Egzista

Leaflet attached to the packaging: patient information

Egzysta, 25 mg, hard capsules
Egzysta, 50 mg, hard capsules
Egzysta, 75 mg, hard capsules
Egzysta, 100 mg, hard capsules
Egzysta, 150 mg, hard capsules
Egzysta, 200 mg, hard capsules
Egzysta, 225 mg, hard capsules
Egzysta, 300 mg, hard capsules
pregabalin

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

1. What is Egzysta and what is it used for

Egzysta belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Neuropathic pain of peripheral and central origin:Egzysta is used to treat long-term pain caused by nerve damage. Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain.
Painful sensations can be described as a feeling of heat, burning, pulsation, shooting, stabbing, as sharp pain, cramps, aching, tingling, or numbness. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances, fatigue, which can affect the patient's physical and social functioning and overall quality of life.
Epilepsy:Egzysta is used to treat certain types of epilepsy (partial seizures, which may or may not be secondarily generalized) in adults. The doctor may prescribe Egzysta if the current treatment does not fully control the course of the disease. Egzysta should always be used as an add-on therapy to the currently used treatment. Egzysta should not be used as monotherapy, but always in combination with other antiepileptic drugs.
Generalized anxiety disorder:Egzysta is used to treat generalized anxiety disorder (GAD). GAD symptoms include prolonged, excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, nervousness, or feeling on edge, easy fatigability, difficulty concentrating or feeling of emptiness in the head, irritability, increased muscle tension, or sleep disturbances. Symptoms are different from the stresses and tensions of everyday life.

2. Important information before taking Egzysta

When not to take Egzysta

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

Warnings and precautions

Before starting to take Egzysta, the patient should discuss it with their doctor.

• Some patients taking Egzysta have experienced symptoms suggesting an allergic reaction. These symptoms included swelling of the face, lips, tongue, and throat, as well as a widespread skin rash. If any of these symptoms occur, the patient should contact their doctor immediately.
• Taking Egzysta has been associated with dizziness and drowsiness: this may cause more frequent accidental injuries (falls) in elderly people. Therefore, caution should be exercised until the patient is aware of the possible effects of the medicine.
• Taking Egzysta may cause blurred vision, loss of vision, or other vision disturbances, most of which are transient. If any changes in vision occur, the patient should inform their doctor immediately.
• In patients with diabetes who gain weight during pregabalin treatment, it may be necessary to adjust their antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may also take other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to Egzysta, and the severity of these effects may be greater when such medicines are taken concomitantly.
• There have been reports of heart failure in some patients taking Egzysta; these were mainly elderly patients with cardiovascular disorders . Before taking this medicine, the patient should inform their doctor about any history of heart disease.
• There have been reports of kidney failure in some patients taking Egzysta. If the patient notices a decrease in urine output while taking Egzysta, they should inform their doctor, as stopping the medicine may cause the symptom to resolve.
• A small number of patients taking antiepileptic drugs, such as Egzysta, have had thoughts of self-harm or suicide, or have exhibited suicidal behavior. If the patient has ever had such thoughts or behavior, they should contact their doctor immediately.
• If Egzysta is taken with other medicines that can cause constipation (such as some painkillers), gastrointestinal problems (e.g., constipation, obstruction, or paralysis of the intestines) may occur. The patient should inform their doctor if they experience constipation, especially if they are prone to it.
• Before starting to take this medicine, the patient should inform their doctor if they have ever abused or been dependent on alcohol, prescription drugs, or any illegal psychoactive substances; this may indicate an increased risk of dependence on Egzysta.
• There have been reports of seizures during treatment with Egzysta or shortly after discontinuation of treatment. If seizures occur, the patient should contact their doctor immediately.
• There have been reports of brain function impairment (encephalopathy) in some patients with other diseases who took Egzysta. The patient should inform their doctor about all serious diseases they have had, including liver or kidney disease.
• There have been reports of breathing difficulties. If the patient has nervous system disorders, respiratory disorders, kidney function disorders, or is over 65 years old, the doctor may recommend a different dosing schedule. If the patient experiences breathing difficulties or shallow breathing, they should contact their doctor.
• Pregabalin has been associated with severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If the patient experiences any of the serious skin reactions listed in section 4, they should discontinue pregabalin and seek medical attention immediately.
  Dependence
  Some people may become dependent on Egzysta (need to continue taking the medicine). After stopping Egzysta, withdrawal symptoms (see section 3 "How to take Egzysta" and "Stopping Egzysta") may occur. If the patient is concerned that they may become dependent on Egzysta, they should talk to their doctor.
  If the patient notices any of the following symptoms while taking Egzysta, it may indicate dependence:
  • Need to take the medicine for a longer period than prescribed by the doctor
  • Feeling the need to take a higher dose than prescribed
  • Taking the medicine for reasons other than prescribed
  • Repeatedly attempting to stop or control the use of the medicine without success
  • Feeling unwell after stopping the medicine and feeling better after taking it 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.

