Package Leaflet: Information for the User

GABAPENTIN ALMUS 800 MG FILM-COATED TABLETS

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of the pack and additional information

Gabapentina Almusbelongs to a group of medicines used to treat epilepsy and neuropathic pain.

Epilepsy: Gabapentina is used to treat various forms of epilepsy (seizures or fits that initially are limited to certain parts of the brain, although the seizure spreads to other parts of the brain or not). Your doctor will prescribe Gabapentina Almus to help you treat your epilepsy when your current treatment does not control your situation completely. You must take Gabapentina Almus in addition to your current treatment, unless otherwise indicated. Gabapentina Almus can be used alone to treat adults and children over 12 years old.

Peripheral neuropathic pain: Gabapentina Almus is used to treat long-lasting pain caused by damage to the nerves. A wide variety of diseases can cause this type of peripheral neuropathic pain, which mainly appears in the legs and/or arms, such as diabetes or herpes or shingles. Pain sensations can be described as heat, burning, palpitations, stinging, pricking, pressure, tingling, numbness, sensation of needle or nail pricks, etc.

Do not take Gabapentina Almus:

If you are allergic to gabapentin or any of the other components of this medication.

Warnings and precautions:

Consult your doctor or pharmacist before taking Gabapentina Almus:

• Before taking this medication, 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 Almus.

Dependence:

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

If you experience any of the following symptoms while taking Gabapentina Almus, 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 its prescription.
• You have tried several times to stop taking the medication or control how you take it, without success.
• You feel unwell when you stop taking the medication 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.

Be especially careful with Gabapentina Almus:

If you have kidney problems.

If you develop persistent stomach pain, discomfort, and a feeling of being unwell, 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.

A small number of people who have been treated with antiepileptic medications like Gabapentina Almus have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

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."

Taking Gabapentina Almus with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Especially, inform your doctor (or pharmacist) if you are taking or have taken recently any medication for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

If you are using medications that contain morphine, please tell your doctor, as morphine may increase the effect of gabapentin.

It is not expected that gabapentin will interact with other antiepileptic medications or with the birth control pill.

Gabapentin may interfere with some laboratory tests. If you need to have a urine test, inform your doctor or analyst that you are taking gabapentin.

If gabapentin and antacids containing aluminum and magnesium are taken at the same time, the absorption of gabapentin in the stomach may be reduced, so it is recommended to take gabapentin at least two hours after taking the antacid.

Taking Gabapentina Almus with food and drinks:

Gabapentin can be taken with or without food.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Gabapentin should not be taken during pregnancy, unless your doctor has told you otherwise. Appropriate contraceptive measures should be taken when the woman has the possibility of becoming pregnant.

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

There are no specific studies with gabapentin in pregnant women, but other medications used to treat seizures have increased the risk of fetal damage, mainly when more than one medication for seizures is used at the same time. Therefore, whenever possible and only following your doctor's recommendations, during pregnancy, you should use only one medication for seizures.

Do not stop treatment with this medication abruptly, as it may cause a seizure relapse, 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 are planning to become pregnant while taking gabapentin.

Gabapentin is excreted in breast milk. Since its effect on the baby is unknown, it is recommended not to start breastfeeding while taking gabapentin.

Driving and operating machinery:

Gabapentin may cause dizziness, drowsiness, and fatigue. Do not drive or operate machinery or perform potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not take a higher dose of medication than prescribed.

Your doctor will determine the appropriate dose for you.

If you estimate that the action of Gabapentina Almus is too strong or too weak, consult your doctor or pharmacist.

If you are elderly (over 65 years old), you should take gabapentin normally, unless you have kidney problems.

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

Swallow the whole tablets with enough water.

Continue taking gabapentin until your doctor tells you to stop.

Peripheral Neuropathic Pain:

Take the number of tablets as indicated by your doctor. Your doctor will increase the dose gradually. The initial dose will normally be between 300 and 900 mg per day. After that, the dose will be increased step by step to a maximum of 3600 mg per day. Your doctor will indicate that you need to take it in three divided doses, for example: one in the morning, one in the afternoon, and one at night.

Epilepsy:

Adults and Adolescents:

Take the number of tablets as indicated by your doctor. Your doctor will increase the dose gradually. The initial dose will normally be between 300 and 900 mg per day. After that, the dose will be increased step by step to a maximum of 3600 mg per day. Your doctor will indicate that you need to take it in three divided doses, for example: one in the morning, one in the afternoon, and one at night.

Children over 6 years old:

The dose that will be given to the child will be decided by your doctor based on the child's weight. The treatment starts with a low initial dose that will be increased gradually over a period of approximately 3 days. The usual dose to control epilepsy is 25-35 mg/kg/day. Normally, it is given in 3 divided doses, for example: one in the morning, one in the afternoon, and one at night.

