GABAPENTIN 100 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Gabapentin Aurovitas, 100 mg, hard capsules
3. Gabapentin Aurovitas, 300 mg, hard capsules
4. Gabapentin Aurovitas, 400 mg, hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Gabapentin Aurovitas and what is it used for
6. Important information before taking Gabapentin Aurovitas
   1. When not to take Gabapentin Aurovitas
   2. Warnings and precautions
   3. Dependence
   4. Important information about potentially serious reactions
   5. Gabapentin Aurovitas and other medicines
   6. Gabapentin Aurovitas with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy
   9. Breastfeeding
   10. Fertility
   11. Driving and using machines
   12. Gabapentin Aurovitas contains sodium
7. How to take Gabapentin Aurovitas
   1. Epilepsy - recommended dose
   2. Peripheral neuropathic pain - recommended dose
   3. Use in patients with renal impairment or in patients undergoing hemodialysis
   4. Elderly patients (over 65 years of age)
   5. Method of administration
   6. Taking a higher dose of Gabapentin Aurovitas than recommended
   7. Missing a dose of Gabapentin Aurovitas
   8. Stopping Gabapentin Aurovitas
8. Possible side effects
   1. Due to possible serious health consequences, the patient should immediately consult a doctor if any of the following symptoms occur after taking the medicine:
   2. Due to possible serious health consequences, the patient should immediately consult a doctor if any of the following symptoms occur after taking the medicine:
   3. These symptoms may be the first sign of a serious reaction. The doctor should examine the patient and decide whether to continue taking Gabapentin Aurovitas.In case of hemodialysis treatment, the patient should inform their doctor about muscle pain and/or weakness.Other side effects include:Very common (may occur in more than 1 in 10 people):
   4. Common (may occur in up to 1 in 10 people):
   5. Uncommon (may occur in up to 1 in 100 people):
   6. Rare (may occur in up to 1 in 1,000 people):
   7. After the medicine Gabapentin Aurovitas was placed on the market, the following side effects were observed:
   8. Frequency not known (frequency cannot be estimated from the available data):
   9. Reporting side effects
9. How to store Gabapentin Aurovitas
10. Contents of the packaging and other information
    1. What Gabapentin Aurovitas contains
    2. What Gabapentin Aurovitas looks like and contents of the pack
    3. Marketing authorization holder and manufacturer/importer
    4. Marketing authorization holder:
    5. Manufacturer/Importer:
    6. This medicine is authorized for use in the Member States of the European Economic Area under the following names:
    8. Date of last revision of the leaflet: 03/2024

Leaflet accompanying the packaging: information for the user

Gabapentin Aurovitas, 100 mg, hard capsules

Gabapentin Aurovitas, 300 mg, hard capsules

Gabapentin Aurovitas, 400 mg, hard capsules

Gabapentinum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gabapentin Aurovitas and what is it used for
• 2. Important information before taking Gabapentin Aurovitas
• 3. How to take Gabapentin Aurovitas
• 4. Possible side effects
• 5. How to store Gabapentin Aurovitas
• 6. Contents of the packaging and other information

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

Gabapentin Aurovitas belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance of Gabapentin Aurovitas is gabapentin.
Gabapentin Aurovitas is indicated for the treatment of:

• Various forms of epilepsy (seizures that initially occur in specific areas of the brain and spread to the rest of the brain or not). Gabapentin Aurovitas is prescribed to adults and children over 6 years of age as an adjunctive therapy for epilepsy, when previous treatments have not fully prevented seizures. Gabapentin Aurovitas should be taken as an adjunctive therapy for epilepsy in adults or children over 6 years of age, unless the doctor advises otherwise. Gabapentin Aurovitas can also be used as monotherapy in adults and children over 12 years of age.
• Peripheral neuropathic pain (long-lasting pain caused by nerve damage). Peripheral (mainly occurring in the lower and/or upper limbs) neuropathic pain is caused by a variety of diseases such as diabetes or shingles. Patients describe the pain they experience as burning, tingling, pulsating, piercing, stabbing, sharp, similar to muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Gabapentin Aurovitas

When not to take Gabapentin Aurovitas

Warnings and precautions

Before starting to take Gabapentin Aurovitas, the patient should discuss it with their doctor or pharmacist:

• before starting to take this medicine, the patient should tell their doctor if they have ever abused or been dependent on alcohol, prescription drugs, or illegal substances; this may mean that the risk of dependence on Gabapentin Aurovitas is higher.

