Gabapentin Stada 800 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Gabapentina Stada 600 mg film-coated tablets EFG
Gabapentina Stada 800 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
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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:
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What Gabapentina Stada is and what it is used for
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What you need to know before taking Gabapentina Stada
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How to take Gabapentina Stada
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Possible side effects
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How to store Gabapentina Stada
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Contents of the pack and other information
1. What Gabapentina Stada is and what it is used for
Gabapentina Stada belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Gabapentina Stada is gabapentin.
Gabapentin is used to treat:
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Various forms of epilepsy (seizures that initially affect specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor will prescribe gabapentin to help manage your epilepsy when your current treatment does not fully control your condition. You should take gabapentin in addition to your current treatment, unless otherwise instructed. Gabapentin may also be used as monotherapy to treat adults and children over 12 years of age.
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Peripheral neuropathic pain (chronic pain caused by nerve damage). Several conditions can cause peripheral neuropathic pain (occurring mainly in the legs, arms, or both), such as diabetes or shingles. The pain may be described as heat, burning, throbbing, shooting, stabbing, sharp, continuous pain, tingling, numbness, or pins and needles, among others.
2. What you need to know before taking Gabapentina Stada
DO NOT take Gabapentina Stada
- If you are allergic to gabapentin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking gabapentin
- 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 experience muscle pain and/or weakness
- if you develop symptoms such as persistent stomach pain, vomiting, and nausea, 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.
A small number of people taking antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If you ever have such thoughts, contact your doctor immediately.
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 Stada" and "If you stop taking Gabapentina Stada"). 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, this 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 symptoms related to these serious skin reactions described in section 4.
Muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell or fever, could be due to abnormal muscle breakdown, which can be potentially life-threatening and may lead to kidney problems. You may also experience discoloration of the 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.
Other medicines and Gabapentina Stada
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 any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of gabapentin. In addition, the combination of gabapentin with opioids may cause symptoms such as drowsiness and/or reduced breathing.
Antacids for indigestion
If you take gabapentin at the same time as antacids containing aluminum and magnesium, the absorption of gabapentin in the stomach may be reduced. Therefore, it is recommended that gabapentin be taken at least two hours after taking an antacid.
Gabapentina Stada
- interactions between gabapentin and other antiepileptic medicines or oral contraceptives are not expected.
- may interfere with certain laboratory tests; if you require a urine test, inform your doctor or hospital that you are taking gabapentin.
Taking Gabapentina Stada with food
Gabapentin may 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
Gabapentin should not be taken during pregnancy unless your doctor tells you otherwise. Women of childbearing potential should use an effective method of contraception.
There are no specific studies on the use of gabapentin in pregnant women, but with 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 recommended to take only one seizure medicine during pregnancy and only under the advice of your doctor.
Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking gabapentin.
Do not stop taking this medicine abruptly, as this may lead to an increased risk of 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 substance in Gabapentina Stada, passes into breast milk. As the effect on the infant is unknown, breastfeeding is not recommended while you are taking gabapentin.
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 complex machinery, or engage in potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Gabapentina Stada contains soya lecithin
If you are allergic to peanuts or soya, do not take this medicine.
3. How to take Gabapentina Stada
Follow exactly the instructions for using 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 decide the most appropriate dose for you.
Epilepsy, the recommended dose is
Adults and adolescents
Take the number of tablets 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, which is divided into three equal doses, for example, one in the morning, one at midday, and one at night.
Children aged 6 years or older
Your doctor will determine 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 normally administered in three divided doses throughout the day, typically one in the morning, one at midday, and one at night.
The use of gabapentin is not recommended in children under 6 years of age.
Peripheral neuropathic pain, the recommended dose is
Adults
Take the number of tablets prescribed by your doctor. Generally, your doctor will gradually increase your dose. The initial dose is usually 300 to 900 mg daily. Afterwards, the dose may be increased, following your doctor’s instructions, up to a maximum of 3,600 mg daily. Your doctor will instruct you to take this dose in three separate doses, i.e., one in the morning, one in the afternoon, and one at night.
If you have kidney problems or are undergoing haemodialysis
Your doctor may prescribe a different dosing schedule and/or different doses if you have kidney problems or are undergoing haemodialysis.
If you are an elderly patient (over 65 years of age)
You should take the normal dose of gabapentin unless you have kidney problems. Your doctor may prescribe a different dosing schedule or different doses if you have kidney problems.
If you think the effect of gabapentin is too strong or too weak, inform your doctor or pharmacist as soon as possible.
Method of administration
Gabapentin is for oral use. Always swallow the tablets whole with plenty of water. Continue taking gabapentin until your doctor tells you to stop.
If you take more Gabapentina Stada than you should
Doses higher than recommended may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhoea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital emergency department if you take more gabapentin than prescribed. Bring any tablets 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 Stada
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 Gabapentina Stada
Do not stop taking gabapentin suddenly. If you wish to discontinue gabapentin, 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. These 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 gabapentin treatment. If you experience this withdrawal syndrome, 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:
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Red, non-raised, target-shaped or circular rashes 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)
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Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
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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 serious allergic reaction)
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Persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas)
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Gabapentin may cause a serious or potentially life-threatening allergic reaction affecting your skin or other parts of the body such as the liver or blood cells. While experiencing this type of reaction, you may or may not develop a rash. This reaction may require hospitalization or discontinuation of gabapentin treatment. Call your doctor immediately if you have any of the following symptoms:
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Skin rash
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Hives
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Fever
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Swollen lymph nodes that do not go away
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Swelling of the lips and tongue
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Yellowing of the skin or whites of the eyes
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Bruising or unusual bleeding
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Severe fatigue or weakness
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Unexpected muscle pain
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Frequent infections
These symptoms may be early signs of a serious reaction. A doctor should examine you and decide whether you should continue taking gabapentin.
