GABAPENTINA STRIDES 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentin Strides 100mg Hard Capsules EFG

Gabapentin Strides 300mg Hard Capsules EFG

Gabapentin Strides 400mg Hard Capsules EFG

Gabapentin

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.

Contents of the pack and other information

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

1. What is Gabapentin Strides and what is it used for

This medicine 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 is gabapentin.

Gabapentin Strides 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 this medicine to you or your child aged 6 years or older to help treat epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take this medicine in combination with your current treatment unless told otherwise. This medicine 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 the legs and/or arms), such as diabetes or herpes. The sensation of pain can be described as heat, burning, throbbing, shooting, stabbing, acute, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

2. What you need to know before you take Gabapentin Strides

Do not take Gabapentin Strides

• if you are allergic (hypersensitive) 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 this medicine:

• 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.

Dependence

Some people may become dependent on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin. (See section 3, "How to take Gabapentin Strides" and "If you stop taking Gabapentin Strides"). If you are concerned about becoming dependent on gabapentin, it is important that you talk to 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 longer than prescribed.
• You feel that you need to take a higher dose than recommended.
• You are taking the medicine for reasons other than its prescription.
• 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 take it again.

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

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 being treated with antiepileptics, such as this medicine, have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

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 gabapentin 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 serious symptoms in section 4 of this leaflet,under "Contact your doctor immediately if you experience any of the following symptoms:" as they can be serious.

Muscle weakness, sensitivity, or pain on palpation, and especially if you feel unwell or have a fever, could be due to abnormal muscle fiber breakdown, which can lead to kidney problems and put your life at risk. You may also experience urine discoloration 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 Gabapentin Strides 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 this medicine. Additionally, the combination of this medicine with opioids can cause symptoms such as drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentin Strides

• 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 Gabapentin Strides with food

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, you must tell your doctor immediately and discuss the possible risks that the medicine you are taking may have for your unborn baby.
• Do not stop your treatment without consulting your doctor.
• If you are planning to become pregnant, you should discuss your treatment with your doctor or pharmacist as soon as possible before becoming pregnant.
• If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin can be used during the first trimester of pregnancy if necessary.

If you are planning to become pregnant or are pregnant or think you may be pregnant, talk to your doctor immediately.

If you have become pregnant and have epilepsy, it is important that you do not stop taking your medicine without first talking to your doctor, as this may worsen your condition. Worsening of epilepsy can put you and your fetus at risk.

In a study that reviewed data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of congenital defects or problems with brain development (neurodevelopmental disorders). However, babies of 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 with opioid analgesics (drugs for treating intense pain).

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

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

This medicine may cause dizziness, drowsiness, and fatigue. Do not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medicine affects your ability to perform these activities. Follow your doctor's or pharmacist's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine what dose is suitable for you.

3. How to take Gabapentin Strides

Follow your doctor's or pharmacist's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine what dose is suitable for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules your doctor has told you to. Your doctor will usually gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as your doctor indicates, 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 at night.

Children aged 6 years and over

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

Gabapentin Strides is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules your doctor has told you to. Your doctor will usually gradually increase your dose. The initial dose will generally be 300 to 900 mg per day. From there, the dose may be increased, as your doctor indicates, 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 at night.

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 this medicine, 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 this medicine is too strong or too weak, tell your doctor or pharmacist as soon as possible.

Method of administration

This medicine is taken orally. Always swallow the capsules whole with a sufficient amount of water.

Continue taking this medicine until your doctor tells you to stop.

If you take more Gabapentin Strides 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 Gabapentin Strides than your doctor prescribed. Bring any capsules you have not taken, along with the packaging and the leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentin Strides

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 Gabapentin Strides

Do not stop taking gabapentin suddenly. If you want to stop taking gabapentin, 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 be aware that you may experience certain side effects, called withdrawal syndrome, after stopping treatment with gabapentin at short or long term. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and a general feeling of being unwell. These effects usually occur within the first 48 hours after stopping treatment with gabapentin. 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

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

• Red, target-like or circular patches 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).
• Expanded rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

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

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they can be serious:

• Severe skin reactions that require immediate attention, inflammation 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)
• This medicine 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. This reaction may or may not be accompanied by a rash. It may require discontinuation of this medicine or even hospitalization.
• Breathing difficulties that, if severe, may require urgent medical attention to breathe normally.
• Contact your doctor immediately if you have any of the following symptoms:
• • skin rash
  • hives
  • fever
  • inflammation of the glands that does not disappear
  • swelling of the lips and tongue
  • yellowish color 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 this medicine.

