Gabapentin Biion

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.

Gabapentin BIJON (Gabapentin Rivopharm), 100 mg, hard capsules

Gabapentinum
Gabapentin BIJON and Gabapentin Rivopharm are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 BIJON and what is it used for
• 2. Important information before taking Gabapentin BIJON
• 3. How to take Gabapentin BIJON
• 4. Possible side effects
• 5. How to store Gabapentin BIJON
• 6. Contents of the packaging and other information

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

Gabapentin BIJON 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 BIJON is gabapentin.
Gabapentin BIJON is used to treat:

• -various forms of epilepsy (seizures initially limited to specific areas of the brain, which spread to the rest of the brain or not). The doctor prescribes Gabapentin BIJON as an adjunctive therapy for epilepsy when the previously used treatment does not provide complete control over seizures. Gabapentin BIJON should be taken as an additional medicine in the treatment of epilepsy, unless the doctor recommends otherwise. Gabapentin BIJON can also be used as monotherapy in adults and children over 12 years old.
• 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 many different diseases, such as diabetes or shingles. Patients describe the pain they feel as burning, tingling, pulsating, piercing, stabbing, sharp, similar to muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Gabapentin BIJON

When not to take Gabapentin BIJON

if the patient is allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Gabapentin BIJON, the doctor or pharmacist should be consulted.
if the patient has kidney disease, the doctor may recommend a different dosage regimen,
if the patient is undergoing hemodialysis (to remove waste products from the blood due to kidney failure), they should inform their doctor if they experience pain and/or muscle weakness,
if the patient experiences symptoms such as persistent abdominal pain, nausea, and vomiting, they should immediately contact their doctor, as these may be symptoms of acute pancreatitis,
if the patient has neurological disorders, respiratory disorders, or is over 65 years old; the doctor may recommend a different dosage.
There have been reports of abuse and dependence associated with the use of gabapentin after its introduction to the market. If the patient has a history of drug abuse or dependence, they should inform their doctor.
A small number of people taking antiepileptic drugs containing gabapentin have thought about harming themselves or committing suicide. If the patient ever has such thoughts, they should immediately contact their doctor.

Important information about potential serious side effects

A small number of people taking Gabapentin BIJON have experienced allergic reactions or potentially severe skin reactions, which, if left untreated, can develop into more severe symptoms. The patient should be aware of the possibility of these symptoms occurring during treatment with Gabapentin BIJON.
Read the description of these symptoms in section 4 of this leaflet"You should immediately contact your doctor if you experience any of the following symptoms after taking this medicine, as they may be serious".
Muscle weakness, tenderness, or pain, especially when 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 contact their doctor.

Gabapentin BIJON and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should inform 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
Patient taking medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Gabapentin BIJON.
Additionally, concomitant use of Gabapentin BIJON and opioids may cause symptoms such as drowsiness and/or shallow breathing.
Antacids for heartburn
In case of concomitant use of Gabapentin BIJON and antacids containing aluminum and magnesium, the absorption of Gabapentin BIJON from the stomach may be reduced. Therefore, it is recommended to take Gabapentin BIJON at least 2 hours after taking the antacid.

Gabapentin BIJON

• is not expected to interact with other antiepileptic medicines or oral contraceptives.
• may affect the results of some laboratory tests; if a urine test is performed, the doctor or hospital should be informed about the use of this medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Gabapentin BIJON should not be taken during pregnancy unless the doctor recommends it.
Women of childbearing age must use effective contraception.
Although there are no studies evaluating the use of gabapentin in pregnant women, other antiepileptic drugs have been reported to increase the risk of harm to the developing child, especially when multiple antiepileptic drugs are used. Whenever possible, but only in consultation with the doctor, pregnant women should take only one antiepileptic drug.
The patient should not stop taking this medicine suddenly, as this may cause breakthrough seizures, which can have serious consequences for both the pregnant woman and her child.
If the patient becomes pregnant, suspects they are pregnant, or plans to become pregnant while taking Gabapentin BIJON, they should immediately contact their doctor.
Breastfeeding
Gabapentin, the active substance of Gabapentin BIJON, passes into breast milk. Since it is not known what effect this may have on the breastfed child, breastfeeding is not recommended during treatment with Gabapentin BIJON.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Gabapentin BIJON may cause dizziness, drowsiness, and fatigue. The patient should not drive or operate complex machinery until they know how this medicine affects their ability to perform these activities.

3. How to take Gabapentin BIJON

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The dose suitable for the patient is determined by the doctor.

Epilepsy - recommended dose

Adults and adolescents
The patient should take the number of capsules prescribed by their doctor. The dose is usually increased gradually. The most commonly used initial dose is 300-900 mg per day. It can then 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).
Children over 6 years old:
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 3 days. The usual dose of the medicine that controls epilepsy is 25-35 mg/kg body weight per day. The medicine is usually taken in three divided doses, one capsule (or capsules) in the morning, one in the afternoon, and one in the evening.
Gabapentin BIJON is not recommended for use in children under 6 years old.

Peripheral neuropathic pain - recommended dose

Adults
The patient should take the number of capsules prescribed by their doctor. The doctor will gradually increase the dose. The usual initial dose is 300-900 mg per day. It can then be gradually increased to a maximum dose of 3600 mg per day, taken as prescribed by the doctor, in 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or undergoing hemodialysis

In patients with kidney disease or undergoing hemodialysis, the doctor may recommend a different dosage regimen and/or dose.
Patients over 65 years oldshould take Gabapentin BIJON according to the normally recommended dosage regimen, unless they have kidney disease. In patients with kidney disease, the doctor may recommend a different dosage regimen and/or dose.
If the patient feels that the effect of Gabapentin BIJON is too strong or too weak, they should consult their doctor or pharmacist.

