Leaflet: information for the user

Gabapentina Stada 600 mg film-coated tablets

Gabapentina Stada 800 mg film-coated tablets

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 you must not give it 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. How to take Gabapentina Stada
2. Possible side effects
3. Storage of Gabapentina Stada

6.Contents of the pack and additional information

Gabapentina Stada belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by a nerve injury).

The active ingredient of Gabapentina Stada is gabapentin.

Gabapentin is used to treat:

• Various forms of epilepsy (seizures initially limited to certain parts of the brain, although the seizures may spread or not to other parts of the brain). Your doctor will prescribe gabapentin to help you treat the epilepsy you have when your current treatment does not completely control your condition. You should take gabapentin in addition to your current treatment, unless otherwise indicated. Gabapentin can also be used as a single medication to treat adults and children over 12 years old.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). There are various diseases that can cause peripheral neuropathic pain (which occurs mainly in the legs, arms, or both), such as diabetes or herpes. The pain sensation can be described as heat, burning, pulsating pain, stabbing pain, sharp pain, acute pain, spasms, continuous pain, tingling, numbness, and a sensation of pinpricks, etc.

Do not take Gabapentina Stada

• If you are allergic to gabapentin, soy, peanuts, or any of the other components of this medication. (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take gabapentin

• If you have kidney problems, your doctor may prescribe a different dosing regimen.
• If you are on hemodialysis (for waste removal due to renal insufficiency), 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 they may be symptoms of acute pancreatitis (inflamed 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.

A small number of people taking antiepileptic medications like gabapentin have had thoughts of harming themselves or suicide. If you ever have these thoughts, consult your doctor immediately.

Before taking this medication, inform your doctor if you have ever abused or been dependent on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing gabapentin dependence.

Dependence

Some people may develop dependence (need to continue taking the medication) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Stada" and "If you interrupt treatment with Gabapentina Stada"). If you are concerned about developing dependence on gabapentin, it is essential 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 the need to take the medication for a longer period than prescribed.

- You feel the need to take a higher dose than recommended.

- You are taking the medication for reasons other than your prescription.

- You have tried several times to stop taking the medication or control how you take it, without success.

- When you stop taking the medication, you feel unwell 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.

Important information about potentially serious reactions

Severe skin reactions associated with gabapentin use have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Muscle weakness, sensitivity, or pain, especially if you also feel unwell or have a fever, could be due to an abnormal muscle rupture that can be potentially fatal and may lead to kidney problems. You may also experience urine discoloration, 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 medications and Gabapentina Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Especially, inform your doctor (or pharmacist) if you are taking or have taken recently any medication for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medications containing opioids such as morphine

If you are taking any medication containing opioids (such as morphine), inform your doctor or pharmacist as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids may cause symptoms such as drowsiness and/or decreased breathing.

Antacids for indigestion

If you take gabapentin at the same time as antacids containing aluminum and 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 Stada

- Gabapentin is not expected to interact with other antiepileptic medications or the birth control pill.

- Gabapentin may interfere with some laboratory tests, if you need a urine test, inform your doctor or the hospital that you are taking gabapentin.

Taking Gabapentina Stada with food

Gabapentin can 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 medication.

Pregnancy

Gabapentin should not be taken during pregnancy, unless your doctor advises otherwise. Women of childbearing age should use an effective contraceptive method.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medications used to treat seizures, an increased risk of damage to the developing fetus has been reported, particularly when more than one medication is used to treat seizures. Therefore, whenever possible, try to take only one medication 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 gabapentin.

Do not stop taking this medication abruptly as this may cause a seizure, which could have serious consequences for you and your baby.

If taken during pregnancy, gabapentin may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medications).

Breastfeeding

Gabapentin, the active ingredient in Gabapentina Stada, passes into breast milk. As the effect on the baby is unknown, it is not recommended to breastfeed while taking gabapentin.

Fertility

No effects on fertility have been observed in animal studies.

Driving and operating machinery

Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, operate complex machines, or perform potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Gabapentina Stada contains soy lecithin

If you are allergic to peanuts or soy, do not take this medication.

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 quantity of medication higher than the prescribed one.

Your doctor will decide what is the most suitable 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 between 300 to 900 mg per day. From there, the dose may 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 at noon, 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 that will be gradually increased over a period of approximately 3 days. The normal dose for controlling epilepsy is between 25-35 mg per kg per day. The dose is usually administered by taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, 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 as prescribed by your doctor. Generally, your doctor will gradually increase the dose. The initial dose will generally be between 300 to 900 mg per day. After that, the dose may be increased, following your doctor's instructions, up to a maximum of 3,600 mg per day, and your doctor will tell you to take this dose in 3 separate doses, that is, one in the morning, one in the afternoon, and one at night.

