Gabapentin Tevagen 300 mg hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Gabapentin Tevagen 300 mg Hard Capsules EFG
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, consult your doctor or pharmacist. ? This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it may 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. |
Package leaflet contents
- What Gabapentina Tevagen is and what it is used for.
- What you need to know before taking Gabapentina Tevagen.
- How to take Gabapentina Tevagen.
- Possible side effects.
- How to store Gabapentina Tevagen.
- Contents of the pack and other information.
1. What Gabapentin Tevagen is and what it is used for
Gabapentin Tevagen 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 Tevagen is gabapentin.
Gabapentin Tevagen is used to treat:
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Certain types of epilepsy (seizures that initially affect only specific parts of the brain, whether or not the seizure spreads to other areas of the brain). Your doctor, or the doctor treating your child aged 6 years or older, may prescribe Gabapentin Tevagen to help manage epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with current treatment, unless otherwise instructed. Gabapentin may also be given as monotherapy in the treatment of adults and children over 12 years of age.
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Peripheral neuropathic pain (chronic pain caused by nerve damage). Various conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles. The pain sensation may be described as warmth, burning, pulsating pain, shooting pain, stabbing pain, sharp pain, spasms, continuous pain, tingling, numbness, and pins and needles, etc.
2. What you need to know before taking Gabapentina Tevagen
Do not take Gabapentina Tevagen:
? If you are allergic (hypersensitive) to gabapentin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Gabapentina Tevagen:
? 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, vomiting, and nausea, tell your doctor immediately, as these may be symptoms of acute pancreatitis (inflamed pancreas).
- 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 myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms.
- before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on gabapentin.
Cases of abuse and dependence on gabapentin have been reported from post-marketing experience. Speak with your doctor if you have a history of substance abuse or dependence.
A small number of people who have taken antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you have such thoughts, contact your doctor immediately.
Dependence
Some people may develop dependence (a need to keep taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin or reduce the dose (see section 3, "How to take Gabapentina Tevagen" and "If you stop taking Gabapentina Tevagen"). If you are concerned about developing dependence on gabapentin, it is important to consult your doctor.
If you experience any of the following signs while taking gabapentin, 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.
Important information about potentially serious reactions
Serious skin rashes have been reported with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction 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.
Read the description of these symptoms in section 4 of this leaflet: “Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as it could be serious.”
Muscle weakness, tenderness, or pain on palpation—and especially if you also feel unwell or have a fever—could be due to abnormal breakdown of muscle fibers, which may lead to kidney problems and may be life-threatening. You may also experience discoloration of urine and changes in blood test results (a significant increase in blood creatine phosphokinase). If you experience any of these signs or symptoms, please contact your doctor immediately.
Taking Gabapentina Tevagen with 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 a medicine that contains opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentina Tevagen. In addition, combining Gabapentina Tevagen with opioids may cause drowsiness, sedation, reduced breathing, or death.
Antacids for indigestion
If you take gabapentin at the same time as antacids containing aluminium and magnesium, the absorption of Gabapentina Tevagen in the stomach may be reduced. It is therefore recommended that Gabapentina Tevagen be taken at least two hours after taking an antacid.
Gabapentina Tevagen
- no interaction between Gabapentina Tevagen and other antiepileptic medicines or oral contraceptive pills is expected.
- 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 Gabapentina Tevagen with food, drinks, and alcohol
Food does not affect the absorption of Gabapentina Tevagen.
Pregnancy, breast-feeding, and fertility
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
You should not take Gabapentina Tevagen during pregnancy unless your doctor has told you to. An effective method of contraception should be used in women of childbearing age.
There are no specific studies on the use of gabapentin in pregnant women, but for other medicines used to treat seizures, an increased risk of harm to the developing baby has been reported, particularly when more than one medicine is used to treat seizures at the same time. Therefore, whenever possible, it is advisable to take only one antiepileptic medicine during pregnancy, and only under the advice of your doctor.
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).
Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking Gabapentina Tevagen. Do not stop taking this medicine abruptly, as this may trigger seizures, which could have serious consequences for both you and your baby.
Breast-feeding
Gabapentin, the active substance in Gabapentina Tevagen, passes into breast milk. Breast-feeding is not recommended while taking Gabapentina Tevagen, as the effect on the baby is unknown.
Fertility
No effects on fertility were observed in animal studies.
Driving and using machines
Gabapentin may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these activities.
Gabapentina Tevagen 300 mg capsules contain sunset yellow FCF.
This medicine can cause allergic reactions because it contains sunset yellow FCF. It may cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Gabapentina Tevagen
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, 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 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 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.