- If you are on hemodialysis, inform your doctor if you experience muscle pain, weakness, or both.
- Breathing difficulties that, if severe, may require emergency medical treatment to maintain normal breathing.
Other possible adverse effects include:
Very common (may affect more than 1 in 10 people):
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Viral infection.
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Drowsiness, dizziness, lack of coordination.
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Fatigue, fever.
Common (may affect up to 1 in 10 people):
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Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections.
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Decreased number of white blood cells.
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Anorexia, increased appetite.
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Irritability, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking.
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Seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), coordination difficulties, unusual eye movements; increased, decreased, or absent reflexes.
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Blurred vision, double vision.
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Dizziness.
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Increased blood pressure, flushing or hot flashes, or blood vessel dilation.
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Difficulty breathing, bronchitis, sore throat, cough, dry nose.
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Vomiting, nausea, dental problems, gum inflammation, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence.
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Facial swelling, bruising, skin rash, itching, acne.
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Joint pain, muscle pain, back pain, tics.
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Erectile difficulties (impotence).
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Swelling of arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms.
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Decreased number of white blood cells, weight gain.
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Accidental injury, fracture, abrasion.
Additionally, in clinical studies conducted in children, aggressive behavior and spasmodic movements have been frequently reported.
Uncommon (may affect up to 1 in 100 people):
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Allergic reaction, such as hives.
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Decreased movement.
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Increased heart rate.
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Swelling that may affect the face, trunk, and limbs.
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Abnormal blood test results suggesting liver problems.
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Progressive mental impairment.
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Fall.
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Increased blood glucose levels (observed more frequently in patients with diabetes).
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Agitation (a state of chronic restlessness and involuntary, purposeless movements).
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Difficulty swallowing.
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).
Following the marketing of gabapentin, the following adverse effects have been reported:
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Decreased platelet count (blood cells that help clotting).
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Hallucinations.
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Abnormal movement problems such as twisting movements, spasmodic movements, and stiffness.
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Ringing in the ears.
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Yellowish appearance of the skin and eyes (jaundice), liver inflammation.
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Acute kidney failure, incontinence.
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Breast tissue growth, breast enlargement.
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Adverse reactions after abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, nausea, pain, sweating), chest pain.
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Muscle fiber breakdown (rhabdomyolysis).
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Changes in blood test results (elevated creatine phosphokinase).
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Sexual function problems, such as inability to achieve orgasm and delayed ejaculation.
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Low sodium levels in the blood.
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Anaphylaxis (serious, potentially life-threatening allergic reaction, including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment).
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Suicidal thoughts.
Frequency not known (cannot be estimated from available data):
- Development of dependence on gabapentin (“drug dependence”).
After stopping short- or long-term treatment with gabapentin, you should be aware that you may experience certain side effects known as withdrawal effects (see “If you stop taking Gabapentin Stada”).
Other possible adverse effects
In very rare cases, soybean-derived unsaturated phospholipids may cause allergic reactions.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Stada
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. Ask your pharmacist how to get rid of medicines and packaging you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Gabapentina Stada
The active substance is gabapentin. Each film-coated tablet contains 600 mg or 800 mg of gabapentin.
The other components of the tablets are:
Tablet core: macrogol 4000, pregelatinized starch (from maize), colloidal anhydrous silica, magnesium stearate.
Coating: poly(vinyl alcohol), titanium dioxide (E171), talc, soya lecithin, xanthan gum.
Appearance of the product and contents of the pack
Film-coated tablet.
The 600 mg film-coated tablets are white, capsule-shaped, film-coated tablets with a logo (600) engraved on one side.
The 800 mg film-coated tablets are white, capsule-shaped and film-coated.
They are supplied in PVC/aluminum blisters containing:
10 film-coated tablets.
20 film-coated tablets.
30 film-coated tablets.
40 film-coated tablets.
50 film-coated tablets.
60 film-coated tablets.
90 film-coated tablets.
100 film-coated tablets.
120 film-coated tablets.
200 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
Centrafarm B.V.
Van de Reijstraat 31-E
4814 NE Breda
The Netherlands
or
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany Gabapentin AL 600 mg Filmtabletten
Gabapentin AL 800 mg Filmtabletten
Spain Gabapentina Stada 600 mg film-coated tablets EFG
Gabapentina Stada 800 mg film-coated tablets EFG
France GABAPENTINE EG LABO 600 mg, comprimé pelliculé
GABAPENTINE EG LABO 800 mg, comprimé pelliculé
Netherlands Gabapentine CF 600 mg, filmomhulde tabletten
Gabapentine CF 800 mg, filmomhulde tabletten
Date of the most recent revision of this leaflet: 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