Gabapentin Combix 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gabapentin Combix 400 mg hard capsules EFG

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Gabapentin Combix is and what it is used for
2. What you need to know before taking Gabapentin Combix
3. How to take Gabapentin Combix
4. Possible side effects
5. How to store Gabapentin Combix
6. Contents of the pack and other information

1. What Gabapentina Combix is and what it is used for

This medicine belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active substance in Gabapentina Combix is gabapentin.

Gabapentina Combix is used to treat

• Certain types of epilepsy (seizures that initially affect only specific parts of the brain, whether or not they spread to other parts of the brain). Your doctor or your child's doctor (aged 6 years or older) will prescribe gabapentin to help treat epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with current treatment, unless otherwise instructed. Gabapentin may also be used as monotherapy in the treatment of adults and children over 12 years of age.
• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation may be described as heat, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, spasms, continuous pain, tingling, numbness, and prickling sensations, etc.

2. What you need to know before taking Gabapentina Combix

Do not take Gabapentina Combix

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentina Combix

• if you have kidney problems, your doctor may prescribe a different dosing regimen
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you start experiencing muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, notify your doctor immediately, as these 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 of age, your doctor may prescribe a different dose
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at higher risk of developing dependence on gabapentin
• if you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin or reduce the dose (see section 3, "How to take Gabapentina Combix" and "If you stop taking Gabapentina Combix"). If you are concerned about developing dependence on gabapentin, it is important 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 different from those for which it was prescribed
• 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 start taking it again

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you have such thoughts, contact your doctor as soon as possible.

Important information about potentially serious reactions

Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Read the description of serious 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, tenderness, or pain on palpation—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and could be life-threatening. You may also experience discolored urine and changes in blood test results (a significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric condition.

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 enhance the effect of gabapentin. In addition, combining gabapentin with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

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

Gabapentina Combix

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

Taking Gabapentina Combix with food

Gabapentina Combix can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you might be pregnant, you must inform your doctor immediately to discuss the possible risks the medicine you are taking may pose to the unborn baby.
• You should not stop your treatment without first consulting your doctor.
• If you are planning to become pregnant, you should review your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin may be used during the first trimester of pregnancy if necessary.

If you are planning to become pregnant or if you are pregnant or think you might be, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important not to stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening of epilepsy could endanger both you and your unborn baby.

In a study reviewing data from women in Nordic countries who took gabapentin during the first three months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking gabapentin. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active substance in Gabapentina Combix, passes into breast milk. Breastfeeding is not recommended while taking this medicine, as the effect on the infant is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

Gabapentina Combix contains lactose and sodium

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

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

3. How to take Gabapentina Combix

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is

Adults and adolescents

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

Children aged 6 years and older

Your doctor will decide the dose for your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. This dose is usually administered by taking the capsules, divided into three equal doses per day, typically one in the morning, one at midday, and one at night.

The use of Gabapentina Combix is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

If you have kidney problems or are receiving hemodialysis treatment

Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems or are undergoing hemodialysis.

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

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

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

Method of administration

Gabapentina Combix is administered orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking this medicine until your doctor tells you to stop.

If you take more Gabapentina Combix than you should

Doses higher than those 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go immediately to the emergency department of the nearest hospital if you take more Gabapentina Combix than prescribed by your doctor. Take any capsules you have not taken, together with the packaging and the package leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Combix

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Gabapentina Combix

Do not stop taking gabapentin suddenly or reduce the dose. If you wish to stop taking gabapentin or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with gabapentin or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping gabapentin treatment or reducing the dose. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Stop taking this medicine and seek immediate medical attention if you notice any of the following symptoms:

• red, flat, target-shaped or circular patches on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread 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:

• persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas)

• gabapentin may cause a serious or potentially life-threatening allergic reaction that may affect the skin or other parts of the body such as the liver or blood cells. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuation of gabapentin or even hospitalization.

• difficulty breathing, which, if severe, may require emergency medical attention to continue breathing normally.

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

• skin rash and redness and/or hair loss
• hives
• fever
• swollen glands that do not go away
• swelling of the lips, face, and tongue
• yellowing of the skin or whites of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

These symptoms may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking gabapentin.

• If you are on hemodialysis, inform your doctor if you begin to experience muscle pain and/or weakness.

Other adverse effects include:

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

Common (may affect up to 1 in 10 people)

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections
• Low white blood cell count
• Anorexia, increased appetite
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, 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, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, jerking
• Erectile dysfunction (impotence)
• Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• Decreased leukocytes, weight gain
• Accidental injuries, fractures, abrasions.

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

Uncommon (may affect up to 1 in 100 people)

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

• Allergic reactions such as hives

• Decreased movement

• Increased heart rate

• Difficulty swallowing

• Swelling that may affect the face, trunk, and limbs

• Abnormal blood test results that may indicate liver problems

• Progressive mental impairment

• Fall

• Increased blood glucose levels (observed more frequently in patients with diabetes).

Rare (may affect up to 1 in 1000 people)

• Loss of consciousness
• Decreased blood glucose levels (observed more frequently in patients with diabetes)
• Breathing problems, shallow breathing (respiratory depression).

Following the marketing of gabapentin, the following adverse effects have been reported:

• Decrease in platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears
• Yellow appearance of the skin and eyes (jaundice), liver inflammation
• Acute renal failure, incontinence
• Breast tissue increase, breast enlargement
• Adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rupture of muscle fibers (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual function problems, such as inability to reach orgasm and delayed ejaculation
• Low sodium levels in blood
• Anaphylaxis (a serious, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment).
• Development of dependence on gabapentin (“drug dependence”).
• Worsening of myasthenia gravis (a disease causing muscle weakness), (frequency not known).

You should be aware that you may experience certain adverse effects called withdrawal syndrome after stopping short- or long-term treatment with gabapentin (see "If you stop taking Gabapentina Combix").

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Combix

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Combix

• The active substance is gabapentin. Each hard gelatin capsule contains 400 mg of gabapentin.
• The other components are:

Capsule contents: monohydrate lactose, corn starch and talc.

Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Gabapentin Combix 400 mg are light orange hard gelatin capsules, with approximate dimensions of 21.8 mm in length and 7.5 mm in width.

The product is available in PVC-Alu blisters contained in packs of 30 or 90 capsules.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible

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

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the most recent review of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/