Leaflet: information for the user

Gabapentin Cinfa 800 mg film-coated tablets

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.

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 gabapentin. Gabapentin is used to treat:

You or your child aged 6 years or older must take gabapentin in combination with your current treatment unless otherwise instructed. Gabapentin can also be administered as a single medication in the treatment of adults and children over 12 years old.

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take gabapentina cinfa

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 medicines such as gabapentina have had thoughts of self-harm or suicide. If you ever experience these thoughts, 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 longer 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 leaflet"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 on palpation, and especially if you feel unwell or have a fever, could be due to an abnormal rupture of muscle fibers that may 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 taking, have taken recently or may need to take any other medicine. In particular, 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 may increase the effect of gabapentina. Additionally, the combination of gabapentina with opioids may cause symptoms such as drowsiness, sedation, decreased breathing or death.

Antacids for indigestion

If you take gabapentina at the same time as antacids containing aluminium and magnesium, the absorption of gabapentina in the stomach may be reduced. It is therefore 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 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.

There are no specific studies on the use of gabapentina in pregnant women, but in the case of other medicines used to treat seizures, there have been reports of an increased risk of damage to the developing fetus, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible, you should try to take only one medicine 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 an anticipation of seizures, 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 concomitantly with opioid analgesics (pain relief medicines).

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

There are no effects on fertility 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 disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Follow exactly the administration instructions of this medication as 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 as 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 can 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 per kg per day. The dose is normally administered by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

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

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of capsules as 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 can 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 are being hemodialyzed

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or are being hemodialyzed.

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.

Method of administration

Gabapentin cinfa is administered orally. Always swallow the capsules with a sufficient amount of water. The capsule can be divided into equal doses.

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, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency department of the nearest hospital if you take more gabapentin than your doctor prescribed. Bring with you 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 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 unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of unwellness. These effects usually occur within the first 48 hours after stopping 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 immediatelyif you experience any of the following symptoms after taking this medicine, as they may be serious:

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

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 people)

• Viral infection.
• Drowsiness, dizziness, discoordination.
• Feeling tired, fever.

Common side 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.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, 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, dry nose.
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, flatulence.
• Swelling of the face, hives, rash, acne.
• Joint pain, muscle pain, back pain, spasms.
• Difficulty achieving an erection (impotence).
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
• Decreased white blood cell count, weight gain.
• Accidental injuries, fractures, bruises.

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common side effects.

Uncommon side effects (may affect up to 1 in 100 people)

• Allergic reactions such as urticaria.
• Decreased movement.
• Accelerated heart rate.
• Swelling that may affect the face, trunk, and limbs.
• Abnormal blood test results that may indicate liver problems.
• Agitation (a chronic state of restlessness and involuntary, purposeless movements).
• Progressive mental damage.
• Fall.
• Increased blood glucose levels (observed more frequently in patients with diabetes).
• Difficulty swallowing.

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

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

Side effects of unknown frequency(cannot be estimated from available data)

• Suicidal thoughts
• Developing dependence on gabapentin cinfa ("drug dependence")

You should know that you may experience certain side effects, called withdrawal syndrome, after interrupting 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:

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

• Decreased platelet count (blood clotting cells).
• Hallucinations.
• Abnormal movements such as contortions, spasmodic movements, 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 of 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 30°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 of 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 film-coated tablet contains 800 mg of gabapentin.

The other components are:

Core: poloxamer, pregelatinized cornstarch, copovidone, magnesium stearate, crospovidone.

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

Appearance of the product and contents of the packaging

Gabapentin cinfa 800 mg film-coated tablets are film-coated tablets that are oblong, biconvex, scored, and white.

They are available in PVC-PVDC/Aluminum blisters in packs of 90 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra)- Spain

Last review date of this leaflet: March 2023

The detailed information on this medicine 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 medicine 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/76214/P_76214.html

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