  Children and adolescents

  The safety and efficacy of pregabalin in children and adolescents (under 18 years of age) have not been established, so Egzysta should not be used in this age group.

  Egzysta 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.
  Egzysta and some medicines may interact with each other (interactions). Egzysta taken with other sedating medicines (e.g., opioids) may enhance the side effects observed during treatment with these medicines and lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and decreased concentration may increase if Egzysta is taken with medicines containing:

  • oxycodone - (painkiller)
  • lorazepam - (medicine used in anxiety states)
  • alcohol

  Egzysta may be taken with oral contraceptives.

  Egzysta with food, drink, and alcohol

  Egzysta capsules may be taken with or without food.
  The patient should not drink alcohol while taking Egzysta.

  Pregnancy and breastfeeding

  Egzysta should not be taken during pregnancy or breastfeeding, unless the doctor decides otherwise. Taking pregabalin during the first 3 months of pregnancy may cause birth defects in the unborn baby. A study in Scandinavian countries analyzed data from women who took pregabalin during the first 3 months of pregnancy and found birth defects in 6 out of every 100 babies born, whereas in women who were not treated with pregabalin, birth defects occurred in 4 out of every 100 babies born. The reported birth defects involved the face (cleft lip and palate), eyes, nervous system (including the brain), kidneys, and genital organs.
  Women of childbearing age should use effective contraception.
  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.

  Driving and using machines

  Egzysta may cause dizziness, drowsiness, and decreased concentration. The patient should not drive a car, operate complex machines, or perform potentially hazardous activities until they have determined the effect of the medicine on their ability to perform these activities.

  Egzysta contains lactose monohydrate

  If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

  3. How to take Egzysta

  This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. The patient should not take more of the medicine than prescribed.
  The doctor will determine the dose of the medicine that is right for the patient.
  Egzysta is for oral use only.
  Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorder:

  • The patient should take the number of capsules prescribed by their doctor.
  • The recommended dose for the patient will be between 150 mg and 600 mg per day.
  • The doctor will inform the patient whether to take Egzysta twice or three times a day. If taken twice a day, Egzysta should be taken in the morning and evening at the same time every day. If taken three times a day, Egzysta should be taken in the morning, at noon, and in the evening at the same time every day.

  If the patient feels that Egzysta is too strong or too weak, they should inform their doctor or pharmacist.
  Patient over 65 years of age should take Egzysta as prescribed, unless they have kidney problems.
  In patients with impaired renal function, the doctor may decide on a different dosing schedule and/or adjust the dose of the medicine.
  The capsule should be swallowed whole with water.
  Egzysta should be taken for as long as the doctor prescribes, and the treatment can only be stopped on the doctor's advice.

  Taking a higher dose of Egzysta than recommended

  The patient should inform their doctor or go immediately to the nearest hospital emergency department. The patient should take the packaging or bottle of Egzysta with them. After taking a higher dose of Egzysta than recommended, the patient may feel drowsy, confused, agitated, or restless. There have also been reports of seizures and loss of consciousness (coma).

