GABAPENTINE STADA 600 mg FILM-COATED TABLETS

2. What you need to know before you take 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

Consult your doctor or pharmacist before taking gabapentin

• if you have kidney problems, your doctor may prescribe a different dosage 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, inform your doctor immediately as they 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 who are treated with antiepileptics such as gabapentin have had thoughts of harming themselves or suicide. If at any time you have these thoughts or ideas, consult your doctor immediately.

Before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of becoming dependent on gabapentin.

Dependence

Some people may become dependent 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 becoming dependent on gabapentin, it is essential that you consult your doctor.

If you experience any of the following signs while taking gabapentin, it may indicate that you have become dependent.

• You feel that you need to take the medicine for a longer period than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medicine for reasons other than your prescription.
• 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 take it again.

If you notice any of the above, talk to your doctor to decide on the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

Important information about potentially serious reactions

Severe skin reactions have been reported in association with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Muscle weakness, sensitivity, or pain, and especially if you feel unwell or have a fever, could be due to abnormal muscle breakdown, which can be potentially life-threatening and may lead to kidney problems. You may also experience urine discoloration and changes in blood test results (significant increase in creatine phosphokinase in blood). 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 take any other medicines. In particular, inform your doctor (or pharmacist) if you are taking or have recently taken any medicine for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric problem.

Medicines containing opioids such as morphine

If you are taking any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids can cause symptoms such as drowsiness and/or decreased 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. It is recommended that gabapentin be taken at least two hours after taking an antacid.

Gabapentina Stada

• gabapentin is not expected to interact with other antiepileptics or with the contraceptive pill.
• may interfere with some laboratory tests; if you need a urine test, inform your doctor or hospital that you are taking gabapentin.

Taking Gabapentina Stada with food

Gabapentina 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Gabapentina should not be taken during pregnancy, unless your doctor tells you otherwise. Women of childbearing age should use an effective method of contraception.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of 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. Therefore, whenever possible, you should try to take only one medicine for seizures during pregnancy and only under the advice of your doctor.

Contact your doctor immediately if you become pregnant, think you may be pregnant, or are planning to become pregnant while taking gabapentina.

Do not stop taking this medicine suddenly, as this may cause your seizures to happen more often, which could have serious consequences for you and your baby.

If you take gabapentina during pregnancy, it may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid painkillers (such as morphine).

Breastfeeding

Gabapentina, the active substance of Gabapentina Stada, passes into breast milk. As the effect on the child is unknown, breastfeeding is not recommended while taking gabapentina.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina may cause dizziness, drowsiness, and fatigue. You should not drive, use complex machines, or engage in potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Gabapentina Stada contains soy lecithin

If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Gabapentina Stada

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the prescribed dose.

Your doctor will decide what dose is best for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of tablets that your doctor has told you to. Your doctor will usually increase your dose gradually. The initial dose will generally be 300 to 900 mg per day. From then on, the dose may be increased, following your doctor's instructions, 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 in the evening.

Children aged 6 years and older

Your doctor will decide on the dose to be given to your child based on the child's weight. The treatment will begin 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. The dose is usually given by taking the tablets, divided into 3 equal doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentina is not recommended for use in children below 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of tablets that your doctor has prescribed for you. Your doctor will usually increase your dose gradually. The initial dose will generally be 300 to 900 mg per day. From then on, the dose may be increased, following your doctor's instructions, 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 in the evening.

If you have kidney problems or are on hemodialysis

Your doctor may prescribe a different dosage regimen and/or different doses if you have kidney problems or are on hemodialysis.

If you are an elderly patient (over 65 years of age)

You should take the normal dose of gabapentina, unless you have kidney problems. Your doctor may prescribe a different dosage regimen or different doses if you have kidney problems.

If you think that the effect of gabapentina is too strong or too weak, tell your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina is for oral use. Always swallow the tablets whole with plenty of water. Continue taking gabapentina until your doctor tells you to stop.

If you take more Gabapentina Stada than you should

Doses higher than recommended may cause an increase in side 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, phone 91 562 04 20, indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital if you take more gabapentina than your doctor prescribed. Bring any remaining tablets, along with the packaging and 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 time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Gabapentina Stada

Do not stop taking gabapentina suddenly. If you want to stop taking gabapentina, talk to your doctor first. Your doctor will tell you how to proceed. If you are going to stop treatment, it should be done gradually over a minimum of one week. You should know that you may experience certain side effects, called withdrawal syndrome, after stopping treatment with gabapentina at short or long term. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with gabapentina. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking gabapentina and seek immediate medical attention if you notice any of these symptoms:

• red patches without relief with a target or circular shape on the trunk, often with blisters in the center; skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

• severe skin reactions that require immediate attention, swelling of the lips and face, skin rash, and redness, and/or hair loss (can be symptoms of a severe allergic reaction)

• persistent stomach pain, vomiting, and nausea, as they can be symptoms of acute pancreatitis (inflammation of the pancreas)

• gabapentina can cause a severe or potentially life-threatening allergic reaction that can affect your skin or other parts of your body, such as the liver or blood cells. While suffering from this type of reaction, you may or may not present a rash. This reaction can cause hospitalization or withdrawal of treatment with gabapentina. Call your doctor immediately if you have any of the following symptoms:

• skin rash

• hives

• fever

• swollen lymph nodes that do not disappear

• swelling of the lip and tongue

• yellowing of the skin or whites of the eyes

• bruises or unusual bleeding

• 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 and decide if you should continue taking gabapentina.

