GABAPENTINE TEVA 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina Teva 100 mg Hard Capsules EFG

gabapentina

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 Gabapentina Teva is and what it is used for.
2. What you need to know before you take Gabapentina Teva.
3. How to take Gabapentina Teva.
4. Possible side effects.
5. Storing Gabapentina Teva.
6. Pack contents and further information

1. What Gabapentina Teva is and what it is used for

Gabapentina Teva 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 Gabapentina Teva is gabapentina.

Gabapentina Teva is used to treat:

• Certain types of epilepsy (seizures that initially are limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe Gabapentina Teva for you or your child aged 6 years or older to help treat epilepsy when your current treatment is no longer controlling the condition. You or your child aged 6 years or older should take gabapentina in combination with your current treatment unless told otherwise. Gabapentina Teva 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 legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing, shooting, stabbing, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

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

Do not take Gabapentina Teva

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentina Teva

• if you have kidney problems, your doctor may prescribe a different dosing schedule.
• 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, feel dizzy or faint, 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 medicine, inform your doctor 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 gabapentina.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentina. They may experience withdrawal symptoms when they stop taking gabapentina (see section 3, "How to take Gabapentina Teva" and "If you stop taking Gabapentina Teva"). If you are concerned about becoming dependent on gabapentina, it is important that you talk to your doctor.

If you experience any of the following signs while taking gabapentina, it may indicate that you have developed 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 your prescription.
• 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 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 being treated with antiepileptics such as gabapentina have had thoughts of self-harm or 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 gabapentina, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina 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 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 it 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.

Using Gabapentina Teva with other medicines

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 medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medicines containing opioids such as morphine

If you are taking any medicines that contain opioids (such as morphine), inform your doctor or pharmacist, as opioids can increase the effect of Gabapentina Teva.

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

Antacids for indigestion

If you take Gabapentina Teva at the same time as antacids that contain aluminum or magnesium, the absorption of Gabapentina Teva in the stomach may be reduced. It is therefore recommended that Gabapentina Teva be taken at least 2 hours after taking an antacid.

Gabapentina Teva

• It 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 that you are taking Gabapentina Teva.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, you must inform your doctor immediately to assess the possible risks that the medicine you are taking may pose to the fetus.
• Do not stop your treatment without first consulting your doctor.
• 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 planning to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

If you are planning 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 important that you do not stop taking your medicine without first consulting your doctor, as this may worsen your condition. Worsening of your epilepsy may put both you and your unborn baby at risk.

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

If taken during pregnancy, gabapentina may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid analgesics (drugs for treating intense pain).

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

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina Teva may cause dizziness, drowsiness, and fatigue. You should 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.

3. How to take Gabapentina Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with 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 capsules 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 then on, the dose may be increased, under medical supervision, 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 in the evening.

Children aged 6 years and over

Your doctor will decide the dose to give to your child based on the child's weight. Treatment will begin with a low initial dose that will be gradually increased over approximately 3 days. The usual dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually given by taking the capsules, divided into 3 separate doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentina Teva is not recommended for 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. 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 then on, the dose may be increased, under medical supervision, 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 if you are on hemodialysis

Your doctor may prescribe a different dosing schedule and/or different doses 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 Gabapentina Teva, unless you have kidney problems. Your doctor may prescribe a different dosing schedule or different doses if you have kidney problems.

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

Method of administration

Gabapentina Teva is taken by mouth.

Always 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 side 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 Toxicology Information Service, phone: 91 562 04 20, if you have taken more Gabapentina Teva than your doctor prescribed, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital if you take more gabapentina Teva than your doctor prescribed. Bring any unused capsules, along with the packaging and leaflet, so that the hospital can easily identify the medicine 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 your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Gabapentina Teva

Do not stop taking Gabapentina Teva suddenly. If you want to stop taking Gabapentina Teva, talk to your doctor first. Your doctor will tell you 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 side effects, called withdrawal symptoms, after stopping treatment with Gabapentina Teva after short or long-term use. 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 Gabapentina Teva. 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 gabapentin and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief with a target 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and enlarged 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:

• persistent stomach pain, vomiting, and nausea, as they can be symptoms of acute pancreatitis (inflammation of the pancreas)
• breathing difficulties that, if severe, may require emergency medical attention to breathe normally.
• Gabapentina Teva 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 Teva or even hospitalization.

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

• skin rash and redness and/or hair loss
• hives
• fever
• inflammation of the glands that does not disappear
• swelling of the lip, face, and tongue
• yellowing of the skin or whites of the eyes
• bruises or unusual bleeding
• severe fatigue or weakness
• unexpected muscle pain
• frequent infections

These symptoms may be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking Gabapentina Teva.

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

Other adverse effects include

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

• viral infection
• feeling of drowsiness, dizziness, discoordination
• feeling of fatigue, fever

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

• pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear or other infections
• low white blood cell count
• anorexia, increased appetite
• irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• seizures, tremors, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, 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
• difficulty breathing, bronchitis, sore throat, cough, dry nose
• vomiting (feeling nauseous), nausea (feeling dizzy), 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, spasms
• 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

Additionally, in clinical trials in children, the following frequent adverse effects were reported:

sudden movements and aggressive behavior

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

• agitation (a state of chronic restlessness and involuntary, purposeless movements).
• allergic reaction such as hives.
• decreased movement.
• accelerated heart rate
• difficulty swallowing
• swelling that can affect the face, trunk, and extremities
• 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 adverse 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 difficulties, shallow breathing (respiratory depression)

The following adverse effects have been reported since the marketing of the medicine:

• decreased platelet count (blood clotting cells)
• suicidal thoughts, hallucinations
• problems with abnormal movements 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.
• 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, 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 adverse effects, called withdrawal syndrome, after interrupting short- or long-term treatment with Gabapentina Tevagen (see "If you stop taking Gabapentina Teva").

Reporting 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 Teva

Keep this medicine out of sight and reach of children.

Do not use this medicine 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.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of 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 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 body/shell: Gelatin, Black iron oxide (E172), Titanium dioxide (E171), Printing ink: Shellac, Black iron oxide (E172), Propylene glycol.

Appearance of the product and package contents.

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

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

Package size: 90 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas. Madrid

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA PHARMA B.V.

Industrieweg 23, P.O. Box 217

Michdrecht Netherlands.

or

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

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

Norway: Gabapentin TEVA 100 mg hard capsule

Spain: Gabapentina Teva 100 mg Capsules

Date of the last revision of this prospectus: June 2024

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