GABAPENTINE SANDOZ 800 mg FILM-COATED TABLETS

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

Do not take Gabapentina Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before taking Gabapentina Sandoz.

• 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 start to feel muscle pain and/or weakness,
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, inform your doctor immediately, as these may be symptoms of acute pancreatitis (inflammation of the pancreas),

• if you have a nervous system disorder or a respiratory disorder or if you are over 65 years old, your doctor may prescribe a different dose,
• if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; this may mean you have a higher risk of becoming dependent on Gabapentina Sandoz.

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

Dependence

Some people may develop dependence (need to continue 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 becoming dependent on Gabapentina Sandoz, 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 longer 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 the best course of treatment is 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 immediately.

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 leafletin the subsection “Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious”.

Muscle weakness, sensitivity, or pain, and especially if you feel unwell or have a fever, could be due to abnormal breakdown of muscle fibers, which can lead to kidney problems and put your life at risk. You may also experience discoloration of the urine and changes in blood test results (significant increase in creatine phosphokinase in the blood). 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 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), tell 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 indigestion

If you take gabapentin at the same time as antacids that contain aluminum and magnesium, the absorption of gabapentin in the stomach may be reduced. Therefore, it is recommended that gabapentin be taken at least 2 hours after taking an antacid.

Gabapentin:

• 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.

Taking Gabapentina Sandoz with food

Gabapentina Sandoz can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or 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 other medicines used to treat seizures have been reported to increase the risk of harm to the developing baby, particularly when used at the same time as more than one medicine 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 of Gabapentina Sandoz, passes into breast milk. Breastfeeding is not recommended while taking gabapentin, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentin 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 soy lecithin and sodium

This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Gabapentina Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the prescribed dose.

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

Epilepsy, the recommended dose is:

Adults and adolescents:

Take the number of tablets that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased as directed 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 in the evening.

Children aged 6 years and older:

Your doctor will decide the dose to be given to your child based on the child's weight. The 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. The dose is usually given in three equal doses per day, usually one in the morning, one at noon, and one in the evening.

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

Gabapentina Sandoz is not recommended for use in children below 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of tablets that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased as directed 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 in the evening.

If you have kidney problems or are on hemodialysis

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

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

Method of administration

Gabapentina Sandoz is taken orally. Always swallow the tablets whole with a sufficient amount of water.

Continue taking gabapentina until your doctor tells you to stop.

If you take more Gabapentina Sandoz than you should

Doses higher than recommended may cause an increase in side effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

Call your doctor or go to the emergency department of the nearest hospital if you take more gabapentina than your doctor has prescribed. Take any remaining tablets, the packaging, and the leaflet with you so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Sandoz

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

If you stop taking Gabapentina Sandoz

Do not stop taking Gabapentina Sandoz suddenly. If you want to stop taking Gabapentina Sandoz, talk to your doctor first. Your doctor will 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 general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with gabapentina. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any further questions on 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 Sandoz and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief 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).
• expanded rash, high body temperature, and increased lymph node size (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, inflammation of the lips and face, skin rash, and redness, and/or hair loss (these can be symptoms of a severe allergic reaction),
• persistent stomach pain, nausea, and vomiting, as they can be symptoms of acute pancreatitis (inflammation of the pancreas),
• breathing difficulties that, if severe, may require urgent medical attention to breathe 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 can lead to hospitalization or discontinuation of gabapentina.

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

• skin rash,
• hives,
• fever,
• inflammation of the glands that does not disappear,
• swelling of the lips and tongue,
• yellowish color of the skin or 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 severe 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, redness, 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 of discomfort, 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, torso, and extremities,
• abnormal blood test results that may indicate liver problems.
• mental damage,
• fall,
• increased blood glucose levels (more frequently observed in patients with diabetes),
• difficulty swallowing.

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

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

After the marketing of gabapentina, the following adverse effects have been reported:

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

• decrease in platelet count (blood coagulation cells),
• hallucinations,
• suicidal thoughts,
• abnormal movement problems such as contortions, spasmodic movements, and rigidity,
• 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 sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain,
• muscle fiber rupture (rhabdomyolysis),
• changes in blood test results (increased creatine phosphokinase),
• problems with sexual activity, such as inability to reach orgasm, delayed ejaculation,
• low sodium levels in the blood
• anaphylaxis (severe, potentially life-threatening allergic reaction that includes difficulty breathing, swelling of the lips, throat, and tongue, 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 Sandoz (see "If you stop taking Gabapentina Sandoz").

Other possible adverse effects

Very rarely, soy lecithin can cause allergic reactions.

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 leaflet. 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 and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Sandoz

The active ingredient is gabapentina.

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

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

The other ingredients are:

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

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

Appearance of the Product and Package Contents

Film-coated tablet.

Gabapentina Sandoz 600 mg film-coated tablets:

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

Gabapentina Sandoz 800 mg film-coated tablets:

are white, capsule-shaped film-coated tablets.

The tablets are presented in PVC/aluminum blisters included in cardboard boxes.

Package sizes:

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

Note: Samples are not applicable in Spain.

Only some 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

Zambon S.p.A.

Via Della Chimica, 9

36100 Vicenza

Italy

or

Salutas Pharma GmbH

Otto-von Guericke Allee 1

39179 Barleben

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with 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 last revision of this leaflet:February 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/