GABAPENTINA ALMUS 800 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

GABAPENTINA ALMUS 800 MG FILM-COATED TABLETS EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Gabapentina Almus 800 mg tablets are and what they are used for
2. What you need to know before taking Gabapentina Almus 800 mg tablets
3. How to take Gabapentina Almus 800 mg tablets
4. Possible side effects
5. Storage of Gabapentina Almus 800 mg tablets

Contents of the pack and additional information

1. What Gabapentina Almus 800 mg tablets are and what they are used for

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

Epilepsy: Gabapentina is used to treat various forms of epilepsy (seizures or attacks that initially affect certain parts of the brain, although the attack may spread 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 completely control your condition. You should 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 of age.

Peripheral neuropathic pain: Gabapentina Almus is used to treat long-lasting pain caused by nerve damage. A wide range of diseases can cause this type of peripheral neuropathic pain, which mainly affects the legs and/or arms, such as diabetes or herpes zoster. The pain sensations can be described as heat, burning, throbbing, stabbing, pinching, pressure, tingling, numbness, sensation of pins and needles or nails, etc.

2. What you need to know before taking Gabapentina Almus 800 mg tablets

Do not take Gabapentina Almus:

If you are allergic to gabapentina 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 been dependent 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 stop taking Gabapentina Almus"). If you are concerned about developing dependence on Gabapentina Almus, it is essential that you consult your doctor.

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

• You feel that you need to take the medication for a longer period than prescribed.
• You feel that you 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.
• 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.

Be careful with Gabapentina Almus:

If you have kidney problems.

If you develop symptoms such as persistent stomach pain, discomfort, and feeling sick, 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 were being treated with antiepileptics 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 have been reported with the use of gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina 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 package leaflet in "Call your doctor immediately if you experience any of the following symptoms after taking this medication, as it may be serious".

Taking Gabapentina Almus with other medications:

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication. In particular, 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 medications that contain morphine, please tell your doctor, as morphine may increase the effect of gabapentina.

It is not expected that gabapentina will interact with other antiepileptic medications or with the contraceptive pill.

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

If you take gabapentina and antacids that contain aluminum and magnesium at the same time, the absorption of gabapentina in the stomach may be reduced, so it is recommended that you take gabapentina at least two hours after taking the antacid.

Taking Gabapentina Almus with food and drinks:

Gabapentina can be taken with or without food.

Pregnancy and breastfeeding:

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

Gabapentina should not be taken during pregnancy, unless your doctor has told you otherwise. You should use adequate contraceptive measures when you have the possibility of becoming pregnant.

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

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

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

Tell your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentina.

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

Driving and using machines:

Gabapentina may cause dizziness, drowsiness, and fatigue. You should not drive or use machinery or perform potentially hazardous activities until you know if this medication affects your ability to perform these activities.

3. How to take Gabapentina Almus 800 mg tablets

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again. Do not take a higher dose of the medication than prescribed.

Your doctor will determine the appropriate dose for you.

If you think the effect 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 gabapentina normally, unless you have kidney problems.

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

Swallow the tablets whole with enough water.

Continue taking gabapentina until your doctor tells you to stop.

Peripheral neuropathic pain:

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

Children over 6 years:

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

Gabapentina 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 Toxicology Information Service, telephone 915 620 420.

If you or someone else has taken many capsules accidentally, or you think your child has swallowed some, contact your doctor or go immediately to the emergency department of the nearest hospital. Since gabapentina 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.

Bring any unused tablets and the package or package leaflet with you so that the doctor or the person treating you in the emergency department can easily identify the medication you have taken.

If you forget to take Gabapentina Almus:

If you forget 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 make up for the forgotten dose, wait for the next dose.

If you stop taking Gabapentina Almus:

Do not stop taking gabapentina 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 side effects, called withdrawal syndrome, after stopping treatment with Gabapentina Almus after short or long-term use. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of being unwell. 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Gabapentina Almus can cause adverse effects, although not all people suffer from them. Stop taking Gabapentina Almus and seek immediate medical attention if you notice any of these symptoms:

• Red patches without relief, target-like or circular in shape on the torso, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Expanded rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Very Common Adverse Effects that may Affect more than 1 in 10 People:

• Viral infection
• Feeling of dizziness, drowsiness, lack of coordination
• Feeling of fatigue, fever

Common Adverse Effects that may Affect between 1 and 10 People in 100:

• Pneumonia, respiratory infection, urinary tract infection, ear infection and inflammation
• Low blood cell count
• Anorexia, increased appetite
• Feelings of anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty concentrating
• Seizures, rapid movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity, difficulty coordinating, unusual eye movements, increased, decreased, or absent reflexes
• Blurred or double vision
• Dizziness
• Increased blood pressure, dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, dry nose, cold
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, acne, itching, redness
• Pain in the joints, muscles, or back, muscle spasms
• Incontinence
• Difficulty achieving an erection
• Swelling of the legs, arms, or even the 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

Uncommon Adverse Effects (may Affect up to 1 in 100 People):

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

Rare Adverse Effects that may Affect between 1 and 10 People in 10,000:

• Decreased platelet count (a type of blood cell)
• Allergic reaction
• Hallucinations
• Problems with abnormal movements, such as twisting, spasms, and stiffness
• Ringing in the ears
• Rapid heartbeat
• Pancreatitis
• Hepatitis, yellowing of the skin and eyes
• Severe skin reactions that require immediate medical attention, such as swelling of the lips and face, itching, and redness of the skin, and hair loss
• Acute kidney failure
• Adverse reactions after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, general discomfort, pain, swelling), chest pain
• Abnormal liver function test results
• Decreased blood glucose levels (more frequently observed in patients with diabetes)
• Loss of consciousness
• Breathing problems, shallow breathing (respiratory depression)

Frequency Not Known (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)
• Suicidal thoughts
• Developing dependence on Gabapentina Almus ("drug dependence")

You should be aware that you may experience certain adverse effects, called withdrawal syndrome, after interrupting short-term 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 a rash or not. If this type of allergic reaction appears, you may need to be hospitalized or stop taking Gabapentina Almus.

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

• Skin rashes
• Hives
• Fever
• Persistent swelling of the glands
• 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 urgent 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es

5. Storage of Gabapentina Almus 800 mg Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging, tightly closed.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Gabapentina Almus 800 mg Tablets

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

The other ingredients (excipients) are:

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

Appearance of the Product and Packaging Contents

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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande 2

Abrunheira, Sintra, 2710-228

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

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