Prospect: information for the patient

Gabapentina Combix 800 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, because 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 should 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.

This medication contains the active ingredient gabapentin. Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

Gabapentin 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 your epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older must take gabapentin in combination with current treatment unless otherwise instructed. Gabapentin can also be administered as a single medication in the treatment of adults and children over 12 years.

• 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, sharp 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 of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Combix:

• 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 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 Combix.

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

If you experience any of the following signs while taking Gabapentina Combix, 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.

- 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.

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 prospectus

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

muscle weakness, sensitivity or pain to palpation, and especially if you feel unwell or have a fever, it could be due to an abnormal rupture of muscle fibers that can 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 the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Children and adolescents

The long-term effects (more than 36 weeks) of gabapentin treatment on learning ability, intelligence, and development in children and adolescents have not been adequately investigated. Therefore, the benefits of prolonged therapy must be weighed against the potential risks.

Other medications and Gabapentina Combix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular, 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.

Medications containing opioids such as morphine

If you are taking any medication containing opioids (such as morphine), inform your doctor or pharmacist as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids can 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

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

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

You should not take gabapentin during pregnancy, unless your doctor has indicated it. 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, 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, you should try to take only one medication for seizures and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, if you think you may be pregnant, or if you plan to become pregnant while taking gabapentin. Do not stop taking this medication abruptly as this may cause an anticipation of seizures, which could have serious consequences for you and your baby.

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).

Breastfeeding

Gabapentin 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 medication affects your ability to perform other tasks.

Follow exactly the administration instructions of this medication 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 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 can 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 that 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 usually administered by taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, and one at night.

It is not recommended to use gabapentin in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of capsules 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 can 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 are being hemodialyzed

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or are being hemodialyzed.

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 Combix is administered orally. Swallow the capsules with a sufficient amount of water (for example, a glass of water). The capsule can be divided into equal doses.

Gabapentin Combix can be taken with or without food.

Treatment duration

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, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 if you take more gabapentin than your doctor prescribed. 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 treatment with Gabapentina Combix

Do not stop taking Gabapentina Combix suddenly. If you want to stop taking Gabapentina Combix, 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 Gabapentina Combix. 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 treatment with Gabapentina Combix. 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 Combix and seek immediate medical attention if you notice any of the following symptoms:

• flat, red 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 swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medications, this medication may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following symptoms after taking this medication, 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)
• Gabapentina 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. There may or may not be a rash when this type of reaction occurs. This may require stopping gabapentina 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:

• skin rash
• hives
• fever
• swollen lymph nodes that do not subside
• swelling of the lips and tongue
• yellow discoloration of the skin or white of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

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 Gabapentina Combix.

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

Other side effects include:

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

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

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

• bronchitis, respiratory infection, urinary tract infection, ear inflammation, or 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, tremors.
• erectile dysfunction.
• swelling in the legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms.
• low white blood cell count, weight gain.
• accidents, fractures, bruises.

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

Rare side effects (may affect up to 1 in 1,000 people):

• agitation (a chronic state of restlessness and involuntary, purposeless movements)
• allergic reactions such as hives.
• decreased movement.
• rapid heartbeat.
• difficulty swallowing.
• swelling that may affect the face, trunk, and limbs.
• abnormal results in blood tests that may indicate liver problems.
• progressive mental damage.
• falling.
• increased blood sugar levels (observed more frequently in patients with diabetes).

Very rare side effects (may affect up to 1 in 1,000 people):

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

Unknown frequency (cannot be estimated from available data):

• suicidal thoughts.
• developing dependence on Gabapentina Combix ("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 Combix (see "If you stop taking Gabapentina Combix").

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

• low platelet count (blood clotting cells).
• hallucinations.
• abnormal movements such as contortions, spasmodic movements, and rigidity.
• tinnitus (ringing in the ears).
• yellow discoloration of the skin and eyes (jaundice), liver inflammation.
• acute kidney failure, incontinence.
• breast enlargement, breast hypertrophy.
• side effects after abrupt discontinuation of gabapentina treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain.
• muscle fiber rupture (rhabdomyolysis).
• abnormal results in blood tests (elevated creatine phosphokinase).
• sexual activity problems, 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 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 Pharmacovigilance of Medicinal Products for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unusedmedications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Gabapentina Combix

• The active ingredient is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.
• The other components are:

• In the tablet core: mannitol, low-substitution hydroxypropylcellulose, copovidone, povidone K-30, poloxamer 407, talc, and magnesium stearate.
• In the tablet coating:hypromellose, titanium dioxide (E171), macrogol 4000, and talc.

Appearance of the product and contents of the packaging

Gabapentina Combix 800 mg film-coated tablets are white to off-white, oval, smooth, and scored on both sides.

They are available in PVC/PVDC-Aluminum blisters or OPA/Aluminum/PVC-Aluminum blisters, in packs of 20, 30, 45, 50, 84, 90, 100, 200, and 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

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:April 2023

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