Prospect: information for the user

Gabapentina Viso Pharmaceutical 400 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Gabapentina Viso Farmacéutica belongs to a group of medications used in the treatment of epilepsy and neuropathic pain (persistent pain caused by a nerve injury).

The active ingredient of Gabapentina Viso Farmacéutica is gabapentin.

Gabapentina Viso Farmacéutica is indicated for the treatment of:

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

Peripheral neuropathic pain(persistent pain caused by a nerve injury in the periphery). Peripheral neuropathic pain can be caused by various diseases (mainly occurring in the legs and/or arms), such as diabetes or herpes zoster. Painful sensations can be described as heat, burning, pulsating pain, stabbing pain, sharp pain, cramps, pain, tingling, numbness, muscle cramps, etc.

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

Consult your doctor or pharmacist before starting to take Gabapentina.

• if you have kidney problems, your doctor may prescribe different dosing regimens
• if you are undergoing hemodialysis (removal of waste products due to renal insufficiency), inform your doctor if you develop muscle pain and/or weakness
• if you experience 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 had dependence on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina Viso Farmacéutica.

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

A small number of patients taking antiepileptic medications like gabapentin have had thoughts of self-harm or suicidal ideation. 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 symptoms when they stop taking Gabapentina Viso Farmacéutica (see section 3, "How to take Gabapentina Viso Farmacéutica" and "If you interrupt treatment with Gabapentina Viso Farmacéutica"). If you are concerned about developing dependence on Gabapentina Viso Farmacéutica, it is essential to consult your doctor.

If you experience any of the following signs while taking Gabapentina Viso Farmacéutica, it may be indicative of dependence.

- You feel the need to take the medicine for longer than prescribed.

- You feel the 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.

- You feel unwell when you stop taking the medicine 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 possible severe reactions

Severe skin reactions associated with gabapentin use have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin 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 severe symptoms that appear in section 4 of this prospectus, following `If you experience any of the following symptoms after taking this medicine, contact your doctor immediately, as they may be severe´.

Muscle weakness, sensitivity, or pain, and particularly if you feel unwell or have a fever, may be caused by an abnormal muscle collapse that can put your life at risk and cause kidney problems. 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 medicines and Gabapentina Viso Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. In particular, inform your doctor (or pharmacist) if you are taking or have taken recently any medicine for treating 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 may increase the effect ofGabapentina. Additionally, the combination of Gabapentina with opioids may causedrowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

When taking Gabapentina with antacids containing aluminum and magnesium, the absorption of Gabapentina in the stomach may be reduced. Therefore, it is recommended to take Gabapentina at leasttwo hours after taking an antacid.

Gabapentina Viso Farmacéutica:

• is not expected to interact with otherantiepileptic medicinesor theoral contraceptive pill.
• may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the 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.
• You should not interrupt your treatment without consulting your doctor first.
• 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 are 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 become pregnant and have epilepsy, it is essential not to stop taking your medicine without consulting your doctor first, as this may worsen your condition. Worsening of your epilepsy may put both you and your unborn baby at risk.

In a study reviewing 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.

Gabapentin may cause withdrawal symptoms in newborns if taken during pregnancy. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medications).

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

Breastfeeding

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

Fertility

No effects on fertility have been observed in animal studies.

Driving and operating machinery

Gabapentina may cause dizziness, numbness, and fatigue. Do not drive, operate complex machines, or participate in activities that may be hazardous 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 a lactose intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Do not take a quantity of medication higher than the prescribed one.

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

Children 6 years or older:

Your doctor will decide on the dose that should be administered to your child, which will be calculated based on their weight. The 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. It is usually administered divided into three doses, usually once in the morning, once in the afternoon, and once at night.

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

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules that your doctor has prescribed for you. It is usually normal for your doctor to 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, up to a maximum daily dose of 3600 mg/day and your doctor will indicate that you take this amount divided into three doses, that is, 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 dosage regimen and/or dose.

Older adults (65 years or older)

You should take the normal dose of Gabapentina, unless you have kidney problems. Your doctor may prescribe a different dosage regimen 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 adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested orgo to the emergency unit of the nearest hospital if you take moreGabapentinathan your doctor prescribed.Bring with you any capsule that you have not taken, along with the packaging and the leaflet so that the hospital can easily identify the medication you have taken.

If you forgot to take Gabapentina Viso Farmacéutica

If you forgot to take a dose, take it as soon as you remember, unless it is time to take the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with 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, this should be done gradually over a minimum of one week. You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment with Gabapentina Viso Farmacéutica. These include seizures, anxiety, difficulty sleeping, feeling of discomfort (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, contact your doctor.

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

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

•Red, flat patches on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

•Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

• Persistent stomach pain, dizziness, and dizziness, as these symptoms may indicate acute pancreatitis (inflammation of the pancreas).
• Respiratory problems, which if severe, may require emergency care and intensive care to breathe normally.
• This may cause asevere or potentially life-threatening allergic reactionthat can affect the skin or other parts of the body, such as the liver or blood cells. Not always a rash appears when this type of reaction occurs. This reaction may require hospitalization or discontinuation of Gabapentina treatment. Contact your doctor immediately if you experience any of the following symptoms:
• • skin rash and redness and/or hair loss)
  • hives
  • fever
  • persistent lymph node inflammation
  • swelling of the lips, face, and tongue
  • yellowing of the skin or white of the eyes
  • unexplained bruises or bleeding
  • intense fatigue or weakness
  • unexplained muscle pain
  • frequent infections

These symptoms may 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 side 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 reasoning
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty falling asleep, headache, skin sensitivity, 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 (dizziness), nausea (dizziness), dental problems, gum inflammation, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence
• Facial swelling, bruises, skin rash, itching, acne.
• Joint pain, muscle pain, back pain, spasms.
• 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 pediatric clinical trials, aggressive behavior and spasmodic movements were also frequently reported.

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

• Agitation (a chronic state of restlessness and involuntary, purposeless movements)
• Allergic reactions such as hives
• Decreased movement
• Accelerated heart rate
• Difficulty swallowing
• Swelling affecting the face, trunk, and legs
• Anomalous 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
• Respiratory problems, shallow breathing (respiratory depression)

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

• Decreased platelet count (cells responsible for blood coagulation)
• Thoughts of suicide, hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity
• Tinnitus in the ears
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute renal failure, incontinence
• Mammary gland enlargement, breast enlargement
• Adverse events that occur after abrupt discontinuation of gabapentina treatment (anxiety, difficulty falling asleep, dizziness, pain, sweating), chest pain
• Muscle fiber rupture (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 (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring urgent treatment)
• Developing dependence on gabapentina ("drug dependence")

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

Reporting 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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication 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 disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Composition of Gabapentina Viso Pharmaceutical

The active ingredient of Gabapentina Viso Pharmaceutical is gabapentin.

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

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

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

Additionally, the 400 mg capsule coatings 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 package

Gabapentina Viso Pharmaceutical 400 mg hard capsules are hard gelatin capsules of size `0´, with a light orange to orange cap and a light orange 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 Pharmaceutical 400 mg hard capsules are available in blisters containing: 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180 and 200 and packaging with 50, 100, 200, 200 (multi-pack including 2 bottles of 100 capsules), 300, 500 and 1000 hard capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible for manufacturing:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, 56617 Vysoké Mýto

Czech Republic

Ó

Glenmark Pharmaceuticals Europe Limited

Building 2, Croxley Green Business Park

Croxley Green, WD18 8YA,

UK

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

Viso 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 with the following names:

Last review date of this leaflet:September 2024

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