GABAPENTINA TECNIGEN 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

GABAPENTIN TECNIGEN 400 MG HARD CAPSULES EFG

Gabapentin

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Gabapentin TecniGen 400 mg capsules are and what they are used for.
2. What you need to know before you take Gabapentin TecniGen 400 mg capsules.
3. How to take Gabapentin TecniGen 400 mg capsules.
4. Possible side effects.
5. Storage of Gabapentin TecniGen 400 mg capsules.
6. Contents of the pack and other information.

1. What Gabapentin TecniGen 400 mg capsules are and what they are used for

Gabapentin TecniGen 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 Gabapentin TecniGen is gabapentin.

Gabapentin TecniGen 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 Gabapentin TecniGen to help you treat your epilepsy when your current treatment does not fully control the disease. You should take Gabapentin TecniGen in combination with your current treatment, unless your doctor tells you otherwise. Gabapentin TecniGen 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): A variety of diseases can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or herpes. The sensations of pain can be described as heat, burning, throbbing pain, stabbing pain, sharp pain, spasms, continuous pain, tingling, numbness, and a feeling of pins and needles, etc.

2. What you need to know before you take Gabapentin TecniGen 400 mg capsules

Do not take Gabapentin TecniGen:

If you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings andprecautions

Consult your doctor, pharmacist, or nurse before starting to take Gabapentin 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 (to remove waste products due to kidney failure), tell your doctor if you start to feel muscle pain and/or weakness.
• - If you develop symptoms such as persistent stomach pain, discomfort, and feeling sick, contact your doctor immediately, as they may be symptoms of acute pancreatitis (inflamed pancreas).
• - Before taking this medicine, tell 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 TecniGen.

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

Dependence

Some people may become dependent on Gabapentin TecniGen. They may experience withdrawal symptoms when they stop taking Gabapentin TecniGen (see section 3, "How to take Gabapentin TecniGen" and "If you stop taking Gabapentin TecniGen"). If you are concerned about becoming dependent on Gabapentin TecniGen, it is important that you consult your doctor.

If you experience any of the following signs while taking Gabapentin TecniGen, it may be indicative of 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 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 is the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

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 severe skin reactions described in section 4.

Important information about potentially serious reactions

A small number of people who take Gabapentin TecniGen have allergic reactions or potentially serious skin reactions, which can lead to more serious problems if not treated. You need to know the symptoms of these reactions and be aware of them while taking Gabapentin TecniGen.

Read the description of these symptoms in section 4 of this leafletin "Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious".

Muscle weakness, sensitivity, or pain, and especially if you do not feel well 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 increased creatine phosphokinase in the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of other medicines and Gabapentin TecniGen

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

Medicines containing opioids, such as morphine

If you are using other medicines that contain opioids (such as morphine), please tell your doctor or pharmacist, as opioids can increase the effect of Gabapentin TecniGen. Additionally, the combination of Gabapentin TecniGen with opioids can cause symptoms such as drowsiness and/or decreased breathing.

Antacids for indigestion

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

Gabapentina TecniGen:

• - It is not expected that gabapentin will 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, tell your doctor or hospital what you are taking.

Taking Gabapentina TecniGen with food and drinks

Gabapentina TecniGen can be taken with or without food.

Pregnancy, breastfeeding, 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 medicine.

Pregnancy

Gabapentina TecniGen should not be used during pregnancy, unless your doctor has told you otherwise. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies with gabapentin in pregnant women, but other medicines used to treat seizures have caused an increased risk of harm to the developing fetus, particularly when used at the same time as more than one medicine 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 TecniGen. Do not stop taking this medicine suddenly, as this may cause seizures to return, which could 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 with opioid painkillers (drugs for treating intense pain).

Breastfeeding

Gabapentin, the active substance of Gabapentina TecniGen, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina TecniGen, as the effect on the baby is unknown.

Fertility

There has been no effect on fertility in animal studies.

Driving and using machines

Gabapentina TecniGen can cause dizziness, drowsiness, and fatigue. You should not drive or use machinery or perform potentially hazardous activities until you know how this medicine affects your ability to perform these activities.

Gabapentina TecniGen contains lactose(a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Gabapentina TecniGen 400 mg capsules

Follow exactly the administration instructions of Gabapentina TecniGen given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Do not take a higher dose of the 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 capsules that your doctor tells you. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. From there, the dose may be increased as your doctor indicates, 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 of age or older

The dose that will be given to your child will be decided by your doctor based on the child's weight. The treatment starts with a low initial dose that will be gradually increased 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.

