Package Leaflet: Information for the User

Gabapentin Cinfa 400 mg Hard Capsules EFG

Read this leaflet carefully before you start to take 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 give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

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

The active ingredient of gabapentina cinfa is gabapentina.

Gabapentina cinfa is used to treat:

• Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child aged 6 years or older will prescribe gabapentina cinfa to help treat your epilepsy when your current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentina cinfa in combination with your current treatment unless otherwise instructed. Gabapentina can also be administered as a single medication in the treatment of adults and children over 12 years.

Peripheral neuropathic pain (chronic pain caused by nerve damage). There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.

Do not take gabapentina cinfa

• If you are allergic to gabapentina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take gabapentina cinfa:

• If you have kidney problems, your doctor may prescribe a different dosing regimen,
• If you are on hemodialysis (for waste removal due to renal insufficiency), inform your doctor if you start feeling 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 had dependence on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing gabapentina dependence.

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

A small number of people taking antiepileptic medications such as gabapentina have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentina cinfa. They may experience withdrawal symptoms when they stop taking gabapentina cinfa (see section 3, "How to take gabapentina cinfa" and "If you interrupt treatment with gabapentina cinfa"). If you are concerned about developing dependence on gabapentina cinfa, it is essential 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 the need to take the medicine for a longer time than prescribed.

- You feel the need to take a higher dose than recommended.

- You are taking the medicine for reasons other than its prescription.

- 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 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

There have been reports of severe skin reactions associated with the use of gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Read the description of these symptoms in section 4 of this prospectus“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, especially if you feel unwell or have a fever, may be due to an abnormal rupture of muscle fibers that 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 cinfa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Especially, inform your doctor (or pharmacist) if you are taking or have taken recently 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 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. It is recommended that gabapentina be taken at least two hours after taking an antacid.

gabapentina cinfa:

No interaction is expected with other antiepileptic medications or with the oral contraceptive pill.

It may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what you are taking.

Taking gabapentina cinfa with food

Gabapentina can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should not take gabapentina during pregnancy, unless your doctor has told you to. You should use an effective contraceptive method in women of childbearing age.

No specific studies have been conducted on the use of gabapentina in pregnant women, but in the case of other medications used to treat seizures, an increased risk of fetal damage has been reported, particularly when multiple medications are used to treat seizures. Therefore, whenever possible, you should try to take only one medication for seizures and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, if you think you may be pregnant, or if you plan to become pregnant while taking gabapentina. Do not stop taking this medicine abruptly as this may cause withdrawal symptoms, which can 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 concomitantly with opioid analgesics (pain medications).

Breastfeeding

Gabapentina, the active ingredient of gabapentina cinfa, passes into breast milk. It is not recommended to breastfeed while taking gabapentina, as its effect on the baby is unknown.

Fertility

No effects on fertility have been found in animal studies.

Driving and operating machinery

Gabapentina may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying condition, may impair 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 evaluates your response to this medicine.

gabapentina cinfa contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not take a higher dose of medication than prescribed.

Your doctor will determine the suitable dose for you.

Epilepsy, the recommended dose is

Adults and adolescents:

Take the number of capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally 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 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

Children 6 years or older:

Your doctor will decide on the dose to be administered to your child based on the child's weight. Treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually administered by ingesting the capsules, divided into 3 equal doses per day, normally, one in the morning, one at noon, and one at night.

Gabapentin cinfa is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain,the recommended dose is

Adults

Take the number of capsules indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally 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 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

If you have kidney problems or if you are receiving hemodialysis treatment

Your doctor may prescribe another dosing regimen or different doses if you have kidney problems or if you are receiving hemodialysis treatment.

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

You should take the normal dose of gabapentin, except if you have kidney problems. Your doctor may prescribe another dosing regimen or different doses if you have kidney problems.

If you consider that the effect of gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Administration method

Gabapentin is administered orally. Swallow the capsules whole with a sufficient amount of 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 cause an increase in adverse 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 Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

Bring any capsules that you have not taken, along with the packaging and the leaflet, so that the hospital can easily identify the medication you have taken.

If you forgot to take gabapentin cinfa

If you forgot 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 compensate for the missed doses.

If you interrupt the treatment with gabapentin cinfa

Do not stop taking gabapentin cinfa suddenly. If you want to stop taking gabapentin cinfa, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week. You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment with gabapentin cinfa. These include seizures, anxiety, difficulty sleeping, feeling of discomfort (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of discomfort. These effects usually occur within the first 48 hours after interrupting treatment with gabapentin cinfa. If you experience this withdrawal syndrome, contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side 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 that require immediate attention, inflammation of the lips and face, skin rash and redness, and/or hair loss (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 can affect the skin or other parts of the body, such as the liver or blood cells. It may or may not have appeared as a rash when this type of reaction occurs. This may require stopping gabapentin or even hospitalization
• Difficulty breathing that, if severe, may require emergency medical attention to breathe normally.

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

• Skin rash
• Hives
• Fever
• Swollen lymph nodes that do not subside
• Swelling of the lips and tongue
• Yellowing of the skin or white 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 have a doctor examine you to decide if you should continue taking gabapentin.

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

Other side effects include:

Very common side effects(may affect more than 1 in 10 patients):

• Viral infection.
• Dizziness, drowsiness, disorientation.
• Feeling tired, fever.

Common side 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.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, muscle spasms, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, numbness, coordination difficulties, 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.
• Swelling of the face, hives, rash, itching, acne.
• Muscle pain, muscle pain, back pain, tremors.
• Difficulty with erection (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Low white blood cell count, weight gain.
• Accidental injuries, fractures, bruises.

Additionally, in pediatric population studies, aggressive behavior and muscle spasms were reported as common side effects.

Common side effects (may affect up to 1 in 100 patients):

• Difficulty swallowing.
• Agitation (a chronic state of 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 results in blood tests that may indicate liver problems.
• Progressive mental damage.
• Falling.
• Increased blood sugar levels (observed more frequently in patients with diabetes).

Rare side effects (may affect up to 1 in 1,000 patients):

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

Unknown frequency (cannot be estimated from available data):

• Developing dependence on gabapentin cinfa ("drug dependence").

You should know that you may experience certain side effects, called withdrawal syndrome, after stopping a short- or long-term treatment with gabapentin cinfa (see "If you stop taking gabapentin cinfa").

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

• Red, flat patches with a target-like appearance on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

After thecommercialization of gabapentin, the following side effects have been reported:

• Decreased platelet count (blood clotting cells).
• Hallucinations.
• Abnormal movements such as contortions, muscle spasms, and rigidity.
• Tinnitus (ringing in the ears).
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence.
• Enlargement of breast tissue, breast enlargement.
• Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis).
• Changes in blood test results (elevated creatine phosphokinase).
• Sexual activity problems, 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 the lips, throat, and tongue, and hypotension that requires urgent treatment).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of gabapentin cinfa

• The active ingredient is gabapentin. Each capsule contains 400 mg of gabapentin.
• The other components are

• Content of the capsule: anhydrous lactose, cornstarch, 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 content of the packaging

Gabapentin cinfa is presented in the form of hard gelatin capsules with a yellowish-orange opaque body and cap containing white powder.

It is presented in PVC/Aluminum blisters and is available in packaging containing 30, 90, or 500 (clinical packaging) capsules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: January 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http:// www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. 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