Gabapentin Tarbis 400 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gabapentin Tarbis 400 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

The active substance of Gabapentin Tarbis is gabapentin.

Gabapentin Tarbis is used to treat

• Certain types of epilepsy (seizures initially limited to certain parts of the brain, whether or not they spread to other parts of the brain). Your doctor or the doctor treating your child aged 6 years or older may prescribe gabapentin to help treat epilepsy when current treatment does not fully control the condition. You or your child aged 6 years or older should take gabapentin in combination with current treatment unless otherwise instructed. Gabapentin may also be used as monotherapy in the treatment of adults and children over 12 years of age.
• Peripheral neuropathic pain (chronic pain caused by nerve damage). Various diseases can cause peripheral neuropathic pain (mainly in legs and/or arms), such as diabetes or herpes. The sensation of pain may be described as heat, burning, throbbing, shooting, stabbing, sharp pain, cramps, continuous pain, tingling, numbness, and pins and needles, etc.

2. What you need to know before taking Gabapentina Tarbis

Do not take Gabapentina Tarbis

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Gabapentina Tarbis

• if you have kidney problems, your doctor may prescribe a different dosing regimen
• if you are on haemodialysis (to remove waste products due to kidney failure), inform your doctor immediately if you start experiencing muscle pain and/or weakness
• if you develop symptoms such as persistent stomach pain, vomiting, and nausea, notify your doctor immediately, as these may be signs of acute pancreatitis (inflamed pancreas)
• if you have a disorder of the nervous system or a respiratory disorder, or if you are over 65 years of age, your doctor may prescribe a different dose
• 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 Gabapentina Tarbis.

Dependence

Some people may develop dependence (a need to keep taking the medicine) on gabapentin. They may experience withdrawal symptoms when they stop taking this medicine (see section 3, "How to take Gabapentina Tarbis" and "If you stop taking Gabapentina Tarbis"). 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 you need to take the medicine for longer than prescribed
• You feel you 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, but have been unsuccessful
• 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 stop treatment and how to do so safely.

A small number of people being treated with antiepileptic medicines such as gabapentin have experienced thoughts of self-harm or suicide. If you ever have such thoughts, contact your doctor immediately.

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 rash with eosinophilia and systemic symptoms (DRESS). Stop taking gabapentin and seek immediate medical attention 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: “Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may 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 may be life-threatening. You may also experience discoloration of the urine and changes in blood test results (a 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 Tarbis

Tell 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 any medicine containing opioids (such as morphine), inform your doctor or pharmacist, as opioids may increase the effect of gabapentin. In addition, combining gabapentin with opioids may cause drowsiness, sedation, reduced breathing, or death.

Antacids for indigestion

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 gabapentin be taken at least two hours after taking an antacid.

Gabapentina Tarbis

• is not expected to interact with other antiepileptic medicines or with oral contraceptive pills
• may interfere with certain laboratory tests; therefore, if you need a urine test, inform your doctor or hospital about the medicines you are taking

Taking Gabapentina Tarbis with food

Gabapentin may be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or think you might be pregnant, inform your doctor immediately and discuss the possible risks that the medicine you are taking may pose to your unborn baby.
• Do not stop treatment without first discussing it with your doctor.
• If you are planning to become pregnant, discuss your treatment with your doctor or pharmacist as soon as possible, preferably before becoming pregnant.
• If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

If you are planning to become pregnant, if you are pregnant, or think you might be pregnant, consult your doctor immediately.

If you become pregnant and have epilepsy, it is important not to stop taking your medicine without first consulting your doctor, as this could worsen your condition. Worsening epilepsy may pose a risk to both you and your unborn baby.

In a study reviewing data from women in Nordic countries who took gabapentin during the first 3 months of pregnancy, no increased risk of congenital malformations or brain development problems (neurodevelopmental disorders) was observed. However, babies born to 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 concomitantly with opioid analgesics (medicines for the treatment of severe pain).

Contact your doctor immediately if you become pregnant, think you might be pregnant, or plan to become pregnant while taking gabapentin. 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 Tarbis, passes into breast milk. Breastfeeding is not recommended while taking this medicine, as the effect on the infant is unknown.

Fertility

No effects on fertility were observed in animal studies.

