Gabapentin bijon

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.
Gabapentin BIJON (Gabapentin Rivopharm), 300 mg, hard capsules
Gabapentinum
Gabapentin BIJON and Gabapentin Rivopharm are different brand names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Gabapentin BIJON is and what it is 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 pack and other information

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

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

• various forms of epilepsy (epileptic seizures initially localized in specific areas of the brain, which may spread to the rest of the brain or not). Your doctor prescribes Gabapentin BIJON as an add-on treatment for epilepsy when previous treatment has not fully controlled seizures. Gabapentin BIJON should be taken as an additional medicine in epilepsy treatment, unless otherwise directed by your doctor. Gabapentin BIJON may 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 pain (occurring mainly in the lower and/or upper limbs) is caused by various diseases, such as diabetes or shingles. Patients describe this pain as burning, stinging, pulsating, shooting, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important information before using Gabapentin BIJON

When not to use Gabapentin BIJON
if the patient is allergic to gabapentin or to any of the other ingredients of this
medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Gabapentin BIJON, discuss this with your doctor or
pharmacist.

• if the patient has kidney disease, the doctor may recommend a different dosing regimen;
• if the patient is undergoing haemodialysis (to remove metabolic waste products due to kidney failure), inform the doctor if pain and/or muscle weakness occur;
• if the patient experiences symptoms such as persistent abdominal pain, nausea and vomiting, contact the doctor immediately, as these may be signs of acute pancreatitis;
• if the patient has neurological disorders, respiratory disorders, or is over 65 years of age, the doctor may recommend a different dosage.

Cases of misuse and dependence have been reported following post-marketing use of gabapentin. If the patient has a history of drug abuse or dependence, this should be reported to the doctor.

A small number of people taking antiepileptic medicines containing gabapentin have had thoughts of harming themselves or taking their own life. If such thoughts ever occur, contact the doctor immediately.

Important information about potentially serious side effects
A small number of people taking Gabapentin BIJON have experienced allergic reactions or potentially severe skin reactions, which, if untreated, may progress to more serious symptoms. The patient should be aware of the possibility of such symptoms occurring during treatment with Gabapentin BIJON.

Please read the description of the above symptoms in section 4 of this leaflet: “Contact your doctor immediately if any of the following symptoms occur 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 breakdown of muscle fibres, a condition that may be life-threatening and lead to kidney problems. Changes in urine colour and changes in blood test results (markedly increased blood creatine kinase levels) may occur. If such subjective or objective symptoms occur, contact the doctor immediately.

Gabapentin BIJON and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take. In particular, inform the doctor (or pharmacist) about all medicines currently or recently used for the treatment of seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.

Medicines containing opioids, such as morphine
Patients 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 respiratory depression.

Antacids used for indigestion
When Gabapentin BIJON is taken together with antacids containing aluminium and magnesium, absorption of Gabapentin BIJON from the stomach may be reduced. It is therefore recommended to take Gabapentin BIJON at least two hours after taking an antacid.

Gabapentin BIJON

• is not expected to interact with other antiepileptic medicines or with oral contraceptives.
• may affect the results of certain laboratory tests; if undergoing urine testing, inform the doctor or hospital of its use.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Gabapentin BIJON should not be taken during pregnancy unless otherwise advised by a doctor.
Women of childbearing potential must use an effective method of contraception.
Although no studies have evaluated the use of gabapentin in pregnant women, increased risk of harm to the developing foetus has been reported with other antiepileptic medicines, particularly when several antiepileptic medicines are used together. Whenever possible, and only in consultation with the doctor, pregnant women should take only one antiepileptic medicine.
Do not stop taking this medicine suddenly, as this may trigger breakthrough seizures, which may have serious consequences for both the pregnant woman and her unborn child.
If pregnancy occurs, is suspected, or is planned while taking Gabapentin BIJON, contact the doctor immediately.

Breastfeeding
Gabapentin – the active substance in Gabapentin BIJON – passes into breast milk. Since its effect on the breastfed infant is unknown, breastfeeding is not recommended during treatment with Gabapentin BIJON.

Fertility
Animal studies have not shown any effect of the medicine on fertility.

Driving and operating machinery
Gabapentin BIJON may cause dizziness, drowsiness and fatigue. Until the patient knows how this medicine affects their ability to drive, operate complex machinery or perform other potentially hazardous activities, such activities should be avoided.

Gabapentin BIJON 300 mg hard capsules contain Orange Yellow FCF (E 110)
This medicine may cause allergic reactions.

3. How to use Gabapentin BIJON

This medicine should always be used exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.

Epilepsy – recommended dose
Adults and adolescents:
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually.
The usual initial dose is 300 to 900 mg per day. This may then be gradually increased up 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 aged 6 years and older:
The dose to be administered to a child will be determined by the doctor based on the child's body weight.
Treatment starts with a low initial dose, which is gradually increased over a period of 3 days.
The usual effective dose for controlling epilepsy is generally 25 to 35 mg/kg body weight/day.
The medicine is usually taken in three divided doses daily – 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 of age.

