Gabacol

Leaflet accompanying the packaging: patient information

Gabacol, 100 mg, hard capsules

Gabacol, 300 mg, hard capsules

Gabacol, 400 mg, hard capsules

Gabapentin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Gabacol and what is it used for

Gabacol 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 Gabacol is gabapentin.
Gabacol 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). Gabacol is prescribed to adults and children over 6 years of age as an adjunctive therapy in the treatment of epilepsy when the current treatment does not fully prevent seizures. Gabacol should be taken as an additional medication in the treatment of epilepsy in adults or children over 6 years of age, unless the doctor advises otherwise. Gabacol can also be used as monotherapy (as the only medication) 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 various diseases, such as diabetes or shingles. Patients describe the pain they experience as burning, stinging, pulsating, piercing, stabbing, sharp, similar to muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Gabacol

When not to take Gabacol:

Warnings and precautions

Before starting to take Gabacol, the patient should talk to their doctor or pharmacist:

Dependence

Some people may become dependent on Gabacol (need to continue taking the medicine). After stopping the use of Gabacol, withdrawal symptoms may occur (see section 3 "How to take Gabacol" and "Stopping Gabacol"). If the patient is concerned that they may become dependent on Gabacol, they should consult their doctor.
The occurrence of any of the following symptoms while taking Gabacol may indicate dependence.

• The patient feels that they need to take the medicine for longer than the doctor recommended.
• The patient feels that they need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than prescribed.
• The patient has made multiple, unsuccessful attempts to stop or control the use of the medicine
• After stopping the use of the medicine, the patient feels unwell and feels better after taking the medicine again.

If the patient notices any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when 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, serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). The patient should stop taking gabapentin and seek medical help immediately if they experience any of the symptoms associated with these serious skin reactions described in section 4.
The description of the symptoms can be found in section 4"The patient should stop taking Gabacol and seek medical help immediately if they experience any of the following symptoms”.
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. The patient's urine may change color, and blood test results may change (significant increase in creatine phosphokinase activity in the blood). If the patient experiences such subjective and objective symptoms, they should contact their doctor immediately.

Gabacol and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take.
They should especially tell their doctor (or pharmacist) about all the medicines they are taking or have recently taken for the treatment of 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 Gabacol.
Additionally, concomitant use of Gabacol and opioids may cause drowsiness, sedation, shallow breathing, or death.
Antacids, used to treat heartburn
If Gabacol is taken with antacids containing aluminum and magnesium, the absorption of Gabacol from the stomach may be reduced. Therefore, it is recommended to take Gabacol at least 2 hours after taking an antacid.

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

Gabacol with food

Gabacol can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Gabacol should not be taken during pregnancy, unless the doctor recommends it. Women of childbearing age must use effective contraception.
Although there are no specific studies on the use of gabapentin in pregnant women, there are reports that other antiepileptic drugs increase the risk of harm to the developing child, especially when multiple antiepileptic drugs are used at the same time. Whenever possible, but only in agreement with the doctor, pregnant women should take only one antiepileptic drug.
If the patient took Gabacol during pregnancy, gabapentin may cause withdrawal symptoms in the newborn baby. This risk may be increased if gabapentin is taken with opioid painkillers (medicines used to treat severe pain).
In case of pregnancy, suspected pregnancy, or planning pregnancy while taking Gabacol, the patient should contact their doctor immediately. The patient should not stop taking Gabacol suddenly, as this may lead to the occurrence of withdrawal seizures, which can have serious consequences for both the pregnant woman and her child.
Breastfeeding
Gabapentin, the active substance of Gabacol, passes into breast milk. Since it is not known what effect it has on the breastfed child, breastfeeding is not recommended while taking Gabacol.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Gabacol may cause dizziness, drowsiness, and fatigue. The patient should not drive, operate complex machines, or perform other potentially hazardous activities until they know how the medicine affects their ability to perform such activities.

Gabacol contains sodium

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

3. How to take Gabacol

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not take more medicine than prescribed.
The doctor determines the dose.

Epilepsy - recommended dose

Adults and adolescents
The patient should take the number of capsules recommended by their doctor. The doses are usually increased gradually. The most commonly used initial dose is 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 increased gradually over a period of about 3 days. The commonly used dose to control epilepsy is 25 to 35 mg/kg body weight per day. This dose is usually divided into 3 separate doses, i.e., one capsule (or capsules) is taken daily, usually in the morning, afternoon, and evening.
Gabacol should not be used in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults
The patient should take the number of capsules recommended by their doctor. The doses are usually increased gradually. The most commonly used initial dose is 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 (in the morning, afternoon, and evening).

Use in patients with renal impairment or in patients undergoing hemodialysis

The doctor may recommend a different dosage regimen and/or a different dose of Gabacol in patients with renal impairment or in patients undergoing hemodialysis.

Elderly patients (over 65 years of age)

Elderly patients (over 65 years of age) should take the normally recommended dose of Gabacol, unless they have kidney problems. In patients with kidney problems, the doctor may recommend a different dosage regimen and/or a different dose.
If it seems that the effect of Gabacol is too strong or too weak, the patient should talk to their doctor or pharmacist as soon as possible.

