GABAPENTINE SANDOZ 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

GabapentinSandoz300 mg Hard Capsules EFG

GabapentinSandoz400 mg Hard Capsules EFG

gabapentin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Gabapentin Sandoz is and what it is used for
2. What you need to know before you take Gabapentin Sandoz
3. How to take Gabapentin Sandoz
4. Possible side effects
5. Storage of 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 (long-lasting pain caused by damage to the nerves).

The active substance in Gabapentin Sandoz is gabapentin.

Gabapentin Sandoz is used to treat:

Certain types of epilepsy(seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe gabapentin for you or your child aged 6 years or older to help treat epilepsy when the current treatment is not fully controlling the condition. You or your child aged 6 years or older should take gabapentin in addition to the current treatment unless otherwise indicated. Gabapentin can also be given as the only medicine in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain(long-lasting pain caused by damage to the nerves). There are various diseases that can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing pain, shooting pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and a feeling of pins and needles, etc.

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

Do not takeGabapentinaSandoz

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

Warnings and precautions

Consult your doctor or pharmacist before taking gabapentin:

• if you have kidney problems, your doctor may prescribe a different dosage 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, 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 dosage regimen,
• if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of developing dependence on gabapentin.

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 continue taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentin Sandoz" and "If you stop taking Gabapentin Sandoz"). If you are concerned about developing dependence on gabapentin, it is important that you consult your doctor.

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

• You feel that you need to take the medicine for a longer period than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medicine for reasons other than its prescription.
• You have tried to stop taking the medicine or control how you take it several times 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 what is 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 antiepileptics such as gabapentin have had thoughts of harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

Important information about potentially serious reactions

Severe skin reactions 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 medical attention immediately if you notice any of the symptoms related to these serious 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 on palpation, and especially if you feel unwell or have a fever, could be due to abnormal muscle fiber breakdown, 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 blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently taken 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 can cause symptoms such as drowsiness and/or decreased breathing.

Antacids for digestion

If you take gabapentin at the same time as antacids that contain aluminum or 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.

Gabapentina Sandoz:

• is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill,
• may interfere with some laboratory tests, so if you need a urine test, inform your doctor or hospital about what you are taking.

TakingGabapentinaSandozwith 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take gabapentin during pregnancy, unless your doctor has told you to. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but with other medicines used to treat seizures, there have been reports of an increased risk of harm to the developing baby, particularly when more than one medicine is used to treat seizures. If you take gabapentin during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken with opioid analgesics (drugs for treating intense pain). Therefore, whenever possible, you should try to take only one medicine for seizures during pregnancy and only under the advice of your doctor.

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 suddenly, as this may cause seizures to return, which could have serious consequences for you and your baby.

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina Sandoz can cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous 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, which is essentially "sodium-free".

3. How to take Gabapentina Sandoz

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not take a higher dose than prescribed.

Your doctor will determine the dose that is right for you.

Epilepsy, the recommended dose is:

Adults and adolescents:

Take the number of capsules that your doctor has told you to. Normally, your doctor will gradually increase your dose.

The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, 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 of age or older:

Your doctor will decide the dose to be given to your child based on the child's weight.

Treatment will begin 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. The usual dose is administered by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one at night.

The use of gabapentin is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of capsules that your doctor has told you to. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, 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 on hemodialysis

Your doctor may prescribe a different dosage regimen and/or a different dose if you have kidney problems or if you are on 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 dosage regimen or a different dose if you have kidney problems.

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

Method of administration

Gabapentin is administered orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking gabapentin until your doctor tells you to stop.

If you take moreGabapentinaSandozthan you should

Doses higher than recommended may lead to an increase in side 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 Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital. Bring any capsules that you have not taken, along with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to takeGabapentinaSandoz

If you forget 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 make up for forgotten doses.

If you stop takingGabapentinaSandoz

Do not stop taking gabapentin suddenly. If you want to stop taking gabapentin, talk to your doctor first. Your doctor will tell you how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should be aware that you may experience certain side effects, called withdrawal syndrome, after stopping short-term or long-term treatment with gabapentin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with gabapentin. If you experience this withdrawal syndrome, you should 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 all people suffer from them.

Stop taking gabapentina and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief and with a target or circular shape on the torso, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread rash, high body temperature, and swelling of the lymph nodes (DRESS or drug hypersensitivity syndrome).

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious:

• severe skin reactions that require immediate attention, lip and face swelling, skin rash, and redness, and/or hair loss (can be symptoms of a severe allergic reaction),
• persistent stomach pain, vomiting, and nausea, as these can be symptoms of acute pancreatitis (inflammation of the pancreas),
• respiratory problems, which if severe may require emergency intensive care to continue breathing normally,
• gabapentina 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. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization. Contact your doctor immediately if you have any of the following symptoms:
• skin rash,
• hives,
• fever,
• swelling of the glands that does not disappear,
• swelling of the lips and tongue,
• yellowish color of the skin or the whites of the eyes,
• unusual bleeding or bruising,
• severe fatigue or weakness,
• unexpected muscle pain,
• frequent infections.

These symptoms can be the first signs of a serious reaction. You should be examined by a doctor to decide if you should continue taking gabapentina.

If you are on hemodialysis, inform your doctor if you start to feel 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,
• fatigue, 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 towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking,
• seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), difficulty with coordination, unusual eye movements, increased, decreased, or absent reflexes,
• blurred vision, double vision,
• vertigo,
• increased blood pressure, flushing, or dilation of blood vessels,
• breathing difficulties, bronchitis, sore throat, cough, runny 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, tremors,
• difficulty with erection (impotence),
• swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms,
• decreased white blood cell count, weight gain,
• accidental injuries, fractures, abrasions.

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent 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,
• accelerated heart rate,
• swelling that can affect the face, trunk, and extremities,
• abnormal blood test results that may indicate liver problems,
• progressive mental damage,
• falls,
• 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,
• respiratory problems, shallow breathing (respiratory depression).

After marketing, the following adverse effects have been reported:

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

• decrease in platelet count (blood clotting cells),
• hallucinations,
• suicidal thoughts,
• abnormal movement problems such as contortions, spasmodic movements, and rigidity,
• ringing in the ears,
• yellowish appearance of the skin and eyes (jaundice), liver inflammation,
• acute kidney failure, incontinence,
• increase in breast tissue, breast enlargement,
• adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain,
• muscle fiber rupture (rhabdomyolysis),
• changes in blood test results (elevated creatine phosphokinase),
• problems with sexual activity, such as inability to reach orgasm and delayed ejaculation,
• low sodium levels in the blood,
• anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, lip, throat, and tongue swelling, and hypotension that requires urgent treatment),
• developing dependence on gabapentina ("drug dependence").

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gabapentina Sandoz

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

Do not use this medicine after 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: Store in the original packaging to protect it from moisture.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Sandoz

• The active ingredient is gabapentina.

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

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

Appearance of Gabapentina Sandoz and Package Contents

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

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

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

Package sizes:

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

Bottle: 50 and 100 hard capsules.

Not all package 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

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

or

Lek S.A.

Ul. Domaniewska 50 C,

02-672 Varsovia

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 medicine 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 hard capsules

Gabapentine Sandoz 400 mg hard capsules

Czech Republic: Gabanox 300 mg tvrdé tobolky

Gabanox 400 mg tvrdé 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

Gabapentin 400 mg Capsules

Date of the last revision of this prospectus:May 2023

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