Gabapentin Sandoz 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gabapentin Sandoz 600 mg film-coated tablets EFG

Gabapentin Sandoz 800 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Gabapentin Sandoz is and what it is used for
2. What you need to know before taking Gabapentin Sandoz
3. How to take Gabapentin Sandoz
4. Possible side effects
5. How to store Gabapentin Sandoz
6. Contents of the pack and other information

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

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

The active substance of Gabapentin Sandoz is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures that initially start in specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe gabapentin to help manage epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with current treatment, unless otherwise instructed. Gabapentin may also be used as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain in adults (long-lasting pain caused by nerve damage). Various medical conditions can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or shingles. The pain sensation may be described as warmth, burning, throbbing, shooting, stabbing, sharp pain, muscle spasms, continuous pain, tingling, numbness, and pins and needles, among others.

2. What you need to know before taking Gabapentina Sandoz

Do not take Gabapentina Sandoz

• if you are allergic (hypersensitive) to gabapentin, soya, peanuts, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentina Sandoz.

• if you have kidney problems, your doctor may prescribe a different dosing regimen,
• if you are undergoing haemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience muscle pain and/or weakness,
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, contact your doctor immediately, as these may be symptoms of acute pancreatitis (inflammation of the pancreas),
• if you have a disorder of the nervous system or a respiratory disorder, or if you are over 65 years of age, your doctor may prescribe a different dose,
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you have an increased risk of developing dependence on Gabapentina Sandoz.

Dependence

Some people may develop dependence (a 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 stop taking Gabapentina Sandoz"). If you are concerned about developing dependence on Gabapentina Sandoz, it is important that you speak to your doctor.

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

• You feel you need to take the medicine for longer than prescribed.
• You feel you need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• 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 start taking it again.

If you notice any of the above, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

A small number of people treated with antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you experience such thoughts, contact your doctor immediately.

Important information about potentially serious reactions

Serious skin rashes have been reported 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 immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Read the description of serious symptoms in section 4 of this leaflet under the heading "Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious."

Muscle weakness, tenderness, or pain—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibres, which may lead to kidney problems and may be life-threatening. You may also experience discolouration of urine and changes in blood test results (a significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric condition.

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 gabapentin. In addition, the combination of gabapentin with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

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

Gabapentin:

• is not expected to interact with other antiepileptic medicines or with oral contraceptive pills,
• may interfere with certain laboratory tests, so if you need a urine test, inform your doctor or hospital about the medicines 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 think you may be pregnant, you must inform your doctor immediately so that the possible risks of the medicine you are taking for the unborn baby can be assessed.
• You should not stop your treatment without first discussing it with your doctor.
• If you are planning to become pregnant, you should review your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin may be used during the first trimester of pregnancy if necessary.

If you are planning to become pregnant, or if you are pregnant or think you may be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening of epilepsy may put both you and your unborn baby at risk.

In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (medicines for the treatment of severe pain).

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 trigger seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active substance in Gabapentina Sandoz, passes into breast milk. Breastfeeding is not recommended while taking gabapentin, as the effect on the baby is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform such activities.

Gabapentina Sandoz contains soya lecithin and sodium

This medicine contains soya lecithin. It must not be used in patients with a peanut or soya allergy.

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

3. How to take Gabapentin Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Gabapentin 600 mg film-coated tablets:

The tablet may be divided into two or four equal doses.

Gabapentin 800 mg film-coated tablets:

The tablet may be divided into two equal doses.

Epilepsy, the recommended dose is:

Adults and adolescents:

Take the number of tablets your doctor has prescribed. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed 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 afternoon, and one at night.

Children aged 6 years and older:

Your doctor will decide the dose for your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. This dose is usually administered by taking the tablets, divided into three equal doses per day, typically one in the morning, one in the afternoon, and one at night.

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

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

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of tablets your doctor has prescribed. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased as directed 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 afternoon, and one at night.

If you have kidney problems or are undergoing hemodialysis

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

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

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

Method of administration

Gabapentin Sandoz is administered orally. Always swallow the tablets whole with sufficient water.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentin Sandoz than you should

Doses higher than recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Call your doctor or go to the nearest hospital emergency department if you take more gabapentin than prescribed. Bring any unused tablets, together with the packaging and the leaflet, so the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Sandoz

If you forget a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentin Sandoz

Do not stop taking Gabapentin Sandoz suddenly. If you wish to stop taking Gabapentin Sandoz, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with gabapentin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Gabapentina Sandoz and seek immediate medical attention if you notice any of the following symptoms:

• red, non-elevated circular or target-shaped patches on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread 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 requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be symptoms of a severe allergic reaction),
• persistent stomach pain, nausea, and vomiting, as they may indicate acute pancreatitis (inflammation of the pancreas),
• breathing difficulties that, if severe, may require emergency medical care to maintain normal breathing,
• gabapentin may cause a severe or potentially life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may lead to hospitalization or the need to discontinue gabapentin.