Method of administration

Gabapentin BIJON should be taken orally. The capsules should always be swallowed whole, with a large amount of water.
Gabapentin BIJON can be taken with or without food.
Treatment with Gabapentin BIJON should not be stopped unless the doctor recommends it.

Taking a higher dose of Gabapentin BIJON than recommended

Taking higher doses than recommended may cause an increased number of side effects, including loss of consciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. If a higher dose of Gabapentin BIJON than recommended is taken, the patient should immediately contact their doctor or go to the nearest hospital emergency department (ER). They should bring any remaining capsules, packaging, and leaflet so that the hospital staff can immediately know what medicine was taken.

Missing a dose of Gabapentin BIJON

If a dose is missed, it should be taken as soon as remembered, unless it is time for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Gabapentin BIJON

Treatment with Gabapentin BIJON should not be stopped unless the doctor recommends it. The medicine should be discontinued gradually, over a minimum period of 1 week. Stopping treatment with Gabapentin BIJON suddenly or without the doctor's recommendation increases the risk of seizures.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately contact their doctor if they experience any of the following symptoms after taking this medicine, as they may be serious:

• Anaphylactic reactions (severe, potentially life-threatening reactions involving difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure requiring immediate treatment)
• Severe skin reactions requiring immediate medical attention, swelling around the mouth, and face, skin rash, and redness, and (or) hair loss (these may be symptoms of a severe allergic reaction)
• Persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• Gabapentin BIJON may cause severe or life-threatening allergic reactions that can affect the skin or other parts of the body, such as the liver or blood cells. During these reactions, a rash may or may not occur. These symptoms may require hospitalization or discontinuation of Gabapentin BIJON. The patient should contact their doctor if they experience any of the following symptoms:
• Rash
• Hives
• Fever
• Swollen lymph nodes that do not go away
• Swelling of the lips and tongue
• Yellowing of the skin or the whites of the eyes (jaundice)
• Unusual bruising or bleeding
• Extreme fatigue or weakness
• Unusual muscle pain
• Frequent infections
• Breathing problems, which in severe cases may require immediate and intensive therapy to restore normal breathing.

The above symptoms may be the first signs of a severe reaction. The doctor should decide whether to continue treatment with Gabapentin BIJON.

If the patient is undergoing hemodialysis, they should inform their doctor if they experience pain and/or muscle weakness.
Other side effects include:

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

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

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

• Pneumonia, respiratory tract infections, urinary tract infections, infection, ear infection, or other infections
• Decreased white blood cell count
• Lack of appetite, increased appetite
• Irritability towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
• Seizures, sudden muscle movements, speech problems, memory loss, tremors, sleep disturbances, headaches, increased skin sensitivity, numbness, coordination problems, abnormal eye movements, exaggerated, weakened, or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing, or vasodilation
• Shortness of breath, bronchitis, sore throat, cough, dryness in the nose
• Vomiting, nausea, dental problems, gum inflammation, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• Face swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle tremors
• Sexual 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

In addition, in clinical studies in children, aggressive behavior and sudden muscle jerks were frequently reported.

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

• Restlessness (a state of constant restlessness and unintentional, purposeless movements)
• Allergic reactions, e.g., hives
• Decreased mobility
• Rapid heartbeat
• Swelling, which may involve the face, trunk, and limbs
• Abnormal blood test results suggesting liver problems
• Psychiatric disorders
• Falls
• Elevated blood glucose levels (most commonly observed in patients with diabetes)
• Difficulty swallowing

Rare (may affect up to 1 in 1000 people):

• Loss of consciousness
• Low blood glucose levels (most commonly observed in patients with diabetes)
• Breathing problems, shallow breathing (respiratory depression)

After the medicine was placed on the market, the following side effects were reported:

• Decreased platelet count (cells responsible for blood clotting)
• Hallucinations
• Abnormal movements, such as twisting of limbs or sudden jerking and stiffness
• Ringing in the ears
• A syndrome of side effects that may include swollen lymph nodes (isolated, small, swollen lumps under the skin), fever, rash, and liver inflammation occurring at the same time
• Yellowing of the skin and eyes (jaundice), liver inflammation
• Acute kidney failure, urinary incontinence
• Breast tissue enlargement, breast enlargement
• Side effects after sudden discontinuation of gabapentin (anxiety, sleep problems, nausea, pain, excessive sweating), chest pain
• Changes in blood glucose levels in patients with diabetes
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (elevated creatine phosphokinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gabapentin BIJON

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the blister and carton after "EXP:". The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store in the original packaging.
Store blisters in the outer packaging.
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 BIJON contains

• The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin.
• Other ingredients are: Capsule core: talc, maize starch, Capsule shell and body: gelatin, iron oxide black (E 172), titanium dioxide (E 171) Printing ink: shellac, iron oxide black (E 172), propylene glycol

What Gabapentin BIJON looks like and contents of the pack

Hard gelatin capsule with a grey cap and body, filled with a white or off-white powder in small lumps. The cap and body are printed with the numbers "93" and "38".
The pack contains 100 hard capsules.

For more information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Sweden, the country of export:

Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland

Manufacturer:

Laboratoires BTT
ZI de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstrasse 31-35
Frankfurt am Main
Hessen, 60528
Germany

Parallel importer:

BIJON medica, UAB
Jonavos str. 16A
LT-44269 Kaunas
Lithuania

Repackaged by:

UAB “Entafarma”,
Klonėnų vs. 1,
LT-19156 Širvintų r. sav.,
Lithuania
Marketing authorization number in Sweden, the country of export:22045

Parallel import authorization number: 1/22

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

Date of leaflet approval: 04.01.2022