Gabapentin Teva-Ratiopharm 800 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Teva-ratiopharm 800 mg film-coated tablets EFG

Contents of the leaflet:

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

1. What Gabapentin Teva-ratiopharm is and what it is used for

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

The active substance in this medicine is gabapentin.

Gabapentin Teva-ratiopharm is used to treat

• certain types of epilepsy (seizures that initially start in specific parts of the brain, whether or not they spread to other areas of the brain). Your doctor or your child's doctor (aged 6 years or older) will prescribe gabapentin to help manage epilepsy when current treatment does not fully control seizures. You or your child aged 6 years or older should take gabapentin in combination with current treatment, unless otherwise instructed by your doctor. Gabapentin Teva-ratiopharm may also be given as monotherapy in the treatment of adults and children over 12 years of age.

• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various conditions can cause peripheral neuropathic pain (mainly in the legs and/or arms), such as diabetes or shingles. The pain may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, muscle cramps, continuous pain, tingling, numbness, or prickling sensations, among others.

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

Do not take Gabapentina Teva-ratiopharm

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

Warnings and precautions

Consult your doctor or pharmacist before taking Gabapentina Teva-ratiopharm

• if you have kidney problems, your doctor may prescribe a different dosage regimen
• if you are on hemodialysis (to remove waste products due to kidney failure), inform your doctor immediately if you begin to experience muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, nausea, contact your doctor immediately, as these 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
• if you suffer from myasthenia gravis (a disease causing muscle weakness), as this medicine may worsen your symptoms
• before taking this medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; you may be at increased risk of developing dependence on gabapentin

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

A small number of people being treated with antiepileptic medicines such as gabapentin have had thoughts of harming themselves or of suicide. If at any time you experience such thoughts, contact your doctor immediately.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking gabapentin or reduce the dose (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 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 different from those for which it was prescribed
• 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 start taking it again

If you notice any of the above, speak with your doctor to determine the best course of treatment for you, including when it is appropriate to discontinue treatment and how to do so safely.

Important information about potentially serious reactions

Serious skin rashes have been reported 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 immediate medical attention if you notice any 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 it could be serious.”

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

Taking Gabapentina Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform 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 conditions.

Medicines containing opioids such as morphine

If you are taking a medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may enhance the effect of Gabapentina Teva-ratiopharm. In addition, the combination of Gabapentina Teva-ratiopharm with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for digestion

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

Gabapentina Teva-ratiopharm

• no interaction with other antiepileptic medicines or with the oral contraceptive pill is expected
• may interfere with certain laboratory tests, so if you require a urine test, inform your doctor or hospital about the medicines you are taking

Taking Gabapentina Teva-ratiopharm with food and drink

Gabapentina Teva-ratiopharm may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take Gabapentina Teva-ratiopharm during pregnancy unless your doctor has specifically instructed you to do so. An effective method of contraception should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but in the case of other medicines used to treat seizures, an increased risk of harm to the developing baby has been reported, particularly when more than one medicine is used simultaneously to treat seizures. Therefore, whenever possible, it is recommended to take only one antiepileptic medicine during pregnancy, and only under the advice of your doctor.

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

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

Breastfeeding

Gabapentin, the active substance in Gabapentina Teva-ratiopharm, is excreted in breast milk. Breastfeeding is not recommended while taking Gabapentina Teva-ratiopharm, as the effect on the infant is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

Gabapentina Teva-ratiopharm may cause dizziness, drowsiness, and fatigue. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know how this medicine affects your ability to perform such tasks.

3. How to take Gabapentina Teva-ratiopharm

Follow exactly the dosing instructions for this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

Your doctor will determine the appropriate dose for you.

Epilepsy, the recommended dose is:

Adults and adolescents

Take the number of tablets your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day.

Therefore, the dose may be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

Children aged 6 years and older

Your doctor will decide the dose for your child based on the child's weight. Treatment will start 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/kg/day. This dose is normally administered by taking tablets, divided into three equal doses per day—usually one in the morning, one at midday, and one at night.

The use of Gabapentina Teva-ratiopharm is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of tablets your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. Therefore, the dose may be increased up to a maximum dose of 3600 mg per day, divided into three equal doses, for example, one in the morning, one at midday, and one at night.

If you have kidney problems or are receiving haemodialysis treatment

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

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

You should take the normal dose of Gabapentina Teva-ratiopharm, unless you have kidney problems. Your doctor may prescribe a different dosing schedule or different doses if you have kidney problems.

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

Method of administration

Gabapentina Teva-ratiopharm is administered orally. Always swallow the tablets with sufficient water.

Continue taking this medicine 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 increase in adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, numbness, and diarrhoea. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested, or go immediately to the nearest hospital emergency department if you take more Gabapentina Teva-ratiopharm than prescribed by your doctor. Bring any tablets you have not taken, together with the packaging and the leaflet, 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 a missed dose.

