Prospect: information for the user

Gabapentina Teva-ratiopharm 800 mg film-coated tablets

Gabapentina Teva-ratiopharm belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active ingredient of this medication is gabapentina.

Gabapentina Teva-ratiopharm 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 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 in combination with current treatment unless otherwise indicated. Gabapentina Teva-ratiopharm 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 Teva-ratiopharm

• if you are allergic (hypersensitive) to gabapentin or to 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 Teva-ratiopharm

• if you have kidney problems, your doctor may prescribe a different dosing regimen
• if you are on hemodialysis (to remove waste products due to renal insufficiency), inform your doctor if you start to feel muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, 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 gabapentin dependence.

There have been reports of gabapentin 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 like gabapentin have had thoughts of harming themselves or suicide. If you ever have these thoughts, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Teva-ratiopharm" and "If you interrupt treatment with Gabapentina Teva-ratiopharm"). If you are concerned about developing dependence on gabapentin, it is essential to consult your doctor.

If you experience any of the following signs while taking gabapentin, 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 your 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 gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin 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, especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle fibers, which 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 the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Gabapentina Teva-ratiopharm with other medicines

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 can increase the effect of Gabapentina Teva-ratiopharm. Additionally, the combination of Gabapentina Teva-ratiopharm with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for digestion

If you take gabapentin at the same time as antacids containing aluminum and magnesium, the absorption of gabapentin in the stomach may be reduced. It is recommended that this medicine be taken at least two hours after taking an antacid.

Gabapentina Teva-ratiopharm

• Gabapentina Teva-ratiopharm is not expected to interact with other antiepileptic medications or oral contraceptives.
• 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 Teva-ratiopharm with food and drinks

Gabapentina Teva-ratiopharm 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 Teva-ratiopharm 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 gabapentin in pregnant women, but in the case of other medications used to treat seizures, there has been a reported increase in the risk of damage to the developing fetus, particularly when more than one medication is 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.

If you take gabapentin during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medications).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Teva-ratiopharm. 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.

Breastfeeding

Gabapentin, the active ingredient in Gabapentina Teva-ratiopharm, is excreted in breast milk. It is not recommended to breastfeed while taking Gabapentina Teva-ratiopharm, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and operating machinery

Gabapentina Teva-ratiopharm may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medicine affects your ability to perform these activities.

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

Your doctor will determine what dose is suitable 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.

Therefore, the dose can be increased up to a maximum dose of 3600 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. The 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 taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, and one at night.

Do not recommend the use of Gabapentina Teva-ratiopharm in children under 6 years old.

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. Therefore, the dose can be increased up to a maximum dose of 3600 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 and/or different doses if you have kidney problems or if you are receiving hemodialysis treatment.

If you are an elderly patient (over 65 years old)

You should take the normal dose of Gabapentina Teva-ratiopharm, 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 Gabapentina Teva-ratiopharm is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina Teva-ratiopharm is administered orally. Swallow the capsules with a sufficient amount of water.

Continue taking this medication until your doctor tells you to stop.

If you take more Gabapentina Teva-ratiopharm 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, pharmacist, 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 Gabapentina Teva-ratiopharm 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 Gabapentina Teva-ratiopharm

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 Gabapentina Teva-ratiopharm

Do not stop taking Gabapentina Teva-ratiopharm suddenly. If you want to stop taking Gabapentina Teva-ratiopharm, 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 Gabapentina Teva-ratiopharm. 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 stopping treatment with Gabapentina Teva-ratiopharm. If you experience this withdrawal syndrome, contact your doctor.

If you have any other questions 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.

Stop taking gabapentin and seek medical attention immediately if you notice any of the following symptoms:

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

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, lip and face inflammation, skin rash, and/or 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 ratiopharm 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 ratiopharm or even hospitalization.
• breathing problems 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
• yellow discoloration 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 whether you should continue taking Gabapentin ratiopharm.

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

Other side effects include:

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

• Viral infection,
• feeling sleepy, dizziness, discoordination,
• feeling tired, fever.

Common (may affect up to 1 in 10 people)

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation, or other infections
• low white blood cell count,
• loss of appetite, increased appetite
• irritability 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, dry nose,
• vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence,
• swelling of the face, hives, rash, itching, acne,
• joint pain, muscle pain, back pain, twitching,
• erectile dysfunction,
• swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms,
• low leukocyte count,
• weight gain,
• accidents, fractures, bruises.

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

Rare: (may affect up to 1 in 1000 people)

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

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

• Suicidal thoughts
• Developing dependence on gabapentin ("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 ratiopharm (see "If you stop taking Gabapentin ratiopharm").

After the marketing of Gabapentin, ratiopharm, the following side effects have been reported:

• Decreased platelets (blood clotting cells),
• hallucinations,
• abnormal movement problems such as contortions, spasmodic movements, and rigidity,
• tinnitus (ringing in the ears),

• yellow discoloration of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• breast enlargement, breast hypertrophy
• side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• muscle fiber rupture (rhabdomyolysis)
• abnormal results in blood tests (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 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.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Gabapentina Teva-ratiopharm

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

The other components are: microcrystalline cellulose, copovidone, isopropyl alcohol, crospovidone (type A), talc, magnesium stearate, Opadry II 85F18422 (polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc).

Appearance of the product and contents of the packaging

Gabapentina Teva-ratiopharm 800 mg are film-coated tablets, white to almost white, oval-shaped, and beveled-edge. One side is engraved with “7174” and the other with “93”. Each package contains 90 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

TEVA Gyógyszergyár Zrt.

Pallagi út 13

H-4042 Debrecen

Hungary

or

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143-Blaubeuren (Germany)

or

Teva Pharma, B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Last review date of this leaflet: January 2023

Detailed and updated information about 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 about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66198/P_66198.html