GABAPENTINA COMBIX 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Gabapentina Combix 400 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

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

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

This medicine belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

The active substance of Gabapentina Combix is gabapentina.

Gabapentina Combix is used to treat

• Certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe gabapentina for you or your child aged 6 years or older to help treat epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentina in combination with your current treatment unless told otherwise. Gabapentina can also be given as the only medicine in the treatment of adults and children over 12 years of age.
• Peripheral neuropathic pain (long-lasting pain caused by damage to the nerves). There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing, shooting, stabbing, acute, spasms, continuous, tingling, numbness, and pinching, etc.

2. What you need to know before you take Gabapentina Combix

Do nottakeGabapentina Combix

• if you are allergic (hypersensitive) to gabapentina or any of the other ingredients 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 dosage regimen
• if you are on hemodialysis (to remove waste products due to kidney failure), tell your doctor if you start to feel muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, tell 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, tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of becoming dependent on gabapentina.

Dependence

Some people may become dependent on gabapentina. They may experience withdrawal symptoms when they stop taking gabapentina (see section 3, "How to take Gabapentina Combix" and "If you stop taking Gabapentina Combix"). If you are concerned about becoming dependent on gabapentina, it is important that you talk to your doctor.

If you experience any of the following signs while taking gabapentina, it may indicate that you have become dependent.

• you feel that you need to take the medicine for longer than prescribed.
• you feel that you need to take a higher dose than recommended.
• you are taking the medicine for reasons other than those prescribed.
• you have tried to stop taking the medicine or control how you take it several times 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 what the best course of treatment is for you, including when it is appropriate to stop treatment and how to do it safely.

A small number of people being treated with antiepileptics such as gabapentina have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

Important 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 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, sensitivity, or pain on palpation, and especially if you feel unwell or have a fever, may be due to abnormal breakdown of muscle fibers, which 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 blood). 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 take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently taken 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 that contains opioids (such as morphine), tell your doctor or pharmacist, as opioids can increase the effect of gabapentina. Additionally, the combination of gabapentina with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

If you take gabapentina at the same time as antacids that contain aluminum and magnesium, the absorption of gabapentina in the stomach may be reduced. Therefore, it is recommended that gabapentina be taken at least 2 hours after taking an antacid.

Gabapentina Combix

• is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.
• may interfere with some laboratory tests, so if you need a urine test, tell your doctor or hospital what 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 may be pregnant, you must tell your doctor immediately to assess the possible risks that the medicine you are taking may pose to the fetus.
• Do not stop your treatment without first talking to your doctor.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentina can be used during the first trimester of pregnancy if necessary.

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

If you become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first talking to your doctor, as this may worsen your condition. Worsening of your epilepsy can put both you and your unborn baby at risk.

In a study that reviewed data from women in Nordic countries who took gabapentina in the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain development (neurodevelopmental disorders). However, babies of women who took gabapentina during pregnancy had a higher risk of low birth weight and premature birth.

If taken during pregnancy, gabapentina may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (drugs for treating intense pain).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentina. Do not stop taking this medicine suddenly, as this may cause a seizure, which could have serious consequences for both you and your baby.

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina can cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may affect your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

.

Gabapentina Combix contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Gabapentina Combix

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. Do not take more than the prescribed dose.

Your doctor will determine the dose that is right for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules that your doctor has told you. Normally, your doctor will gradually increase your dose. The initial dose will usually 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 3600 mg per day, divided into three equal doses, i.e., one in the morning, one at noon, and one in the evening.

Children aged 6 years or older

Your doctor will decide the dose to be given to your child based on the child's weight. The treatment will start with a low initial dose that 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. The usual dose is given by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentina Combix is not recommended for children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules that your doctor has told you. Normally, your doctor will gradually increase your dose. The initial dose will usually 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 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one in the evening.

If you have kidney problems or if you are on hemodialysis

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

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

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

If you think that the effect of this medicine is too strong or too weak, tell 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 recommended may cause an increase in side effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital if you take more Gabapentina Combix than your doctor prescribed. Bring any capsules that you have not taken, along with the packaging and the 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 the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Gabapentina Combix

Do not stop taking gabapentina suddenly. If you want to stop taking gabapentina, talk to your doctor first. Your doctor will tell you how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should be aware that you may experience certain side effects, called withdrawal syndrome, after stopping short-term or long-term treatment with gabapentina. 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 gabapentina treatment. 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 all people suffer from them.

Stop taking this medicine and seek medical attention immediately if you notice any of these symptoms:

• red patches without relief with a target or circular shape on the trunk, 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).
• widespread rash, high body temperature, and enlargement of the 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 can be serious:

• persistent stomach pain, vomiting, and nausea, as they can 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. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization.
• breathing problems that, if severe, may require urgent medical attention to breathe normally.

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

• skin rash and redness and/or hair loss
• hives
• fever
• inflammation of the glands that does not disappear
• swelling of the lips, face, and tongue
• yellowing of the skin or the whites 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 be examined by a doctor to decide if you should continue taking gabapentina.

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

Other adverse effects include:

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

• viral infection
• feeling of drowsiness, dizziness, discoordination
• feeling of fatigue, 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, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), difficulty coordinating, abnormal eye movements, increased, decreased, or absent reflexes
• blurred vision, double vision
• vertigo
• 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, tremors
• difficulty with erection (impotence)
• swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms
• decreased leukocytes, weight gain
• accidental injuries, fractures, abrasions.

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent 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
• accelerated heart rate
• difficulty swallowing
• swelling that can affect the face, trunk, and extremities
• abnormal blood test results that may indicate liver problems
• progressive mental damage
• 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).

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

• decrease in platelets (blood clotting cells)
• suicidal thoughts, hallucinations
• problems with abnormal movements such as contortions, spasmodic movements, and rigidity
• ringing in the ears
• yellowing of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• increase in breast tissue, breast enlargement
• adverse effects after abrupt discontinuation of gabapentina treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain
• rupture of muscle fibers (rhabdomyolysis)
• changes in blood test results (elevated creatine phosphokinase)
• problems with sexual activity, such as inability to reach orgasm and delayed ejaculation
• low sodium levels in the blood
• anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).
• developing dependence on gabapentina ("drug dependence").

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

Reporting of Adverse Effects

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

5. Storage of Gabapentina Combix

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

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

Do not store at a temperature above 25°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Combix

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

Capsule content: lactose monohydrate, cornstarch, 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 Package Contents

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

The product is presented in PVC-Alu blisters included in packages 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

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

O

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

O

Netpharmalab Consulting Services

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

O

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the Last Revision of this Prospectus: March 2025

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/