Children aged 6 years and older
Your doctor will decide the dose for your child based on the child's weight. Treatment will start with a low initial dose, which will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25–35 mg per kg per day. This dose is usually administered by taking the capsules in three equal doses per day, typically one in the morning, one at midday, and one at night.
The use of Gabapentina Tevagen 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 3,600 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 receiving hemodialysis treatment
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 Gabapentina Tevagen, unless you have kidney problems. Your doctor may prescribe a different dosing schedule or different doses if you have kidney problems.
If you think that the effect of Gabapentina Tevagen is too strong or too weak, inform your doctor or pharmacist as soon as possible.
Method of administration
Gabapentina Tevagen is administered orally. Always swallow the capsules whole with sufficient water.
Continue taking Gabapentina Tevagen until your doctor tells you to stop.
If you take more Gabapentina Tevagen than you should
Doses higher than those recommended may cause an increase in adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhea. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department. Bring any capsules you have not taken, together with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.
If you forget to take Gabapentina Tevagen
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 forgotten doses.
If you stop taking Gabapentina Tevagen
Do not stop taking Gabapentina Tevagen suddenly or reduce the dose without consulting your doctor first. If you wish to stop taking Gabapentina Tevagen 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 Gabapentina Tevagen or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling of discomfort (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Tevagen 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 or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop taking gabapentin and seek immediate medical attention if you notice any of the following symptoms:
- Raised red patches with a target or circular shape on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, and eye ulcers. 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).
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 symptoms of a severe allergic reaction)
- Persistent stomach pain, vomiting, and nausea, as they may indicate acute pancreatitis (inflammation of the pancreas)
- Gabapentin Tevagen 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. A rash may or may not be present in this type of reaction. This may require discontinuation of Gabapentin Tevagen or even hospitalization.
- Breathing difficulties that, if severe, may require emergency medical treatment to maintain normal breathing
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 lip 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. You should be examined by a doctor to determine whether you should continue taking gabapentin.
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, infection, ear inflammation, or other infections,
? Low white blood cell count,
? Anorexia, increased appetite,
? Irritability towards others, confusion, mood changes, depression, anxiety, restlessness,
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 vision, 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, jerking,
? Erectile difficulties,
? Swelling in the arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms,
? Decreased leukocytes,
? Weight gain,
? Accidental injuries, fractures, abrasions.
Additionally, in clinical trials in children, aggressive behavior and jerking were reported as common adverse effects.
Uncommon (may affect up to 1 in 100 people)
? Agitation (a state of chronic restlessness and involuntary, purposeless movements),
- Allergic reactions such as hives
- Decreased movement
- Rapid heartbeat
? Difficulty swallowing,
- Swelling affecting the face, trunk, and limbs
- Abnormal blood test results that may indicate liver problems
? Falls
? Progressive mental impairment?
- Increased blood glucose levels (observed more frequently in patients with diabetes)
Rare (may affect up to 1 in 1,000 people)
- Loss of consciousness
- Decreased blood glucose levels (observed more frequently in patients with diabetes)
- Breathing problems, shallow breathing (respiratory depression)
Frequency not known: (cannot be estimated from available data)
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Suicidal thoughts.
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Development of dependence on gabapentin (“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 Tevagen or after reducing the dose (see "If you stop taking Gabapentin Tevagen").
The following adverse effects have been reported following the marketing of Gabapentin Tevagen:
? Decreased platelet count (blood clotting cells),
? Hallucinations,
? Abnormal movement problems such as twisting movements, spasmodic movements, and rigidity,
? 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 abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
- Muscle fiber breakdown (rhabdomyolysis)
- Changes in blood test results (elevated creatine phosphokinase)
- Sexual function problems, such as inability to achieve orgasm and delayed ejaculation
- Low sodium levels in the blood
- Anaphylaxis (severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
- Worsening of myasthenia gravis (a disease causing muscle weakness).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gabapentin Tevagen
Keep this medicine 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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Gabapentin Tevagen
The active substance is gabapentin. Each capsule contains 300 mg of gabapentin.
The other components (excipients) are: talc, pregelatinized starch (derived from corn).
Excipients of the capsule cap/body: titanium dioxide (E171), erythrosine (E127), orange yellow S (E110), and gelatin.
Printing ink: shellac, black iron oxide (E172), and propylene glycol.
Appearance of the product and contents of the pack
Gabapentin Tevagen 300 mg is presented as hard capsules with orange cap and body, containing a white to off-white powder with small aggregates.
The capsule cap and body are marked with the numbers '93' and '39'.
Each pack contains 30 or 90 capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura 11,
Edificio Albatros B, 1st floor,
28108 Alcobendas, Madrid, Spain
Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi Street 13,
Debrecen, H-4042
Hungary
Date of the most recent review of this leaflet: April 2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/