Gabapentin Tecnigen 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GABAPENTIN TECNIGEN 800 MG FILM-COATED TABLETS EFG

Gabapentin

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Gabapentin TecniGen 800 mg tablets are and what they are used for.

2. What you need to know before taking Gabapentin TecniGen 800 mg tablets.

3. How to take Gabapentin TecniGen 800 mg tablets.

4. Possible side effects

5. How to store Gabapentin TecniGen 800 mg tablets.

6. Contents of the pack and other information

1. What Gabapentin TecniGen 800 mg Tablets Are and What They Are Used For

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

The active substance in Gabapentin TecniGen is gabapentin.

Gabapentin TecniGen is used to treat:

• Certain types of epilepsy (seizures that initially affect only specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor will prescribe Gabapentin TecniGen to help manage your epilepsy when your current treatment does not fully control the condition. You should take Gabapentin TecniGen in combination with your current treatment, unless otherwise instructed. Gabapentin TecniGen may also be used as monotherapy in the treatment of adults and children over 12 years of age.

Peripheral neuropathic pain (chronic pain caused by nerve damage): A variety of diseases can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles. Pain sensations may be described as warmth, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and pins-and-needles sensations, among others.

2. What you need to know before taking Gabapentin TecniGen 800 mg tablets

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 and precautions:

Talk to your doctor, pharmacist, or nurse before starting 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), inform your doctor if you start experiencing muscle pain and/or weakness.
• If you develop symptoms such as persistent stomach pain, discomfort, and feeling unwell, contact your doctor immediately, as these may be symptoms of acute pancreatitis (inflamed pancreas).
• Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs, as you may have a higher risk of developing dependence on Gabapentin TecniGen.
• If you have myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.

Cases of abuse and dependence with gabapentin have been reported in post-marketing experience. Speak with your doctor if you have a history of abuse or dependence.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on Gabapentin TecniGen. They may experience withdrawal symptoms when they stop taking Gabapentin TecniGen or reduce the dose (see section 3, "How to take Gabapentin TecniGen" and "If you stop taking Gabapentin TecniGen"). If you are concerned about developing dependence on Gabapentin TecniGen, it is important to consult your doctor.

If you experience any of the following signs while taking Gabapentin TecniGen, it may indicate that you have developed dependence:

• You feel you need to take the medicine for longer than prescribed.
• You feel you need to take a higher dose than recommended.
• You are taking the medicine for reasons different from those for which it was prescribed.
• 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 start taking it again.

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to stop treatment and how to do so safely.

Serious skin rashes associated with the use of gabapentin have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

Important information about potentially serious reactions

A small number of people taking Gabapentin TecniGen experience allergic reactions or potentially serious skin reactions, which can lead to more serious problems if not treated. It is important that you are aware of the symptoms of these reactions and monitor for them while taking Gabapentin TecniGen.

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

Muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell or having a high fever, which may be caused by abnormal muscle breakdown that can be life-threatening and lead to kidney problems. You may also experience discolored urine and changes in blood test results (especially increased blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.

Use of other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform 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 conditions.

Medicines containing opioids such as morphine

If you are taking medicines containing opioids (such as morphine), please inform your doctor or pharmacist, as opioids may increase the effect of Gabapentin TecniGen.

In addition, the combination of Gabapentin TecniGen with opioids may cause symptoms such as drowsiness and/or slowed breathing.

Antacids for indigestion

If you take Gabapentin TecniGen at the same time as antacids containing aluminium 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.

Gabapentin TecniGen:

• No interaction between gabapentin and other antiepileptic medicines or oral contraceptive pills is expected.
• It may interfere with certain laboratory tests, so if you need a urine test, inform your doctor or hospital about the medicines you are taking.

Taking Gabapentin TecniGen with food and drink:

Gabapentin TecniGen 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Gabapentin TecniGen should not be taken during pregnancy unless your doctor has specifically instructed you otherwise. An effective method of contraception 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 been associated with an increased risk of harm to the developing fetus, particularly when more than one medicine is used to treat seizures. Therefore, whenever possible, only one seizure medicine should be used 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 Gabapentin TecniGen. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both 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 (medicines for severe pain).

Breastfeeding

Gabapentin, the active ingredient in Gabapentin TecniGen, passes into breast milk. Breastfeeding is not recommended while taking Gabapentin TecniGen, as the effect on the infant is unknown.

Fertility

No effect on fertility has been observed in animal studies.

Driving and using machines:

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

3. How to take Gabapentin TecniGen 800 mg tablets

Follow exactly the dosing instructions for Gabapentin TecniGen provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is:

Adults and adolescents:

Take the number of tablets your doctor has indicated. Normally, your doctor will gradually increase your dose. The initial dose is usually 300 to 900 mg per day. From there, 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 midday, and one at night.

Use in children aged 6 years or older:

The dose your child will receive will be determined by your doctor based on the child's weight. Treatment is initiated with a low starting dose, which 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 normally administered by taking the tablets, divided into three equal daily doses—usually one in the morning, one at midday, and one at night.

