Gabapentin Alter 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gabapentin Alter 800 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Gabapentin Alter 800 mg tablets are and what they are used for
2. Before you take Gabapentin Alter 800 mg tablets
3. How to take Gabapentin Alter 800 mg tablets
4. Possible side effects
5. How to store Gabapentin Alter 800 mg tablets
6. Further information

1. What Gabapentin Alter 800 mg Tablets Are and What They Are Used For

Gabapentin Alter 800 mg tablets belong to a group of medicines used to treat epilepsy and peripheral neuropathic pain.

Epilepsy: Gabapentin Alter 800 mg tablets are used to treat certain types of epilepsy (seizures that initially affect only specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor will prescribe Gabapentin Alter to help manage your epilepsy when your current treatment does not fully control the condition. You should take it in addition to your current treatment unless otherwise instructed. It may also be given as monotherapy in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain: Gabapentin Alter 800 mg tablets are used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles. The pain sensation may be described as heat, burning, pulsations, stabbing pain, sharp pain, spasms, continuous pain, tingling, numbness, and pinprick sensations, among others.

2. Before taking Gabapentina Alter 800 mg tablets

Do not take Gabapentina Alter 800 mg

• If you are allergic (hypersensitive) to gabapentin or any of the other ingredients of Gabapentina Alter.

Take special care with Gabapentina Alter 800 mg

Talk to your doctor or pharmacist before taking Gabapentina Alter:

• If you have kidney problems.

• If you develop symptoms such as persistent stomach pain, dizziness or feel lightheaded, inform your doctor immediately.

• A small number of people who have been treated with antiepileptic medicines such as Gabapentina Alter have had thoughts of harming themselves or suicide. If you have these thoughts at any time, contact your doctor immediately.

• 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 be at higher risk of developing dependence on Gabapentin.

• If you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on Gabapentin. They may experience withdrawal symptoms when they stop taking Gabapentin or reduce the dose (see section 3, "How to take" and "If you stop taking Gabapentina Alter"). If you are concerned about developing dependence on Gabapentin, it is important to consult your doctor.

If you experience any of the following signs while taking Gabapentin, 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 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 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.

Additional 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 these symptoms in section 4 of this leaflet under “Call your doctor immediately if you experience any of the following symptoms after taking this medicine, as it may be serious.”

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Especially, inform your doctor (or pharmacist) if you are taking or have recently taken any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric condition.

If you are taking any medicine containing morphine, inform your doctor or pharmacist, as morphine may increase the effect of gabapentin.

No interaction is expected between gabapentin and other antiepileptic medicines or with oral contraceptive pills.

Gabapentin may interfere with certain laboratory tests. Therefore, if you need a urine test, inform your doctor or the hospital that you are taking gabapentin.

If you take gabapentin at the same time as antacids containing aluminium or magnesium, the absorption of gabapentin in the stomach may be reduced. It is therefore recommended that Gabapentina Alter 800 mg tablets be taken at least two hours after taking an antacid.

Taking Gabapentina Alter 800 mg with food and drinks

Gabapentina Alter 800 mg tablets can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You must not take Gabapentina Alter 800 mg tablets during pregnancy unless your doctor has specifically instructed you to do so. An effective method of contraception should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medicines used to treat seizures, an increased risk of fetal harm has been reported, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medicine during pregnancy.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborn babies. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.

Inform your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking Gabapentina Alter 800 mg tablets.

Gabapentin passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Alter 800 mg tablets, as the effect on the infant is unknown.

Driving and using machines

Gabapentina Alter 800 mg tablets 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 Gabapentin Alter 800 mg tablets

Follow exactly the instructions for taking Gabapentin Alter 800 mg tablets as given by your doctor. Consult your doctor or pharmacist if you have any doubts. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

If you think the effect is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years of age), you should take Gabapentin Alter 800 mg tablets as usual, unless you have kidney problems.

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

Always swallow the tablets with sufficient liquid.

The tablet may be divided into equal doses.

Continue taking Gabapentin Alter 800 mg tablets until your doctor tells you to stop.

Peripheral neuropathic pain:

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.

The dose may then be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

Epilepsy:

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.

