Leaflet: information for the user

Gabapentina Viso Farmacéutica 600mg film-coated tablets

Gabapentina

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to 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 additional information

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

The active ingredient of Gabapentina Viso Farmacéutica is gabapentin.

Gabapentina Viso Farmacéutica is used to treat:

- Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child aged 6 years 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 aged 6 years 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 old.

- Peripheral neuropathic pain(chronic pain caused by nerve damage). There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles etc.

Do not takeGabapentina Viso Farmacéutica

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Viso Farmacéutica:

• if you have kidney problems, your doctor may prescribe a different dosing regimen
• if you are on hemodialysis (to remove waste products from kidney failure), inform your doctor if you start to feel muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately as they may be symptoms of acute pancreatitis (inflamed pancreas).
• if you have a nervous system disorder or a respiratory disorder or if you are over 65 years old, your doctor may prescribe a different dose.
• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescribed medicines, 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 from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

A small number of people taking antiepileptic medicines such as Gabapentina Viso Farmacéutica have had thoughts of harming themselves or suicide. If you ever experience these thoughts, contact your doctor as soon as possible.

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" and "If you interrupt treatment with"). 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 indicate that you have developed 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 your 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 on the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

Important information about potentially serious reactions

There have been reports of severe skin reactions associated 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 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 in section 4 of this leaflet“Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they may be serious”.

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle fibers that can lead to kidney problems and put your life at risk. You may also experience urine discoloration, and changes in blood test results (significant increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Gabapentina Viso Farmacéutica with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. In particular, inform your doctor (or pharmacist) if you take or have taken recently medicines for 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 Viso Farmacéutica. Additionally, the combination of Gabapentina Viso Farmacéutica with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentina Viso Farmacéutica

- is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.

- may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what you are taking.

Taking Gabapentina Viso Farmacéutica with food

Gabapentina Viso Farmacéutica 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 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 are planning to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin 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 first consulting your doctor, as this may worsen your condition. Worsening of your epilepsy can 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 development (neurodevelopmental disorders). However, babies of women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

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

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Viso Farmacéutica. Do not stop taking this medicine abruptly as this may cause an anticipation of seizures, which can have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient of Gabapentina Viso Farmacéutica, passes into breast milk. It is not recommended to breastfeed while taking Gabapentina Viso Farmacéutica, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and operating machinery

Gabapentina Viso Farmacéutica may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medicine affects your ability to perform other activities.

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

Your doctor will determine what dose is suitable for you.

Epilepsy, the recommended dose is:

Adults and adolescents

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased as indicated by your doctor up to a maximum dose of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

Children 6 years or older

Your doctor will decide on the dose to be administered to your child based on the child's weight.The treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg per kg per day. The dose is normally administered by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

It is not recommended to use Gabapentina Viso Farmacéutica in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased as indicated by your doctor up to a maximum dose of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

If you have kidney problems or are being hemodialyzed

Your doctor may prescribe a different dosing regimen and/or dose if you have kidney problems or are being hemodialyzed.

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

You should take the normal dose of Gabapentina Viso Farmacéutica, except if you have kidney problems.

Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

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

Administration form

Gabapentina Viso Farmacéutica is administered orally.Swallow the capsules with a sufficient amount of water.

The capsule can be divided into two equal halves.

Continue taking Gabapentina Viso Farmacéutica 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, or go to the emergency department of the nearest hospital if you take more Gabapentina Viso Farmacéutica than your doctor prescribed.Bring with you any capsules 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 takeGabapentina Viso Farmacéutica

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

If you interrupt the treatment withGabapentina 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 interrupting 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 with a target-like appearance or circular 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

Contact your doctor immediatelyif you experience any of the following symptoms after taking this medication, as they may be severe:

• Difficulty breathing that, if severe, may require emergency medical attention to breathe normally.
• Persistent stomach pain, vomiting, and nausea, which may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentina may cause a severe or potentially life-threatening allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. This may or may not be accompanied by a rash. You may need to stop taking Gabapentina Viso Farmacéutica or even be hospitalized. Contact your doctor immediately if you experience any of the following symptoms:
  • Skin rash and redness and/or hair loss
  • Urticaria
  • Fever
  • Persistent swelling of the glands
  • Swelling of the lips, face, and tongue
  • Yellowing of the skin or white of the eyes
  • Unusual bleeding or bruising
  • Severe fatigue or weakness
  • Sudden muscle pain
  • Frequent infections

These symptoms may be the first signs of a severe reaction. You should have a doctor examine you to decide whether you should continue taking Gabapentina Viso Farmacéutica.

