Gabapentin Viso Farmaceutica 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentina Viso Farmacéutica 800 mg film-coated tablets

Gabapentin

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Gabapentina Viso Farmacéutica is and what it is used for
2. What you need to know before taking Gabapentina Viso Farmacéutica
3. How to take Gabapentina Viso Farmacéutica
4. Possible adverse effects
5. How to store Gabapentina 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 to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active substance in Gabapentin Viso Farmacéutica is gabapentin.

Gabapentin Viso Farmacéutica is used to treat:

• Certain types of epilepsy (seizures that initially affect specific parts 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 Gabapentin 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 Gabapentin Viso Farmacéutica in combination with current treatment unless otherwise instructed. Gabapentin Viso Farmacéutica may also be given as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The sensation of pain may be described as warmth, burning, throbbing, shooting, stabbing, sharp pain, cramps, continuous pain, tingling, numbness, and prickling sensations, 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

Consult your doctor or pharmacist before taking Gabapentina Viso Farmacéutica:

• if you have kidney problems, your doctor may prescribe a different dosage regimen
• if you are undergoing hemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, notify your doctor immediately, as these 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 of age, 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 medicines, or illegal drugs; you may have an increased risk of developing dependence on Gabapentina Viso Farmacéutica.

Cases of abuse and dependence on gabapentin have been reported 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 of suicide. If at any time you experience such thoughts, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (a 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 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.
• 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 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 potentially 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 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, tenderness, or pain on palpation—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and be life-threatening. 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.

Taking Gabapentina Viso Farmacéutica with other medicines

Inform 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 medicines 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 Viso Farmacéutica. In addition, the combination of Gabapentina Viso Farmacéutica with opioids may cause drowsiness, sedation, reduced 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 therefore 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 oral contraceptive pills.
• may interfere with certain laboratory tests; therefore, if you require a urine test, inform your doctor or hospital about the medicines 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 should inform your doctor immediately to discuss the possible risks this medicine 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

Gabapentin 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 may be pregnant, 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 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 three 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 may be pregnant, or plan to become pregnant while taking Gabapentina Viso Farmacéutica. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active substance in 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

No effects on fertility were observed 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 how this medicine affects your ability to perform such activities.

3. How to take Gabapentina Viso Farmacéutica

Follow exactly the administration instructions for this medicine as indicated 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:

Adults and adolescents

Take the number of tablets your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed 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 midday, and one at night.

Children aged 6 years or older

Your doctor will decide the dose to administer to your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. The dose is normally administered by taking tablets, divided into three equal doses per day, usually one in the morning, one at midday, 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 your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed 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 midday, and one at night.

If you have kidney problems or are undergoing hemodialysis

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

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

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

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

If you think 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 sufficient water.

The tablet may 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 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 telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go immediately to the nearest hospital emergency department if you take more Gabapentina Viso Farmacéutica than prescribed by your doctor. Bring any tablets you have not taken, along with the packaging and the patient information leaflet, so 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 forgotten doses.

If you stop taking Gabapentina Viso Farmacéutica

Do not stop taking Gabapentina Viso Farmacéutica suddenly. If you wish to stop taking Gabapentina Viso Farmacéutica, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment, 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. These 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. 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 medical attention immediately if you notice any of the following symptoms:

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

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

• difficulty breathing, which in severe cases may require emergency medical treatment to maintain normal breathing.
• persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin 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 may or may not have appeared when this type of reaction occurs. This may require discontinuation of Gabapentin Viso Farmacéutica or even hospitalization. Contact your doctor immediately if you have any of the following symptoms: • skin rash, redness and/or hair loss • hives • fever • swollen glands that do not go away • 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 may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking Gabapentin Viso Farmacéutica.

• If you are on hemodialysis, inform your doctor if you begin to experience 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
• Feeling tired, fever

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

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation, 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, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, unusual eye movements, increased, decreased, or absent 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 or throat, flatulence
• Swelling of the face, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, jerking
• Erectile difficulties (impotence)
• Swelling in the arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common 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

• Increased heart rate

• Difficulty swallowing

• Swelling that may affect the face, trunk, and limbs

• Abnormal blood test results that may indicate liver problems.

• Progressive mental impairment

• Fall

• Increased blood glucose levels (observed more frequently in patients with diabetes)

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

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

Frequency not known (cannot be estimated from available data)

• Development of dependence on Gabapentin Viso Farmacéutica ("drug dependence")

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

Following the marketing of Gabapentin Viso Farmacéutica, the following adverse effects have been reported:

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement disorders such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears
• Yellow appearance of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increase in breast tissue, breast enlargement
• Adverse effects following abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rupture of muscle fibers (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual function problems, such as inability to achieve orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (serious, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://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 the 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.

PVC/PVDC-Al blister: Do not store above 25°C.

Al/Al blister and bottle: Do not store above 30°C.

For bottles only:

Validity period after first opening: 120 days.

Keep in the original packaging to protect from moisture.

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

6. Contents of the pack and other information

Composition of Gabapentin Viso Farmacéutica

The active substance is gabapentin.

Each film-coated tablet contains 800 mg of gabapentin.

The other components are:

Tablet core: poloxamer 407, copovidone, corn starch, and magnesium stearate.

Coating: Opadry 12B58900 [hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433)], macrogol, talc.

Appearance of the product and contents of the container

Film-coated tablet.

White to almost white, oval-shaped, 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.

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

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

566 17 Vysoke Myto

Czech Republic

Further information about this medicinal product is available from 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 following Member States of the European Economic Area under the following name:

Country	Medicinal product name
Germany	Gabapentin Glenmark 800 mg Film-coated tablets
Denmark	Gabapentin Glenmark
Austria	Gabapentin Glenmark 800 mg Film-coated Tablets
Spain	Gabapentin Viso Farmacéutica 800 mg film-coated tablets EFG
Finland	Gabapentin Glenmark 800 mg film-coated tablets
Poland	EPIGAPENT

Date of the most recent review 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/