Method of administration

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

Taking a higher dose of Gabacol 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. If the patient takes a higher dose of Gabacol than recommended, they should contact their doctor or go to the nearest hospital emergency department (ER) immediately. In such a situation, the patient should also take all the remaining capsules, packaging, and leaflet, so that the hospital staff knows which medicine was taken.

Missing a dose of Gabacol

If a dose is missed, the patient should take it as soon as possible, unless it is almost time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping Gabacol

The patient should not stop taking Gabacol suddenly. If the patient wants to stop taking Gabacol, they should consult their doctor to discuss how to do it. The patient should stop taking Gabacol gradually, over a minimum period of 1 week. The patient should be aware that after stopping short-term or long-term treatment with Gabacol, certain side effects may occur, known as withdrawal symptoms. These symptoms may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headache, depression, abnormal feelings, dizziness, and general malaise. These symptoms usually occur within 48 hours after stopping Gabacol. If the patient experiences withdrawal symptoms, they should contact their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gabacol can cause side effects, although not everybody gets them.
The patient should stop taking Gabacol and seek medical help immediatelyif they experience any of the following symptoms:

• Red spots resembling a target or round spots on the torso, often with central blisters, peeling 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 the possible serious health consequences, the patient should contact their doctor immediately if they experience any of the following symptoms after taking Gabacol:

• • severe skin reactions requiring immediate medical attention, swelling around the face, skin rash, and redness, and/or hair loss (may be symptoms of a severe allergic reaction)
• • 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
• • Gabacol 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 cases, a rash may occur. This reaction may require hospitalization or stopping Gabacol. The patient should contact their doctor immediately if they experience any of the following symptoms:
• • skin rash
• • hives
• • fever
• • persistent swollen lymph nodes
• • swelling of the lips and tongue
• • yellowing of the skin or whites of the eyes
• • unusual bruising or bleeding
• • severe fatigue or weakness
• • unexpected 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 Gabacol.

• In case of hemodialysis, the patient should inform their doctor about any 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
• fatigue, 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
• loss of appetite, increased appetite
• irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking disorders
• seizures, sudden muscle movements, speech difficulties, 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
• high blood pressure, 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
• facial swelling, bruising, rash, itching, acne
• 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 continuous restlessness and unintentional, purposeless movements)
• allergic reactions, such as hives
• limited mobility
• palpitations
• swelling involving the face, torso, limbs
• abnormal blood test results indicating liver function disorders
• psychiatric disorders
• falls
• increased blood glucose levels (most commonly observed in patients with diabetes)
• difficulty swallowing

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

• loss of consciousness
• low blood glucose levels (most commonly observed in patients with diabetes)
• breathing difficulties, which may be severe and require immediate medical attention

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

• dependence on Gabacol ("drug dependence")

The patient should be aware that after stopping short-term or long-term treatment with Gabacol, certain side effects may occur, known as withdrawal symptoms (see "Stopping Gabacol").

After the marketing of Gabacol, the following side effects have been observed:

• decreased platelet count (blood cells responsible for blood clotting)
• suicidal thoughts, hallucinations
• abnormal movements, such as limb twisting or sudden flexion, muscle stiffness
• 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 (increased creatine phosphokinase activity)
• sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• low sodium levels in the blood
• anaphylactic reactions (severe, life-threatening allergic reactions, including difficulty breathing, lip, throat, and tongue swelling, and low blood pressure, requiring immediate treatment)

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
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 Gabacol

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
PVC/PVDC/Aluminum blisters: Do not store above 30°C.
HDPE bottle and Aluminum/Aluminum blisters: No special storage temperature instructions.
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 Gabacol contains

• The active substance of Gabacol is gabapentin. Each hard capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.
• Other ingredients are: cornstarch, copovidone, poloxamer 407, magnesium stearate
• Capsule shell: gelatin and sodium lauryl sulfate, purified water. The capsule also contains colorants: titanium dioxide (E 171), iron oxide red (E 172) (400 mg capsules), iron oxide yellow (E 172) (300 and 400 mg capsules). The ingredients of the ink are: shellac, propylene glycol, concentrated ammonia solution, indigo carmine (E 132)

What Gabacol looks like and contents of the pack

Gabacol, 100 mg, hard capsules: two-part, white, opaque, gelatin capsules, size 3, length 15.4-16.2 mm, with blue printing "G 100" on the capsule cap, containing white or almost white powder.
Gabacol, 300 mg, hard capsules: two-part, yellow, opaque, gelatin capsules, size 1, length 18.9-19.7 mm, with blue printing "G 300" on the capsule cap, containing white or almost white powder.
Gabacol, 400 mg, hard capsules: two-part, orange, opaque, gelatin capsules, size 0, length 21.0-21.8 mm, with blue printing "G 400" on the capsule cap, containing white or almost white powder.
The capsules are packaged in PVC/PVDC/Aluminum blisters, Aluminum/Aluminum blisters, or HDPE bottles.
Pack sizes:
PVC/PVDC/Aluminum or Aluminum/Aluminum blisters: 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
HDPE bottle: 100 or 500 capsules

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer/importer:

Laboratori Fundacio Dau
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: May 2023