, gum inflammation, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, skin rash, itching, acne.
• Joint pain, muscle pain, back pain, tremors.
• Erectile dysfunction (impotence)
• Swelling of the legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental injuries, fractures, and abrasions.

In clinical trials conducted in the pediatric population, aggressive behavior and spasmodic movements were also frequently reported.

Uncommon(may affect more than 1 in 100 people):

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Allergic reactions such as hives
• Decreased movement
• Rapid heartbeat
• Difficulty swallowing
• Swelling with facial, torso, and leg involvement
• Abnormal test results that may indicate liver problems
• Mental disability
• Falls
• Increased blood glucose levels (more frequently in patients with diabetes)

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

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

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

• Decreased platelet count (cells responsible for blood coagulation)
• Suicidal thoughts, 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
• Breast tissue growth, breast enlargement
• Adverse events that occur after sudden discontinuation of treatment with gabapentina (anxiety, difficulty falling asleep, feeling of dizziness, pain, sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis)
• Changes in blood test results (increased creatine phosphokinase)
• Sexual function problems, including inability to achieve sexual climax, delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of lips, throat, and tongue, and hypotension that requires urgent treatment)
• Developing dependence on gabapentina ("drug dependence")

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gabapentina Viso Farmacéutica

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

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

Store below 30°C.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina Viso Farmacéutica

The active ingredient of Gabapentina Viso Farmacéutica is gabapentina.

Gabapentina Viso Farmacéutica 400 mg hard capsules contain 400 mg of gabapentina.

The other ingredients present in the capsule content are: lactose monohydrate, cornstarch, and talc.

The capsule shells contain: gelatin, titanium dioxide (E171), and sodium lauryl sulfate.

In addition, the shells of the 400 mg capsules contain yellow iron oxide (E172) and red iron oxide (E172).

The printing ink contains shellac and black iron oxide (E172).

Appearance of the product and package contents

Gabapentina Viso Farmacéutica 400 mg hard capsules are hard gelatin capsules of size `0`, with an orange-yellow to orange cap and an orange-yellow to orange body, with a `G` on the cap and a `458` on the body with black ink, filled with white to off-white powder.

Gabapentina Viso Farmacéutica 400 mg hard capsules are available in blisters containing: 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180, and 200, and containers with 50, 100, 200, 200 (multi-container that includes 2 bottles of 100 capsules), 300, 500, and 1000 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, WD18 8YA

United Kingdom

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:September 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)