Leaflet: information for the patient

GabapentinSandoz300 mg hard capsules EFG

GabapentinSandoz400 mg hard capsules EFG

gabapentin

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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.

1.What is Gabapentin Sandoz and what it is used for

2.What you need to know before starting to take Gabapentin Sandoz

3.How to take Gabapentin Sandoz

4.Possible side effects

5.Storage of Gabapentin Sandoz

6.Contents of the pack and additional information

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

The active substance in Gabapentina Sandoz is gabapentin.

Gabapentina Sandoz 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 your epilepsy when your current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentin in addition to 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.

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 takeGabapentinaSandoz

-if you are allergic (hypersensitive) to gabapentina 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:

• if you have kidney problems, your doctor may prescribe a different dosing regimen,
• if you are on haemodialysis (for waste removal due to renal insufficiency), inform your doctor if you experience muscle pain and/or weakness,
• if you develop persistent stomach pain, vomiting, and nausea, inform your doctor immediately as these may be symptoms of acute pancreatitis (inflamed pancreas),
• if you have nervous system disorders, respiratory disorders, or if you are over 65 years old, your doctor may prescribe a different dosing regimen,
• if you have ever abused or been dependent 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.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentina. They may experience withdrawal symptoms when they stop taking gabapentina (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, it is essential to consult your doctor.

If you experience any of the following signs while taking gabapentina, it may indicate that you have developed dependence.

• You feel the need to take the medicine for a longer period 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.
• You feel unwell when you stop taking the medicine 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 gabapentina have had thoughts of self-harm or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.

Important information about potentially serious reactions

There have been reports of severe skin reactions associated with gabapentina use, 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 breakdown 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 Sandoz

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 and/or decreased breathing.

Antacids for digestion

If you take gabapentina at the same time as antacids containing aluminum or 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 Sandoz:

• 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.

TakingGabapentinaSandozwith food

Gabapentina Sandozcan 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 has been a reported increase in the 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 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). 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 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.

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and operating machinery

GabapentinaSandozmay 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.

Gabapentina Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially "sodium-free".

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 appropriate 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 in the middle of the day, 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, which 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 in the middle of the day, and one at night.

Do not recommend the use of gabapentin 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 the 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 in the middle of the day, 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 dose if you have kidney problems or if you are receiving hemodialysis treatment.

If you are an elderly patient (over 65 years old), take the normal dose of gabapentin, except if you have kidney problems. Your doctor may prescribe another dosing regimen or different dose 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 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 moreGabapentin Sandozthan you should

Doses higher than recommended may lead to an increase in adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, numbness, and diarrhea.In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested, or go to the emergency department of the nearest hospital. 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 takeGabapentin 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 withGabapentin Sandoz

Do not stop taking gabapentin suddenly. If you want to stop taking gabapentin, 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 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 these may be symptoms of acute pancreatitis (inflammation of the pancreas),
• respiratory problems, which if severe may require emergency intensive care 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. It may or may not have appeared as a rash when this type of reaction occurs. This may require stopping gabapentin or even hospitalization. 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,
• increased frequency of 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,
• increased 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, feeling unwell, flu-like symptoms,
• decreased 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,
• decreased movement,
• accelerated heart rate,
• swelling that can 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),
• difficulty swallowing.

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

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

Adverse reactions reported after marketing:

Unknown frequency (cannot be estimated from available data):

• decreased 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 growth, 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 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),
• 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 (see "If you stop taking Gabapentina Sandoz").

Reporting adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: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 medicationafter the expiration date that appears on the packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.

Store below 25°C.

Blister pack: Store in the original packaging to protect it from moisture.

Bottle: Keep the bottle perfectly closed to protect it from moisture.

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

Composition ofGabapentinaSandoz

-The active ingredient is gabapentin.

Cada cápsula dura contiene300 mgo400 mgde gabapentina.

-The other components are:

• Content of the capsule: maize pregelatinized starch, maize starch, talc, and anhydrous colloidal silica.
• Capsule: consists of gelatin,laurilsulfate of sodium, colored withdióxido of titanium(E 171), yellow iron oxide (E 172) and red iron oxide (E 172) (only the 400 mg capsules).

Appearance ofGabapentinaSandozand contents of the package

GabapentinaSandoz300 mg are hard gelatin capsules with a yellow opaque body and cap.

GabapentinaSandoz400 mg are hard gelatin capsules with a brown opaque body and cap.

The hard capsules are packaged in PVC/PE/PVDC//Alu blisters or in HDPE bottles with a child-resistant closure, inside a cardboard package.

Package sizes:

Blister: 20, 30, 50, 60, 90, 100, 200 and 500 hard capsules.

Bottle: 50 and 100 hard capsules.

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

or

Lek S.A.

Ul. Domaniewska50 C,

02-672 Warsaw

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d

Verovskova 57

SLO - 1526Ljubljana

Slovenia

or

Lek Pharmaceutical d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

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

Austria:Gabapentin Sandoz 300 mg – HartKapseln

Gabapentin Sandoz 400 mg – HartKapseln

Belgium:Gabapentine Sandoz 300 mg harde capsules

Gabapentine Sandoz 400 mg harde capsules

Czech Republic:Gabanox 300 mgtvrdetobolky

Gabanox 400 mgtvrdetobolky

Denmark:Gabapentin Sandoz 300 mghårde kapsler

Finland:Gabapentin Sandoz300 mg kapseli, kova

Gabapentin Sandoz 400 mg kapseli, kova

Iceland:Gabapentin Sandoz 300 mg hörð hylki

Gabapentin Sandoz 400 mg hörð hylki

Italy:Gabapentin Sandoz GmbH 300 mg capsule rigide

Gabapentin Sandoz GmbH 400 mg capsule rigide

Netherlands:Gabapentine Sandoz 300 mg, capsules, hard

Gabapentine Sandoz 400 mg, capsules, hard

Sweden:Gabapentin 1A-Farma 300 mg, hårda kapslar

Gabapentin 1A-Farma 400 mg, hårda kapslar

United Kingdom:Gabapentin 300 mg Capsules

Gabapentin 400 mg Capsules

Last review date of this leaflet:May 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/