PATIENT INFORMATION LEAFLET

Gabapentin Alter 800 mg Film-Coated Tablets

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

Epilepsy:Gabapentina Alter 800 mg tablets 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). Your doctor will prescribe Gabapentina Alter to help treat your epilepsy when your current treatment does not fully control the disease. You must take it added to your current treatment unless otherwise indicated. It can also be administered as a single medication in the treatment of adults and children over 12 years old.

Peripheral neuropathic pain:Gabapentina Alter 800 mg tablets is used to treat 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, palpitations, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.

Do not take Gabapentina Alter 800 mg

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

Be especially careful with Gabapentina Alter 800 mg

Consult your doctor or pharmacist before taking Gabapentina Alter:

• If you have kidney problems.

• If you develop persistent stomach pain, feel dizzy or nauseous, inform your doctor immediately.
• A small number of people who have been treated with antiepileptic drugs like Gabapentina Alter have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• 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 medication, inform your doctor if you have ever abused or been dependent on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina.

Dependence

Some people may develop dependence (need to continue taking the medication) on Gabapentina. They may experience withdrawal symptoms when they stop taking Gabapentina (see section 3, "How to take" and "If you interrupt treatment with Gabapentina Alter"). If you are concerned about developing dependence on Gabapentina, it is essential to consult your doctor.

If you experience any of the following signs while taking Gabapentina, it may indicate that you have developed dependence.

- You feel the need to take the medication for a longer time than prescribed.

- You feel the need to take a higher dose than recommended.

- You are taking the medication for reasons other than your prescription.

- You have tried several times to stop taking the medication or control how you take it, without success.

- When you stop taking the medication, 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.

Additional information about potentially serious 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 these symptoms in section 4 of this prospectus in “Call your doctor immediately if you experience any of the following symptoms after taking this medication, as they may be serious”.

Use of other medications

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

If you are using any medication that contains morphine, inform your doctor or pharmacist as morphine may increase the effect of gabapentin.

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

Gabapentin may interfere with some laboratory tests, so 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 aluminum or magnesium, the absorption of gabapentin in the stomach may be reduced. It is 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 medication.

You should not take Gabapentina Alter 800 mg tablets during pregnancy, unless your doctor has told you to. You should use a reliable contraceptive method in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medications used to treat seizures, an increased risk of fetal damage has been reported, particularly when multiple medications are used to treat seizures. Therefore, whenever possible and only under the advice of your doctor, you should try to take only one medication for seizures during pregnancy.

If you take gabapentin during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medications).

Do not stop taking this medication abruptly as this may cause a seizure, which could have serious consequences for you and your baby.

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

Gabapentin passes into breast milk. It is not recommended to breastfeed while taking Gabapentina Alter 800 mg tablets, as the effect on the baby is unknown.

Driving and operating machinery

Gabapentina Alter 800 mg tablets may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Follow exactly the administration instructions for Gabapentina Alter 800 mg tablets that your doctor has given you. Consult your doctor or pharmacist if you have any doubts.Do not take a higher dose of medication than prescribed.

Your doctor will determine the appropriate dose for you.

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

If you are an elderly patient (over 65 years old), you should take Gabapentina Alter 800 mg tablets normally, except if you have kidney problems.

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

Swallow the tablets with a sufficient amount of water.

The tablet can be divided into equal doses.

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

Peripheral neuropathic pain:

Take the number of tablets that your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will generally be between 300 to 900 mg per day.

Therefore, the dose can 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 noon, and one at night.

Epilepsy:

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 between 300 to 900 mg per day.

Therefore, the dose can 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 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 start with a low initial dose that will be gradually increased over a period of approximately three days. The normal dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually administered by taking the tablets, divided into three equal doses per day, usually one in the morning, one at noon, and one at night.

It is not recommended to use Gabapentina Alter 800 mg tablets in children under 6 years old.

If you take more Gabapentina Alter 800 mg tablets than you should:

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: (91) 562 04 20. Bring any remaining tablets, along with the packaging and label, so that the hospital can easily identify the medication you have taken.

