Label: information for the user

Gabapentin Alter 400 mg hard capsules EFG

Gabapentina Alter belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain.

Epilepsy:Gabapentina Alter 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 Gabapentina Alter in addition to your current treatment unless otherwise instructed. Gabapentina Alter can also be administered as a single medication in the treatment of adults and children over 12 years old.

Peripheral neuropathic pain:Gabapentina Alter 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, pulsating pain, stabbing pain, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.

Do not take Gabapentina Alter:

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

Be careful with Gabapentina Alter:

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 reduced number of people who were 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 medicine, inform your doctor if you have ever abused or had dependence 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 medicine) on Gabapentina. They may have 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 medicine for a longer time 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.

Additional information about potentially serious reactions

Severe skin reactions associated with the use of gabapentin 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 leaflet in “Call your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious”.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, 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 taking any medication that contains morphine, inform your doctor or pharmacist as morphine may increase the effect of Gabapentina Alter.

No interaction is expected between Gabapentina Alter and other antiepileptic drugs or oral contraceptives.

Gabapentina Alter may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital that you are taking Gabapentina Alter.

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

Take Gabapentina Alter 400 mg with food and drinks

Gabapentina Alter can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

You should not take Gabapentina Alter during pregnancy, unless your doctor has told you to. You should use an effective 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 more than one medication 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 medication for seizures during pregnancy.

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

Do not stop taking this medicine abruptly as this may cause an anticipation of seizures, which could have serious consequences for you and your baby.

Contact 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.

Gabapentin, the active ingredient in Gabapentina Alter, passes into breast milk. It is not recommended to breastfeed while taking Gabapentina Alter, as the effect on infants is unknown.

Driving and operating machinery

Gabapentina Alter 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 these activities.

Important information about some of the components of Gabapentina Alter:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions for Gabapentina Alter 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 of Gabapentina Alter is too strong or too weak, inform your doctor or pharmacist.

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

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

Swallow the capsules whole with a sufficient amount of water.

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

Peripheral neuropathic pain:

Take the number of capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually 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 capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will usually 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. 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/kg/day. The dose is usually administered by taking the capsules, 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 in children under 6 years old.

If you take more Gabapentina Alter than you should

Consult your doctor immediately or go to the nearest hospital emergency department. Bring with you any remaining capsules, along with the packaging and the leaflet, so that the hospital can easily identify the medication you have taken.

You can also call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Gabapentina Alter

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 interrupt treatment with Gabapentina Alter

Do not stop taking Gabapentina Alter suddenly. 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 general 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 these 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 rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medications, Gabapentina Alter 400 mg can cause 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.

After 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
• Hives
• Fever
• Swollen lymph nodes that do not subside
• Lip and tongue swelling
• Yellow discoloration of the skin or white of the eyes
• Unusual bleeding or bruising
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections
• Difficulty breathing that, 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 if you should continue taking Gabapentina Alter.

The very common side effects that may affect more than 1 in 10 people are:

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

The common side effects that may affect more than 1 in 100 people are:

• 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 thinking
• Seizures, convulsions, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensations, coordination difficulties, 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 (dizziness), nausea (feeling dizzy), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swollen face, hives, rash, itching, acne
• Muscle pain, muscle cramps, back pain, spasms
• Incontinence
• Erectile dysfunction
• Swelling in the legs and arms or swelling that can affect the face, trunk, and extremities, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Low white blood cell count, weight gain
• Accidental injuries, fractures, bruises

The uncommon side effects that may affect at least 1 in 100 people are:

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

The rare side effects that may affect less than 1 in 1,000 people are:

• Decreased platelet count (blood clotting cells)
• Allergic reaction such as hives
• Hallucinations
• Abnormal movement problems such as contortions, convulsions, and rigidity
• Tinnitus (ringing in the ears)
• Increased heart rate
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver), yellow discoloration of the skin and eyes
• Severe skin reactions that require immediate medical attention, lip and facial swelling, rash, and redness, hair loss
• Acute kidney failure
• Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Fluctuations in blood glucose in diabetic patients, 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, lip, throat, and tongue swelling, and hypotension that require urgent treatment).

- Thoughts of suicide

- Developing dependence on Gabapentina Alter ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after stopping 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 common: aggressive behavior and seizures.

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es

Keep out of reach and sight of children.

Do not store above 25°C.

Do not use Gabapentina Alter 400 mg after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Gabapentina Alter 400 mgcapsules

• The active ingredient is gabapentin. Each capsule contains 400 mg of gabapentin.

• The other components of Gabapentina Alter 400 mg capsules are: anhydrous lactose, cornstarch, and talc.Components of the capsule coating: titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and gelatin.

Appearance of the product and contents of the package

Hard capsules.

The hard gelatin capsules are orange in color. It is presented in a blister pack, in containers of 90 capsules.

Marketing Authorization Holder

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Responsible for Manufacturing

KERN PHARMA, S.L.

Polígono Industrial Colón II

C/ Venus, 72

08228 Terrassa (Barcelona)

or

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Text Review Date: 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/