If you stop taking Gabapentina Teva-ratiopharm

Do not stop taking Gabapentina Teva-ratiopharm suddenly or reduce the dose. If you wish to stop taking Gabapentina Teva-ratiopharm or reduce the dose, speak to your doctor first. Your doctor will advise you on how to proceed. If you are going to stop treatment or reduce the dose, this should be done gradually over a minimum of one week. You should be aware that you may experience certain adverse effects, known as withdrawal syndrome, after stopping short- or long-term treatment with Gabapentina Teva-ratiopharm or after reducing the dose. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping treatment with Gabapentina Teva-ratiopharm or reducing the dose. 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 everyone will experience them.

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

• Red, non-raised, target-shaped or circular patches on the trunk, often with blisters in the center; skin peeling, mouth, throat, nose, genital, and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread 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:

• Severe skin reactions requiring immediate attention, swelling of the lips and face, skin rash and redness, and/or hair loss (these may be signs of a severe allergic reaction)

• Persistent stomach pain, vomiting, and nausea, as these may be symptoms of acute pancreatitis (inflammation of the pancreas)

• Gabapentin ratiopharm may cause a serious or potentially life-threatening allergic reaction affecting the skin or other parts of the body, such as the liver or blood cells. A rash may or may not be present when this type of reaction occurs. This may require discontinuation of Gabapentin ratiopharm or even hospitalization.

• Breathing difficulties that, if severe, may require urgent medical care to maintain normal breathing

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

• Skin rash
• Hives
• Fever
• Persistent gland swelling
• Swelling of the lip 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 early signs of a serious reaction. You should be examined by a doctor to determine whether you should continue taking Gabapentin ratiopharm.

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

Other adverse effects include:

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

• Viral infection,
• drowsiness, dizziness, lack of coordination,
• feeling tired, fever.

Common (may affect up to 1 in 10 people)

• Pneumonia, respiratory infection, urinary tract infection, infection, ear inflammation, or other infections
• low white blood cell count,
• anorexia, increased appetite
• irritability towards others, confusion, mood changes, depression, anxiety, restlessness, difficulty thinking,
• seizures, spasmodic movements, difficulty speaking, memory loss, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation (numbness), coordination problems, 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,
• facial swelling, bruising, rash, itching, acne,
• joint pain, muscle pain, back pain, jerking,
• erection difficulties (impotence),
• swelling in arms and legs, difficulty walking, weakness, pain, feeling unwell, flu-like symptoms,
• decreased leukocytes,
• weight gain,
• accidental injuries, fractures, abrasions.

Additionally, in clinical trials in children, aggressive behavior and spasmodic movements were reported as common 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
• increased heart rate,
• difficulty swallowing
• swelling that may affect the face, trunk, and limbs
• abnormal blood test results that may indicate liver problems
• progressive mental impairment
• fall
• increased blood glucose levels (observed more frequently in patients with diabetes),

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 problems, shallow breathing (respiratory depression)

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

• Suicidal thoughts
• developing dependence on gabapentin (“drug dependence”)

You should be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with Gabapentin Teva-ratiopharm or after reducing the dose (see "If you stop taking Gabapentin Teva-ratiopharm").

Following the marketing of Gabapentin Teva-ratiopharm, the following adverse effects have been reported:

• decreased platelets (blood clotting cells),

• hallucinations,

• movement disorders such as twisting movements, spasmodic movements, and rigidity,

• 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 abrupt discontinuation of gabapentin treatment (anxiety, difficulty sleeping, dizziness, pain, and sweating), chest pain

• muscle fiber breakdown (rhabdomyolysis)

• changes in blood test results (elevated creatine phosphokinase)

• sexual function 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 lips, throat, and tongue, and hypotension requiring urgent treatment)

• worsening of myasthenia gravis (a disease causing muscle weakness).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentin Teva-ratiopharm

The active substance is gabapentin. Each film-coated tablet contains 800 mg of gabapentin.

The other components are: microcrystalline cellulose, copovidone, isopropyl alcohol, crospovidone (type A), talc, magnesium stearate, Opadry II 85F18422 (polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc).

Appearance of the product and pack contents

Gabapentin Teva-ratiopharm 800 mg are film-coated tablets, white to almost white, oval-shaped with bevelled edges. One side is marked with “7174” and the other with “93”. Each pack contains 90 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Manufacturer

TEVA Gyógyszergyár Zrt.

Pallagi út 13

H-4042 Debrecen

Hungary

or

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren (Germany)

or

Teva Pharma B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Date of the most recent revision of this leaflet: April 2026

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66198/P_66198.html