Leaflet: information for the user

Gabapentin Teva 100 mg hard capsules EFG

gabapentin

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 should not be given 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. What is Gabapentin Teva and what it is used for.

2. What you need to know before starting to take Gabapentin Teva.

3. How to take Gabapentin Teva.

4. Possible side effects.

5. Storage of Gabapentin Teva.

6. Contents of the pack and additional information

Gabapentina Teva belongs to a group of medications used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active ingredient in Gabapentina Teva is gabapentin.

Gabapentina Teva is used to treat:

• Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child aged 6 years or older will prescribe Gabapentina Teva to help treat epilepsy when your current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentin in combination with current treatment unless otherwise indicated. Gabapentina Teva can also be administered as a single medication in the treatment of 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 (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, tingling, numbness, and pins and needles etc.

Do not take Gabapentina Teva

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina Teva

• 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, feel dizzy or nauseous, contact your doctor immediately, as these 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.
• before taking this medication, inform your doctor if you have ever abused or had dependence on alcohol, prescribed medications, or illegal drugs; you may have a higher risk of developing dependence on gabapentin.

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 Teva" and "If you interrupt treatment with Gabapentina Teva"). 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 time 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.

A small number of people taking antiepileptic medications like gabapentin have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.

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.

Read the description of severe symptoms in section 4 of this leaflet“Contact your doctor immediately if you experience any of the following symptoms after taking this medication, as they may be serious”.

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle fibers, which may 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 the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of Gabapentina Teva with other medications

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 may increase the effect of Gabapentina Teva.

Additionally, the combination of Gabapentina Teva with opioids may cause symptoms such as drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

If you take Gabapentina Teva at the same time as antacids containing aluminum or magnesium, the absorption of Gabapentina Teva in the stomach may be reduced.It is recommended that Gabapentina Teva be taken at least two hours after taking an antacid.

Gabapentina Teva

• No interaction with other antiepileptic medications or oral contraceptives is expected.
• Gabapentina Teva may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital that you are takingGabapentina Teva.

Pregnancy, breastfeeding, and fertility

•If you are pregnant or think you may be pregnant, you must inform your doctor immediately to analyze the possible risks that the medication you are taking may represent for the fetus.

•You should not interrupt your treatment without consulting your doctor first.

•If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.

If you are breastfeeding or are planning to breastfeed, consult your doctor or pharmacist before taking this medication.

Pregnancy

Gabapentina Teva can be used during the first trimester of pregnancy if necessary.

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

If you become pregnant and have epilepsy, it is essential not to stop taking your medication without consulting your doctor first, as this may worsen your condition. The worsening of your epilepsy may put both you and your unborn baby at risk.

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

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

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina Teva.Do not stop taking this medication abruptly, as this may cause an anticipation of seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient in Gabapentina Teva, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Teva, as the effect on infants is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and operating machinery

Gabapentina Teva may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

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 determine what dose is suitable 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, under medical prescription, up to a maximum dose of 3600 mg per day, divided into three separate 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 25-35mg/kg/day. The dose is normally administered by taking the capsules, divided into 3 separate doses per day, usually one in the morning, one at noon, and one at night.

It is not recommended to use Gabapentina Teva in children under 6 years old.

Peripheral neuropathic pain, the recommended dose is

Adults

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 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 receiving hemodialysis treatment

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

If you are an elderly patient (over 65 years old)

You should take the normal dose of Gabapentina Teva, except if you have kidney problems. Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

If you consider that the effect of Gabapentina Teva is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina Teva is administered orally.

Swallow the capsules whole with a sufficient amount of water.

Gabapentina Teva can be taken with or without food.

Continue taking Gabapentina Teva until your doctor tells you to stop.

If you take more Gabapentina Teva than you should

Doses higher than recommended may cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, 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 if you have taken more Gabapentina Teva than your doctor prescribed, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospital if you take more gabapentina Teva 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 forget to take Gabapentina Teva

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 compensate for the missed doses.

If you interrupt the treatment with Gabapentina Teva

Do not stop taking Gabapentina Teva abruptly. If you want to stop taking Gabapentina Teva, 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 Gabapentina Teva. 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 treatment with Gabapentina Teva. 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 the following symptoms:

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

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

• persistent stomach pain, vomiting, and nausea, which may be symptoms of acute pancreatitis (inflammation of the pancreas).
• breathing problems that, if severe, may require emergency medical attention to breathe normally.
• Gabapentin Teva may 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. There may or may not be a rash when this type of reaction occurs. This may require stopping Gabapentin Teva or even hospitalization.

