GABAPENTINA RATIOPHARM 400 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina ratiopharm 400 mg hard capsules EFG

Contents of the pack:

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

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

Gabapentina ratiopharm 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 ratiopharm 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 epilepsy when your current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with your current treatment unless told otherwise. Gabapentina ratiopharm 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, acute, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

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

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

Talk to your doctor or pharmacist before taking Gabapentina ratiopharm

• if you have kidney problems, your doctor may prescribe a different dosage regimen
• if you are on haemodialysis (to remove waste products due to kidney failure), inform 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 of age, 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 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 antiepileptics, such as gabapentin, have had thoughts of harming themselves 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 stop taking Gabapentina ratiopharm"). 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 developed dependence.

• 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 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 what the best course of treatment is 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 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 these serious 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 on palpation, and especially if you feel unwell or have a fever, may be due to abnormal breakdown of muscle fibers, 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 blood). If you experience any of these signs or symptoms, please contact your doctor immediately.

Other medicines and Gabapentina ratiopharm

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 Gabapentina ratiopharm. Additionally, the combination of Gabapentina ratiopharm with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for digestion

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

Gabapentina ratiopharm

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

Taking Gabapentina ratiopharm with food and drinks

Gabapentina ratiopharm can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• do not stop your treatment without first talking to your doctor.

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, you must tell your doctor immediately.

If you 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 your epilepsy may put both you and your unborn baby 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 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.

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

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

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

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

Gabapentina ratiopharm 400 mg hard capsules contain lactose.

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

3. How to take Gabapentina ratiopharm

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not take more than the prescribed 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. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, 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 the dose to be given to your child based on the child's weight. Treatment will begin with a low initial dose that will be gradually increased over a period of approximately 3 days. The usual dose for controlling epilepsy is 25-35 mg/kg/day. The dose is usually given by taking the capsules, divided into 3 equal doses per day, normally one in the morning, one at noon, and one in the evening.

This medicine is not recommended for children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules that your doctor has told you. Normally, your doctor will gradually increase your dose. The initial dose will usually be 300 to 900 mg per day. From there, the dose may be increased, as indicated by your doctor, 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.

If you have kidney problems or if you are on haemodialysis

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

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 dosage regimen or different doses if you have kidney problems.

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

Method of administration

This medicine is taken by mouth. Always 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 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 ratiopharm than your doctor prescribed. Bring any capsules you have not taken, along with the packaging and leaflet, so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina ratiopharm

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 ratiopharm

Do not stop taking this medicine suddenly. If you want to stop taking Gabapentina ratiopharm, 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 this medicine 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 this medicine. 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

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 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 enlargement of 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 can be serious:

• persistent stomach pain, vomiting, and nausea, as they can be symptoms of acute pancreatitis (inflammation of the pancreas)
• Gabapentina ratiopharm 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 ratiopharm 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 after taking this medicine, as they can be serious:

• skin rash and redness and/or hair loss
• hives
• fever
• inflammation of the glands that does not disappear
• swelling of the lips, face, and tongue
• yellowish color of the skin or the whites of the eyes
• unusual bleeding or bruising
• severe fatigue or weakness
• unexpected muscle pain

• frequent infections

These symptoms can be the first signs of a severe reaction. You should be examined by a doctor to decide if you should continue taking Gabapentina ratiopharm.

• 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, discoordination
• feeling of fatigue, fever.

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

• pneumonia, respiratory infection, 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
• vertigo
• increased blood pressure, reddening 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, 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, torso, and extremities
• abnormal blood test results that may indicate liver problems
• progressive mental damage
• fall
• 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)

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

• decrease in platelets (blood clotting cells)
• suicidal thoughts, hallucinations
• problems with abnormal movements such as contortions, spasmodic movements, and rigidity
• ringing in the ears
• yellowish appearance of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, incontinence
• increase in breast tissue, breast enlargement
• adverse effects after sudden discontinuation of gabapentina treatment (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 that includes difficulty breathing, swelling of the lips, throat, and tongue, and hypotension that requires urgent treatment)
• developing dependence on gabapentina ('drug dependence').

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

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. Conservation of Gabapentina ratiopharm

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 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 down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gabapentina ratiopharm

The active ingredient is gabapentina. Each hard capsule contains 400 mg of gabapentina.

The other components (excipients) are: lactose, cornstarch, and talc (E553b). See section 2 Gabapentina ratiopharm 400 mg hard capsules contain lactose.

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

Printing ink: shellac, black iron oxide (E172), propylene glycol, potassium hydroxide (E525), and ammonia solution.

Appearance of the Product and Package Contents

Gabapentina ratiopharm 400 mg are hard gelatin capsules, orange in color, with "400" and "G" engraved on the cap and body of the capsule, respectively.

Each package contains 90 capsules, and each capsule contains 400 mg of gabapentina.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid

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

Date of the Last Revision of this Prospectus:July 2024

Other sources of information:

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