Gabapentina TecniGen is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults

Take the number of capsules that your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. From there, the dose may be increased as your doctor indicates, 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 on hemodialysis

Your doctor may prescribe a different dosing 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 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. Always swallow the capsules whole with plenty of water.

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

If you take more Gabapentina TecniGen than you should

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

Bring any capsules that you have not taken, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

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

If you forget to take Gabapentina TecniGen

If you forget 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 forgotten dose.

If you stop taking 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, it should be done gradually over a minimum of one week. You should know that you may experience certain side effects, called withdrawal syndrome, after stopping short-term or long-term treatment with Gabapentina TecniGen. 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 TecniGen. If you experience this withdrawal syndrome, you should contact your doctor.

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

4. Possible Adverse Effects

Stop taking Gabapentina TecniGen 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).
• Expanded rash, high body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome).

Like all medicines, Gabapentina TecniGen can cause adverse effects, although not all people suffer from them.

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

• severe skin reactions that require immediate attention, lip and face inflammation, 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)
• breathing difficulties that, if severe, may require urgent medical attention to breathe normally.
• Gabapentina TecniGen can cause a severe or potentially life-threatening allergic reaction that can affect the skin or other parts of your body, such as the liver or blood cells. When this type of reaction occurs, it may or may not have a rash. This can lead to hospitalization or discontinuation of treatment with Gabapentina TecniGen. Consult your doctor immediately if you have any of the following symptoms:
• • skin rashes
  • hives
  • fever
  • inflammation of the glands that does not disappear
  • swelling of the lips and tongue
  • yellowish color 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. A doctor must examine you to decide if you should continue taking Gabapentina TecniGen.

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, lack of coordination
• Feeling of fatigue, fever

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

• Pneumonia, respiratory infection, urinary tract infection, ear inflammation, or other infections
• Low blood cell count
• Anorexia, increased appetite
• Feelings of anger 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 with coordination, unusual eye movements, increased, decreased, or absent reflexes
• Blurred or double vision
• Dizziness
• Increased blood pressure, redness, or dilation of blood vessels
• Breathing difficulties, bronchitis, sore throat, cough, dry nose
• Vomiting (being sick), nausea (feeling sick), 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, contractures
• Difficulty with erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, and feeling of discomfort, and flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, abrasions

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent adverse effects.

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

• Allergic reactions such as hives
• Slowness of movements
• Accelerated heartbeats
• Swelling that can affect the face, trunk, and extremities
• Abnormal blood test results that may indicate liver problems
• Mental deterioration
• Falling
• Increased blood glucose levels (more frequently observed in patients with diabetes)
• Agitation (state of chronic agitation and involuntary, unintentional movements)
• Difficulty swallowing

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

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

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

• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, lip, throat, and tongue swelling, and hypotension that requires emergency treatment)
• Developing dependence on Gabapentina TecniGen ("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 TecniGen (see "If you stop taking Gabapentina TecniGen").

Since the marketing of Gabapentina TecniGen, the following adverse effects have been reported:

• Decrease in platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and stiffness
• Ringing in the ears
• Yellowish appearance of the skin and eyes (jaundice)
• Liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse effects after sudden discontinuation of gabapentin treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis)
• Change in blood test results (increased creatine phosphokinase)
• Sexual function problems, including inability to reach a sexual climax, delayed ejaculation.
• Low sodium levels in the blood (hyponatremia)

Reporting of adverse effects

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

even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gabapentina TecniGen 400 mg capsules

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina TecniGen 400 mg capsules

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

The other components (excipients) are:

• Capsule content: lactose monohydrate, cornstarch, and talc.
• Capsule shell: the 400 mg capsule (No. 0, green and white) contains:

Carmine indigo (E132),

Titanium dioxide (E171),

Yellow iron oxide (E172), and

Gelatin

Appearance of the product and package contents

Gabapentina TecniGen is presented in the form of hard capsules.

Gabapentina TecniGen 400 mg capsules are packaged in PVC/PVD/Aluminum blisters.

The available package sizes are 20, 50, 60, 90, 100, or 500 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Tel: 91 3835166

Fax: 91 3835167

E-mail: registros@tecnimede.es

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)

Tecnimede – Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos (Portugal)

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

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

Spain: Gabapentina TecniGen

Italy: Gabapentina Farmoz

Portugal: Gabapentina Farmoz

United Kingdom: Gabapentin 400 mg

This leaflet was approved in March 2023

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