GABAPENTINA TECNIGEN 800 mg FILM-COATED TABLETS

2. What you need to know before you take Gabapentina TecniGen 800 mg film-coated tablets

Do not take Gabapentina TecniGen:

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

Warnings and precautions:

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

• 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 Gabapentina 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 develop dependence (need to continue taking the medicine) 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 stop taking Gabapentina TecniGen"). If you are concerned about developing dependence on Gabapentina TecniGen, it is important that you consult your doctor.

If you experience any of the following signs while taking Gabapentina 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 Gabapentina TecniGen have allergic reactions or potentially serious skin reactions, which can lead to more serious problems if not treated. It is necessary that you know the symptoms of these reactions and be aware of them while taking Gabapentina 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 may 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:

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 medicines containing opioids (such as morphine), please tell 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 that contain aluminum and magnesium, the absorption of Gabapentina TecniGen in the stomach may be reduced. Therefore, it is recommended that Gabapentina 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, inform your doctor or hospital about 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentina TecniGen should not be taken 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 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 analgesics (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:

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

3. How to take Gabapentina TecniGen 800 mg film-coated tablets

Take Gabapentina TecniGen exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again. 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. Your doctor will usually increase your dose gradually. The initial dose will generally be 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 noon, and one at night.

Use in children 6 years of age and older:

The dose that will be given to your child will be decided by your doctor based on the child's weight. Treatment is started 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 tablets, divided into 3 equal doses per day, usually 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 tablets 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 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 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 think that the effect of Gabapentina TecniGen is too strong or too weak, talk to your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina TecniGen is for oral use. Always swallow the tablets 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 tablets, or if you think that a child has swallowed some of the tablets, contact your doctor or go to the nearest hospital emergency department immediately. As Gabapentina TecniGen tablets can cause drowsiness, it is recommended that you ask someone to drive you to your doctor or hospital, or call an ambulance.

Bring any remaining tablets and the package and leaflet with you to the hospital so that the medicine can be easily identified.

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 almost time for your next dose. Do not take a double dose to make up for a 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 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 on 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, target-shaped or circular patches 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 or drug hypersensitivity syndrome).

Like all medicines, Gabapentina TecniGen can cause adverse 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 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)
• Breathing difficulties that, if severe, may require emergency medical attention to maintain normal breathing.
• 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, there may or may not be 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
  • Persistent swelling of the glands
  • 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 can 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 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, dryness of the nose
• Vomiting (being sick), nausea (feeling sick), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dryness of the mouth or throat, flatulence
• Swelling of the face, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle spasms
• Difficulty with erection
• 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 common adverse effects.

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

• Allergic reactions such as hives
• Slowness of movement
• Rapid heartbeat
• Swelling that can 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 (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 that includes difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure 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 introduction of the medication to the market, 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
• Yellowing 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 800 mg tablets

Keep out of sight and reach of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina TecniGen 800 mg tablets

• The active ingredient is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.
• The other ingredients (excipients) are:

• Core of the tablet:

Povidone K-90,

crospovidone,

Poloxamer 407,

magnesium stearate.

• Coating:

Opadry 20A28569 (Hydroxypropylcellulose, talc).

Appearance of the product and package contents

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 800 mg tablets are available in packages of 10, 50, 60, 90, or 100 tablets.

Not all 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) ESPAÑA

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

Spain: Gabapentina TecniGen

Portugal: Gabapentina Farmoz

United Kingdom: Gabapentin 800 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/