Gabapentin Sandoz 300 mg hard capsules EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Gabapentin Sandoz 300 mg hard capsules EFG

Gabapentin Sandoz 400 mg hard capsules 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 must not be given to other people, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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 in Gabapentin Sandoz is gabapentin.

Gabapentin Sandoz 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 your child's doctor (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 addition to your current treatment, unless otherwise instructed by your doctor. Gabapentin may also be used as monotherapy in the treatment of adults and children over 12 years of age.

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

2. What you need to know before taking Gabapentina Sandoz

Do not take Gabapentina Sandoz

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

Warnings and precautions

Talk to your doctor or pharmacist before taking gabapentin:

• if you have kidney problems, your doctor may prescribe a different dosing regimen,
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor if you experience muscle pain and/or weakness,
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, tell your doctor immediately, as these may be signs of acute pancreatitis (inflamed pancreas),
• if you have nervous system disorders, respiratory disorders, or are over 65 years of age, your doctor may prescribe a different dosing regimen,
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on gabapentin.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Sandoz" and "If you stop taking Gabapentina Sandoz"). If you are concerned about becoming dependent on gabapentin, it is important 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 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, speak with 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 as soon as possible.

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 rash 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: "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 on palpation—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and may be life-threatening. You may also experience discoloration of urine and changes in blood test results (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 conditions.

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 digestion

If you take gabapentin at the same time as antacids containing aluminium or 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.

Gabapentina Sandoz:

• is not expected to interact with other antiepileptic medicines or with oral contraceptive pills,
• may interfere with certain laboratory tests; therefore, 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 to the unborn baby can be evaluated.
• 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 are planning 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 ingredient in Gabapentina Sandoz, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Sandoz, as the effect on the baby is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentina Sandoz may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether 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, i.e., essentially "sodium-free".

3. How to take Gabapentin Sandoz

Follow exactly the administration instructions for this medicine as indicated 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.

Epilepsy, the recommended dose is:

Adults and adolescents:

Take the number of capsules indicated by your doctor. 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 at midday, and one at night.

Children aged 6 years and older:

Your doctor will decide the dose to administer to 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/kg/day. This dose is normally administered by taking the capsules in three equal doses per day, usually one in the morning, one at midday, and one at night.

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 capsules indicated by your doctor. 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 at midday, and one at night.

If you have kidney problems or are receiving hemodialysis treatment

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 is administered orally. Always swallow the capsules 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department. Bring any capsules you have not taken, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Sandoz

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

If you stop taking Gabapentin Sandoz

Do not stop taking gabapentin suddenly. If you wish to stop taking gabapentin, 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 sensation, 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 gabapentin and seek immediate medical attention if you notice any of the following symptoms:

• red, flat, target-shaped or circular patches on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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 signs of a severe allergic reaction),
• persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas),
• breathing problems, which in severe cases may require emergency intensive 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 in this type of reaction. This may require discontinuation of gabapentin or even hospitalization. Contact your doctor immediately if you experience any of the following symptoms:
• skin rash and redness and/or hair loss,
• hives,
• fever,
• swollen glands that do not go away,
• 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,
• irritability, 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 problems, unusual eye movements, increased, decreased, or absent reflexes,
• blurred vision, double vision,
• dizziness,
• increased blood pressure, flushing 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 leukocytes, 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,
• increased heart rate,
• swelling affecting the face, trunk, and limbs,
• abnormal blood test results that may indicate liver problems,
• progressive 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 marketing, 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,
• movement disorders such as twisting movements, spasmodic movements, and stiffness,
• ringing in the ears,
• yellow appearance of the 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 (elevated creatine phosphokinase),
• sexual dysfunction, such as inability to achieve orgasm and delayed ejaculation,
• low sodium levels in the 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 known as withdrawal syndrome after stopping short- or long-term treatment with gabapentin (see "If you stop taking Gabapentin Sandoz").

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 after "CAD/EXP". The expiry date refers to the last day of the month indicated.

Store below 25°C.

Blister packs: Keep in the original packaging to protect from moisture.

Bottle: Keep the bottle tightly closed to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located in the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina Sandoz

• The active substance is gabapentin.

Each hard capsule contains 300 mg or 400 mg of gabapentin.

• The other components are:
  • Capsule contents: pregelatinized corn starch, corn starch, talc and colloidal anhydrous silica.
  • Capsule shell: composed of gelatin, sodium lauryl sulfate, colored with titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172) (only in the 400 mg capsules).

Appearance of Gabapentina Sandoz and contents of the pack

Gabapentina Sandoz 300 mg are hard gelatin capsules with opaque yellow body and cap.

Gabapentina Sandoz 400 mg are hard gelatin capsules with opaque brown body and cap.

The hard capsules are packed in PVC/PE/PVDC//Alu blisters or in HDPE bottles with child-resistant closure, contained within a cardboard carton.

Pack sizes:

Blister: 20, 30, 50, 60, 90, 100, 120, 200 and 500 hard capsules.

Bottle: 50 and 100 hard capsules.

Only some pack sizes may be commercially available.

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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

or

Lek S.A.

Ul. Domaniewska 50 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 - 1526 Ljubljana

Slovenia

or

Lek Pharmaceutical d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under 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 mg tvrde tobolky

Gabanox 400 mg tvrde tobolky

Denmark: Gabapentin Sandoz 300 mg hårde kapsler

Finland: Gabapentin Sandoz 300 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

(Northern Ireland) Gabapentin 400 mg Capsules

Date of the most recent revision of this leaflet: June 2025

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