Package Insert: Information for the User

Gabapentina ratiopharm 300 mg Hard Capsules EFG

Gabapentina ratiopharm belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (chronic pain caused by nerve damage).

The active ingredient of Gabapentina ratiopharm is gabapentin.

Gabapentin is used to treat:

• Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not). The doctor treating you or your child aged 6 years or older will prescribe gabapentin to help treat epilepsy when your current treatment does not fully control the disease. You or your child aged 6 years or older must take gabapentin in combination with current treatment unless otherwise indicated. Gabapentina ratiopharm can also be administered as a single medication in the treatment of adults and children over 12 years old.

• Peripheral neuropathic pain (chronic pain caused by nerve damage).There are various diseases that can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The pain sensation could be described as heat, burning, pulsating pain, stabbing pain, acute pain, spasms, continuous pain, numbness, tingling, and pins and needles, etc.

Do not take Gabapentina ratiopharm

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gabapentina ratiopharm.

• if you have kidney problems, your doctor may prescribe a different dosing regimen.
• if you are on hemodialysis (for waste removal due to renal insufficiency), inform your doctor if you start feeling 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.
• before taking this medicine, inform your doctor if you have ever abused or had dependence on alcohol, prescribed medicines, or illegal drugs; you may have a higher risk of developing dependence 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 self-harm or suicide. If you experience these thoughts at any time, contact your doctor as soon as possible.

Dependence

Some people may develop dependence (need to continue taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina ratiopharm" and "If you interrupt treatment with Gabapentina ratiopharm"). If you are concerned about developing dependence on gabapentin, it is essential 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 the need to take the medicine for longer than prescribed.

- you feel the 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

There have been reports of severe skin reactions associated 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 medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Read the description of these severe symptoms in section 4 of this leaflet“Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious”.

Muscle weakness, sensitivity, or pain, especially if you feel unwell or have a fever, could be due to an abnormal rupture of muscle fibers that may 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 blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Especially, inform your doctor (or pharmacist) if you are taking or have taken recently 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 may increase the effect of Gabapentina ratiopharm. Additionally, the combination of Gabapentina ratiopharm with opioids may cause drowsiness, sedation, decreased breathing, or death.

Antacids for digestion

If you take gabapentin at the same time as antacids containing aluminum or magnesium, the absorption of gabapentin in the stomach may be reduced. It is recommended that this medicine be taken at least two hours after taking an antacid.

Gabapentina ratiopharm

• Gabapentina ratiopharm is not expected to interact with other antiepileptic medicines or oral contraceptives.
• It may interfere with some laboratory tests, so if you need a urine test, inform your doctor or the hospital about what you are taking.

Taking Gabapentina ratiopharm with food and drinks

Gabapentina ratiopharm can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you may be pregnant, inform your doctor immediately to analyze the potential risks that the medicine you are taking may pose to the fetus.
• You should not interrupt your treatment without consulting your doctor first.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist.
• If you are breastfeeding or planning 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 plan to become pregnant or are pregnant or think you may be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is essential not to stop taking your medicine without consulting your doctor first, as this may worsen your condition. The worsening of your epilepsy may put both you and your unborn baby at risk.

In a study reviewing data from women in Nordic countries who took gabapentin in the first 3 months of pregnancy, there was no increased risk of birth 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.

Gabapentin taken during pregnancy may cause withdrawal symptoms in newborns. This risk may be higher when gabapentin is taken concomitantly with opioid analgesics (pain medicines).

Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking Gabapentina ratiopharm. Do not stop taking this medicine abruptly, as this may cause an anticipation of seizures, which could have serious consequences for both you and your baby.

Breastfeeding

Gabapentin, the active ingredient of Gabapentina ratiopharm, passes into breast milk. It is not recommended to breastfeed while taking Gabapentina ratiopharm, as the effect on the baby is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and operating machinery

Gabapentina ratiopharm 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.

Gabapentina ratiopharm 300 mg hard capsules contain lactose.

This medicine contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Do not take a dose of medication higher than the prescribed one.

Your doctor will determine what dose is suitable for you.

Epilepsy, the recommended dose is

Adults and adolescents

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be from 300 to 900 mg per day. From there, the dose can be increased, as indicated by your doctor, up to a maximum dose of 3,600 mg per day, divided into three equal doses, for example, one in the morning, one at noon, and one at night.

Children 6 years or older

Your doctor will decide on the dose to be administered 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 normal dose for controlling epilepsy is 25-35 mg/kg/day. The dose is normally administered by taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, and one at night.

Do not recommend the use of this medication in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules as indicated by your doctor. Normally, your doctor will gradually increase your dose. The initial dose will generally be from 300 to 900 mg per day. From there, the dose can be increased, as indicated by your doctor, up to a maximum dose of 3,600 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 receiving hemodialysis treatment

Your doctor may prescribe a different dosing regimen and/or dose if you have kidney problems or if you are receiving hemodialysis treatment.

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

You should take the normal dose of this medication, except if you have kidney problems. Your doctor may prescribe a different dosing regimen or dose if you have kidney problems.

If you consider that the effect of Gabapentina ratiopharm is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

This medication is administered orally. Swallow the capsules whole with a sufficient amount of water.

Continue taking Gabapentina ratiopharm until your doctor tells you to stop.

If you take more Gabapentina ratiopharm than you should

Doses higher than recommended may cause an increase in adverse 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency unit of the nearest hospital if you take more gabapentina ratiopharm than your doctor prescribed. Bring with you any capsules that you have not taken, along with the packaging and the leaflet, so that the hospital can easily identify the medication you have taken.

If you forgot to take Gabapentina ratiopharm

If you forgot to take a dose, take it as soon as you remember, unless it is time for the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Gabapentina ratiopharm

Do not stop taking this medication suddenly. If you want to stop taking Gabapentina ratiopharm, talk to your doctor first. Your doctor will indicate how to proceed. If you are going to stop treatment, this should be done gradually over a minimum of one week.You should know that you may experience certain adverse effects, called withdrawal syndrome, after interrupting a short or long-term treatment with this medication. Among them are seizures, anxiety, difficulty sleeping, feeling of discomfort (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of discomfort. These effects occur usually within the first 48 hours after interrupting treatment with Gabapentina ratiopharm. If you experience this withdrawal syndrome, contact your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking gabapentin and seek medical attention immediately if you notice any of the following symptoms:

• flat red patches with a target-like appearance or circular patches on the trunk, often with blisters in the center; skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• expanded 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, which may be symptoms of acute pancreatitis (inflammation of the pancreas).
• Gabapentin ratiopharm can cause a severe or potentially life-threatening allergic reaction that may affect the skin or other parts of the body, such as the liver or blood cells. You may or may not have a rash when this type of reaction occurs. This may require stopping Gabapentin ratiopharm or even hospitalization.
• breathing problems that, if severe, may require emergency medical attention to breathe normally.

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
• urticaria
• fever
• inflammation of the glands that does not subside
• swelling of the lips, face, and tongue
• yellow discoloration of the skin or white 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 have a doctor examine you to decide if you should continue taking Gabapentin ratiopharm.

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

Other side effects include:

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

• viral infection
• feeling sleepy, dizziness, discoordination
• feeling tired, fever.

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

• bronchitis, respiratory infection, urinary tract infection, ear inflammation, or other infections
• low white blood cell count
• loss of appetite, 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, numbness, coordination difficulties, 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, hives, rash, acne
• joint pain, muscle pain, back pain, twitching
• erectile dysfunction
• swelling in the legs and arms, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms
• low white blood cell count
• weight gain
• accidents, fractures, bruises.

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common side effects.

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

• agitation (a chronic state of restlessness and involuntary, purposeless movements)
• allergic reactions such as urticaria
• decreased movement
• accelerated heart rate
• difficulty swallowing
• swelling that may affect the face, trunk, and limbs
• abnormal results in blood tests that may indicate liver problems
• progressive mental damage
• falling
• increased blood sugar levels (observed more frequently in patients with diabetes)

Rare: (may affect up to 1 in 1000 people)

• loss of consciousness
• low blood sugar levels (observed more frequently in patients with diabetes)
• breathing difficulties, shallow breathing (respiratory depression)

After the marketing of Gabapentin ratiopharm, the following side effects have been reported:

• decreased platelet count (blood clotting cells)
• suicidal thoughts, hallucinations
• abnormal movements such as contortions, spasmodic movements, and rigidity
• ringing in the ears
• yellow discoloration of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• breast enlargement, breast hypertrophy
• side effects after abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain
• muscle fiber rupture (rhabdomyolysis)
• abnormal results in blood tests (elevated creatine phosphokinase)
• sexual dysfunction, such as inability to achieve 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)
• developing dependence on gabapentin ("drug dependence").

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

Reporting side effects

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

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

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. By doing so, you will help protect the environment.

Composition of Gabapentina ratiopharm

The active ingredient is gabapentin. Each hard capsule contains 300 mg of gabapentin.

The other components (excipients) are: lactose, cornstarch and talc (E553b).See section 2Gabapentina ratiopharm 300 mg hard capsules contain lactose.

The excipients of the cap/ body are: titanium dioxide (E171), yellow iron oxide (E172) and gelatin.

Printing ink: shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide (E525) and ammonium solution

Appearance of the product and contents of the packaging

Gabapentina ratiopharm 300 mg are hard gelatin capsules of yellow color,with “300” and “G” engraved on the cap and on the body of the capsule respectively.

Each package contains 90 capsules and each capsule contains 300 mg of gabapentin.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143-Blaubeuren

Germany

or

Merckle GmbH

Graf Arco Strasse 3

89079 Ulm

Germany

or

Teva Operations Poland SP.Z.O.O.

Ul. Mogilska 80,

31-546 Cracovia

Poland

Last review date of this leaflet:July 2024

Other sources of information:

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/