The dose may then be increased up to a maximum dose of 3600 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 and older:

Your doctor will decide the dose for 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 three days. The usual dose for controlling epilepsy is 25–35 mg/kg/day. This dose is usually administered by taking the tablets, divided into three equal doses per day, typically one in the morning, one at midday, and one at night.

The use of Gabapentin Alter 800 mg tablets is not recommended in children under 6 years of age.

If you take more Gabapentin Alter 800 mg tablets than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: (91) 562 04 20. Take any remaining tablets with you, along with the container and label, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Alter 800 mg tablets

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentin Alter 800 mg tablets

Do not stop taking Gabapentin Alter suddenly or reduce the dose. If you wish to stop taking Gabapentin Alter 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.

You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentin Alter or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentin Alter or reducing the dose. If you experience this withdrawal syndrome, you should 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 Alter and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-elevated circular patches or target-shaped rashes 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, Gabapentin Alter 800 mg tablets can cause adverse effects, although not everyone experiences them.

Gabapentin Alter 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. This type of allergic reaction may occur with or without a rash. If such an allergic reaction occurs, you may need to be hospitalized or stop taking Gabapentin Alter.

The following adverse effects have been reported after marketing of Gabapentin Alter:

Inform your doctor if you experience any of the following symptoms:

• Skin rashes
• Hives
• Fever
• Swollen glands that do not go away
• Swelling of the lips and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
• Breathing problems that, if severe, may require emergency medical treatment to maintain normal breathing.

These symptoms may be early signs of a serious reaction. Your doctor will examine you to determine whether you should continue taking Gabapentin Alter.

The following are drug-related adverse reactions listed by frequency of occurrence:

Very common (affects more than 1 in 10 people):

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

Common (affects between 1 and 10 in 100 people):

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation.
• Low white blood cell count.
• Anorexia, increased appetite.
• Feelings of anger toward others, confusion, mood changes, depression, anxiety, restlessness, difficulty concentrating.
• Seizures, jerking movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, decreased sensation, difficulty with coordination, 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, nasal dryness.
• Vomiting, nausea, dental 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, muscle spasms.
• Incontinence.
• Difficulty with erection.
• Swelling in the arms and legs or swelling that may affect the face, trunk, and limbs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental overdose, fractures, abrasions.

Uncommon (affects at least 1 in 100 people):

• Agitation (a state of chronic restlessness and involuntary, purposeless movements)
• Difficulty swallowing

Rare (affects between 1 and 10 in 10,000 people):

• Decreased platelet count (blood clotting cells).
• Allergic reaction such as hives (itching).
• Hallucinations.
• Abnormal movement problems such as twisting movements, jerking, and stiffness.
• Ringing in the ears.
• Increased heart rate.
• Inflammation of the pancreas.
• Liver inflammation, yellow appearance of skin and eyes.
• Severe skin reactions requiring immediate medical attention, swelling of lips and face, skin rash and redness, hair loss.
• Acute kidney failure.
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Changes in blood glucose levels in diabetic patients, abnormal blood test results that may indicate liver problems.
• Breathing difficulties, shallow breathing (respiratory depression).

Frequency not known (cannot be estimated from available data):

• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment).
• Suicidal thoughts
• Development of dependence on Gabapentin Alter ("drug dependence")
• 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 Alter or after reducing the dose (see "If you stop taking Gabapentin Alter").

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

Reporting of adverse effects

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

5. Storage of Gabapentin Alter 800 mg Tablets

Keep out of the reach and sight of children.

Do not use Gabapentin Alter 800 mg tablets after the expiry date stated on the container. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point (or any other medicine waste collection system) at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Gabapentin Alter 800 mg

• The active substance is Gabapentin. Each film-coated tablet contains 800 mg of gabapentin.

• The other components are: Macrogol 4000, pregelatinized starch, anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, lecithin, and xanthan gum.

Appearance of the medicinal product and contents of the container

White, oblong, film-coated tablets, scored on both sides.

The tablet can be divided into equal doses.

Gabapentin Alter 800 mg film-coated tablets: pack containing 90 film-coated tablets. The tablets are packaged in PVC/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS ALTER S.A
Mateo Inurria, 30
28036 Madrid
Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.
C/Solana, 26,
Torrejón de Ardoz,
28850 Madrid
Spain

This patient information leaflet was approved in December 2025

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