Gabapentin Tecnigen 400 mg hard capsules EFG

Package leaflet: Information for the user

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 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 be harmful to them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Gabapentin TecniGen 400 mg capsules are and what they are used for.
2. What you need to know before taking Gabapentin TecniGen 400 mg capsules.
3. How to take Gabapentin TecniGen 400 mg capsules.
4. Possible side effects
5. How to store 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 (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 certain 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 given 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 conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or herpes. Pain sensations may be described as warmth, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, spasms, continuous pain, tingling, numbness, and prickling sensations, etc.

2. What you need to know before taking Gabapentina TecniGen 400 mg capsules

Do not take Gabapentina 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 Gabapentina TecniGen.

• − if you have a disorder of the nervous system 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 undergoing hemodialysis (to remove waste products due to kidney failure), inform your doctor if you begin to experience 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; you may have an increased risk of developing dependence on Gabapentina TecniGen.

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

Dependence

Some people may develop dependence (a need to keep 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 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 medicine for longer than prescribed.
• You feel the 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 to control how you take it, but 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 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, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. Stop taking gabapentin and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Important information about potentially serious reactions

A small number of people taking Gabapentina TecniGen may experience allergic reactions or potentially serious skin reactions, which could 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 Gabapentina 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 at the same time you feel unwell or have 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 discoloration of the 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.

Taking other medicines and Gabapentina TecniGen

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 other medicines containing opioids (such as morphine), please inform your doctor or pharmacist, as opioids may increase the effect of Gabapentina TecniGen. In addition, the combination of Gabapentina TecniGen with opioids may cause symptoms such as drowsiness and/or reduced breathing.

Antacids for indigestion

If you take Gabapentina TecniGen at the same time as antacids containing aluminium 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:

• No interaction of gabapentin with other antiepileptic medicines or with oral contraceptive pills is expected.

• May interfere with certain laboratory tests; therefore, if you require a urine test, inform your doctor or hospital about the medicines 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Gabapentina TecniGen should not be used during pregnancy unless your doctor has advised 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, it is recommended to use only one antiepileptic medicine 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 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 the treatment of severe pain).

Breastfeeding

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

Fertility

No effect on fertility has been observed in animal studies.

Driving and using machines

Gabapentina TecniGen 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.

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

3. How to take Gabapentin TecniGen 400 mg capsules

Follow exactly the dosing instructions for Gabapentin TecniGen provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more 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 indicated by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 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 in the afternoon, and one at night.

Use in children aged 6 years or older

The dose for your child will be determined by your doctor based on the child's weight. Treatment starts with a low initial 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 usually administered by taking the capsules, divided into three equal doses per day—typically one in the morning, one in the afternoon, and one at night.

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 capsules prescribed by your doctor. Usually, your doctor will gradually increase your dose. The initial dose is generally 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 in the afternoon, and one at night.

If you have kidney problems or are undergoing hemodialysis

Your doctor may prescribe a different dosing regimen 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 capsules whole with plenty of water.

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

If you take more Gabapentin TecniGen than you should

If you or someone else accidentally takes too many capsules, or if you think a child has swallowed any capsules, contact your doctor or go to the nearest hospital emergency department immediately. Since Gabapentin capsules can 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 capsules, the packaging, and the leaflet so that the hospital can easily identify the medication 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. If you wish to stop taking Gabapentin TecniGen, speak to your doctor first. Your doctor will advise you on 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 adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentin TecniGen. These may include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentin 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 Gabapentin TecniGen and seek medical attention immediately if you notice any of the following symptoms:

• red, flat, circular patches resembling targets or rings 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 can cause adverse effects, although not everyone experiences 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 (may be signs of a severe allergic reaction)
• persistent stomach pain, vomiting, and nausea, which 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 severe 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 experience any of the following symptoms:
  • skin rash
  • 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 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 inflammation, or other infections
• Low blood cell count
• Anorexia, increased appetite
• Feelings of anger toward others, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, reduced 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
• Difficulty with erection (impotence)
• Swelling in the arms and legs, difficulty walking, weakness, pain and malaise, 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 that may affect 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 problems, shallow breathing (respiratory depression)

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

• Anaphylaxis (severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring emergency treatment)
• Development of dependence on Gabapentin TecniGen ("drug dependence").

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 (see "If you stop taking Gabapentin TecniGen").

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

• Decreased platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness
• Ringing in the ears
• Yellow appearance of the skin and eyes (jaundice)
• Liver inflammation
• Acute kidney failure, incontinence
• Increase in breast tissue, breast enlargement
• Adverse effects following abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Muscle fiber breakdown (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 through 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 400 mg capsules

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 30°C. Keep in the original container to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina TecniGen 400 mg capsules

The active substance is gabapentin. Each hard capsule contains 400 mg of gabapentin.

The other components (excipients) are:

• Capsule contents: lactose monohydrate, corn starch and talc.
• Capsule shell: the 400 mg capsule (size 0, green and white) contains:

Indigo carmine (E132),

Titanium dioxide (E171),

Iron oxide yellow (E172) and

Gelatin.

Appearance of the product and contents of the pack

Gabapentina TecniGen is available as hard capsules.

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

Pack sizes available contain 20, 50, 60, 90, 100 or 500 hard capsules.

Only some 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)

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 medicinal product is authorized in the Member States of the European Economic Area under 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/