Dependence

In some people, dependence on Gabapentin Aurovitas (the need for continuous use of the medicine) may develop. After stopping the use of Gabapentin Aurovitas, withdrawal symptoms (see section 3, "How to take Gabapentin Aurovitas" and "Stopping Gabapentin Aurovitas") may occur in them. If the patient is concerned that they may become dependent on Gabapentin Aurovitas, it is essential to consult a doctor.
If, while taking Gabapentin Aurovitas, the patient notices any of the following signs, it may indicate the development of dependence.

• Feeling that they need to take the medicine for longer than prescribed by the doctor
• Feeling that they need to take a higher dose than prescribed
• Taking the medicine for purposes other than prescribed
• Making multiple, unsuccessful attempts to stop or control the use of the medicine
• Feeling unwell after stopping the medicine and feeling better after taking it again

If the patient notices any of the above behaviors, they should talk to their doctor to discuss the best course of treatment for them, including determining when it is appropriate to stop taking the medicine and how to do it safely.
A small number of patients taking antiepileptic drugs, such as gabapentin, have had thoughts of self-harm or suicide. If the patient has ever had such thoughts, they should contact their doctor immediately.

Important information about potentially serious reactions

In connection with the use of gabapentin, severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred. If any of the symptoms associated with severe skin reactions described in section 4 occur, the patient should stop taking gabapentin and immediately consult a doctor.
The description of the symptoms can be found in section 4 of this leaflet under:"Due to possible serious health consequences, the patient should immediately consult a doctor if any of the following symptoms occur after taking the medicine".
Muscle weakness, tenderness, or pain, especially if accompanied by malaise and high fever, may be caused by abnormal muscle fiber breakdown, which can be life-threatening and lead to kidney problems. There may be a change in urine color and changes in blood test results (significantly elevated creatine phosphokinase levels in the blood). If such subjective and objective symptoms occur, the patient should immediately consult a doctor.

Gabapentin Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, recently taken, or plan to take. In particular, the patient should tell their doctor (or pharmacist) about all medicines recently or currently used to treat seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
The patient taking medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Gabapentin Aurovitas.
Additionally, concomitant use of Gabapentin Aurovitas and opioids may cause drowsiness, sedation, shallow breathing, or death.
Antacids for heartburn
In the case of concomitant use of Gabapentin Aurovitas and antacids containing aluminum and magnesium, the absorption of Gabapentin Aurovitas from the stomach may be limited. Therefore, it is recommended to take Gabapentin Aurovitas at least 2 hours after taking the antacid.

• Gabapentin Aurovitas does not interact with other antiepileptic medicines or oral contraceptives,
• it may affect the results of some laboratory tests; in case of a urine test, the patient should inform their doctor or hospital about the medicines they are currently taking.

Gabapentin Aurovitas with food, drink, and alcohol

Gabapentin Aurovitas can be taken with or without food.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or thinks they may be pregnant, they should immediately consult a doctor to discuss the potential risk to the unborn child associated with taking this medicine.
• The patient should not stop taking the medicine without discussing it with their doctor.
• If the patient plans to have a child, they should discuss their treatment with their doctor or pharmacist as soon as possible before becoming pregnant.
• If the patient is breastfeeding or plans to breastfeed, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Gabapentin Aurovitas can be used during the first trimester of pregnancy if necessary.
If the patient plans to become pregnant, is pregnant, or thinks they may be pregnant, they should immediately consult a doctor.
If the patient becomes pregnant and has epilepsy, it is essential not to stop taking the medicine without prior consultation with a doctor, as this may worsen the course of the disease. The severity of epilepsy may pose a risk to the patient and their unborn child.
In a study involving data from Scandinavian women who took gabapentin during the first 3 months of pregnancy, no increased risk of birth defects or developmental problems (neurodevelopmental disorders) was found. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and premature birth.
In case of pregnancy, suspected pregnancy, or planning pregnancy while taking Gabapentin Aurovitas, the patient should immediately consult a doctor. The patient should not suddenly stop taking Gabapentin Aurovitas, as this may lead to the occurrence of withdrawal seizures, which can have serious consequences for both the pregnant woman and her child.
Taking gabapentin during pregnancy may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken with opioid painkillers (medicines used to treat severe pain).

Breastfeeding

Gabapentin, the active substance of Gabapentin Aurovitas, passes into breast milk. Since it is not known what effect it has on the breastfed child, breastfeeding is not recommended while taking Gabapentin Aurovitas.

Fertility

In animal studies, no effect on fertility has been found.

Driving and using machines

Gabapentin Aurovitas may cause dizziness, drowsiness, and fatigue. Until it is known how this medicine affects the patient's ability to drive vehicles, operate complex machines, or perform other potentially hazardous activities, they should refrain from doing so.