  Missing a dose of Egzysta

  It is important to take Egzysta regularly at the same times every day. If a dose is missed, the patient should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should continue treatment as prescribed. The patient should not take a double dose to make up for the missed dose.

  Stopping Egzysta

  The patient should not stop taking Egzysta suddenly. If the patient wants to stop taking Egzysta, they should first talk to their doctor. The doctor will inform them how to do it.
  If treatment needs to be stopped, it should be done gradually over at least one week.
  The patient should be aware that after stopping short-term or long-term treatment with Egzysta, certain side effects, known as withdrawal symptoms, may occur. These symptoms include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may be more frequent or severe if the patient has taken Egzysta for a longer period. If withdrawal symptoms occur, the patient should contact their doctor.
  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, Egzysta can cause side effects, although not everybody gets them.

  Very common - may affect more than 1 in 10 people:

  Dizziness, drowsiness, headache

  Common - may affect up to 1 in 10 people:

  • Increased appetite
  • Elevated mood, confusion, disorientation, decreased sexual interest, irritability
  • Difficulty concentrating, clumsiness, memory impairment, memory loss, tremors, speech disturbances, tingling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
  • Blurred vision, double vision
  • Dizziness, balance disturbances, falls
  • Dry mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
  • Difficulty achieving an erection
  • Body swelling, including limb swelling
  • Feeling drunk, ataxia
  • Weight gain
  • Muscle spasms, joint pain, back pain, limb pain
  • Sore throat

  Uncommon - may affect up to 1 in 100 people:

  • Loss of appetite, weight loss, low blood sugar, high blood sugar
  • Changes in self-perception, restlessness, depression, agitation, mood swings, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychotic disorders, difficulty thinking, increased sexual interest, sexual problems, including inability to achieve orgasm, delayed ejaculation
  • Changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, nystagmus, decreased reflexes, increased activity, dizziness when standing up, skin hypersensitivity, loss of taste, feeling of burning, tremor when moving, impaired consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
  • Dry eyes, eye swelling, eye pain, decreased eye movements, lacrimation, eye irritation
  • Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure
  • Sudden flushing of the skin of the face, sudden hot flushes
  • Breathing difficulties, feeling of dryness in the nose, feeling of a blocked nose
  • Increased salivation, heartburn, feeling of numbness around the mouth
  • Sweating, rash, chills, fever
  • Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
  • Chest pain
  • Difficulty urinating or painful urination, urinary incontinence
  • Weakness, thirst, chest tightness
  • Changes in blood test results and liver function (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
  • Hypersensitivity, facial swelling, itching, hives, rhinitis, nosebleeds, coughing, snoring
  • Painful menstruation
  • Coldness of hands and feet

  Rare - may affect up to 1 in 1,000 people:

  • Changed sense of smell, feeling of swaying, changed sense of depth, bright vision, loss of vision
  • Dilated pupils, strabismus
  • Cold sweats, throat constriction, tongue swelling
  • Pancreatitis
  • Difficulty swallowing
  • Slow or limited movements
  • Difficulty writing
  • Ascites
  • Fluid in the lungs
  • Seizures
  • Changes in ECG tracing corresponding to heart rhythm disturbances
  • Muscle damage
  • Nipple discharge, breast enlargement, gynecomastia
  • Amenorrhea
  • Kidney failure, decreased urine output, urinary retention
  • Decreased white blood cell count
  • Inappropriate behavior, suicidal behavior, suicidal thoughts
  • Allergic reactions, which may be characterized by difficulty breathing, eye inflammation (keratitis), and severe skin reactions characterized by red, flat, plate-like, or round patches on the torso, often with blisters in their center, peeling of the skin, ulcers in the mouth, throat, nose, genital area, and eyes. The occurrence of such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Jaundice (yellowing of the skin and whites of the eyes)
  • Parkinsonian syndrome, i.e., symptoms similar to Parkinson's disease, such as tremors, slowed movement (decreased ability to move), and stiffness (muscle stiffness)

  Very rare - may affect up to 1 in 10,000 people:

  • Liver failure
  • Hepatitis

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

  • Dependence on Egzysta ("drug dependence")

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

  If the patient experiences swelling of the face or tongue, or if a skin rash with blisters or peeling occurs, they should seek medical attention immediately.

  Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may also take other medicines, e.g., painkillers or muscle relaxants, which have similar side effects to Egzysta, and the severity of these effects may be greater when such medicines are taken concomitantly.
  After the medicine was placed on the market, the following side effect was also reported: breathing difficulties, shallow breathing.

  Reporting side effects

  If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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:
  Jerozolimskie Avenue 181C
  02-222 Warsaw
  tel.: 22 49-21-301
  fax: 22 49-21-309
  Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects will help to gather more information on the safety of the medicine.

  5. How to store Egzysta

  The medicine should be stored out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton after EXP.
  The expiry date refers to the last day of the month stated.
  Store below 30°C. Store in the original packaging to protect from light.
  Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

  6. Contents of the packaging and other information

  What Egzysta contains

  The active substance of the medicine is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, or 300 mg of pregabalin.
  The other ingredients are: lactose monohydrate, cornstarch, talc, gelatin, titanium dioxide (E171),

  • iron oxide black (E172) for 25 mg capsules
  • iron oxide yellow (E172) for 50 mg, 200 mg, 225 mg capsules
  • iron oxide red (E172) for 75 mg, 100 mg, 200 mg, 225 mg, 300 mg capsules,
  • black ink (containing: shellac, iron oxide black (E 172), propylene glycol, ammonia solution, 28% concentration) for 75 mg, 100 mg, 225 mg capsules.

  What Egzysta looks like and contents of the pack

  Egzysta 25 mg, hard capsules
  Hard gelatin capsules, size 4, cap and body: opaque, gray. Capsule contents: white or almost white powder.
  Egzysta 50 mg, hard capsules
  Hard gelatin capsules, size 3, cap and body: opaque, light beige.
  Egzysta 75 mg, hard capsules
  Hard gelatin capsules, size 4, cap: opaque, reddish-brown; body: opaque, white with black inscription "75 mg". Capsule contents: white or almost white powder.
  Egzysta 100 mg, hard capsules
  Hard gelatin capsules, size 3, cap: opaque, reddish-brown; body: opaque, reddish-brown with black inscription "100 mg". Capsule contents: white or almost white powder.
  Egzysta 150 mg, hard capsules
  Hard gelatin capsules, size 2, cap and body: opaque, white. Capsule contents: white or almost white powder.
  Egzysta 200 mg, hard capsules
  Hard gelatin capsules, size 1, cap and body: opaque, caramel.
  Egzysta 225 mg, hard capsules
  Hard gelatin capsules, size 0, cap: opaque, caramel; body: opaque, caramel with black inscription "225 mg". Capsule contents: white or almost white powder.
  Egzysta 300 mg, hard capsules
  Hard gelatin capsules, size 0, cap: opaque, reddish-brown; body: opaque, white. Capsule contents: white or almost white powder.
  Egzysta is available in packs of 14, 20, 28, 50, 56, 98 hard capsules.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Adamed Pharma S.A.
  Pieńków, ul. M. Adamkiewicza 6A
  05-152 Czosnów

  Manufacturer/Importer

  Adamed Pharma S.A.
  ul. Marszałka Józefa Piłsudskiego 5
  95-200 Pabianice
  To obtain more detailed information about the medicine, the patient should contact the local representative of the marketing authorization holder:
  Adamed Pharma S.A.
  Pieńków, ul. M. Adamkiewicza 6A
  05-152 Czosnów

  Date of last revision of the leaflet: 08.2025