GABAPENTINA COMBIX 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Gabapentina Combix 600 mg Film-Coated Tablets 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 get 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 the Pack

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. Storing Gabapentina Combix
6. Contents of the pack and other information

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

This medication contains the active substance gabapentin. Gabapentin belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

Gabapentina 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 your 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 otherwise advised by your doctor. 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 the 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 a feeling of pins and needles, etc.

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

Do not take Gabapentina Combix

• if you are allergic 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), inform your doctor if you start to feel 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 been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina Combix.

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

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

Dependence

Some people may develop dependence (need to continue taking the medicine) 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 stop taking Gabapentina Combix"). If you are concerned about developing dependence on Gabapentina Combix, it is important that you talk to your doctor.

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

• 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 your prescription.
• 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 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

Severe skin reactions have been reported in association 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 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, tenderness, or pain, and especially if you feel unwell or have a fever, could be due to abnormal muscle fiber breakdown, 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 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 gabapentina treatment on learning ability, intelligence, and development in children and adolescents have not been adequately investigated. Therefore, the benefits of prolonged therapy should be weighed against the potential risks.

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 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 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 containing aluminum and magnesium, the absorption of gabapentina in the stomach may be reduced. Therefore, it is recommended that gabapentina be taken at least two hours after taking an antacid.

Gabapentina

• 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, inform your doctor or hospital about what you are taking.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take gabapentina during pregnancy, unless your doctor has told you to. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies on the use of gabapentina in pregnant women, but with other medicines used to treat seizures, there have been reports of an increased risk of harm to the developing baby, particularly when more than one medicine is used to treat seizures. Therefore, whenever possible, you should try to take only one medicine for seizures during pregnancy 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 gabapentina. Do not stop taking this medicine suddenly, as this may cause seizures to return, which could have serious consequences for you and your baby.

If you take gabapentina during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid painkillers (strong pain relief medicines).

Breast-feeding

Gabapentina passes into breast milk. Breast-feeding is not recommended while taking gabapentina, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and Using Machines

Gabapentina may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

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 tablets that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be between 300 and 900 mg per day. From then on, the dose may be increased as advised 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.

Children aged 6 years and older

Your doctor will decide the dose to give to your child based on the child's weight. The treatment will start with a low initial dose that will be gradually increased over approximately 3 days. The usual dose to control epilepsy is 25-35 mg per kg per day. The dose is usually given in three equal doses, normally one in the morning, one at noon, and one in the evening.

Gabapentina should not be used in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of tablets that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be between 300 and 900 mg per day. From then on, the dose may be increased as advised 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 are on hemodialysis

Your doctor may prescribe a different dosage regimen and/or different doses if you have kidney problems or 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 gabapentina is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of Administration

Gabapentina Combix is taken by mouth. Always swallow the tablets with a sufficient amount of water (e.g., a glass of water). The tablet can be divided into equal doses.

Gabapentina Combix can be taken with or without food.

Duration of Treatment

Continue taking gabapentina until your doctor tells you to stop.

If you take more Gabapentina Combix than you should

Doses higher than recommended may cause an increased risk of side 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 Toxicology Information Service, telephone 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 than your doctor prescribed. Take any remaining tablets, the packaging, and the leaflet with you 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 Gabapentina Combix suddenly. If you want to stop taking Gabapentina Combix, talk to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment, it should be done gradually over at least one week. You should be aware that you may experience certain side effects, called withdrawal symptoms, after stopping treatment with Gabapentina Combix after short or long-term use. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Combix. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible Adverse Effects

Stop taking Gabapentina Combix and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief with a target or circular 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).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• severe skin reactions that require immediate attention, lip and face swelling, skin rash, and redness, and/or hair loss (can be symptoms of a severe allergic reaction)
• persistent stomach pain, vomiting, and nausea, as they can be symptoms of acute pancreatitis (inflammation of the pancreas)
• gabapentina 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. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization.
• breathing difficulties 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
• hives
• fever
• swelling of the glands that does not disappear
• swelling of the lips and tongue
• yellowish color of the skin or whites of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

These symptoms can be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking Gabapentina Combix.

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

Other adverse effects include:

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

• Viral infection.
• Feeling of drowsiness, dizziness, discoordination.
• Feeling of fatigue, fever.

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

• Pneumonia, respiratory infection, 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, 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.
• Facial swelling, 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.

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

Uncommon adverse effects (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, torso, and extremities.
• Abnormal blood test results that may indicate liver problems.
• Progressive mental damage.
• Falling.
• Increased blood glucose levels (observed more frequently in patients with diabetes).

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

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

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

• Suicidal thoughts.
• Developing dependence on Gabapentina Combix ("drug dependence")

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

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

• Decrease in platelets (blood clotting cells).
• Hallucinations.
• Problems with abnormal movements such as contortions, spasmodic movements, and stiffness.
• Ringing in the ears.
• Yellowish appearance of the skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increased breast tissue, breast enlargement.
• Adverse effects after sudden 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, including difficulty breathing, lip, throat, and tongue swelling, and hypotension that requires urgent treatment).

Reporting 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 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 thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines 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 film-coated tablet contains 600 mg of gabapentina.
• 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 Package Contents

Gabapentina Combix 600 mg film-coated tablets are white to off-white, oval, smooth, and scored on both sides.

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

Only some package sizes may be marketed.

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

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

Date of the Last Revision of this Prospectus:April 2023

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