GABAPENTINA TEVAGEN 400 mg HARD CAPSULES

Introduction

Package leaflet: information for the user

Gabapentina Tevagen 400 mg hard capsules EFG

Contents of the pack

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

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

Gabapentina Tevagen 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 Tevagen is gabapentin.

Gabapentina Tevagen 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 Tevagen 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 the legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing, shooting, stabbing, acute, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

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

Do not take Gabapentina Tevagen:

? if you are allergic (hypersensitive) 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 Tevagen:

? 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 becoming dependent 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 who were being 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.

Dependence

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

If you experience any of the following signs while taking gabapentin, it may indicate that you have developed dependence.

• ? You feel that you need to take the medicine for a longer period 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.

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 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 the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Using Gabapentina Tevagen 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 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), inform your doctor or pharmacist, as opioids can increase the effect of Gabapentina Tevagen. Additionally, the combination of Gabapentina Tevagen with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentina Tevagen

• ? Gabapentina Tevagen is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.
• ? it 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 Tevagen with food, drinks, and alcohol

Food does not affect the absorption of Gabapentina Tevagen.

Pregnancy, breastfeeding, and fertility

Pregnancy

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.

You should not take Gabapentina Tevagen during pregnancy, unless your doctor has told you to do so. 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 with other medicines used to treat seizures, there have been reports of an increased risk of harm to the developing baby, 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.

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

Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning to become pregnant while taking Gabapentina Tevagen. 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 Tevagen, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Tevagen, 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. 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 Tevagen

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 increase your dose gradually. 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.

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, 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 by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentina Tevagen is not recommended for use in children below 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 increase your dose gradually. 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 if you are on hemodialysis

Your doctor may prescribe a different dosage regimen 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 Tevagen, 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 Tevagen is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

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

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

If you take more Gabapentina Tevagen 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, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital. Bring any capsules you have not taken, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Tevagen

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 Tevagen

Do not stop taking Gabapentina Tevagen suddenly. If you want to stop taking Gabapentina Tevagen, 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 Tevagen 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 Tevagen. If you experience this withdrawal syndrome, you should contact your doctor.

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 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).
• widespread rash, high body temperature, and enlargement of 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, inflammation of the lips and face, 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 Tevagen 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 Tevagen 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

? inflammation of the glands that does not disappear

? swelling of the lip and tongue

? yellowish color of the skin or whites of the eyes

? bruising or bleeding or unusual 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,

? feeling of drowsiness, dizziness, discoordination,

? feeling of fatigue, fever.

Common (may affect up to 1 in 10 people)

? pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation, or other infections,

? low white blood cell count,

? anorexia, increased appetite,

? anger towards others, confusion, mood changes, depression, anxiety, nervousness,

difficulty thinking,

? convulsions, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensations (numbness), difficulty coordinating, 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, nasal dryness,

? 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,

? erection difficulties,

? swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms,

? decreased leukocytes,

? weight gain,

? accidental injuries, fractures, abrasions.

Additionally, in clinical trials in children, aggressive behavior and tremors 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

? difficulty swallowing

• swelling that can affect the face, torso, and extremities
• abnormal blood test results that may indicate liver problems
• progressive mental damage

? falls

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

Rare: (may affect up to 1 in 1000 people)

• loss of consciousness
• decreased blood glucose levels (observed more frequently in patients with diabetes)
• 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-term or long-term treatment with Gabapentina Tevagen (see "If you stop treatment with Gabapentina Tevagen").

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

? Decrease in platelets (blood clotting cells),

? hallucinations,

? problems with abnormal movements such as contortions, spasmodic movements, and rigidity,

? ringing in the ears,

• yellowish appearance of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• increase in breast tissue, breast enlargement
• adverse effects after sudden discontinuation of gabapentina treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain
• 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, swelling of the lips, throat, and tongue, 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 Tevagen

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

Do not store at a temperature above 25°C.

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 Tevagen

The active ingredient is gabapentina. Each capsule contains 400 mg of gabapentina.

The other components (excipients) are: talc, pregelatinized starch (derived from corn).

The excipients of the cap/body are: titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), and gelatin. Printing ink: shellac, black iron oxide (E 172), and propylene glycol.

Appearance of the Product and Package Contents

Gabapentina Tevagen 400 mg is presented in the form of hard capsules with a brown 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 '40'.

Each package contains 30 or 90 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 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/