Peripheral neuropathic pain – recommended dose
Adults:
Take the number of capsules as prescribed by your doctor. Your doctor will gradually increase the dose.
The usual initial dose is 300 to 900 mg per day. This may then be gradually increased up to a maximum dose of 3600 mg per day, taken as directed by your doctor, in 3 divided doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or undergoing hemodialysis
For patients with kidney disease or those undergoing hemodialysis, your doctor may recommend a different dosing schedule and/or a different dose.

Elderly patients (over 65 years of age) should take Gabapentin BIJON according to the normally recommended dosing schedule, unless they have kidney disease. In patients with kidney disease, the doctor may recommend a different dosing schedule and/or a different dose.

If you feel that the effect of Gabapentin BIJON is too strong or too weak, consult your doctor or pharmacist.

Method of administration
Gabapentin BIJON should be taken orally. The capsules must always be swallowed whole, with a large amount of water.

Gabapentin BIJON may be taken with or without food.

Do not stop taking Gabapentin BIJON unless instructed to do so by your doctor.

Taking more Gabapentin BIJON than recommended
Taking more than the recommended dose may increase the risk of adverse effects, including loss of consciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhoea.
If you have taken more Gabapentin BIJON than recommended, contact your doctor or go immediately to the nearest hospital emergency department (A&E).
Take any remaining capsules, the packaging, and the leaflet with you so that hospital staff can immediately identify which medicine has been taken.

If you miss a dose of Gabapentin BIJON
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose.
Do not take a double dose to make up for a missed dose.

Stopping Gabapentin BIJON
Do not stop taking Gabapentin BIJON unless your doctor tells you to. The medicine should be discontinued gradually over a period of at least 1 week.
Stopping Gabapentin BIJON suddenly or before your doctor advises may increase the risk of seizures.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if any of the following symptoms occur after taking this medicine,
as they may be serious:

• Anaphylactic reactions (severe, potentially life-threatening reactions including breathing difficulties, swelling of the lips, throat and tongue, and hypotension 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 affecting the skin or other parts of the body such as the liver or blood cells. During such reactions, a rash may or may not appear. The above symptoms may require hospitalization or discontinuation of Gabapentin BIJON treatment. You should contact your doctor if any of the following symptoms occur:
  • Rash
• Urticaria
• Fever
• Persistent swelling of lymph nodes
• Swelling of lips and tongue
• Yellowing of the skin or sclera (whites) of the eye
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected 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 early signs of a serious reaction. Your doctor should decide whether continued treatment with Gabapentin BIJON is necessary.
If the patient is undergoing hemodialysis, inform the doctor if muscle pain and (or)
weakness occurs.
Other adverse reactions include:
Very common (may occur in more than 1 in 10 people):

• Viral infections
• Somnolence, dizziness, lack of coordination
• Feeling of fatigue, fever

Common (may occur in no more than 1 in 10 people):

• Pneumonia, respiratory tract infections, urinary tract infections, infection, ear infection or other infections
• Decreased white blood cell count
• Loss of appetite, increased appetite
• Irritability towards others, confusion, mood swings, depression, anxiety, restlessness, difficulty thinking
• Seizures, sudden muscle movements, speech problems, memory loss, tremor, sleep disturbances, headache, increased skin sensitivity, reduced sensation (numbness), coordination disorders, unusual eye movements, exaggerated, weakened or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dryness in nose
• Vomiting, nausea, dental problems, gingivitis, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• Facial swelling, bruising, rash, itching, acne
• Joint pain, muscle pain, back pain, muscle twitching
• Erectile dysfunction (impotence)
• Swelling of hands and feet, 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 jerking movements were commonly reported.
Uncommon (may occur in no more than 1 in 100 people):

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

Rare (may occur in no more than 1 in 1000 people):

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

Adverse reactions reported after marketing authorization of the medicine:

• Decreased platelet count (cells responsible for blood clotting)
• Hallucinations
• Abnormal movements such as limb twisting, sudden jerking and stiffness
• Tinnitus
• A syndrome of adverse reactions which may include enlarged lymph nodes (isolated, small, enlarged lumps under the skin), fever, rash and hepatitis occurring simultaneously
• Yellowing of the skin and eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue enlargement, breast enlargement
• Adverse reactions following abrupt 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 (increased creatine phosphokinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low sodium levels in blood.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Gabapentin BIJON

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton
after "EXP:". The expiry date refers to the last day of the specified month.
Do not store above 25°C. Store in the original packaging.
Keep blisters in the outer packaging.
Medicines should not be disposed of via sewage or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Gabapentin BIJON contains

• The active substance is gabapentin. Each hard capsule contains 300 mg of gabapentin.
• The other ingredients are:
  Capsule core: talc, pregelatinized starch, corn starch
  Capsule cap and body: gelatin, erythrosine (E 127), orange yellow FCF (E 110), titanium dioxide (E 171)
  Printing ink: shellac, black iron oxide (E 172), propylene glycol

What Gabapentin BIJON looks like and contents of the pack
A hard gelatin capsule with an orange cap and body, filled with white or almost white powder forming small aggregates. Numbers "93" and "39" are printed on the cap and body. The pack contains 100 hard capsules.

For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
UAB “Entafarma”,
Klonėnų vs. 1,
LT-19156 Širvintų r. sav.,
Lithuania

Marketing authorisation number in Sweden, the country of export: 22046
Parallel import authorisation number: 4/22
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names: