Gabapentin Viso Farmaceutica 400 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gabapentin Viso Farmaceutica 400 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given 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.

Leaflet Contents

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

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

Gabapentina 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 Gabapentina Viso Farmacéutica is gabapentin.

Gabapentina 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 areas of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe Gabapentina Viso Farmacéutica to help manage epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take Gabapentina Viso Farmacéutica in combination with current treatment unless otherwise instructed. Gabapentina 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. Painful sensations may be described as warmth, burning, pulsating pain, stabbing, sharp, cramping, pain, tingling, numbness, muscle soreness, 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 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 old, 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 increased risk of developing dependence on Gabapentina Viso Farmacéutica.

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

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

Dependence

Some people may develop dependence (a 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, but failed.
• When you stop taking the medicine, you feel unwell and feel better when you start taking it again.

If you notice any of the above, speak with 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 reactions 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 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 you also 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 urine and changes in blood test results (a 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric conditions.

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, combining Gabapentina with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

When Gabapentin is taken at the same time as antacids containing aluminium and magnesium, the absorption of Gabapentin in the stomach may be reduced. Therefore, it is recommended to take Gabapentin 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 certain laboratory tests, so if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Gabapentina Viso Farmacéutica with food

Gabapentin can 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 discuss the possible risks that the medicine you are taking may 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 can 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 not to stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening epilepsy may put both you and your unborn baby at risk.

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 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 it could trigger recurrent seizures, which could have serious consequences for you and your child.

Breastfeeding

Gabapentin, the active substance in Gabapentina Viso Farmacéutica, is excreted in breast milk. Since the effect on newborns is unknown, Gabapentin 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 told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gabapentina Viso Farmacéutica

Follow exactly the instructions for administration of this medicine provided 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. Afterwards, 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 in the evening.

Children aged 6 years or older:

Your doctor will decide the dose for your child, 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 in the evening.

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. Afterwards, 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 in the evening.

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 of age)

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 Gabapentina Viso Farmacéutica than you should

Doses higher than recommended may increase the risk of 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 91 562 04 20 immediately, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department if you take more Gabapentina than prescribed by your doctor. Bring any unused capsules, together with the packaging and the package 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 almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentina Viso Farmacéutica

Do not stop taking Gabapentina Viso Farmacéutica suddenly or reduce the dose without consulting your doctor. If you wish to stop taking Gabapentina 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 of one week. Be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentina Viso Farmacéutica or after reducing the dose. These may include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Viso Farmacéutica or reducing the dose. If you experience this withdrawal syndrome, 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 severe 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 dizzy or actual 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 affecting the skin or other parts of the body, such as the liver or blood cells. A rash does not always appear with this type of reaction. 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 lymph node swelling
  • 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 may experience.

Other adverse effects are:

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, nervousness, 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 sick), 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, 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
• Reduced 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 observed 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)

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 twisting movements, 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 occurring after abrupt discontinuation of gabapentin treatment (anxiety, difficulty falling asleep, dizziness, pain, sweating), chest pain
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (increased creatine phosphokinase)
• Sexual dysfunction, 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 effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina Viso Farmacéutica

The active substance in Gabapentina Viso Farmacéutica is gabapentin.

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

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

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

In addition, the capsule 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 contents of the pack

Gabapentina Viso Farmacéutica 400 mg hard capsules are size 0´ hard gelatin capsules with a light orange to orange cap and a light orange to orange body, marked with a G´ on the cap and `458´ on the body in 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 capsules, and in containers with 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 further information about this medicinal product, please 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 for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).