Driving and using machines

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

Gabapentina Tarbis 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 Tarbis

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. 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 capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

Children aged 6 years or 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 per kg per day. This dose is normally administered by taking the capsules, divided into three equal doses per day, usually one in the morning, one at midday, and one at night.

The use of Gabapentin Tarbis is not recommended in children under 6 years of age.

Peripheral neuropathic pain, the recommended dose is

Adults

Take the number of capsules your doctor has indicated. Usually, your doctor will gradually increase your dose. The initial dose is generally 300 to 900 mg per day. From there, the dose may be increased, as directed 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 midday, and one at night.

If you have kidney problems or are receiving hemodialysis treatment

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

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 regimen or different doses if you have kidney problems.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist as soon as possible.

Method of administration

Gabapentin Tarbis is administered 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 Tarbis 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount ingested, or go immediately to the nearest hospital emergency unit if you take more Gabapentin Tarbis than prescribed by your doctor. Bring any capsules 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 Gabapentin Tarbis

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 Tarbis

Do not stop taking gabapentin suddenly. If you wish to stop taking gabapentin, speak to your doctor first. Your doctor will advise you on 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, known as withdrawal syndrome, after stopping short- or long-term treatment with gabapentin. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensations, dizziness, and general malaise. These effects usually occur within the first 48 hours after stopping gabapentin treatment. If you experience this withdrawal syndrome, 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-elevated circular patches resembling a target or bullseye rash on the trunk, often with blisters in the center; skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. 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:

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

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

• Gabapentin 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 with this type of reaction. This may require discontinuation of Gabapentina Tarbis or even hospitalization. Contact your doctor immediately if you experience any of the following symptoms:

• Skin rash, redness, and/or hair loss

• Hives

• Fever

• Persistent swelling of the glands

• Swelling of the lips, face, 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.

• 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 infections, urinary tract infection, ear inflammation, or other infections
• Low white blood cell count
• Anorexia, increased appetite
• Irritability, confusion, mood changes, depression, anxiety, nervousness, 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, swollen gums, diarrhea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, jerking movements
• Erectile dysfunction (impotence)
• Swelling in the 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
• Rapid heartbeat
• Difficulty swallowing
• Swelling affecting the face, trunk, and limbs
• Abnormal blood test results that may indicate liver problems
• Progressive mental impairment
• Falls
• 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)

Following the marketing of gabapentin, the following adverse effects have been reported:

Frequency not known: cannot be estimated from the available data

• Decreased platelet count (blood clotting cells)
• Suicidal thoughts, hallucinations
• Abnormal movement problems such as twisting movements, spasmodic movements, and rigidity
• Ringing in the ears
• Yellow appearance of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, incontinence
• Increase in 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 achieve orgasm and delayed ejaculation
• Low sodium levels in the blood
• Anaphylaxis (a severe, potentially life-threatening allergic reaction including difficulty breathing, swelling of lips, throat, and tongue, and hypotension requiring urgent treatment)
• Development of dependence on gabapentin ("drug dependence")
• Worsening of myasthenia gravis (a condition causing muscle weakness)

Please be aware that you may experience certain adverse effects known as withdrawal syndrome after stopping short- or long-term treatment with gabapentin or after reducing the dose.

(See "If you stop taking Gabapentina Tarbis").

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gabapentin Tarbis

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

Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gabapentina Tarbis

The active substance is gabapentin.

Each hard capsule contains 400 mg of gabapentin.

The other components are:

Capsule contents: Mannitol, pregelatinized starch (from maize), talc

Capsule coating: Titanium dioxide (E171), gelatin, sodium lauryl sulfate

Printing ink: Shellac (E904), indigo carmine (E132)

Appearance of the product and contents of the container

Hard capsule.

Gabapentina Tarbis 400 mg hard capsules EFG

White to almost white granular powder filled in size “0” hard gelatin capsules with a white opaque cap printed in blue with “H” and a white opaque body printed in blue with “G3”.

Gabapentina Tarbis is available in blisters containing 20, 30, 50, 90, 100 and 200 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta.

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

Germany: Gabapentin Amarox 400 mg Hartkapseln

Netherlands: Gabapentine Amarox 400 mg, harde capsules

Spain: Gabapentina Tarbis 400 mg cápsulas duras EFG

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

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