GABAPENTINA TARBIS 400 mg HARD CAPSULES

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

Consult 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, prescribed 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.

A small number of people being treated with antiepileptics such as gabapentin have had thoughts of harming themselves or suicide. If at any time you have these thoughts, 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 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 consult 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 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 is 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 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 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 gabapentina with opioids can cause drowsiness, sedation, decreased breathing, or death.

Antacids for indigestion

If you take gabapentina at the same time as antacids containing aluminum and magnesium, the absorption of gabapentina in the stomach may be reduced. Therefore, it is recommended that gabapentina be taken at least two 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 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 gabapentina 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 you take gabapentina during pregnancy, gabapentina may cause withdrawal symptoms in newborns. This risk may be higher when gabapentina is taken with opioid painkillers. Contact your doctor immediately if you become pregnant, think you may be pregnant, or plan to become pregnant while taking gabapentina. 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

Gabapentina, 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

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again. Do not take more medicine than prescribed.

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 generally 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 over

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, 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 usual dose is administered 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 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 generally 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 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 gabapentina, 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, tell your doctor or pharmacist as soon as possible.

Method of administration

Gabapentina 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 Gabapentina Tarbis 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 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 gabapentina suddenly. If you want to stop taking gabapentina, 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 know that you may experience certain side effects, called withdrawal syndrome, after stopping treatment with gabapentina after short or long-term use. These include seizures, anxiety, difficulty sleeping, feeling unwell (nausea), pain, sweating, tremors, headache, depression, abnormal sensation, dizziness, and general feeling of discomfort. These effects usually occur within the first 48 hours after stopping treatment with gabapentina. 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 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).

• 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 may be serious:

• severe skin reactions that require immediate attention, lip and face inflammation, skin rash, and redness, and/or hair loss (may be symptoms of a severe allergic reaction)
• persistent stomach pain, vomiting, and nausea, as they may be symptoms of acute pancreatitis (inflammation of the pancreas)
• breathing difficulties that, if severe, may require urgent medical attention to breathe normally.
• Gabapentina may 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 may 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 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 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, 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 leukocytes, 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, trunk, 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 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 (see "If you stop treatment with Gabapentina Tarbis").

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

• decrease in platelets (blood clotting cells)
• hallucinations
• problems with abnormal movements such as contortions, spasmodic movements, and stiffness
• 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 abrupt 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 that includes 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 the 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 away through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that 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 gabapentina.

Each hard capsule contains 400 mg of gabapentina.

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 400 mg hard capsules EFG

White to off-white granular powder filled in hard gelatin capsules of size "0" with a white opaque cap printed with "H" in blue and a white opaque body printed with "G3" 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 400 mg Hartkapseln

Netherlands: Gabapentine Amarox 400 mg, hard capsules

Spain: Gabapentina Tarbis 400 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/