Gabapentin Teva 100 mg hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gabapentin Teva 100 mg hard capsules 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 or pharmacist.
- 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. It could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Gabapentin Teva is and what it is used for.
- What you need to know before taking Gabapentin Teva.
- How to take Gabapentin Teva.
- Possible side effects.
- How to store Gabapentin Teva.
- Contents of the pack and other information
1. What Gabapentin Teva is and what it is used for
Gabapentin Teva 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 Teva is gabapentin.
Gabapentin Teva 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 they spread to other areas of the brain). Your doctor or your child's doctor (aged 6 years or older) may prescribe Gabapentin Teva 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 by your doctor. Gabapentin Teva may also be used as monotherapy in the treatment of adults and children aged 12 years and older.
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Peripheral neuropathic pain (chronic pain caused by nerve damage). Various medical conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles. The pain may be described as burning, tingling, shooting, stabbing, sharp, pulsating, constant pain, pins and needles, numbness, spasms, or prickling sensations, etc.
2. What you need to know before taking Gabapentina Teva
Do not take Gabapentina Teva
- if you are allergic 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 taking Gabapentina Teva
- if you have kidney problems, your doctor may prescribe a different dosing regimen.
- if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor if you experience muscle pain and/or weakness.
- if you develop symptoms such as persistent stomach pain, dizziness or feeling faint, contact 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.
- 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.
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 (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.
- You feel unwell when you stop taking the medicine and feel better when you take 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.
A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor immediately.
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 serious 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 may be serious.”
Muscle weakness, tenderness or pain on palpation, especially if accompanied by feeling unwell or fever, could be due to abnormal breakdown of muscle fibres, which may lead to kidney problems and may be life-threatening. You may also experience discoloured 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 Teva with other medicines
Inform 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 containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of Gabapentina Teva.
In addition, the combination of Gabapentina Teva with opioids may cause symptoms such as drowsiness, sedation, reduced breathing, or death.
Antacids for indigestion
If you take Gabapentina Teva at the same time as antacids containing aluminium or magnesium, the absorption of Gabapentina Teva in the stomach may be reduced. Therefore, it is recommended that Gabapentina Teva be taken at least two hours after taking an antacid.
Gabapentina Teva
- is not expected to interact with other antiepileptic medicines or with oral contraceptive pills.
- may interfere with certain laboratory tests, so if you require a urine test, inform your doctor or hospital that you are taking Gabapentina Teva.
Pregnancy, breastfeeding and fertility
- If you are pregnant or think you may be pregnant, you must inform your doctor immediately to discuss the possible risks that the medicine you are taking may pose to the unborn baby.
- You should not stop your treatment without first discussing it with your doctor.
- If you are planning to become pregnant, you should review your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
If you are breastfeeding or considering breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Gabapentina Teva may be used during the first trimester of pregnancy if necessary.
If you are planning to become pregnant, are pregnant, or think you may be pregnant, consult your doctor immediately.
If you become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening of your epilepsy could put both you and your unborn baby at risk.
In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, there was no increased risk of birth defects or problems with brain function development (neurodevelopmental disorders). However, babies born to women who took gabapentin during pregnancy had a higher risk of low birth weight and premature birth.
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 may be pregnant, or plan to become pregnant while taking Gabapentina Teva. Do not stop taking this medicine abruptly, as this may trigger epileptic seizures, which could have serious consequences for both you and your baby.
Breastfeeding
Gabapentin, the active ingredient in Gabapentina Teva, passes into breast milk. Breastfeeding is not recommended while taking Gabapentina Teva, as the effect on infants is unknown.
Fertility
No effects on fertility were observed in animal studies.
Driving and using machines
Gabapentina Teva may cause dizziness, drowsiness and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these tasks.
3. How to take Gabapentina Teva
Follow exactly the dosing instructions for this medicine provided 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 indicated by your doctor. Your doctor will usually gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, under medical prescription, up to a maximum dose of 3600 mg per day, divided into three separate doses, for example, one in the morning, one at midday, and one at night.
Children aged 6 years or older
Your doctor will decide the dose to administer to 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/kg/day. The dose is normally administered by taking the capsules, divided into three separate doses per day, usually one in the morning, one at midday, and one at night.
The use of Gabapentina Teva is not recommended in children under 6 years of age.
Peripheral neuropathic pain, the recommended dose is
Adults
Take the number of capsules indicated by your doctor. Your doctor will usually 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 at midday, and one at night.
If you have kidney problems or are receiving hemodialysis treatment
Your doctor may prescribe a different dosing regimen and/or different doses if you have kidney problems or are receiving hemodialysis treatment.
If you are an elderly patient (over 65 years of age)
You should take the normal dose of Gabapentina Teva, unless you have kidney problems. Your doctor may prescribe a different dosing regimen or different doses if you have kidney problems.
If you think the effect of Gabapentina Teva is too strong or too weak, inform your doctor or pharmacist as soon as possible.
Method of administration
Gabapentina Teva is administered orally.
Always swallow the capsules whole with sufficient water.
Gabapentina Teva may be taken with or without food.
Continue taking Gabapentina Teva until your doctor tells you to stop.
