Prospect: information for the patient

Gabapentina Sandoz 600 mg film-coated tablets

Gabapentina Sandoz 800 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

The active ingredient of Gabapentina Sandoz is gabapentin.

Gabapentin 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 gabapentin to help treat epilepsy when the current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentin in combination with the 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 in adults (long-lasting 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 Sandoz

• if you are allergic (hypersensitive) to gabapentin, soy, peanuts, 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 Sandoz.

• 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 feeling 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 (inflammation of the 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,
• if you have ever abused or been dependent on alcohol, prescribed medications, or illegal drugs; this may mean you have a higher risk of developing dependence on Gabapentina Sandoz.

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

Dependence

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

If you experience any of the following signs while taking gabapentin, it may be

indicative of 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.

A small number of people treated with antiepileptic drugs such as gabapentin have had thoughts of harming themselves or committing suicide. If you ever experience these thoughts, contact your doctor immediately.

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 in the section“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, and especially if you feel unwell or have a fever, could be due to an abnormal breakdown 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 Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 that contains opioids (such as morphine), inform your doctor or pharmacist, as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids may cause symptoms such as drowsiness and/or decreased breathing.

Antacids for indigestion

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

Gabapentin:

• is not expected to interact with other antiepileptic drugs 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 Sandoz with food

Gabapentina Sandoz 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 gabapentin 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 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. 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). 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, think you may be pregnant, or plan to become pregnant while taking gabapentin. 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 of Gabapentina Sandoz, passes into breast milk. It is not recommended to breastfeed while taking gabapentin, as its effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and operating machinery

Gabapentin 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 other activities.

Gabapentina Sandoz contains lecithin from soy and sodium

This medicine contains lecithin from soy. Do not use it in case of an allergy to peanuts or soy.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

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 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 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.

Not all recommended doses are possible with this formulation. There are other gabapentin preparations available that may be more suitable.

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 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 receiving hemodialysis

Your doctor may prescribe another dosing regimen and/or a different dose if you have kidney problems or are receiving hemodialysis.

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 form

Gabapentin Sandoz 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 Gabapentina Sandoz 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.

Call your doctor or go to the nearest hospital emergency room if you take more gabapentin than your doctor prescribed. Bring with you any capsules 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 Sandoz

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 Sandoz

Do not stop taking Gabapentina Sandoz suddenly. If you want to stop taking Gabapentina Sandoz, 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. 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 gabapentin treatment. 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.

Stop taking Gabapentina Sandoz 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 (these may be symptoms of a severe allergic reaction),
• persistent stomach pain, nausea, and vomiting, as they may be symptoms of acute pancreatitis (inflammation of the pancreas),
• breathing problems that, if severe, may require emergency medical attention to breathe normally,
• gabapentin can 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. You may or may not have a rash when this type of reaction occurs. This may lead to hospitalization or stopping gabapentin.

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

• skin rash,
• hives,
• fever,
• swollen glands 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 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: (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 infections, urinary tract infections, 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,
• high blood pressure, redness, or dilation of blood vessels,
• difficulty breathing, bronchitis, sore throat, cough, nasal discharge,
• vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth, 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, discomfort, flu-like symptoms,
• low white blood cell count, weight gain,
• accidents, fractures, bruises.

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

Uncommon: (may affect up to 1 in 100 people)

• agitation (a chronic state of restlessness and involuntary, purposeless movements),
• allergic reactions such as hives,
• reduced movement,
• rapid heartbeat,
• swelling that may affect the face, trunk, and limbs,
• abnormal results in blood tests that may indicate liver problems.
• mental damage,
• fall,
• increased blood glucose levels (observed more frequently in patients with diabetes),
• difficulty swallowing.

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

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

Adverse reactions reported after the marketing of gabapentin:

Unknown frequency:(cannot be estimated from available data)

• low platelet count (blood clotting cells),
• hallucinations,
• suicidal thoughts,
• 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 tissue enlargement, breast enlargement,
• adverse reactions 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, 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),
• 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 Gabapentina Sandoz (see "If you stop taking Gabapentina Sandoz").

Other possible side effects

Very rarely, soy lecithin may cause allergic reactions.

Reporting of adverse reactions

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 adverse reactions, 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 and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Gabapentina Sandoz

The active ingredient is gabapentin.

Gabapentina Sandoz 600 mg: Each film-coated tablet contains 600 mg of gabapentin.

Gabapentina Sandoz 800 mg: Each film-coated tablet contains 800 mg of gabapentin.

The other components are:

Core tablet: macrogol 4000, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

Appearance of the product and contents of the package

Film-coated tablet.

Gabapentina Sandoz 600 mg film-coated tablets:

are white, film-coated tablets in capsule shape with an inscription (600) on one side.

Gabapentina Sandoz 800 mg film-coated tablets:

are white, film-coated tablets in capsule shape.

The tablets are presented in PVC/aluminium blisters included in carton boxes.

Package sizes:

50, 60, 90, 100, 200, 200 (2x100) and sample packs with 20 film-coated tablets.

Note: The samples do not apply to Spain.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Zambon S.p.A.

Via Della Chimica, 9

36100 Vicenza

Italy

or

Salutas Pharma GmbH

Otto-von Guericke Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bélgica:Gabapentin Sandoz 600 mg filmomhulde tabletten

Gabapentin Sandoz 800 mg filmomhulde tabletten

Finlandia:Gabapentin Sandoz 600 mg tabletti, kalvopäällysteinen

Gabapentin Sandoz 800 mg tabletti, kalvopäällysteinen

Francia:GABAPENTINE SANDOZ 600 mg, comprimé pelliculé

GABAPENTINE SANDOZ 800 mg, comprimé pelliculé

Holanda:Gabapentine Sandoz 600 mg filmomhulde tabletten

Gabapentine Sandoz 800 mg filmomhulde tabletten

Suecia:Gabapentin 1A-Farma 600 mg filmdragerade tabletter

Gabapentin 1A-Farma 800 mg filmdragerade tabletter

Reino Unido:GabapentinSandoz600 mg Tablets

Gabapentin Sandoz 800 mg Tablets

Last review date of this leaflet:February 2023.

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/