GABAPENTINE TEVA 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gabapentina Teva 600 mg film-coated tablets EFG

Contents of the pack

1. What is Gabapentina Teva and what is it used for
2. What you need to know before you take Gabapentina Teva
3. How to take Gabapentina Teva
4. Possible side effects
5. Storage of Gabapentina Teva
6. Contents of the pack and other information

1. What is Gabapentina Teva and what is it 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 of Gabapentina Teva is gabapentin.

Gabapentina Teva 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 Gabapentina Teva for you or your child aged 6 years or older to help treat epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with your current treatment unless told otherwise. 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 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 gabapentin 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 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 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.
• 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 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.

A small number of people being treated with antiepileptics such as gabapentin have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

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 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 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 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 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 it may be serious".

Muscle weakness, tenderness, or pain on palpation, 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 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 using, have recently used, or might use 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 using any medicine containing morphine, inform your doctor or pharmacist, as morphine may increase the effect of Gabapentina Teva. Additionally, the combination of gabapentina with opioids may cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentina Teva:

• 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 what you are taking.

Taking Gabapentina Teva with food

Gabapentina Teva 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 Gabapentina Teva during pregnancy, unless your doctor has told you to. An effective method of contraception should be used in women of childbearing potential.

There are no specific studies of the use of gabapentina in pregnant women, but with other medicines used to treat seizures, an increased risk of harm to the unborn child has been reported, particularly when more than one medicine is used to treat seizures.

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 plan to become pregnant while taking Gabapentina Teva. 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

Gabapentina, the active substance of Gabapentina Teva, is excreted in 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 may 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.

3. How to take Gabapentina Teva

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 medicine 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 tablets 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 then on, the dose may be increased 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 give to your child based on the child's weight. The treatment will start with a low initial dose that will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually given by taking the tablets, divided into 3 equal doses per day, normally one in the morning, one at noon, and one in the evening.

Gabapentina Teva 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. Normally, your doctor will gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From then on, 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 different doses 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 Gabapentina Teva unless you have kidney problems.

Your doctor may prescribe a different dosage regimen or different doses if you have kidney problems.

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

Method of administration

Gabapentina Teva is taken by mouth. Always swallow the tablets whole with a sufficient amount of water.

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

If you take more Gabapentina Teva than you should

Doses higher than those recommended may cause an increased risk of side 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital if you have taken more gabapentina than your doctor prescribed. Bring any remaining tablets, the packaging, and the 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, it 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.

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If you have any further questions on the use of this product, 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 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 swollen 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 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 they can be symptoms of acute pancreatitis (inflammation of the pancreas)
• 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.
• breathing difficulties that, if severe, may require urgent medical attention to breathe normally.

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

? skin rash.

? hives

? fever

? swelling of the glands that does not disappear

? lip and tongue swelling

? yellowing 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 adverse effects (may affect more than 1 in 10 people):

• Viral infection
• Feeling of drowsiness, dizziness, discoordination
• Feeling of fatigue, fever

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

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation
• 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 coordinating, unusual eye movements, increased, decreased, or absent reflexes

• Blurred vision, double vision
• Dizziness
• Increased blood pressure, redness or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, dry nasal passages
• 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
• Incontinence
• Difficulty with erection (impotence)
• Swelling in the legs and arms,

difficulty walking, weakness, pain, feeling of discomfort, symptoms similar to those of the flu

• Decreased white blood cell count, weight gain,
• Accidental injuries, fractures, scrapes

In addition, in clinical trials in children, aggressive behavior and tremors were reported as common adverse effects.

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

• 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 glucose levels in the blood (more frequently observed in patients with diabetes)

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

• Decreased glucose levels in the blood (more frequently observed in patients with diabetes)
• Loss of consciousness
• Breathing difficulties, shallow breathing (respiratory depression)

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

• Suicidal thoughts

• Developing dependence on gabapentina ("drug dependence")

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

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

• Decrease in platelets (blood clotting cells)
• Allergic reaction such as hives
• Hallucinations
• 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.
  • Rupture of muscle fibers (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, including difficulty breathing, lip, throat, and tongue swelling, and hypotension that requires urgent treatment).

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. Conservation 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.

Store below 30°C. Store in the original packaging. Store the blister in the outer packaging.

Medicines should not be thrown away through the sewers or in 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 gabapentina. Each tablet contains 600 mg of gabapentina.
• The other components are: Copovidona, talc, crospovidona (type A), microcrystalline cellulose, isopropyl alcohol, magnesium stearate, and in the tablet coating, Opadry II 85F18422 white (polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc).

Appearance of the Product and Package Contents

Gabapentina Teva 600 mg are film-coated tablets, white or almost white, oval-shaped, and beveled-edged. Engraved with "7173" on one side and "93" on the other.

Each package contains 90 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid Spain

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi Street 13.

Debrecen, H-4042

Hungary

Date of the Last Revision of this Prospectus:January 2023

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/