Gabapentin CINFA 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

gabapentin cinfa 400 mg hard capsules 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 must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What gabapentin cinfa is and what it is used for
2. What you need to know before taking gabapentin cinfa
3. How to take gabapentin cinfa
4. Possible side effects
5. How to store gabapentin cinfa

Pack contents and additional 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 cinfa 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 areas of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe gabapentin cinfa 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 cinfa in combination with current treatment, unless otherwise instructed. Gabapentin may also be given 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 may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, muscle spasms, continuous pain, tingling, numbness, and prickling sensations, among others.

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 or pharmacist before taking gabapentina cinfa:

• if you have kidney problems, your doctor may prescribe you a different dosing regimen,
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience 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 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 medicines, or illegal drugs; you may have an increased risk of developing dependence on gabapentin.
• if you have myasthenia gravis (a disease 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 abuse or dependence.

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

Dependence

Some people may develop dependence (a need to continue 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 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, 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, talk to 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 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 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 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

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 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 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 cinfa:

No interaction with other antiepileptic drugs or with oral contraceptive pills is expected.

It may interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or the hospital about the medicines you are taking.

Taking gabapentina cinfa with food

Gabapentin may be taken with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 fetal harm has been reported, particularly when more than one medicine is used simultaneously to treat seizures. Therefore, whenever possible, only one antiepileptic medicine should be used 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 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 the treatment of severe pain).

Breast-feeding

Gabapentin, the active ingredient in gabapentina cinfa, passes into breast milk. Breast-feeding 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 ability. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special alertness until your doctor has assessed your response to this medicine.

gabapentina cinfa contains lactose

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

3. How to take gabapentin cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 prescribed by your doctor. Your doctor will usually 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 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/kg/day. The 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 gabapentin cinfa is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules prescribed by your doctor. Your doctor will usually 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 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 gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin is administered orally. Always swallow the capsules whole with sufficient water.

Continue taking gabapentin until your doctor tells you to stop.

If you take more gabapentin cinfa 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.

Take with you any capsules you have not taken, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take gabapentin cinfa

If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking gabapentin cinfa

Do not stop taking gabapentin cinfa suddenly or reduce the dose without consulting your doctor. If you wish to stop taking gabapentin 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 gabapentin cinfa 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 cinfa or reducing the dose. If you experience this withdrawal syndrome, you should 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 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
• breathing difficulties that, if severe, may require urgent medical care 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 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 haemodialysis, 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 patients):

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

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

• Pneumonia, respiratory infection, urinary tract infection, ear inflammation, 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, redness or dilation of blood vessels.
• Difficulty breathing, bronchitis, sore throat, cough, nasal dryness.
• 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, twitching.
• Erectile difficulties (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Decreased leukocytes, weight gain.
• Accidental injuries, fractures, abrasions.

Additionally, in clinical trials in the paediatric population, aggressive behaviour and spasmodic movements were reported as common adverse effects.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Difficulty swallowing.
• Agitation (a state of chronic restlessness and involuntary, purposeless movements).
• Allergic reactions such as hives.
• Decreased movement.
• Increased heart rate.
• 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 adverse effects (may affect up to 1 in 1,000 patients):

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

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

• Development of dependence on gabapentina cinfa ("drug dependence").

You should be aware that you may experience certain adverse effects called withdrawal syndrome after stopping short- or long-term treatment with gabapentina cinfa or after reducing the dose (see "If you stop taking gabapentina cinfa").

Stop taking gabapentina 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).

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

• Decrease in platelets (blood clotting cells).
• Hallucinations.
• Abnormal movement problems such as dystonia, spasmodic movements, and rigidity.
• Ringing in the ears.
• Yellow 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 (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 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 cinfa

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of gabapentina cinfa

• The active substance is gabapentin. Each capsule contains 400 mg of gabapentin.

• The other components are

• Capsule contents: anhydrous lactose, corn starch and talc.

• Hard gelatin capsule: gelatin, yellow iron oxide (E-172), red iron oxide (E-172) and titanium dioxide (E-171).

Appearance of the product and contents of the pack

gabapentina cinfa is presented as hard gelatin capsules with an opaque orange body and cap containing white powder.

It is available in PVC/aluminum blisters and comes in packs containing 30, 90 or 500 capsules (hospital pack).

Only certain pack sizes may be marketed.

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 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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67969/P_67969.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67969/P_67969.html