• 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, lack of coordination
• 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 with coordination, unusual eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Increased blood pressure, redness, or dilation of blood vessels
• Breathing difficulties, 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, tremors
• Difficulty with erection (impotence)
• Swelling in the legs and arms, difficulty walking, weakness, pain, feeling of discomfort, flu-like symptoms
• Decreased leukocytes, weight gain
• Accidental injuries, fractures, abrasions

In addition, in clinical trials in children, aggressive behavior and spasmodic movements were reported as frequent 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
• Accelerated heart rate
• Difficulty swallowing
• Swelling that can affect the face, trunk, and extremities
• Abnormal blood test results that may indicate liver problems.
• Progressive mental impairment
• Falling
• Increased blood glucose levels (observed more frequently in patients with diabetes)

Rare: (may affect up to 1 in 1000 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 available data)

• Developing dependence on Gabapentin ("drug dependence")

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

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

• Decrease in platelets (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as contortions, spasmodic movements, and stiffness
• 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 sudden discontinuation of gabapentin treatment (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain
• Muscle fiber rupture (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase)
• Sexual activity problems, 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 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 Gabapentin Strides

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

The medicine should be consumed within 100 days after its first opening. Do not use this medicine after the expiration date shown on the bottle and packaging after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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 Strides

The active ingredient is gabapentin. Each hard capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.

The other components of Gabapentina Strides hard capsules are: Mannitol (E-421), Cornstarch, Talc (E-553b), Magnesium stearate (E-470b)

Capsule shell:

Gelatin (E-441), Titanium dioxide (E-171), Yellow iron oxide (E-172, 300 mg Capsule), Brilliant blue FCF, aluminum salt (E-133, 400 mg Capsule)

Printing ink:

Cap: Shellac (E904) (in blue ink), Carmine, aluminum salt (E-132) (in blue ink), Titanium dioxide (E-171) (in white ink), Ammonia, Propylene glycol

Body: Shellac (E-904), Yellow iron oxide (E-172) (in green ink), Brilliant blue FCF aluminum salt (E-133) (in green ink), Titanium dioxide (E-171) (in white ink), Ammonia, Propylene glycol

Appearance of the product and package contents

Hard capsule.

Gabapentin 100 mg hard capsules EFG: two-piece capsules of white opaque color, which are printed with "S617/100 mg" on the cap with edible blue ink and "" on the body with edible green ink and contain a white to off-white powder. The capsule size is 15.80 mm ± 0.4 mm.

Gabapentin 300 mg hard capsules EFG: two-piece capsules of yellow opaque color, which are printed with "S618/300 mg" on the cap with edible blue ink and "" on the body with edible green ink and contain a white to off-white powder. The capsule size is 19.30 mm ± 0.4 mm.

Gabapentin 400 mg hard capsules EFG: two-piece capsules of blue opaque color, which are printed with "S619/400 mg" on the cap with edible white ink and "" on the body with edible white ink and contain a white to off-white powder. The capsule size is 21.40 mm ± 0.4 mm.

HDPE bottle with a child-resistant white opaque closure or an HDPE cap with a white opaque coating.

The bottle contains 90 and 100 capsules.

Packaged in PVC/PVDV-Al blisters. The blisters are packaged in cardboard boxes.

The blisters contain 50, 100, or 200 capsules

Only some pack sizes may be marketed.

Marketing authorization holder:

Strides Pharma (Cyprus) Limited

Themistokli, Dervi, 3,

Julia House, 1st Floor

Nicosia 1066, Cyprus

Manufacturer:

SANTA S.A.

Str. Panselelor, nr.25, nr. 27, nr. 29

Municipiul Brasov, Judet Brasov,

cod postal 500419,

Romania

Fairmed Healthcare GmbH

Maria-Goeppert-Strasse 3

23562 Lübeck

Germany

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

Date of last revision of this prospectus:

01/2024

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