If you take more Gabapentina Teva than you should
Doses higher than those recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, difficulty speaking, numbness, and diarrhea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone: 91 562 04 20 immediately if you have taken more Gabapentina Teva than prescribed, indicating the medicine and amount ingested, or go to the nearest hospital emergency department if you have taken more Gabapentina Teva than prescribed by your doctor. Bring any unused capsules, together with the container and package leaflet, so that the hospital can easily identify the medicine you have taken.
If you forget to take Gabapentina Teva
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 Teva
Do not stop taking Gabapentina Teva suddenly. If you wish to stop taking Gabapentina Teva, 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 Gabapentina Teva. These may 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 treatment with Gabapentina Teva. 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking gabapentin and seek immediate medical attention if you notice any of the following symptoms:
- red, non-raised circular or target-shaped rashes 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:
- persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas)
- breathing difficulties, which, if severe, may require emergency medical treatment to maintain normal breathing.
- Gabapentin Teva 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. A rash may or may not be present when this type of reaction occurs. This may require discontinuation of Gabapentin Teva or even hospitalization.
Contact your doctor immediately if you have any of the following symptoms after taking this medicine, as they may be serious:
- skin rash and redness and/or hair loss
- hives
- fever
- persistent swelling of the glands
- swelling of the lips, face, and tongue
- yellowing of the skin or whites of the eyes
- bruising or unusual bleeding
- severe tiredness 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 Teva.
If you are on hemodialysis, inform your doctor if you develop muscle pain and/or weakness.
Other side effects include
Very common side effects (may affect more than 1 in 10 people):
- Viral infection
- Drowsiness, dizziness, lack of coordination
- Feeling tired, fever
Common side effects (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
- Loss of appetite, increased appetite
- Irritability, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking
- Seizures, jerking, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, skin sensitivity, decreased sensation (numbness), coordination problems, unusual eye movements, increased, decreased, or absent reflexes
- Blurred vision, double vision
- Dizziness
- Increased blood pressure, flushing or dilation of blood vessels
- Difficulty breathing, bronchitis, sore throat, cough, dry nose
- Vomiting (feeling sick), nausea (feeling of sickness), dental problems, swollen gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
- Facial swelling, bruising, rash, itching, acne
- Joint pain, muscle pain, back pain, spasms
- Erectile difficulties (impotence)
- Swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
- Decreased white blood cells, weight gain
- Accidental injuries, fractures, abrasions
Additionally, in clinical trials in children, the following were reported as common side effects:
sudden jerky movements and aggressive behavior
Uncommon side effects (may affect up to 1 in 100 people):
- Agitation (a state of chronic restlessness and involuntary, purposeless movements)
- Allergic reaction such as hives
- Decreased movement
- Increased heart rate
- Difficulty swallowing
- Swelling that may affect the face, trunk, and limbs
- Abnormal blood test results suggesting liver problems
- Progressive mental impairment
- Falls
- Increased blood glucose levels (observed more frequently in patients with diabetes)
- Difficulty swallowing
Rare side effects (may affect up to 1 in 1,000 people):
- Decreased blood glucose levels (observed more frequently in patients with diabetes)
- Loss of consciousness
- Breathing problems, shallow breathing (respiratory depression)
The following side effects have been reported since the medicine was marketed:
- Decreased platelet count (blood clotting cells)
- Suicidal thoughts, hallucinations
- Abnormal movement problems such as: twisting movements, spasmodic movements, and stiffness
- Ringing in the ears
- Yellowing of the skin and eyes (jaundice), liver inflammation
- Acute kidney failure, incontinence
- Breast tissue enlargement, breast enlargement
- Rupture of muscle fibers (rhabdomyolysis)
- Changes in blood test results (elevated creatine phosphokinase)
- Sexual function problems, such as inability to reach orgasm and delayed ejaculation
- Low sodium levels in the blood
- Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
- Development of dependence on gabapentin (“drug dependence”)
You should be aware that you may experience certain side effects called withdrawal symptoms after stopping short-term or long-term treatment with Gabapentin Teva (see "If you stop taking Gabapentin Teva").
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Gabapentin Teva
Keep this medicine out of the 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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Gabapentin Teva
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The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin.
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The other components of Gabapentin Teva 100 mg capsules are: Talc, pregelatinized starch (corn), Capsule shell / body: Gelatin, black iron oxide (E172), titanium dioxide (E171), Printing ink: Shellac, black iron oxide (E172), propylene glycol.
Appearance of the product and contents of the pack
Hard gelatin capsule with grey body and cap, containing a white to almost white powder with small aggregates.
The cap and body of the capsule are marked with the numbers '93' and '38'.
Pack size: 90 hard 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 út 13, 4042 Debrecen
Hungary
or
TEVA PHARMA B.V.
Industrieweg 23, P.O. Box 217
Micheldegracht, the Netherlands
or
Pharmachemie B.V.
Swensweg 5,
2031 GA Haarlem
the Netherlands
This medicine has been authorized in member states under the following names:
Norway: Gabapentin TEVA 100 mg hard capsule
Spain: Gabapentina Teva 100 mg Capsules
Date of the most recent review of this leaflet: June 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/