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

• skin rash and redness and/or hair loss.
• urticaria.
• fever.
• swollen glands that do not subside.
• swelling of the lips, face, and tongue.
• yellow discoloration of the skin or white of the eyes.
• bruises or bleeding or unusual.
• severe fatigue or weakness.
• unexpected muscle pain.
• frequent infections.

These symptoms may be the first signs of a severe reaction. You should have a doctor examine you to decide if you should continue taking Gabapentin Teva.

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

Other side effects include

Very common side effects (may affect more than 1 in 10 patients):

• viral infection.
• drowsiness, dizziness, discoordination.
• feeling tired, fever.

Common side effects (may affect up to 1 in 10 patients):

• bronchitis, respiratory infection, urinary tract infection, infection, ear inflammation, or other infections.
• low white blood cell count.
• loss of appetite, increased appetite.
• irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• convulsions, tremors, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, numbness, coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes.
• blurred vision, double vision.
• dizziness.
• high blood pressure, redness or dilation of blood vessels.
• difficulty breathing, bronchitis, sore throat, cough, dry nose.
• vomiting (feeling dizzy), nausea (feeling dizzy), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence.
• swelling of the face, hives, rash, acne.
• joint pain, muscle pain, back pain, spasms.
• erectile dysfunction.
• swelling in the legs and arms, difficulty walking, weakness, pain, discomfort, flu-like symptoms.
• low white blood cell count, weight gain.
• accidents, fractures, bruises.

Additionally, in clinical trials in children, the following side effects were reported as common:

brusque movements and aggressive behavior.

Uncommon side effects (may affect up to 1 in 100 patients):

• agitation (a chronic state of restlessness and involuntary, purposeless movements).
• allergic reaction such as urticaria.
• decreased movement.
• accelerated heart rate.
• difficulty swallowing.
• swelling that can affect the face, trunk, and limbs.
• abnormal blood test results suggesting liver problems.
• progressive mental damage.
• falls.
• increased blood glucose levels (observed more frequently in patients with diabetes).
• difficulty swallowing.

Rare side effects (may affect up to 1 in 1,000 patients):

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

Since the marketing of the medicine, the following side effects have been reported:

• decreased platelets (blood clotting cells).
• suicidal thoughts, hallucinations.
• abnormal movements such as: contortions, spasmodic movements, and rigidity.
• tinnitus in the ears.
• yellow discoloration of the skin and eyes (jaundice), liver inflammation,
• acute kidney failure, incontinence.
• breast tissue enlargement, breast enlargement.
• muscle fiber rupture (rhabdomyolysis).
• changes in blood test results (elevated creatine phosphokinase).
• sexual activity problems, such as the inability to achieve orgasm and delayed ejaculation.
• low sodium levels in the blood.
• anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).
• developing dependence on gabapentin ("drug dependence").

You should know that you may experience certain side effects, called withdrawal syndrome, after interrupting a short or long-term treatment with Gabapentin Teva (see "If you stop taking Gabapentin Teva").

Reporting 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 after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gabapentina Teva

• The active ingredient is gabapentin. Each hard capsule contains 100 mg of gabapentin.

• The other components of Gabapentina Teva 100 mg capsules are: Talc, Pregelatinized cornstarch, Capsule shell / body: Gelatin, Iron oxide black (E172), Titanium dioxide (E171), Printing ink: Shellac, Iron oxide black (E172), Propylene glycol.

Appearance of the product and contents of the packaging.

Hard gelatin capsule with a grey body and cap, containing a white to off-white powder with small aggregates.

The cap and body of the capsule are marked with the numbers ‘93’ and ‘38’.

Packaging size: 90 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas. Madrid

Responsible for manufacturing:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA PHARMA B.V.

Industrieweg 23, P.O. Box 217

Michelsteen Netherlands.

or

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

This medicine has been authorized in member states under the following names:

Norway:Gabapentin TEVA 100 mg hard capsule

Spain:Gabapentina Teva 100 mg Capsules

Last review date of this leaflet: June 2024

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