Gabapentin Viso Farmaceutica 100 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Viso Farmacéutica 100 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, 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Gabapentin Viso Farmacéutica belongs to a group of medicines used in the treatment of epilepsy and neuropathic pain (persistent pain caused by nerve damage).

The active substance in Gabapentin Viso Farmacéutica is gabapentin.

Gabapentin Viso Farmacéutica is indicated for the treatment of:

• Various forms of epilepsy (seizures initially limited to specific areas of the brain, whether or not they spread to other brain regions). Your doctor or your child's doctor (6 years of age or older) may prescribe Gabapentin Viso Farmacéutica to help manage epilepsy when the current treatment does not fully control the condition. You or your child (6 years of age or older) should take Gabapentin Viso Farmacéutica in combination with the current treatment, unless otherwise instructed by your doctor. Gabapentin Viso Farmacéutica may also be used as monotherapy in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain (persistent neuropathic pain caused by nerve damage). Peripheral neuropathic pain may result from various diseases (occurring mainly in the legs and/or arms), such as diabetes or shingles (herpes zoster). Painful sensations may be described as warmth, burning, pulsating, stabbing, shooting, sharp, cramping, pain, tingling, numbness, muscle cramps, etc.

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

Do not take Gabapentina Viso Farmacéutica:

• 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 taking Gabapentina.

• if you have kidney problems, your doctor may prescribe you different dosage regimens
• if you are undergoing hemodialysis (removal of waste products due to renal 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 indicate acute pancreatitis (inflammation of the pancreas).
• if you have disorders of the nervous system, respiratory disorders, or if you are over 65 years of age, your doctor may prescribe a different dosing regimen.
• if you suffer from myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms
• 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 higher risk of developing dependence on Gabapentina Viso Farmacéutica.

Cases of abuse and dependence on gabapentin have been reported after marketing. Speak with your doctor if you have a history of abuse or dependence.

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

Dependence

Some people may develop dependence (need to keep taking the medicine) on Gabapentina Viso Farmacéutica. They may experience withdrawal symptoms when they stop taking Gabapentina Viso Farmacéutica or reduce the dose (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 important to 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 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, talk to 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 possible 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 serious symptoms 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, tenderness, or pain, and particularly if, at the same time, you feel unwell or have a fever, may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems. You may also experience discoloration of the urine and changes in blood test results (significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Viso Farmacéutica

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. 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 condition.

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentina. In addition, the combination of Gabapentina with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

When Gabapentina is taken at the same time as antacids containing aluminium 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 medicines or the oral contraceptive pill.
• 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 Viso Farmacéutica with food

Gabapentin may be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you might be pregnant, you must inform your doctor immediately to assess the possible risks that the medicine you are taking could pose to the fetus.
• You should not stop your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should review your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

If you are planning to become pregnant or if you are pregnant or think you might be, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening of your epilepsy could endanger both you and your unborn child.

In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to 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 concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Contact your doctor immediately if you become pregnant, think you might be pregnant, or are planning to become pregnant while being treated with Gabapentina. Do not stop treatment with this medicine abruptly, as this could cause recurrent seizures, which could 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 during breastfeeding.

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 complex machinery, or engage in activities that could be dangerous until you know whether this medicine affects your ability to perform these activities.

Gabapentin contains lactose

Gabapentin hard capsules contain 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 Gabapentin Viso Farmacéutica

Follow exactly the instructions for using 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

Use in children and adolescents:

Take the number of capsules prescribed by your doctor. Usually, your doctor will gradually increase the dose. The initial dose is typically 300 to 900 mg per day. Thereafter, the dose may be increased up to a maximum daily dose of 3600 mg/day, which your doctor will instruct you to take in three divided doses—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 given to your child, which will be calculated based on their body weight. Treatment starts with a low initial dose, which is gradually increased over a period of about 3 days. The usual dose for controlling epilepsy is 25 to 35 mg/kg/day. This is usually administered in three divided doses, typically once in the morning, once in the afternoon, and once at the 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 prescribed by your doctor. Usually, your doctor will gradually increase the dose. The initial dose is typically 300 to 900 mg per day. Thereafter, the dose may be increased, as directed by your doctor, up to a maximum daily dose of 3600 mg/day, which your doctor will instruct you to take in three divided doses—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 (aged over 65 years)

You should take the normal dose of Gabapentin 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 Gabapentin is too strong or too weak, speak to your doctor or pharmacist as soon as possible.

