Prospect: information for the user

Gabapentina Combix 300 mg hard capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Gabapentina Combix belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active ingredient of Gabapentina Combix is gabapentin.

Gabapentina Combix 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). The doctor treating you or your child aged 6 years or older will prescribe gabapentin to help treat epilepsy when the current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentin in combination with the current treatment unless otherwise indicated. Gabapentin can also be administered as a single medication in the treatment of adults and children over 12 years old.

- Peripheral neuropathic pain (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, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.

Do not take Gabapentina Combix

• if you are allergic to gabapentin or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take gabapentin.

• if you have kidney problems, your doctor may prescribe a different dosing regimen
• if you are on hemodialysis (for waste removal due to renal insufficiency), inform your doctor if you start feeling muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately as they may be symptoms of acute pancreatitis (inflamed pancreas).
• 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 gabapentin dependence.

There have been reports of gabapentin abuse and dependence from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

A small number of people taking antiepileptic medications such as gabapentin have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Combix" and "If you interrupt treatment with Gabapentina Combix"). If you are concerned about developing dependence on gabapentin, it is essential 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 other than its prescribed use.

- 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.

Important information about potentially serious reactions

There have been reports of severe skin reactions associated with gabapentin use, 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“Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they may be serious”

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal muscle fiber rupture that may lead to kidney problems and put your life at risk. You may also experience urine discoloration, and changes in blood test results (significant increase in creatine phosphokinase in blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Combix

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. In particular, inform your doctor (or pharmacist) if you are taking or have taken recently any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist as opioids may increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids may cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentin

• is not expected to interact with other antiepileptic medications or with the oral contraceptive pill.
• may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what you are taking.

Taking Gabapentina Combix with food

Gabapentin can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take gabapentin during pregnancy, unless your doctor has told you to. Women of childbearing age should use an effective contraceptive method.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medications used to treat seizures, there have been reports of an increased risk of damage to the developing fetus, particularly when more than one medication is used to treat seizures. Therefore, whenever possible, try to take only one medication for seizures and only under the advice of your doctor.

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

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).

Breastfeeding

Gabapentin, the active ingredient in this medicine, passes into breast milk.It is not recommended to breastfeed while taking gabapentin, as its effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and operating machinery

Gabapentin 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.

Gabapentina Combix contains sodium

This medicine contains less than 23mg of sodium (1mmol) per capsule; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.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 suitable dose for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, up to a maximum dose of 3,600 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 begin with a low initial dose, which will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg per kg per day. The dose is normally administered by ingesting the capsules, divided into 3 equal doses per day, normally, one in the morning, one at noon, and one at night.

Do not recommend the use of gabapentin in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase the dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, up to a maximum dose of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

If you have kidney problems or if you are receiving hemodialysis treatment

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or if you are receiving hemodialysis treatment.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of gabapentin, except if you have kidney problems. Your doctor may prescribe another dosing regimen or different doses if you have kidney problems.

If you consider that the effect of gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin is administered orally. Swallow the capsules whole with a sufficient amount of water.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentina Combix than you should

Doses higher than recommended may cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, drowsiness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospital.

Bring with you any capsules that you have not taken, along with the packaging and the leaflet so that the hospital can easily identify the medication you have taken.

If you forgot to take Gabapentina Combix

If you forgot 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 the treatment with Gabapentina Combix

Do not stop taking gabapentin suddenly. If you want to stop taking gabapentin, talk to your doctor first. Your doctor will indicate 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 gabapentin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of unwellness. These effects usually occur within the first 48 hours after stopping gabapentin treatment. 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking gabapentin and seek medical attention immediately if you notice any of the following symptoms:

• flat red patches with a target-like appearance or circular patches 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).
• expanded rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious:

• severe skin reactions that require immediate attention, lip and face inflammation, skin rash, and/or redness, and/or hair loss (may be symptoms of a severe allergic reaction)
• persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas)
• gabapentin can 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. There may or may not be a rash when this type of reaction occurs. This may require stopping gabapentin or even hospitalization.
• breathing problems that, if severe, may require emergency medical attention to breathe normally.

Contact your doctor immediately if you have any of the following symptoms:

These symptoms may be the first signs of a severe reaction. You should have a doctor examine you to decide if you should continue taking gabapentin.

• If you are on hemodialysis, inform your doctor if you start feeling muscle pain and/or weakness.

Other side effects include:

Very common: (may affect more than 1 in 10 people)

• viral infection
• drowsiness, dizziness, discoordination
• feeling tired, fever

Common: (may affect up to 1 in 10 people)

• bronchitis, respiratory infections, urinary tract infections, ear inflammation, and other infections
• low white blood cell count
• loss of appetite, increased appetite
• irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes
• blurred vision, double vision
• dizziness
• high blood pressure, redness or dilation of blood vessels
• difficulty breathing, bronchitis, sore throat, cough, dry nose
• vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence
• swelling of the face, hives, rash, itching, acne
• joint pain, muscle pain, back pain, muscle spasms
• erectile dysfunction
• swelling in the legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms
• low leukocyte count, weight gain
• accidental injuries, fractures, bruises

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common side effects.

Rare: (may affect up to 1 in 1000 people)

• loss of consciousness
• low blood glucose levels (observed more frequently in patients with diabetes)
• breathing problems, shallow breathing (respiratory depression)

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

• suicidal thoughts
• developing dependence on gabapentin ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after interrupting a short- or long-term treatment with gabapentin (see "If you stop taking Gabapentin Combix").

After the marketing of gabapentin, the following side effects have been reported:

• low platelet count (blood clotting cells)
• hallucinations
• abnormal movement problems such as contortions, spasmodic movements, and rigidity
• tinnitus (ringing in the ears)
• yellowing of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• breast enlargement, breast growth
• side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• muscle fiber rupture (rhabdomyolysis)
• abnormal results in blood tests (elevated creatine phosphokinase)
• problems with sexual activity, such as inability to achieve orgasm and delayed ejaculation
• 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)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Gabapentina Combix

- The active ingredient is gabapentin. Each hard capsule contains 300 mg of gabapentin.

- The other components are: cornstarch and talc. The gelatin capsule is composed of: gelatin, titanium dioxide (E171), yellow iron oxide (E172), sodium lauryl sulfate, and printing ink (shellac, propylene glycol, concentrated ammonium solution, black iron oxide (E172), and potassium hydroxide).

Appearance of the product and content of the container

The 300 mg capsules are hard gelatin capsules with a yellow body and cap, bearing black ink printing with "300" on the body. The length of the capsule is approximately 19.3 mm and the width is approximately 6.9 mm.

Gabapentina Combix 300 mg hard capsules EFG are presented in blisters included in containers of 30 and 90 capsules.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Last review date of this leaflet: January 2023

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