The use of Gabapentin TecniGen is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is:

Adults:

Take the number of tablets prescribed by your doctor. Normally, your doctor will gradually increase your dose. The initial dose is usually 300 to 900 mg per day. From there, 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 midday, and one at night.

If you have kidney problems or are undergoing hemodialysis

Your doctor may prescribe a different dosing schedule and/or different doses if you have kidney problems or are undergoing hemodialysis.

If you are an elderly patient (over 65 years of age), you should take the normal dose of Gabapentin 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 Gabapentin TecniGen is too strong or too weak, consult your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin TecniGen is for oral use. Always swallow the tablets whole with plenty of water.

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

If you take more Gabapentin TecniGen than you should:

If you or someone else accidentally takes too many tablets, or if you think a child has swallowed any of the tablets, contact your doctor or go to the nearest hospital emergency department immediately. Since Gabapentin tablets may cause drowsiness, it is recommended that you ask someone to take you to the doctor or hospital, or call an ambulance.

Take with you any unused tablets, along with the packaging and the leaflet, so the hospital can easily identify the medicine you have taken.

Symptoms of overdose include dizziness, double vision, difficulty speaking, loss of consciousness, drowsiness, and mild diarrhea.

If you forget to take Gabapentin TecniGen:

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Gabapentin TecniGen:

Do not stop taking Gabapentin TecniGen suddenly or reduce the dose. If you wish to stop taking Gabapentin TecniGen or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentin TecniGen or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping Gabapentin TecniGen or reducing the dose. 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 Gabapentin TecniGen and seek medical help immediately if you notice any of the following symptoms:

• red, flat, non-elevated patches with a target-like or circular appearance on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medicines, Gabapentin TecniGen may cause adverse effects, although not everyone gets them.

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

• severe skin reactions requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be signs of a severe allergic reaction)
• persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)
• difficulty breathing which, if severe, may require urgent medical care to maintain normal breathing.
• Gabapentin TecniGen may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body such as the liver or blood cells. This type of reaction may occur with or without a rash. It may lead to hospitalization or the need to stop treatment with Gabapentin TecniGen. Contact your doctor immediately if you have any of the following symptoms:
  • skin rash
  • hives
  • fever
  • swollen glands that do not go away
  • swelling of the lips and tongue
  • yellowing of the skin or whites of the eyes
  • unusual bleeding or bruising
  • severe fatigue or weakness
  • unexpected muscle pain
  • frequent infections

These symptoms may be early signs of a serious reaction. A doctor should examine you to determine whether you should continue taking Gabapentin TecniGen.

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

Other adverse effects include:

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

• Viral infection
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

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

• Pneumonia, respiratory infection, urinary tract infection, ear infection, or other infections
• Low blood cell count
• Anorexia, increased appetite
• Feelings of anger toward others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, 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, dry nose
• 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, cramps
• Erectile dysfunction
• Swelling in the arms and legs, difficulty walking, weakness, pain, malaise, and flu-like symptoms
• Decreased white blood cells, weight gain
• Accidental injuries, fractures, abrasions

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

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

• Allergic reactions such as hives
• Slowness of movement
• Rapid heartbeat
• Swelling affecting the face, trunk, and limbs
• Abnormal blood test results that may indicate liver problems
• Mental deterioration
• Falls
• Increased blood glucose levels (more frequently observed in patients with diabetes)
• Agitation (a state of chronic restlessness 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 available data):

• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment).
• Development of dependence on Gabapentin TecniGen ("drug dependence").
• Worsening of myasthenia gravis (a disease causing muscle weakness)

You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with Gabapentin TecniGen or after reducing the dose (see "If you stop taking Gabapentin TecniGen").

Since the medicine was introduced to the market, the following adverse effects have been reported:

• Decrease in platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears
• Yellowish appearance of the skin and eyes (jaundice)
• Inflammation of the liver
• Acute kidney failure, incontinence
• Increase in breast tissue, breast enlargement
• Adverse effects after abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Rupture of muscle fibers (rhabdomyolysis)
• Changes in blood test results (increased creatine phosphokinase)
• Sexual function problems including inability to reach sexual climax, delayed ejaculation
• Low sodium levels in the blood (hyponatremia)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin TecniGen 800 mg Tablets

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina TecniGen 800 mg tablets

• The active substance is gabapentin. Each film-coated tablet contains 800 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 medicinal product and contents of the pack

Gabapentina TecniGen is available as film-coated tablets. The tablets are white, convex and elliptical in shape.

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

Gabapentina TecniGen 800 mg tablets are available in packs of 10, 50, 60, 90 or 100 tablets.

Only certain pack 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: [email protected]

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 medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Gabapentina TecniGen

Portugal: Gabapentina Farmoz

United Kingdom: Gabapentin 800 mg

This patient information leaflet has been approved in March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/