GABAPENTINA TARBIS 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gabapentina Tarbis 100 mg Hard Capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

This medicine 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 Tarbis is gabapentin.

Gabapentina Tarbis 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. Gabapentin 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, sharp, spasms, continuous, tingling, numbness, and a feeling of pins and needles, etc.

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

Do not take Gabapentina Tarbis

• if you are allergic (hypersensitive) 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 Tarbis

• 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 if you start to feel 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 been dependent on alcohol, prescription drugs, or illegal drugs; you may have a higher risk of developing dependence on Gabapentina Tarbis.

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.

Dependence

Some people may develop dependence (need to continue 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 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 its prescription.
• 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 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

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 immediate medical attention 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 may be serious"

Muscle weakness, tenderness, or pain on palpation, and especially if you feel unwell or have a fever, could 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 Tarbis

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, inform 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 containing opioids (such as morphine), inform your doctor or pharmacist as opioids can increase the effect of gabapentin. Additionally, the combination of gabapentin with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

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

Gabapentina Tarbis

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

Taking Gabapentina Tarbis with food

Gabapentina can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take this medicine during pregnancy, unless your doctor has told you to. An effective contraceptive method should be used in women of childbearing age.

There are no specific studies on the use of gabapentin in pregnant women, but with other medicines used to treat seizures, there have been reports of an increased risk of harm to the developing baby, particularly when more than one medicine is used to treat seizures. Therefore, whenever possible, you should try to take only one medicine for seizures 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 with opioid painkillers.

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

Breastfeeding

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

Fertility

There are no effects on fertility in animal studies.

Driving and using machines

Gabapentina Tarbis may 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 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

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. Your doctor will usually increase your dose gradually. The initial dose will generally be 300 to 900 mg per day. From then on, the dose may be increased, as directed 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. The treatment will begin 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. The dose is usually given by taking the capsules, divided into 3 equal doses per day, usually one in the morning, one at noon, and one in the evening.

Gabapentina Tarbis 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. Your doctor will usually increase your dose gradually. The initial dose will generally be 300 to 900 mg per day. From then on, the dose may be increased, as directed 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 hemodialysis

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

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

Method of administration

Gabapentina Tarbis is taken by mouth. 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 Gabapentina Tarbis than you should

Doses higher than those recommended may cause an increased risk of 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 Tarbis 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 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 Gabapentina Tarbis

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, this 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 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 gabapentin. If you experience this withdrawal syndrome, you should contact your doctor.

If you have any further questions on 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 gabapentin 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).
• Expanded rash, high body temperature, and increased lymph node size (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:

• severe skin reactions that require immediate attention, lip and face inflammation, skin rash, and redness, and/or hair loss (can be symptoms of a severe allergic reaction)
• 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.
• Gabapentin 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 Tarbis or even hospitalization. Contact your doctor immediately if you have any of the following symptoms:

• skin rash
• hives
• fever
• inflammation of the glands that does not disappear
• swelling of the lips and tongue
• yellowish color of the skin or 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 gabapentin.

• 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 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, 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, 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, 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 1,000 people)

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

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

• suicidal thoughts
• developing dependence on gabapentin ("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 (see "If you stop treatment with Gabapentina Tarbis").

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

• decrease in platelets (blood clotting cells)
• hallucinations
• abnormal movement problems 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 treatment with gabapentina (anxiety, difficulty sleeping, feeling of dizziness, pain, and sweating), chest pain
• 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, lip, throat, and tongue swelling, and hypotension that requires urgent treatment)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Gabapentina Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the containers 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 containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Gabapentina Tarbis

The active ingredient is gabapentin.

Each hard capsule contains 100 mg of gabapentin.

The other components are:

Capsule content: Mannitol, pregelatinized starch (from corn), talc

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

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

Appearance of the product and package contents

Hard capsule.

Gabapentina Tarbis 100 mg hard capsules EFG

White to off-white granular powder filled in hard gelatin capsules of size "3" with a white opaque cap printed with "H" in blue and a white opaque body printed with "G1" in blue.

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

Only some package 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 medicine is authorized in the member states of the European Economic Area under the following names:

Germany: Gabapentin Amarox 100 mg hard capsules

Netherlands: Gabapentine Amarox 100 mg, hard capsules

Spain: Gabapentina Tarbis 100 mg hard capsules EFG

Date of the last revision of this prospectus: December 2022

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