Gabapentin Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Gabapentin Aurovitas

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist. The patient should not take more medicine than prescribed.
The dose is determined by a doctor.

Epilepsy - recommended dose

Adults and adolescents:
The patient should take the number of capsules prescribed by their doctor. The doses are usually increased gradually. The most commonly used initial dose is from 300 mg to 900 mg per day.
Then it can be gradually increased according to the doctor's instructions to a maximum dose of 3600 mg per day divided into 3 separate doses (one in the morning, one in the afternoon, and one in the evening).
Children over 6 years of age:
The dose to be given to the child is determined by the doctor based on the child's body weight. Treatment starts with a small initial dose, which is gradually increased over a period of about 3 days. The usual dose of the medicine that controls epilepsy is from 25 to 35 mg/kg body weight per day. This dose is usually given in three separate doses, which means giving the child a capsule (or capsules) daily, usually once in the morning, once in the afternoon, and once in the evening.
Gabapentin Aurovitas is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults:
The patient should take the number of capsules prescribed by their doctor. The doses are usually increased gradually. The most commonly used initial dose is from 300 mg to 900 mg per day.
Then it can be gradually increased to a maximum dose of 3600 mg per day divided into 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or in patients undergoing hemodialysis

The doctor may recommend a different dosing schedule and/or a different dose of the medicine in patients with renal impairment or in patients undergoing hemodialysis.

Elderly patients (over 65 years of age)

They should take the normally recommended dose of Gabapentin Aurovitas, unless they have kidney problems. In the case of patients with kidney problems, the doctor may recommend a different dosing schedule and/or a different dose.
If it seems that the effect of Gabapentin Aurovitas is too strong or too weak, the patient should consult their doctor or pharmacist as soon as possible.

Method of administration

Gabapentin Aurovitas is taken orally. The capsules should be swallowed with a large amount of water.
Gabapentin Aurovitas should not be stopped until the doctor advises it.

Taking a higher dose of Gabapentin Aurovitas than recommended

Taking higher doses than recommended may cause an increased number of side effects, including loss of consciousness, dizziness, double vision, blurred speech, drowsiness, and diarrhea. In case of taking a higher dose of Gabapentin Aurovitas than recommended, the patient should immediately call a doctor or go to the nearest hospital emergency department (ER). In such a situation, the patient should also take all the remaining capsules, packaging, and leaflet, so that the hospital staff knows immediately which medicine was taken.

Missing a dose of Gabapentin Aurovitas

In case of missing a dose, the patient should take it as soon as they remember, unless it is time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping Gabapentin Aurovitas

The patient should not suddenly stop taking Gabapentin Aurovitas. If the patient wants to stop taking Gabapentin Aurovitas, they should first discuss it with their doctor. The doctor will inform the patient how to do it. The medicine should be stopped gradually, over a minimum period of 1 week. After stopping short-term or long-term treatment with Gabapentin Aurovitas, the patient should be aware that certain side effects, so-called withdrawal symptoms, may occur. These symptoms may include seizures, anxiety, sleep disturbances, nausea (nausea), pain, sweating, tremors, headache, depression, feeling abnormal, dizziness, and general malaise. These symptoms usually occur within 48 hours of stopping Gabapentin Aurovitas. If withdrawal symptoms occur, the patient should contact their doctor.
In case of any further doubts about the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to possible serious health consequences, the patient should immediately consult a doctor if any of the following symptoms occur after taking the medicine:

• •red, non-raised, plate-like or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Due to possible serious health consequences, the patient should immediately consult a doctor if any of the following symptoms occur after taking the medicine:

• persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• breathing difficulties, which may require immediate and intensive medical attention to restore normal breathing
• Gabapentin Aurovitas may cause serious or life-threatening allergic reactions, which may affect the skin or other parts of the body, such as the liver or blood cells. In such a reaction, a rash may occur. This reaction may require hospitalization or discontinuation of Gabapentin Aurovitas. The patient should immediately consult a doctor if any of the following symptoms occur:
• skin rash and redness, and (or) hair loss
• hives
• fever
• persistent swollen lymph nodes
• swelling of the lips, face, and tongue
• yellowing of the skin and whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unusual muscle pain
• frequent infections

These symptoms may be the first sign of a serious reaction. The doctor should examine the patient and decide whether to continue taking Gabapentin Aurovitas.

