GABAPENTINA TEVA-RATIOPHARM 400 mg HARD CAPSULES

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

Do not take Gabapentina Teva-ratiopharm

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking gabapentin

• if you have kidney problems, your doctor may prescribe a different dosing schedule.
• if you are on haemodialysis (to remove waste products due to kidney failure), tell your doctor if you experience muscle pain and/or weakness.
• if you develop symptoms such as persistent stomach pain, feel sick or being sick, contact your doctor immediately, as these can 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, prescribed drugs, or illegal drugs; you may have a higher risk of developing dependence on gabapentin.

Dependence

Some people may develop dependence (need to keep taking the medicine) on gabapentin. They may have withdrawal symptoms when they stop taking gabapentin (see section 3, "How to take Gabapentina Teva-ratiopharm" and "If you stop taking Gabapentina Teva-ratiopharm"). If you are concerned about developing dependence 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 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 what it was prescribed for.
• 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 is the best course of treatment for you, including when it is appropriate to stop treatment and how to do it safely.

A small number of people taking antiepileptics, such as gabapentin, have had thoughts of harming themselves or suicide. If at any time you have these thoughts, contact your doctor immediately.

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 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 can be serious".

Muscle weakness, tenderness, or pain and especially if you feel unwell or have a fever, could be due to an abnormal breakdown of muscle tissue that 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.

Other medicines and Gabapentina Teva-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 medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric disorder.

Medicines containing opioids such as morphine

If you are taking any medicines that contain 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, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentina Teva-ratiopharm

• It is not expected to 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 gabapentin.

Taking Gabapentina Teva-ratiopharm 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 to assess the possible risks that the medicine you are taking may have on the fetus.
• Do not stop your treatment without first talking to your doctor.
• If you are planning to become pregnant, you should evaluate your treatment as soon as possible with your doctor or pharmacist before becoming pregnant.
• If you are breastfeeding or planning to breastfeed, ask your doctor or pharmacist for advice 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, consult 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 can worsen your condition. Worsening of your epilepsy can 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.

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

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).

Breastfeeding

Gabapentin, the active substance in this medicine, passes into breast milk. Breastfeeding is not recommended while taking gabapentin, as its effect on newborns is unknown.

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina Teva-ratiopharm can 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 Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Gabapentina Teva-ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with 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 to. Normally, your doctor will gradually increase your dose. The initial dose will generally be between 300 and 900 mg per day. From then on, the dose may be increased, under medical supervision, up to a maximum dose of 3600 mg per day, divided into three separate doses, for example, one in the morning, one at noon, and one in the evening.

Use in children

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 begin with a low initial dose that 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 given by taking the capsules, divided into 3 separate doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentin is not recommended for use 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. Normally, your doctor will gradually increase your dose. The initial dose will generally be between 300 and 900 mg per day. From then on, the dose may be increased, under medical supervision, 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 receiving haemodialysis treatment

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

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

You should take the normal dose of gabapentin, 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

Gabapentina Teva-ratiopharm is taken by mouth.

Always swallow the capsules whole with a sufficient amount of water.

Gabapentina Teva-ratiopharm can be taken with or without food.

Continue taking gabapentin until your doctor tells you to stop.

If you take more Gabapentina Teva-ratiopharm than you should

Doses higher than those recommended may cause an increased risk of side effects, including loss of consciousness, dizziness, double vision, difficulty speaking, numbness, and diarrhea.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone: 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 than your doctor prescribed. Bring any remaining capsules, the packaging, and the leaflet with you so that the hospital can easily identify the medicine you have taken.

If you forget to take Gabapentina Teva-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 Teva-ratiopharm

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 symptoms, after stopping treatment with gabapentin after short or long-term use. 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 other 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 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).

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)
• breathing difficulties that, if severe, may require urgent medical attention to breathe normally
• 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. It may or may not have appeared as a rash when this type of reaction occurs. This may require discontinuing gabapentina or even hospitalization. Contact your doctor immediately if you have any of the following symptoms:

• 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
• yellowing of the skin or the whites of the eyes
• bruises or unusual bleeding
• 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.

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

Other adverse effects include

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

• viral infection
• feeling of drowsiness, dizziness, discoordination
• feeling of fatigue, fever

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

• 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, jerks, difficulty speaking, memory loss, tremors, difficulty sleeping, headache, skin sensitivity, decreased sensitivity (numbness), difficulty with coordination, unusual eye movements, increased, decreased, or absent reflexes
• blurred vision, double vision
• vertigo
• increased blood pressure, redness, or dilation of blood vessels
• difficulty breathing, bronchitis, sore throat, cough, dry nose
• vomiting (feeling nauseous), nausea (feeling dizzy), 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, spasms
• 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

Additionally, in clinical trials in children, the following frequent adverse effects were reported:

sudden movements and aggressive behavior

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

• agitation (a state of chronic restlessness and involuntary, purposeless movements).
• allergic reaction such as hives.
• decreased movement.
• accelerated heart rate
• difficulty swallowing
• swelling that can affect the face, trunk, and extremities
• abnormal blood test results suggesting liver problems.
• progressive mental damage
• falls
• increased blood glucose levels (observed more frequently in patients with diabetes)

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

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

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

• decreased platelet count (blood clotting cells)
• suicidal thoughts, hallucinations
• problems with abnormal movements 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.
• muscle fiber rupture (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).
• 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 Teva-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 does not appear 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 Teva-ratiopharm

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.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in 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 the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina Teva-ratiopharm

• The active ingredient is gabapentina.

Each hard capsule contains 400 mg of gabapentina.

• The other components are:

Capsule content: cornstarch, mannitol (E421), talc (E553b)

Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), purified water, sodium lauryl sulfate.

Printing ink:

Black printing ink: shellac (E904), black iron oxide (E172)

Product appearance and package contents.

Hard capsules (approximately 22 mm in length), with an orange opaque body and marked with TV 3496 in black and a light brown cap marked with TV 3496 in black.

It is available in blisters containing 20, 30, 50, 60, 90, 100, or 200 hard capsules, in pre-cut unit-dose blisters containing 20x1, 30x1, 50x1, 60x1, 90x1, 100x1, or 200x1 hard capsules, or in bottles with 50, 100, or 200 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva Operations Poland Sp. z.o.o,

ul. Mogilska 80. 31-546,

Krakow, Poland

or

Teva Nederland BV

Swensweg 5,

2031 GA Haarlem

Netherlands

Local representative:

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus: December 2024

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/XXXXX/P_XXXXX.html