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

Other side effects include:

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

Common: (may affect up to 1 in 10 people)

• Pneumonia, respiratory infections, urinary tract infections, ear inflammation, and other infections
• Low white blood cell count
• Loss of appetite, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasms, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, coordination difficulties, abnormal eye movements, increased or decreased reflexes
• Blurred vision, double vision
• Dizziness
• Increased blood pressure, redness or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nose
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence
• Swelling of the face, hives, acne,
• Muscle pain, back pain, joint pain, muscle spasms
• Difficulty achieving an erection (impotence)
• Swelling in the legs and arms,difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Low white blood cell count,weight gain
• Accidental injuries, fractures, bruises

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent side effects.

Uncommon: (may affect up to 1 in 100 people)

• Restlessness (a chronic state of anxiety and involuntary, purposeless movements)
• Allergic reactions such as urticaria
• Decreased movement
• Increased heart rate
• Difficulty swallowing
• Swelling that may affect the face, trunk, and limbs

• Abnormal results in blood tests that may indicate liver problems.
• Progressive mental damage
• Falling
• Increased blood sugar levels (observed more frequently in patients with diabetes)

Rare: (may affect up to 1 in 1000 people)

• Loss of consciousness
• Low blood sugar levels (observed more frequently in patients with diabetes)
• Difficulty breathing, shallow breathing (respiratory depression)

Frequency not known (cannot be estimated from available data)

• Developing dependence on Gabapentina Viso Farmacéutica ("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 Viso Farmacéutica (see "If you stop taking Gabapentina Viso Farmacéutica").

After the marketing of Gabapentina Viso Farmacéutica, the following side effects have been reported:

• Decreased platelet count (blood clotting cells)
• Thoughts of suicide, hallucinations
• Abnormal movements such as contortions, spasms, and rigidity
• Tinnitus (ringing in the ears)
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Enlargement of breast tissue, breast enlargement
• Side effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rhabdomyolysis (muscle fiber rupture)
• Abnormal results in blood tests (elevated creatine phosphokinase)
• Sexual dysfunction, such as inability to achieve orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring urgent treatment)

Reporting of side effects

If you experience any type of side effect, consultyour doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side 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 packaging after “CAD”. The expiration date is the last day of the month indicated.

PVC/PVDC-Al Blister: Do not store at a temperature above 25°C.

Al/Al Blister and bottle: Do not store at a temperature above 30°C.

Only for bottles:

Valid period after first opening: 120 days.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Gabapentina Viso Pharmaceutical

The active ingredient is gabapentin.

Each film-coated tablet contains 600 mg of gabapentin.

The other components are:

Core of the tablets:polaxamer 407, copovidone, cornstarch and magnesium stearate.

Coating: Opadry 12B58900 [Hypromellose (E464), Titanium dioxide (E171), Macrogol 400 (E1521), Polysorbate 80 (E433)], Macrogol, Talc

Appearance of theproduct and contents of the package

Film-coated tablet.

Film-coated tablet white to almost white, oval, biconvex scored marked with“G”and“31”on one side, approximately 17.40 ± 0.2 mm in length.

The tablet can be divided into equal doses.

Gabapentina Viso Pharmaceutical is available in blisters of 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180, 200 film-coated tablets.

Only some package sizes may be marketed.

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

566 17 Vysoke Myto

Czech Republic

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor,

28045 Madrid,

Spain

This medicinal product is authorized in the following member states of the European Economic Area with the following name:

Last review date of this leaflet:May 2024.

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