Gabapentina Combix 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gabapentin Combix 600 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 is Gabapentin Combix and what is it used for

This medicine contains the active substance 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 that initially begin in specific areas of the brain, whether or not they spread to other parts of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe gabapentin to help manage 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 the legs and/or arms), such as diabetes or herpes. The sensation of pain may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, cramps, continuous pain, tingling, numbness, and pins and needles, among others.

2. What you need to know before taking Gabapentina Combix

Do not take Gabapentina Combix

• if you are allergic to gabapentin or to 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 dosing regimen
• if you are on haemodialysis (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, inform your doctor immediately, as these may be symptoms of acute pancreatitis (inflamed pancreas)
• if you have a disorder of the nervous system 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 increased risk of developing dependence on Gabapentina Combix.

Cases of abuse and dependence on gabapentin have been reported from post-marketing experience. Speak with your doctor if you have a history of abuse or dependence.

Dependence

Some people may develop dependence (a 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 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 you need to take the medicine for longer than prescribed.
• you feel you 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, but have been unsuccessful.
• 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.

Important information about potentially serious reactions

Serious skin rashes associated with the use of gabapentin have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention 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 on palpation, especially if accompanied by feeling unwell or having a fever, could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and be life-threatening. You may also experience discoloration of 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.

Children and adolescents

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

Other medicines and Gabapentina Combix

Inform 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 a 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.

Gabapentin

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should not take gabapentin during pregnancy unless your doctor has specifically instructed you to do so. An effective method of contraception should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medicines used to treat seizures, an increased risk of harm to the developing baby has been reported, particularly when more than one medicine is used to treat seizures simultaneously. Therefore, whenever possible, it is recommended to use only one seizure medicine during pregnancy, and only under the advice of your doctor.

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.

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

Breastfeeding

Gabapentin passes into breast milk. Breastfeeding is not recommended while taking gabapentin, as the effect on the baby is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform such activities.

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 tablets 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.

Children aged 6 years and older

Your doctor will decide the dose to give 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 to control epilepsy is 25–35 mg per kg per day. This dose is normally administered by taking the tablets, divided into three equal doses per day—typically one in the morning, one at midday, and one at night.

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

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of tablets 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 undergoing hemodialysis

Your doctor may prescribe a different dosing schedule 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 schedule or different doses if you have kidney problems.

If you think the effect of gabapentin 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 tablets with sufficient liquid (for example, a glass of water). The tablet may be divided into equal doses.

Gabapentina Combix may be taken with or without food.

Duration of treatment

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentina Combix than you should

Doses higher than recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency unit if you take more gabapentin than prescribed by your doctor. Bring any tablets you have not taken, along with the container and the package leaflet, so 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 almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentina Combix

Do not stop taking Gabapentina Combix suddenly. If you wish to stop taking Gabapentina Combix, speak 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 a minimum of one week. Be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short-term or long-term treatment with Gabapentina Combix. These may include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Stop taking Gabapentin Combix 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, ulcers in the mouth, 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).

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Severe skin reactions requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these 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 may cause a severe 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 urgent medical care to maintain normal breathing.

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

• Skin rash
• Hives
• Fever
• Swollen glands that do not go away
• Swelling of the lips 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 the first signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking Gabapentin Combix.

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

Other adverse effects include:

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

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

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

• Pneumonia, respiratory infection, urinary tract infection, ear infection, or other infections.
• Low white blood cell count.
• Anorexia, increased appetite.
• Anger 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, flushing 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 movements.
• Erectile dysfunction (impotence).
• Swelling in the arms and legs, difficulty walking, weakness, pain, feeling unwell, 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 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.
• 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.
• Falls.
• 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 Gabapentin Combix ("drug dependence").

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

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

• Decreased platelet count (blood clotting cells).
• Hallucinations.
• Abnormal movement problems such as twisting movements, spasmodic movements, and rigidity.
• Ringing in the ears.
• Yellow appearance of the skin and eyes (jaundice), liver inflammation.
• Acute kidney failure, incontinence.
• Increased breast tissue, 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).
• Problems with sexual function, 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 lips, throat, and tongue, and hypotension requiring urgent treatment).

Reporting of adverse effects

If you experience any type 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 sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Combix

• The active substance is gabapentin. Each film-coated tablet contains 600 mg of gabapentin.

• The other components are:

• In the tablet core: mannitol, low-substituted 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 pack

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

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

Only certain pack 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 most recent revision of this leaflet: April 2023

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