Package Insert: Information for the User

GABAPENTINE TECNIGEN 600 MG FILM-COATED TABLETS

Gabapentin

Read this package insert carefully before starting to take this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experienceside effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

The active ingredient of Gabapentina TecniGen is gabapentin.

Gabapentina TecniGen 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). Your doctor will prescribe Gabapentina TecniGen to help you treat your epilepsy when your current treatment does not control the disease completely. You must take Gabapentina TecniGen in combination with your current treatment, unless otherwise instructed. Gabapentina TecniGen 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): A wide variety of diseases can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or herpes. Pain sensations can be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, numbness, tingling, and a sensation of pinpricks, etc.

Do not take Gabapentina TecniGen:

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

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Gabapentina TecniGen.

• 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.
• 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 start feeling muscle pain and/or weakness.
• If you develop symptoms such as persistent stomach pain, discomfort, and nausea, contact your doctor immediately, as they may be symptoms of acute pancreatitis (inflamed pancreas).
• 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 Gabapentina TecniGen.

In post-marketing experience, cases of abuse and dependence with gabapentin have been reported. Talk to your doctor if you have a history of abuse or dependence.

Dependence

Some people may develop dependence (need to continue taking the medication) on Gabapentina TecniGen.They may experience withdrawal symptoms when they stop taking Gabapentina TecniGen (see section 3, "How to take Gabapentina TecniGen" and "If you interrupt treatment with Gabapentina TecniGen").If you are concerned about developing dependence on Gabapentina TecniGen, it is essential to consult your doctor.

If you experience any of the following signs while taking Gabapentina TecniGen, 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 its 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.

Severe skin reactions associated with the use of gabapentin 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.

Important information about potentially serious reactions

A small number of people taking Gabapentina TecniGen have experienced allergic reactions or potentially serious skin reactions, which can lead to more severe problems if not treated. It is essential to be aware of the symptoms of these reactions and be on the lookout for them while taking Gabapentina TecniGen.

Read the description of these symptoms in section 4 of this prospectusin “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 also feel unwell or have a high fever, which can be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems. You may also experience urine discoloration and changes in blood test results (especially an increase in serum creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 using medications containing opioids (such as morphine), please inform your doctor or pharmacist, as opioids can increase the effect of Gabapentina TecniGen.

Additionally, the combination of Gabapentina TecniGen with opioids can cause symptoms such as drowsiness and/or decreased breathing.

Antacids for indigestion

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

Gabapentina TecniGen:

• Gabapentin is not expected to interact with other antiepileptic medications or oral contraceptives.
• It may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what you are taking.

Taking Gabapentina TecniGen with food and drinks:

Gabapentina TecniGen can be taken with or without food.

Pregnancy, lactation, 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

Gabapentina TecniGen should not be taken during pregnancy, unless your doctor has told you otherwise. Women of childbearing age should use an effective contraceptive method.

No specific studies have been conducted with gabapentin in pregnant women, but other medications used to treat seizures have increased the risk of fetal damage, particularly when used in combination with more than one medication for 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 Gabapentina TecniGen. Do not stop taking this medication abruptly, as this may cause an anticipation of seizures, which can 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).

Lactation

Gabapentin, the active ingredient in Gabapentina TecniGen, passes into breast milk. It is not recommended to breastfeed while taking Gabapentina TecniGen, as its effect on the baby is unknown.

Fertility

No effect on fertility has been found in animal studies

Driving and operating machinery:

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

Follow exactly the administration instructions for Gabapentina TecniGen indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Do not take a higher dose of medication than prescribed.

Your doctor will determine the appropriate 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 increase the dose gradually. The initial dose will generally be 300 to 900 mg per day. From there, the dose can 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.

Use in children 6 years or older:

The dose to be given to your child will be decided by your doctor based on the child's weight. Treatment begins with a low initial dose that will be increased gradually over a period of approximately 3 days. The recommended dose for controlling epilepsy is 25-35 mg per kg of body weight 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.

It is not recommended to use Gabapentina TecniGen 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 increase the dose gradually. The initial dose will generally be 300 to 900 mg per day. From there, the dose can 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 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 old),you should take the normal dose of Gabapentina TecniGen unless you have kidney problems. Your doctor may prescribe a different dose and/or a different dosing schedule if you have kidney problems.

If you feel that the effect of Gabapentina TecniGen is too strong or too weak, consult your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina TecniGen is for oral use. Swallow the capsules whole with plenty of water.

Continue taking Gabapentina TecniGen until your doctor tells you to stop treatment.

If you take more Gabapentina TecniGen than you should:

If you or someone accidentally takes too many capsules, or if you think a child has swallowed one of the capsules, contact your doctor or go to the nearest hospital emergency room immediately. Since Gabapentina capsules can cause drowsiness, it is recommended that you ask someone to take you to your doctor or hospital, or that you call an ambulance.

Bring some of the capsules that you have not taken along with the packaging and leaflet so that the hospital can easily identify the medication you have taken.