In case of hemodialysis treatment, the patient should inform their doctor about muscle pain and/or weakness.
Other side effects include:

Very common (may occur in more than 1 in 10 people):

• Viral infections
• Drowsiness, dizziness, lack of coordination
• Feeling tired, fever

Common (may occur in up to 1 in 10 people):

• Pneumonia, respiratory tract infections, urinary tract infections, ear infections, or other infections
• Decreased white blood cell count
• Lack of appetite, increased appetite
• Irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking disorders
• Seizures, sudden muscle movements, speech problems, memory loss, tremors, sleep disturbances, headaches, increased skin sensitivity, numbness, coordination disorders, abnormal eye movements, increased, decreased, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing, or vasodilation
• Shortness of breath, bronchitis, sore throat, cough, feeling of dryness in the nose
• Vomiting, nausea, dental problems, gum inflammation, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• Facial swelling, bruising, rash, itching
• Joint pain, muscle pain, back pain, muscle tremors
• Erectile dysfunction (impotence)
• Swelling of the feet and hands, difficulty walking, weakness, pain, malaise, flu-like symptoms
• Decreased white blood cell count, weight gain
• Accidental injuries, bone fractures, skin abrasions

Additionally, in clinical trials in children, aggressive behavior and sudden limb flexion were frequently reported.

Uncommon (may occur in up to 1 in 100 people):

• Restlessness (a state of constant restlessness and unintentional, purposeless movements)
• Allergic reactions, e.g., hives
• Movement restrictions
• Palpitations
• Swelling involving the face, torso, limbs
• Abnormal blood test results indicating liver function disorders
• Psychiatric disorders
• Falls
• Elevated blood glucose levels (most commonly observed in patients with diabetes)
• Difficulty swallowing

Rare (may occur in up to 1 in 1,000 people):

• Loss of consciousness
• Low blood glucose levels (most commonly observed in patients with diabetes)

After the medicine Gabapentin Aurovitas was placed on the market, the following side effects were observed:

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

• Decreased platelet count (blood cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Abnormal movements, such as twisting of limbs or sudden flexion
• Ringing in the ears
• Yellowing of the skin and whites of the eyes (jaundice), liver inflammation
• Acute kidney failure, urinary incontinence
• Breast tissue growth, breast enlargement
• Side effects after sudden stopping of gabapentin (anxiety, sleep disturbances, nausea, pain, excessive sweating), chest pain
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase levels)
• Sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood
• Anaphylactic reactions (severe, life-threatening allergic reactions, including breathing difficulties, swelling of the lips, throat, and tongue, and low blood pressure, requiring immediate treatment)
• Development of dependence on Gabapentin Aurovitas ("drug dependence")

After stopping short-term or long-term treatment with Gabapentin Aurovitas, the patient should be aware that certain side effects, so-called withdrawal symptoms (see "Stopping Gabapentin Aurovitas"), may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gabapentin Aurovitas

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiration date stated on the box and blister after: EXP.
The expiration date refers to the last day of the specified month.
Store at a temperature below 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gabapentin Aurovitas contains

• The active substance of Gabapentin Aurovitas is gabapentin. Each hard capsule contains 100 mg of gabapentin. Each hard capsule contains 300 mg of gabapentin.

Each hard capsule contains 400 mg of gabapentin.

• Other ingredients are: Capsule contents: cornstarch and talc. Capsule shell: 100 mg: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water. 300 mg: yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water. 400 mg: red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water. Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.

What Gabapentin Aurovitas looks like and contents of the pack

Hard capsule
Gabapentin Aurovitas, 100 mg, hard capsules:
White - white, size "3", hard gelatin capsules with the imprint "D" on the white cap and "02" on the white body, printed with black edible ink, containing a white or almost white, crystalline powder.
Gabapentin Aurovitas, 300 mg, hard capsules:
Yellow - yellow, size "1", hard gelatin capsules with the imprint "D" on the yellow cap and "03" on the yellow body, printed with black edible ink, containing a white or almost white, crystalline powder.
Gabapentin Aurovitas, 400 mg, hard capsules:
Orange - orange, size "0", hard gelatin capsules with the imprint "D" on the orange cap and "04" on the orange body, printed with black edible ink, containing a white or almost white, crystalline powder.
Gabapentin Aurovitas capsules are available in blister packs of transparent PVC/PVDC/Aluminum. Pack sizes: 20, 30, 60, 90, and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13 D lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Malta:
Gabapentin Aurobindo 100 mg/300 mg capsules, hard
Poland:
Gabapentin Aurovitas
Portugal:
Gabapentina Aurovitas
Spain:
Gabapentina Aurovitas 300 mg/400mg cápsulas duras EFG

Date of last revision of the leaflet: 03/2024