Gabapentin is not recommended for use in children under 6 years old.

If you take more Gabapentina Almus than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420.

If you or someone takes accidentally many capsules, or you think your child has swallowed some, contact your doctor or go immediately to the nearest hospital emergency department. Since gabapentin can cause drowsiness, it is recommended that you ask someone to take you to the doctor or hospital or call an ambulance. The symptoms of an overdose are dizziness, double vision, slurred speech, loss of consciousness, drowsiness, and moderate diarrhea.

Carry some of the tablets that you have not taken and the packaging or leaflet so that the doctor or the person attending to you in the emergency department can easily identify the medication you have taken.

If you forgot to take Gabapentina Almus:

If you forgot to take a dose, take it as soon as you remember, unless it is already time to take the next dose. Do not take a double dose to compensate for the missed dose, wait for the next dose.

If you interrupt the treatment with Gabapentina Almus

Do not stop taking gabapentin suddenly. If you want to stop taking Gabapentina Almus, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, you should do it 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 Almus. These include seizures, anxiety, difficulty sleeping, feeling of discomfort (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 Almus. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Gabapentina Almus may cause side effects, although not everyone will experience them. Stop taking Gabapentina Almus 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 rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Very common side effects that may affect more than 1 in 10 people:

• Viral infection
• Dizziness, drowsiness, lack of coordination
• Feeling tired, fever

Common side effects that may affect between 1 and 10 people in every 100:

• Pneumonia, respiratory infection, urinary tract infection, ear infection and inflammation
• Low white blood cell count
• Loss of appetite, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty concentrating
• Seizures, rapid movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headaches, sensitive skin, decreased sensitivity, coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes
• Blurred or double vision
• Dizziness
• Increased blood pressure, blood vessel dilation
• Difficulty breathing, bronchitis, sore throat, nasal dryness, cold
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, acne, itching, redness, hives
• Joint, muscle, or back pain, muscle spasms
• Incontinence
• Difficulty achieving an erection
• Swelling of the legs, arms, face, neck, and lips, difficulty walking, weakness, pain, and general discomfort, and flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injury, fracture, abrasion

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

• Falling
• Difficulty thinking
• Agitation (a chronic state of restlessness and involuntary, purposeless movements)
• Increased blood sugar levels (observed more frequently in patients with diabetes)
• Difficulty swallowing

Rare side effects that may affect between 1 and 10 people in every 10,000:

• Decreased platelets (a type of blood cell)
• Allergic reaction
• Hallucinations
• Abnormal movements, such as twisting, pulling, and stiffness
• Ear ringing
• Accelerated heart rate
• Pancreatitis (inflammation of the pancreas)
• Hepatitis, yellowing of the eyes and skin
• Severe skin reactions that require immediate medical attention, such as swelling of the lips and face, itching, and redness, and hair loss
• Acute kidney failure
• Severe adverse reactions after stopping gabapentin treatment (anxiety, difficulty sleeping, general discomfort, pain, swelling), chest pain
• Abnormal results in blood tests indicating liver problems
• Decreased blood sugar levels (observed more frequently in patients with diabetes)
• Loss of consciousness
• Difficulty breathing, shallow breathing (respiratory depression)

Unknown frequency (cannot be estimated from available data):

• Low sodium levels in the blood
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment)
• Thoughts of suicide
• Developing dependence on Gabapentina Almus ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after stopping short- or long-term treatment with Gabapentina Almus (see "If you stop taking Gabapentina Almus").

Additionally, in clinical trials in children, aggressive behavior and excessive movement were frequently reported.

Gabapentina Almus 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. When this type of reaction occurs, it may be accompanied by or without a rash. In the event of this type of allergic reaction, you may need to be hospitalized or stop taking Gabapentina Almus.

Inform your doctor immediately if you experience any of the following symptoms.

• skin eruptions
• hives
• fever
• swollen lymph nodes that do not subside
• swelling of the lips and tongue
• yellowing 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 can continue taking Gabapentina Almus.

Reporting side effects

If you experience any type ofsideeffects, 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 use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C. Store in the original packaging well closed.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

Composition of Gabapentina Almus 800 mg tablets

The active ingredient is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.

The other components (excipients) are:

Core: Povidone K-90, crospovidone, Poloxamer 407, magnesium stearate. Coating (Opadry 20A28569): Hydroxypropylcellulose, talc.

Appearance of the product and contents of the packaging

Gabapentina Almus is presented in the form of film-coated tablets. The tablets are white, convex, and elliptical in shape.

The tablets are packaged in PVC+PVdC/aluminum or OPA/aluminum blisters.

The packaging contains 90 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2

Abrunheira, Sintra

Portugal

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares,

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

This leaflet was approved in July 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/