Gabapentin CINFA 800 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

gabapentina cinfa 800 mg film-coated tablets 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What gabapentin cinfa is and what it is used for

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

The active substance in gabapentin cinfa is gabapentin. Gabapentin is used to treat:

• Certain types of epilepsy (seizures that initially affect only certain parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor (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 your current treatment, unless otherwise instructed by your doctor. 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 shingles. The sensation of pain may be described as heat, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and pins-and-needles sensations, etc.

2. What you need to know before taking gabapentina cinfa

Do not take gabapentina cinfa

• 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, pharmacist, or nurse before taking gabapentina cinfa

• if you have kidney problems, your doctor may prescribe a different dosing regimen.
• if you are undergoing hemodialysis (to remove waste products due to kidney failure), inform your doctor immediately if you begin to experience 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 signs of acute pancreatitis (inflamed pancreas).
• if you have a neurological 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 condition causing muscle weakness), as this medicine may worsen your symptoms.

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

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

Dependence

Some people may develop dependence (a need to keep taking the medicine) on gabapentina cinfa. They may experience withdrawal symptoms when they stop taking gabapentina cinfa or reduce the dose (see section 3, "How to take gabapentina cinfa" and "If you stop taking gabapentina cinfa"). If you are concerned about developing dependence on gabapentina cinfa, it is important to consult your doctor.

If you experience any of the following signs while taking gabapentina cinfa, 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.
• You feel unwell when you stop taking the medicine and feel better when you take it again.

If you notice any of the above, talk to your doctor to determine the best treatment approach 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 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 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—especially if accompanied by feeling unwell or fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and may 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.

Other medicines and gabapentina cinfa

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 conditions.

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 increase the effect of gabapentin. In addition, combining gabapentin with opioids may cause symptoms such as drowsiness, sedation, reduced 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. Therefore, it is 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 oral contraceptive pills.
• may interfere with certain laboratory tests; therefore, if you require a urine test, inform your doctor or hospital about the medicines you are taking.

Taking gabapentina cinfa with food

Gabapentin can be taken with or without food.

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. Women of childbearing age should use an effective method of contraception.

There are no specific studies on the use of gabapentin in pregnant women, but with 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. Therefore, whenever possible, it is recommended to use only one antiepileptic 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 concomitantly with opioid analgesics (medicines for severe pain).

Breastfeeding

Gabapentin, the active substance in gabapentina cinfa, passes into breast milk. Breastfeeding is not recommended while taking gabapentin, 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 capability. These effects, as well as your underlying condition, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take gabapentina cinfa

Follow exactly the instructions for use of this medicine 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 prescribed by your doctor. 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 for your child based on the child's weight. Treatment will begin 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 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 prescribed by your doctor. 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 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 the effect of gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

gabapentina cinfa is administered orally. Always swallow the tablets with a sufficient amount of water. The tablet may be divided into equal doses.

Continue taking gabapentina until your doctor tells you to stop.

If you take more gabapentina cinfa than you should

Doses higher than recommended may increase 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 gabapentina than prescribed by your doctor. Bring any unused tablets, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take gabapentina cinfa

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 cinfa

Do not stop taking gabapentina cinfa suddenly or reduce the dose abruptly. If you wish to stop taking gabapentina cinfa 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 gabapentina cinfa or after reducing the dose. 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 cinfa or reducing the dose. 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

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 these 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.
• breathing difficulties, which, if severe, may require urgent medical attention to continue breathing normally.

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. A doctor should examine you to decide 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 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 inflammation, or other infections.
• Low white blood cell count.
• Anorexia, increased appetite.
• Irritability towards others, confusion, mood changes, depression, anxiety, restlessness, 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 movements.
• Erectile difficulties (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)

• Allergic reactions such as hives.
• Decreased movement.
• Rapid heartbeat.
• Swelling that may affect the face, trunk, and limbs.
• Abnormal blood test results that may indicate liver problems.
• Agitation (a state of chronic restlessness and involuntary, purposeless movements).
• Progressive mental impairment.
• Falls.

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 problems, shallow breathing (respiratory depression).

Adverse effects with unknown frequency (cannot be estimated from available data)

• Suicidal thoughts
• Development of dependence on gabapentin cinfa ("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 cinfa or after reducing the dose (see "If you stop taking gabapentin cinfa").

Stop taking gabapentin cinfa and seek immediate medical attention if you notice any of these symptoms:

• red, non-elevated, target-shaped or circular patches on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe 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).

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

• Decreased platelet count (blood clotting cells).

• Hallucinations.

• Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness.

• Ringing in the ears.

• Yellowish appearance of the skin and eyes (jaundice), liver inflammation.

• Acute kidney failure, incontinence.

• Increase in 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 reach orgasm and delayed ejaculation.

• Low sodium levels in the blood.

• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment).

• Worsening of myasthenia gravis (a disease causing muscle weakness).

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 cinfa

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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.

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of gabapentin cinfa

The active substance is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.

The other components are:

Core: poloxamer, pregelatinized corn starch, copovidone, magnesium stearate, crospovidone.

Coating: Opadry Y-1-7000 (hypromellose, titanium dioxide, macrogol).

Appearance of the product and contents of the pack

gabapentin cinfa 800 mg film-coated tablets are white, oblong, biconvex, film-coated tablets with a break line.

Available in PVC-PVDC/Aluminum blisters, packs of 90 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

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

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the package leaflet and carton with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76214/P_76214.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76214/P_76214.html