The symptoms of an overdose are dizziness, double vision, difficulty speaking,loss of consciousness, drowsiness, and mild diarrhea.

If you forgot to take Gabapentina TecniGen:

If you forgot to take a dose, take it as soon as you remember, unless it is already time to take the next dose. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Gabapentina TecniGen

Do not stop taking Gabapentina TecniGen suddenly. If you want to stop taking Gabapentina TecniGen, 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 know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment withGabapentina TecniGen. 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 withGabapentina TecniGen. If you experience this withdrawal syndrome, contact your doctor.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Stop taking Gabapentina TecniGen and seek immediate medical attention if you notice any of the following symptoms:

• Flat, red patches 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).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medications, Gabapentina TecniGen can cause side effects, although not everyone will experience them.

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

• Severe skin reactions that require immediate attention, lip and face inflammation, skin 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)
• Difficulty breathing that, if severe, may require emergency medical attention to breathe normally.
• Gabapentina TecniGen 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. When this type of reaction occurs, it may or may not be accompanied by a rash. This may lead to hospitalization or discontinuation of Gabapentina TecniGen treatment. Consult your doctor immediately if you experience any of the following symptoms:
• • skin rashes
  • hives
  • fever
  • swollen lymph nodes that do not subside
  • swelling of the lips and tongue
  • yellowing of the skin or white of the eyes
  • unusual bleeding or bruising
  • severe fatigue or weakness
  • unexplained muscle pain
  • frequent infections

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

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

Other side effects include:

Very common (may affect more than 1 in 10 people):

• Viral infection
• Dizziness, drowsiness, lack of coordination
• Feeling tired, fever

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

• Pneumonia, respiratory infection, urinary tract infection, ear inflammation, or other infections
• Low 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, headache, skin sensitivity, numbness, coordination difficulties, unusual eye movements, increased, decreased, or absent reflexes
• Blurred or double vision
• Dizziness
• Increased blood pressure, redness, or dilation of blood vessels
• Difficulty breathing, bronchitis, sore throat, cough, nasal dryness
• Vomiting, nausea, dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, hives, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle spasms
• Difficulty achieving orgasm, delayed ejaculation
• Swelling in the legs and arms, difficulty walking, weakness, pain, and flu-like symptoms
• Low white blood cell count, weight gain
• Accidental injuries, fractures, bruises

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent side effects.

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

• Allergic reactions such as hives
• Slowness of movement
• Accelerated heart rate
• Swelling that may affect the face, trunk, and limbs
• Abnormal blood test results that may indicate liver problems
• Mental deterioration
• Falling
• Increased blood glucose levels (more frequently observed in patients with diabetes)
• Agitation (chronic agitation and involuntary, non-intentional movements)
• Difficulty swallowing

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

• Loss of consciousness
• Low blood glucose levels (more frequently observed in patients with diabetes)
• Difficulty breathing, shallow breathing (respiratory depression)

Unknown frequency(cannot be estimated from available data):

• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires emergency treatment).
• Developing dependence on Gabapentina TecniGen ("drug dependence").

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

Since the introduction of the medication to the market, the following side effects have been reported:

• Low platelet count (blood clotting cells)
• Thoughts of suicide, hallucinations
• Abnormal movements such as contortions, spasms, and rigidity
• Tinnitus (ringing in the ears)
• Yellowing of the skin and eyes (jaundice)
• Liver inflammation
• Acute kidney failure, incontinence
• Enlargement of breast tissue, breast hypertrophy
• Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rhabdomyolysis (muscle fiber rupture)
• Abnormal blood test results (increased creatine phosphokinase)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood (hyponatremia)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,

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 Pharmacovigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep 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 above25ºC. Store in the original packaging to protect from light and moisture.

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

Composition of Gabapentina TecniGen 600 mg tablets

• The active ingredient is gabapentin. Each film-coated tablet contains 600 mg of gabapentin.
• The other components (excipients) are:

Tablet core:

Povidone K-90,

crospovidone,

Poloxamer 407,

magnesium stearate.

Coating:

Opadry 20A28569 (Hydroxypropylcellulose, talc).

Appearance of the product and contents of the packaging

Gabapentina TecniGen is presented in the form of film-coated tablets. The tablets are white, convex, and elliptical in shape.

The tablets are packaged in PVC+PVdC/aluminum or OPA/aluminum blisters.

Gabapentina TecniGen 600 mg tablets are available in packaging of 10, 50, 60, 90, or 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid). SPAIN

Phone: 91 3835166

Fax: 91 3835167

Email: [email protected]

Responsible manufacturer

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora (Portugal).

Atlantic Pharma – Produções Farmacêuticas S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

Farmalabor – Produtos Farmacêuticos, S.A.

Zona Industrial de Condeixa-a-Nova

3150-194 Condeixa-a-Nova

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Gabapentina TecniGen

Poland: Gabatem

Portugal: Gabapentina Farmoz

United Kingdom: Gabapentin 600 mg

This leaflet was approved in March 2023

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/