Leaflet: information for the user

GABAPENTINE TECNIGEN 400 MG HARD CAPSULES EFG

Gabapentin

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only 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 leaflet. 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 typesof epilepsy (seizures that initially are 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 should take Gabapentina TecniGen in combination with your current treatment, unless otherwise instructed. Gabapentina TecniGen may also be administered as a single medication in the treatment ofadults 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 pins and needles, 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 to feel 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).

During 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.

A small number of patients treated with antiepileptic medications like gabapentin have had thoughts of self-harm or suicide. If you have these thoughts at any time, contact your doctor immediately.

Important information about potentially serious reactions

A small number of people taking Gabapentina 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 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 and Gabapentina TecniGen

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 other medications that contain 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 containing aluminum and magnesium, the absorption of Gabapentina TecniGen in the stomach may be reduced. It is therefore 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

There are no specific studies with gabapentin in pregnant women, but other medications used to treat seizures have increased the risk of damage to the developing fetus, particularly when used simultaneously with more than one medication to treat seizures. Therefore, whenever possible, you should try to take only one medication for seizures during pregnancy, under the advice of your doctor.

Contact your doctor immediately if you become pregnant, if you think you may be pregnant, or if you plan to become pregnant while taking Gabapentina TecniGen. Do not stop taking this medication abruptly, as this may cause an anticipation of seizures, which could have serious consequences for you and your baby.

Lactation

Gabapentin, the active ingredient inGabapentina TecniGen, passes into breast milk. It is not recommended to breastfeed while takingGabapentina TecniGen, as the effect on the baby is unknown.

Fertility

There has been no effect on fertility in animal studies.

Driving and operating machinery

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

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

Follow exactly the administration instructions of Gabapentina TecniGen indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 may 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. The treatment starts 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 ingesting 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.

Recommended 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 may 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 some 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.

Take some of the capsules that you have not taken with the packaging and the 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 compensate for the missed dose.

If you interrupt treatment with Gabapentina TecniGen

Do not stop taking Gabapentina TecniGen unless your doctor tells you to. If you are going to stop treatment, this should be done gradually over a minimum of one week. If you stop taking Gabapentina TecniGen suddenly or before your doctor tells you to, there is a risk of increased seizures.

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

Like all medications, Gabapentina TecniGen may 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, inflammation of the lips and face, skin eruption and 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, which, 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 your 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 result in hospitalization or discontinuation of Gabapentina TecniGen treatment. Consult your doctor immediately if you experience any of the following symptoms:
• • skin eruptions
  • 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
  • unexpected 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
• 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 white blood cell count
• Loss of appetite, increased appetite
• Anger towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headaches, sensitive skin, 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 (being sick), nausea (feeling sick), dental problems, inflamed gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Swelling of the face, hives, rash, acne
• Joint pain, muscle pain, back pain, muscle contractures
• Difficulty achieving an erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, and discomfort, and flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, bruises

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

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

• Allergic reactions such as hives
• Slowed movements
• 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
• Decreased blood glucose levels (more frequently observed in patients with diabetes)
• Difficulty breathing, shallow breathing (respiratory depression)

Unknown frequency:

• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment)

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

• Decreased platelet count (blood clotting cells)
• Hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity
• Tinnitus (ringing in the ears)
• A group of side effects that may include lymph node inflammation (isolated, small, elevated lumps under the skin), fever, rash, and liver inflammation, all at the same time
• Yellowing of the skin and eyes (jaundice)
• Liver inflammation
• Acute kidney failure, incontinence
• Mammary gland enlargement, breast enlargement
• Side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis)
• 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 at a temperature above 30°C. Store in the original packaging to protect from light and humidity.

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

Composition of Gabapentina TecniGen 400 mg capsules

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

The other components (excipients) are:

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

Indigo carmine (E132),

Titanium dioxide (E171),

Yellow iron oxide (E172) and

Gelatin

Appearance of the product and contents of the package

Gabapentina TecniGen is presented in the form of hard capsules.

Gabapentina TecniGen 400 mg capsulesare 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 commercially available

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

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

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)

Tecnimede – Sociedade Técnico-Medicinal, S.A.

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

Medinfar Manufacturing, S.A.

Armando Martins Tavares Industrial Park

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

This medicine is authorized in themember states of the European Economic Area withthe following names:

Spain: Gabapentina TecniGen

Italy: Gabapentina Farmoz

Portugal: Gabapentina Farmoz

United Kingdom: Gabapentin 400 mg

This leaflet was approved in April 2017

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/