If you have kidney problems or are being hemodialyzed

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems or are being hemodialyzed.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of gabapentin, except if you have kidney problems. Your doctor may prescribe another dosing regimen or different doses 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.

Administration form

Gabapentin is for oral use. Swallow the capsules whole, with plenty of water. Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentina Stada than you should

Doses higher than recommended may cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospital if you take more gabapentin than your doctor prescribed. 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 take Gabapentina Stada

If you forgot 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 compensate for the missed doses.

If you interrupt the treatment with Gabapentina Stada

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 doubts 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 these symptoms:

• flat red patches with a target-like or circular shape on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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)

• severe skin reactions that require immediate attention, swelling of the lips and face, rash, and/or redness, and/or hair loss (may be symptoms of a severe allergic reaction)

• persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas)

• gabapentin may cause a severe or potentially life-threatening allergic reaction that can affect your skin or other parts of your body, such as the liver or blood cells. While you are experiencing this type of reaction, you may or may not have a rash. This reaction may require hospitalization or withdrawal of gabapentin treatment. Call your doctor immediately if you have any of the following symptoms:

• fever

• swollen lymph nodes, which do not subside

• swelling of the lips and tongue

• yellowing of the skin or white of the eyes

• unusual bruising or bleeding

• severe fatigue or weakness

• unexpected muscle pain

• frequent infections

These symptoms may be the first signs of a severe reaction. A doctor should examine you and decide if you should continue taking gabapentin.

• if you are on hemodialysis, inform your doctor if you experience muscle pain, weakness, or both.
• breathing problems that, if severe, may require emergency medical attention to breathe normally.

Other side effects may include the following:

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):

• Respiratory tract infections, pneumonia, urinary tract infections, ear inflammation, and other infections.
• Decreased white blood cell count.
• Loss of appetite, increased appetite.
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasms, difficulty speaking, memory loss, tremors, difficulty sleeping, headaches, sensitive skin, numbness, coordination difficulties, 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, nasal dryness.

• Vomiting, nausea, dental problems, gum inflammation, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence.

• Facial swelling, petechiae, rash, itching, acne.

• Joint pain, muscle pain, back pain, tics.

• Difficulty achieving erection (impotence).

• Swelling of the legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms.

• Decreased white blood cell count, weight gain.

• Accidental injury, fracture, abrasion.

Additionally, in clinical studies conducted with children, aggressive behavior and spasmodic movements have been frequently reported.

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

• allergic reaction, such as hives.

• Decreased movement.

• Increased heart rate.

• Swelling that may affect the face, trunk, and limbs.

• Abnormal blood test results suggesting liver problems.
• Progressive mental damage.
• Fall.
• Increased blood glucose levels (observed more frequently in patients with diabetes).
• Agitation (a chronic state of restlessness and involuntary, purposeless movements).
• Difficulty swallowing.

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

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

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

• Developdependence on gabapentin (“drug dependence”).

After stopping a short- or long-term treatment with gabapentin, you should know that you may experience certain side effects, known as withdrawal symptoms (see “If you stop taking Gabapentin Stada”).

Other possible side effects

In rare cases, soybean-derived unsaturated phospholipids may cause allergic reactions.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, 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 medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Gabapentina Stada

The active ingredient is gabapentin. Each film-coated tablet contains 600 mg or 800 mg of gabapentin.

The other components of the tablets are:

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

Coating: poly(vinyl alcohol), titanium dioxide (E171), talc, soy lecithin, xanthan gum.

Appearance of the product and contents of the package

Film-coated tablet.

The 600 mg film-coated tablets are white, capsule-shaped, and film-coated, with a logo (600) engraved on one side.

The 800 mg film-coated tablets are white, capsule-shaped, and film-coated.

They are supplied in PVC/aluminium blisters of:

10 film-coated tablets.

20 film-coated tablets.

30 film-coated tablets.

40 film-coated tablets.

50 film-coated tablets.

60 film-coated tablets.

90 film-coated tablets.

100 film-coated tablets.

120 film-coated tablets.

200 film-coated tablets.

They may only be marketed in some package sizes.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Centrafarm B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

GermanyGabapentin AL 600mg Filmtabletten

Gabapentin AL 800mg Filmtabletten

SpainGabapentina Stada 600 mg film-coated tablets EFG

Gabapentina Stada 800 mg film-coated tablets EFG

FranceGABAPENTINE EG LABO 600mg, coated tablet

GABAPENTINE EG LABO 800mg, coated tablet

NetherlandsGabapentine CF 600mg, film-coated tablets

Gabapentine CF 800mg, film-coated tablets

Last review date of this leaflet:March 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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