• if you are on hemodialysis, inform your doctor if you experience muscle pain, weakness, or both.
• breathing problems that, if severe, may require urgent medical attention to breathe normally.

Other adverse effects may be the following:

Very common(may affect more than 1 in 10 people):

• Viral infection.

• Feeling of drowsiness, dizziness, lack of coordination.

• Fatigue, fever.

Common (may affect up to 1 in 10 people):

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections.
• Decrease in the number of white blood cells.
• Anorexia, increased appetite.
• Irritability towards others, confusion, mood changes, depression, anxiety, nervousness, difficulty thinking.
• Seizures, spasmodic movements, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, sensitive skin, decreased sensitivity (numbness), difficulty with coordination, unusual eye movements; increased, decreased, or absent reflexes.

• Blurred vision, double vision.

• Vertigo.

• Increased blood pressure, flushing, or dilation of blood vessels.

• Difficulty breathing, bronchitis, sore throat, cough, dryness of the nose.

• Vomiting, nausea, dental problems, gum inflammation, diarrhea, stomach pain, indigestion, constipation, dryness of the mouth or throat, flatulence.

• Facial swelling, bruising, skin rash, itching, acne.

• Joint pain, muscle pain, back pain, tics.

• Difficulty with erection (impotence).

• Swelling of the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms.

• Decrease in the number of white blood cells, weight gain.

• Accidental injury, fracture, abrasion.

Additionally, in clinical studies conducted with children, aggressive behavior and spasmodic movements have been frequently reported.

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

• Allergic reaction, such as hives.

• Decreased movement.

• Increased heart rate.

• Swelling that can affect the face, trunk, and extremities.

• Abnormal blood test results suggesting liver problems.
• Progressive mental damage.
• Fall.
• Increased blood glucose levels (more frequently observed in patients with diabetes).
• Agitation (a state of chronic restlessness and involuntary, purposeless movements).
• Difficulty swallowing.

Rare (may affect up to 1 in 1,000 people):

• Loss of consciousness.
• Decrease in blood glucose levels (more frequently observed in patients with diabetes).
• Breathing problems, shallow breathing (respiratory depression).

After the marketing ofgabapentina, the following adverse effects have been reported:

• Decrease in platelet count (blood cells that clot blood).

• Hallucinations.

• Abnormal movement problems such as contortions, spasmodic movements, and stiffness.

• Ringing in the ears.

• Yellowing of the skin and eyes (jaundice), liver inflammation.

• Acute kidney failure, incontinence.

• Increased breast tissue, breast enlargement.

• Adverse reactions after acute discontinuation of gabapentina (anxiety, difficulty sleeping, nausea, pain, sweating), chest pain.

• Rupture of muscle fibers (rhabdomyolysis).

• Changes in blood test results (elevated creatine phosphokinase).
• Problems with sexual activity, such as inability to reach orgasm and delayed ejaculation.
• Low sodium levels in the blood.
• Anaphylaxis (severe, potentially life-threatening allergic reaction, including difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment).
• Suicidal thoughts.

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

• Developing dependence on gabapentina (“drug dependence”).

After suspending short- or long-term treatment with gabapentina, you should know that you may experience certain side effects, called withdrawal effects (see “If you stop treatment with Gabapentina Stada”).

Other possible adverse effects

In very rare cases, unsaturated soy phospholipids can cause allergic reactions.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Gabapentina Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina Stada

The active ingredient is gabapentina. Each film-coated tablet contains 600 mg or 800 mg of gabapentina.

The other components of the tablets are:

Core of the tablet: macrogol 4000, pregelatinized starch (from corn), colloidal anhydrous silica, magnesium stearate.

Coating: poly(vinyl) alcohol, titanium dioxide (E171), talc, soy lecithin, xanthan gum.

Appearance of the product and package contents

Film-coated tablet.

The 600 mg film-coated tablets are white, capsule-shaped, and film-coated, 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 packaging:

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.

Not all package 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

[email protected]

Manufacturer

Centrafarm B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Gabapentin AL 600 mg film-coated tablets

Gabapentin AL 800 mg film-coated tablets

Spain Gabapentina Stada 600 mg film-coated tablets EFG

Gabapentina Stada 800 mg film-coated tablets EFG

France GABAPENTINE EG LABO 600 mg, film-coated tablet

GABAPENTINE EG LABO 800 mg, film-coated tablet

Netherlands Gabapentine CF 600 mg, film-coated tablets

Gabapentine CF 800 mg, film-coated tablets

Date of the last revision of this prospectus:March 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

/