If you forget to take Gabapentina Alter 800 mg tablets:

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 compensate for the missed doses.

If you stop taking Gabapentina Alter 800 mg tablets:

Do not stop taking Gabapentina Alter abruptly. If you want to stop taking Gabapentina Alter, talk to your doctor first. Your doctor will tell you 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 Alter. These include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headaches, depression, abnormal sensations, dizziness, and a general feeling of discomfort. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Alter. 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 Alter and seek immediate medical attention if you notice any of the following symptoms:

• Flat, red patches with a target-like or circular shape 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 eruption, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medications, Gabapentina Alter 800 mg tablets may have side effects, although not everyone will experience them.

Gabapentina Alter can cause a severe or potentially fatal allergic reaction that can affect the skin or other parts of the body, such as the liver or blood cells. When this type of reaction occurs, it may or may not be accompanied by a rash. In the event of this type of allergic reaction, you may need to be hospitalized or stop taking Gabapentina Alter.

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

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

• Skin rashes
• Urticaria
• Fever
• Swollen lymph nodes that do not subside
• Lip and tongue swelling
• Yellowish discoloration of the skin or white of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
• Difficulty breathing, which, if severe, may require emergency medical attention to breathe normally.

These symptoms may be the first signs of a severe reaction. Your doctor will examine you to decide whether you should continue taking Gabapentina Alter.

The following are adverse reactions to medication in relation to their frequency of occurrence:

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

• Viral infection.
• Drowsiness, dizziness, discoordination.
• Feeling tired, fever.

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

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation.
• Low white blood cell count.
• Anorexia, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty concentrating.
• Seizures, convulsions, difficulty speaking, memory loss, tremors, difficulty sleeping, headaches, skin sensitivity, decreased sensations, coordination difficulties, abnormal 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.
• Swelling of the face, hives, rash, acne.
• Joint pain, muscle pain, back pain, muscle spasms.
• Incontinence.
• Difficulty achieving an erection.
• Swelling in the legs and arms or swelling that can affect the face, trunk, and extremities, difficulty walking, weakness, pain, discomfort, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental overdoses, fractures, bruises.

Uncommon (affects at least 1 in 100 people):

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

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

• Decreased platelet count (blood clotting cells).
• Allergic reaction such as urticaria (hives).
• Hallucinations.
• Abnormal movements such as contortions, convulsions, and rigidity.
• Tinnitus (ringing in the ears).
• Increased heart rate.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver), yellowish discoloration of the skin and eyes.
• Severe skin reactions that require immediate medical attention, swelling of the lips and face, rash, and redness, hair loss.
• Acute renal failure.
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• Variations in blood glucose levels in patients with diabetes, abnormal blood test results that may indicate liver problems.
• Difficulty breathing, shallow breathing (respiratory depression).

Unknown frequency(cannot be estimated from available data):

• Anaphylaxis (severe, potentially fatal allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).
• Suicidal thoughts
• Developing dependence on Gabapentina Alter ("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 Alter (see "If you stop taking Gabapentina Alter").

Additionally, in clinical trials in children, the following side effects were reported as frequent: aggressive behavior and convulsions.

Reporting of adverse effects

If you experience any type ofsideeffects, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, Website:www.notificaRAM.es

Keep out of reach and sight of children.

Do not use Gabapentina Alter 800 mg tablets after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point (or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Composition of Gabapentina Alter 800 mg

- The active ingredient 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 product and contents of the package

Film-coated white, oblong, scored tablets on both sides.

The tablets can be divided into equal doses.

Gabapentina Alter 800 mg film-coated tablets: package with 90 film-coated tablets. The tablets are packaged inPVC/Aluminum blisters.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

LABORATORIOS ALTER S.A

Mateo Inurria, 30

28036 Madrid

Spain

Responsible manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/Solana, 26,

Torrejón de Ardoz,

28850 Madrid

Spain

This leaflet was approved in May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es