GABAPENTINA STADA 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina Stada 300 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What is Gabapentina Stada and what is it used for
2. What you need to know before you take Gabapentina Stada
3. How to take Gabapentina Stada
4. Possible side effects
5. Storing Gabapentina Stada
6. Contents of the pack and other information

1. What is Gabapentina Stada and what is it used for

Gabapentina Stada belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by damage to the nerves).

The active substance of Gabapentina Stada is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures that are initially limited to certain parts of the brain, whether or not the seizure spreads to other parts of the brain). Your doctor will prescribe gabapentin for you or your child aged 6 years or older to help treat your epilepsy when your current treatment is no longer controlling your condition. You or your child aged 6 years or older should take gabapentin in combination with your current treatment unless told otherwise. Gabapentin can also be given as the only medicine in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (long-lasting pain caused by damage to the nerves). There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing, shooting, stabbing, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

2. What you need to know before you take Gabapentina Stada

Do not take Gabapentina Stada:

• if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentina Stada:

• if you have kidney problems, your doctor may prescribe a different dosing schedule
• if you are on hemodialysis (to remove waste products due to kidney failure), tell your doctor if you start to feel muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, tell 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.
• before taking this medicine, tell 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.

There have been reports of abuse and dependence on gabapentin from post-marketing experience. Talk to your doctor if you have a history of abuse or dependence.

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 as soon as possible.

Dependence

Some people may become dependent on gabapentin (need to keep taking the medicine). They may have 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 important to talk to your doctor.

If you experience any of the following signs while taking gabapentina, it may be a sign that you have become dependent:

• You feel that you need to take the medicine for longer than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medicine for reasons other than prescribed.
• You have tried to stop taking the medicine or control how you take it several times 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, 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 with the use of gabapentin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentina and seek medical attention immediately 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"Stop taking gabapentina and seek medical attention immediately if you notice any of these symptoms"

Muscle weakness, tenderness, or pain on palpation, and especially if you feel unwell or have a fever, could be due to abnormal breakdown of muscle fibers, which can lead to kidney problems and put your life at risk. You may also experience discoloration of the urine and changes in blood test results (significant increase in creatine phosphokinase in the blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Using Gabapentina Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell 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 that contains opioids (such as morphine), tell your doctor or pharmacist, as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids may cause symptoms such as drowsiness and/or decreased breathing.

Antacids for indigestion

If you take gabapentina at the same time as antacids that contain aluminum and magnesium, the absorption of gabapentina in the stomach may be reduced. Therefore, it is recommended that gabapentina be taken at least 2 hours after taking an antacid.

Gabapentina:

• is not expected to interact with other antiepileptic medicines or with the oral contraceptive pill.
• may interfere with some laboratory tests, so if you need a urine test, tell your doctor or hospital what you are taking.

Taking Gabapentina Stada with food, drinks, and alcohol

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

Do not take gabapentina during pregnancy, unless your doctor has told you to. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies on the use of gabapentina in pregnant women, but with other medicines used to treat seizures, there have been reports of an increased risk of harm to the developing baby, 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.

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 (strong pain-relieving medicines).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentina. Do not stop taking this medicine suddenly, as this may cause seizures to return, which could have serious consequences for you and your baby.

Breastfeeding

Gabapentin, the active substance of gabapentina, passes into breast milk. Breastfeeding is not recommended while taking gabapentina, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

Gabapentina Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Gabapentina Stada

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more than the recommended dose.

Your doctor will determine the dose that is right for you.

Epilepsy, the recommended dose is

Adults and adolescents:

Take the number of capsules that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be between 300 and 900 mg per day. The dose may then be increased, as advised by your doctor, up to a maximum 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 the dose to give to your child based on the child's weight. The treatment will start with a low initial dose, which will be gradually increased over approximately 3 days. The usual dose to control epilepsy is 25-35 mg per kg per day. The dose is usually given in three divided doses, for example, one in the morning, one at noon, and one in the evening.

Gabapentina should not be used in children below 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults:

Take the number of capsules that your doctor has told you to. Your doctor will usually start you on a low dose and gradually increase it. The initial dose will generally be between 300 and 900 mg per day. The dose may then be increased, as advised by your doctor, up to a maximum of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one in the evening.

If you have kidney problems or if you are on hemodialysis

Your doctor may prescribe a different dosing schedule and/or different doses if you have kidney problems or if you 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 dosing schedule or different doses if you have kidney problems.

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

Method of administration

Gabapentina is taken by mouth. Always swallow the capsules whole with plenty of water.

Continue taking gabapentina until your doctor tells you to stop.

If you take more Gabapentina Stada than you should

Taking more than the recommended dose 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. Take any unused capsules, packaging, and leaflet with you 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 do it. If you are going to stop treatment, it should be done gradually over at least one week.

You should know that you may experience certain side effects, called withdrawal symptoms, after stopping treatment with gabapentina after short or long-term use. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping 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 and unremitting patches with a target or circular shape on the torso, 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 swelling of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• severe skin reactions that require immediate attention, inflammation of the lips and face, 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 the skin or other parts of the body, such as the liver or blood cells. A rash may or may not have appeared when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization.
• breathing difficulties that, if severe, may require urgent medical attention to breathe normally.

Contact your doctor immediately if you experience any of the following symptoms:

• skin rash
• hives
• fever
• inflammation of the glands that does not disappear
• swelling of the lips 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 the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking gabapentina.

• If you are on hemodialysis, inform your doctor if you start to feel muscle pain and/or weakness.

Other adverse effects include:

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

• Viral infection
• Feeling of drowsiness, dizziness, disorientation
• Feeling of fatigue, fever

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

• Pneumonia, respiratory infections, urinary tract infection, ear inflammation, or other infections
• Low white blood cell count
• 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 coordinating, 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
• Swelling of the face, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, tremors
• Difficulty with erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, fractures, abrasions

In addition, in clinical trials in children, the following adverse effects were reported as frequent:

aggressive behavior and spasmodic movements.

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
• Accelerated heart rate
• Swelling that can affect the face, torso, and limbs
• Abnormal blood test results that may indicate liver problems
• Progressive mental damage
• Falling
• Increased blood glucose levels (observed more frequently in patients with diabetes)
• 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 difficulties, shallow breathing (respiratory depression)

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

• Suicidal thoughts
• Developing dependence on gabapentina ("drug dependence")

You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting short- or long-term treatment with gabapentina (see "If you stop treatment with Gabapentina Stada").

After the marketing of gabapentina, the following adverse effects have been reported:

• Decrease in platelets (blood clotting cells)
• Hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and rigidity
• Ringing in the ears
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increased breast tissue, breast enlargement
• Adverse effects after sudden discontinuation of treatment with gabapentina (anxiety, difficulty sleeping, feeling of dizziness, pain, and 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)

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 it 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. Conservation of Gabapentina Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 25°C.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina Stada

• The active ingredient is gabapentina. Each hard capsule contains 300 mg of gabapentina.
• The other components are lactose, cornstarch, and talc. The capsule is composed of titanium dioxide (E 171), yellow iron oxide (E 172), and gelatin.

Appearance of the Product and Package Size

Gabapentina Stada 300 mg are hard gelatin capsules, with a yellow opaque body and cap, containing white powder.

Gabapentina Stada 300 mg capsules are available in blister packs with 90 or 500 (clinical package) hard capsules.

Only some 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

LAMP S. PROSPERO S.P.A.

Via DellaPace, 25/A

41030 San Prospero (Modena)

Italy

or

KERN PHARMA, S.L.

Polígono Ind. Colón II

c/ Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the Last Revision of this Prospectus:December 2022

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/