Method of administration

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

Continue taking Gabapentin until your doctor tells you to stop.

If you take more Gabapentin Viso Farmacéutica 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go immediately to the nearest hospital emergency department if you have taken more Gabapentin than prescribed by your doctor. Take with you any unused capsules, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Viso Farmacéutica

If you forget to take a dose, take it as soon as possible once 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 Gabapentin Viso Farmacéutica

Do not stop taking Gabapentin Viso Farmacéutica suddenly or reduce the dose without consulting your doctor. If you wish to stop taking Gabapentin Viso Farmacéutica 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 period of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping treatment with Gabapentin Viso Farmacéutica either after short- or long-term use, or after reducing the dose. These may 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 Gabapentin Viso Farmacéutica 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

Stop taking Gabapentin Viso Farmacéutica and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-elevated patches with a target-like or circular shape on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, 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).

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 unwell and dizziness, as these symptoms may indicate acute pancreatitis (inflammation of the pancreas).
• Breathing problems, which, if severe, may require emergency treatment and intensive care to maintain normal breathing.
• It may cause a serious 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 does not always appear when this type of reaction occurs. This reaction could require hospitalization or discontinuation of treatment with Gabapentin. Contact your doctor immediately if you experience any of the following symptoms:
  • Skin rash, redness, and/or hair loss
  • Hives
  • Fever
  • Persistent swelling of 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 early signs of a serious reaction. Your doctor will examine you and determine whether you should continue treatment with Gabapentin.

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

Other adverse effects include:

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

• Viral infections
• Drowsiness, 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, restlessness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty falling asleep, headache, skin sensitivity, decreased sensation (numbness), coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, flushing or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting (nausea), nausea (feeling of sickness), dental problems, 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, jerking movements
• Erectile dysfunction (impotence)
• Swelling of arms and legs, difficulty walking, weakness, pain, malaise, 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 affecting the face, trunk, and legs
• Abnormal blood test results that could 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 problems, shallow breathing (respiratory depression)

The following adverse effects have been reported since the marketing of Gabapentin:

• Decreased platelet count (cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Movement disorders such as dystonia, spasmodic movements, and rigidity
• Ringing in the ears
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Breast tissue growth, enlargement of the breast
• Adverse events occurring after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, sweating), chest pain
• Rupture of muscle fibers (rhabdomyolysis)
• Changes in blood test results (increased creatine phosphokinase)
• Problems with sexual function, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
• Development of dependence on gabapentin (“drug dependence”)

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

• Worsening of myasthenia gravis (a disease causing muscle weakness)

You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with gabapentin or after reducing the dose (see “If you stop taking Gabapentin Viso Farmacéutica”).

Reporting of adverse effects

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

5. Storage of Gabapentin Viso Farmacéutica

Keep this medicine out of sight and reach of children.

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

Store below 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a 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 Viso Farmacéutica

The active substance in Gabapentin Viso Farmacéutica is gabapentin.

Gabapentin Viso Farmacéutica 100 mg hard capsules contain 100 mg of gabapentin.

The other components present in the capsule contents are: lactose monohydrate, maize starch and talc.

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

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

Appearance of the product and pack contents

Gabapentin Viso Farmacéutica 100 mg hard capsules are size 3´ hard gelatin capsules, with an opaque white cap and an opaque white body, marked with a G´ on the cap and `456´ on the body in black ink, filled with white to off-white powder.

Gabapentin Viso Farmacéutica 100 mg hard capsules are available in blisters containing: 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180 and 200 capsules, and in containers with 20, 50, 100, 200, 200 (multi-pack containing 2 bottles of 100 capsules each), 300, 500 and 1000 hard capsules.

Only certain pack 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

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of the last revision of this leaflet: April 2026.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).