GABAPENTINE VISO PHARMACEUTICAL 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gabapentina Viso Farmacéutica 800 mg Film-Coated Tablets

Gabapentina

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 Gabapentina Viso Farmacéutica is and what it is 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 Gabapentina Viso Farmacéutica is and what it is used for

Gabapentina Viso Farmacéutica belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

The active substance of Gabapentina Viso Farmacéutica is gabapentina.

Gabapentina Viso Farmacéutica is used to treat:

• Certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe Gabapentina Viso Farmacéutica for you or your child aged 6 years or older to help treat epilepsy when your 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 your current treatment unless otherwise indicated by your doctor. Gabapentina Viso Farmacéutica can also be administered as a single drug in the treatment of adults and children over 12 years of age.

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

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

Do not takeGabapentina Viso Farmacéutica

• if you are allergic (hypersensitive) to gabapentina or 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 Viso Farmacéutica:

• if you have kidney problems, your doctor may prescribe a different dosage regimen
• if you are on hemodialysis (to remove waste products due to 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, prescription 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 gabapentina from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

A small number of people being treated with antiepileptics such as Gabapentina Viso Farmacéutica have had thoughts of harming themselves or suicide. If at any time you have 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 stop taking"). If you are concerned about developing dependence on Gabapentina Viso Farmacéutica, it is important 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 a longer period 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 potentially serious reactions

Severe skin reactions have been reported in association with the use of gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina 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 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 on palpation, and especially if you feel unwell or have a fever, could be due to abnormal rupture of muscle fibers, which 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.

Using Gabapentina Viso Farmacéutica with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken 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 that contains 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 that contain aluminum and magnesium, the absorption of Gabapentina Viso Farmacéutica in the stomach may be reduced. Therefore, it is recommended that Gabapentina Viso Farmacéutica be taken at least 2 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 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.
• Do not stop 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 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 important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your disease. The worsening of your epilepsy may put both you and your unborn baby at risk.

In a study that reviewed data from women in Nordic countries who took gabapentina 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 gabapentina during pregnancy had a higher risk of low birth weight and premature birth.

If taken during pregnancy, gabapentina may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina 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 plan to become pregnant while taking Gabapentina Viso Farmacéutica. Do not stop taking this medicine abruptly, as this may cause a seizure, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentina, the active substance of Gabapentina Viso Farmacéutica, passes into breast milk. Breastfeeding is not recommended 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 using machines

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

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 higher dose of the medicine than prescribed.

Your doctor will determine what dose is suitable for you.

Epilepsy, the recommended dose is:

Adults and adolescents

Take the number of tablets that your doctor has indicated. 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 according to your doctor's instructions 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 over 6 years

Your doctor will decide 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 normal dose is usually administered by taking the tablets, divided into 3 equal doses per day, normally one in the morning, one at noon, and one at night.

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

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of tablets that your doctor has indicated. 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 according to your doctor's instructions 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 on hemodialysis

Your doctor may prescribe a different dosage regimen and/or different doses if you have kidney problems or are on hemodialysis.

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 dosage regimen or different doses 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.

Method of administration

Gabapentina Viso Farmacéutica is administered orally. Always swallow the tablets with a sufficient amount of water.

The tablet 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 side 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 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 Viso Farmacéutica than your doctor prescribed. Bring any unused tablets, 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 the 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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

Contact your doctor immediatelyif you experience any of the following symptoms after taking this medicine, as they can be serious:

• Breathing problems that, if severe, may require emergency medical attention to breathe normally.
• Persistent stomach pain, vomiting, and nausea, as they can 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 reaction may or may not be accompanied by a rash. It may require discontinuing Gabapentina Viso Farmacéutica or even hospitalization. Contact your doctor immediately if you experience any of the following symptoms: • Skin rash and redness and/or hair loss • Hives • Fever • Swollen glands that do not disappear • Swelling of the lips, face, and tongue • Yellowing of the skin or whites of the eyes • Unusual bleeding or bruising • Severe fatigue or weakness • Unexpected muscle pain • Frequent infections

These symptoms can be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking Gabapentina Viso Farmacéutica .

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

Other adverse effects include:

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Fatigue, fever

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

• Pneumonia, respiratory infections, urinary tract infections, ear inflammation, or other infections
• Low white blood cell count
• Anorexia, increased appetite
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), difficulty with coordination, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• High blood pressure, redness, or dilation of blood vessels
• Breathing difficulties, bronchitis, sore throat, cough, dry nose
• Vomiting, nausea, tooth problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, tremors
• Difficulty with erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, abrasions

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent adverse effects.

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

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Allergic reactions such as hives
• Decreased movement
• Accelerated heart rate
• Difficulty swallowing
• Swelling that can affect the face, trunk, and extremities

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

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

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

Frequency not known (cannot be estimated from available data)

• Developing dependence on Gabapentina Viso Farmacéutica ("drug dependence")

You should be aware that you may experience certain side effects, called withdrawal syndrome, after interrupting short-term 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 adverse effects have been reported:

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and stiffness
• Ringing in the ears
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual activity problems, such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure that requires urgent treatment)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://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 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:

Validity period after first opening: 120 days.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging 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 is gabapentina.

Each film-coated tablet contains 800 mg of gabapentina.

The other ingredients are:

Tablet core: 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 package contents

Film-coated tablet.

White to almost white, oval, biconvex, scored film-coated tablet marked with "G"and "13"on one side, approximately 19.10 ± 0.2 mm in length.

The tablet can be divided into equal doses.

Gabapentina Viso Farmacéutica is available in blisters of 1, 10, 30, 45, 50, 60, 84, 90, 100, 120, 180, 200 film-coated tablets and in bottles of 100, 500, and 1000 film-coated tablets.

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

566 17 Vysoke Myto

Czech Republic

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, 7th floor

28045 Madrid

Spain

This medicine is authorized in the following European Economic Area member states with the following name:

Date of the last revision of this leaflet:May 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/