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

• skin rash and redness and/or hair loss,
• hives,
• fever,
• persistent swelling of the glands,
• swelling of the lips, face, and tongue,
• yellowing of the skin or whites of the eyes,
• unusual bleeding or bruising,
• severe fatigue or weakness,
• unexpected muscle pain,
• frequent infections.

These symptoms may be early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking gabapentin.

If you are on hemodialysis, inform your doctor if you begin to experience muscle pain and/or weakness.

Other adverse effects include:

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

• viral infection,
• drowsiness, dizziness, lack of coordination,
• feeling tired, fever.

Common: (may affect up to 1 in 10 people)

• pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections,
• low white blood cell count,
• anorexia, increased appetite,
• anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking,
• seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes,
• blurred vision, double vision,
• vertigo,
• 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 or throat, flatulence,
• facial swelling, bruising, rash, itching, acne,
• joint pain, muscle pain, back pain, jerking,
• erection difficulties (impotence),
• swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms,
• decreased white blood cells, weight gain,
• accidental injuries, fractures, abrasions.

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

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

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

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

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

Following the marketing of gabapentin, the following adverse effects have been reported:

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

• decreased platelet count (blood clotting cells),
• hallucinations,
• suicidal thoughts,
• abnormal movement problems such as twisting movements, spasmodic movements, and stiffness,
• ringing in the ears,
• yellowish appearance of skin and eyes (jaundice), liver inflammation,
• acute kidney failure, incontinence,
• increased breast tissue, breast enlargement,
• adverse effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain,
• muscle fiber breakdown (rhabdomyolysis),
• changes in blood test results (increased creatine phosphokinase),
• sexual function problems, such as inability to reach orgasm, delayed ejaculation,
• low sodium levels in blood,
• anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment),
• development of dependence on gabapentin (“drug dependence”).

You should be aware that you may experience certain adverse effects called withdrawal syndrome after stopping short- or long-term treatment with Gabapentina Sandoz (see "If you stop taking Gabapentina Sandoz").

Other possible adverse effects

Soybean lecithin very rarely may cause allergic reactions.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP/CAD. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Sandoz

The active substance is gabapentin.

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

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

The other components are:

Tablet core: macrogol 4000, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.

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

Appearance of the product and contents of the pack

Gabapentin Sandoz 600 mg film-coated tablets:

white, round, film-coated tablets with a cross-shaped score on one side.

Gabapentin Sandoz 800 mg film-coated tablets:

white, oblong, film-coated tablets with a break line on both sides.

The tablets are presented in PVC/aluminum blisters contained in cardboard packaging.

Pack sizes:

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

Note: sample packs are not available in Spain.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Zambon S.p.A.

Via Della Chimica, 9

36100 Vicenza

Italy

or

Salutas Pharma GmbH

Otto-von Guericke Allee 1

39179 Barleben

Germany

or

Laboratorios Medicamentos Internacionales, S. A.

C/Solana, 26, Torrejón de Ardoz,

28850 Madrid

Spain

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:

Belgium: Gabapentin Sandoz 600 mg filmomhulde tabletten
Gabapentin Sandoz 800 mg filmomhulde tabletten

Finland: Gabapentin Sandoz 600 mg tabletti, kalvopäällysteinen
Gabapentin Sandoz 800 mg tabletti, kalvopäällysteinen

France: GABAPENTINE SANDOZ 600 mg, comprimé pelliculé
GABAPENTINE SANDOZ 800 mg, comprimé pelliculé

Netherlands: Gabapentine Sandoz 600 mg filmomhulde tabletten
Gabapentine Sandoz 800 mg filmomhulde tabletten

Sweden: Gabapentin 1A-Farma 600 mg filmdragerade tabletter
Gabapentin 1A-Farma 800 mg filmdragerade tabletter

United Kingdom: Gabapentin Sandoz 600 mg Tablets
Gabapentin Sandoz 800 mg Tablets

Date of the most recent review of this leaflet: July 2025.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/